Royal Decree 832/2014 of 3 October, establishing the title of Superior Technician in the Manufacture of Pharmaceutical, Biologological and Purposes Products and fixing its minimum teachings, acts in accordance with the Royal Decree Decree 1147/2011 of 29 July 2011 laying down general arrangements for the vocational training of the education system, as defined in Article 9 of the structure of vocational training qualifications and courses of specialisation, based on the National Catalogue of Professional Qualifications, the guidelines laid down by the European Union and other aspects of social interest and plant the said title of Manufacture of Pharmaceutical, Biotech and Purposes Products.

Organic Law 2/2006, of 3 May, of Education, provides that educational administrations will develop the curriculum of vocational training diplomas, starting with the basic curriculum and under the conditions laid down in the Article 6a 4. The teaching centres shall develop and complete, where appropriate and as established by the educational authorities, the curriculum of the different stages and cycles in use of their autonomy as set out in Chapter II of Title V of the said Directive. Organic Law.

Royal Decree 832/2014 of 3 October, in its First Derogation Provision, repeals Royal Decree 1069/1993 of 2 July 1993 establishing the curriculum of the higher education cycle corresponding to the title of the Superior Technician in Manufacturing of Pharmaceutical Products, Bitechnologicals and Aends, established under the Organic Law 1/1990 of 3 October, of General Ordination of the Educational System.

In accordance with the above and once the Royal Decree 832/2014, of October 3, has set the professional profile of the title of Superior Technician in Manufacturing of Pharmaceutical Products, Biologicals and Aends, the aspects (a) basic curriculum and other aspects of academic management which ensure a common training and ensure the validity of diplomas throughout the national territory, it is now appropriate to determine, in the field of management of the Ministry of Education, Culture and Sport, the extension and contextualization of the contents of the professional modules included in this title, respecting the professional profile of the same. "Pharmaceutical product" means, in the framework of this order, all "medicinal products and medical devices" which are classified as such in the legislation in force in this field.

The needs of an integrated labour market in the European Union require that vocational training courses pay particular attention to the languages of the Member States, incorporating them into their training offer. In this sense, this formative cycle incorporates in the curriculum training in the English language, in response to the provisions of Royal Decree 1147/2011, of July 29.

addition, the curriculum of this training cycle is established from the respect of the pedagogical, organizational and management autonomy of the centers that provide professional training, promoting these the work in the team of the teachers and the development of training, research and innovation plans in their teaching field and actions to promote the continuous improvement of training processes.

On the other hand, vocational training centres will develop the curriculum established in this order, taking into account the characteristics of pupils, with particular attention to the needs of people with disability.

Finally, it should be specified that the curriculum of this formative cycle integrates the scientific, technological and organizational aspects of the teachings established to achieve that the students acquire an overall view of the processes own production of the professional profile of the top technician in the manufacture of pharmaceutical, bio-technical and Finnish products.

In the process of drafting this order, the State School Board has issued a report.

For all of the above, in its virtue, I have:

CHAPTER I

General provisions

Article 1. Object.

This order is intended to determine, from the basic curriculum set out in Royal Decree 832/2014 of 3 October, establishing the title of Superior Technician in Manufacturing of Pharmaceutical Products, Biotechnologicals and Aends and their minimum teachings are set, the curriculum of the higher grade training cycle corresponding to the aforementioned title.

Article 2. Scope.

The curriculum established in this order will be applied in the territorial area of management of the Ministry of Education, Culture and Sport.

CHAPTER II

Curriculum

Article 3. Curriculum.

1. The curriculum for the vocational training of the educational system corresponding to the title of Senior Technician in the manufacture of pharmaceutical, biotechnological and Finnish products, as set out in Royal Decree 832/2014 of 3 October, is determined in the terms set in this order.

2. The professional profile of the curriculum, which is expressed by the general competence, the professional, personal and social skills, and the qualifications and the competence units of the National Catalogue of Professional Qualifications, is the included in the title of Superior Technician in Manufacturing of Pharmaceutical Products, Bitechnologicals and Aends, referred to in the previous section.

3. The general objectives of the training cycle curriculum, the objectives of the professional modules expressed in terms of learning outcomes and their assessment criteria are those included in the title of Higher Technician in Manufacturing Pharmaceutical, Biotechnological and Finnish Products referred to in paragraph 1 of this Article.

4. The contents of the professional modules that make up this curriculum, adapted to the socio-economic reality as well as to the perspectives of economic and social development of the environment, are those set out in Annex I of this order.

Article 4. Adaptation to the socio-productive environment.

1. The curriculum of the training cycle regulated in this order is established taking into account the socio-economic reality and the geographical, socio-productive and labour characteristics of the environment for the implementation of the title.

2. Vocational training centres shall have the necessary educational, organisational and economic management autonomy for the development of the teaching and their adaptation to the specific characteristics of the socio-economic, cultural and professional.

3. The centres authorised to provide this training cycle will concretize and develop the organizational and curricular measures that are most appropriate to the characteristics of their students and their productive environment, in a flexible way and in the use of their Pedagogical autonomy, in the general framework of the educational project, in the terms established by the Organic Law 2/2006, of Education.

4. The curriculum of the training cycle regulated in this order will be developed in the didactic programs or curricular development, strengthening or creating the culture of prevention of occupational risks in the spaces where the different modules are delivered professionals, as well as promoting a culture of environmental respect, excellence in work, compliance with quality standards, creativity, innovation, gender equality and respect for equal opportunities, the " design for all people " and universal accessibility, especially in relation to people with disabilities.

Article 5. Adaptation to the educational environment.

1. The vocational training centres managed by the Ministry of Education, Culture and Sport will develop the curriculum established in this order, taking into account the characteristics of pupils and the environment, particularly in the light of persons with disabilities, in conditions of accessibility and with the necessary support resources to ensure that this student can cure these teachings under the same conditions as the rest.

2. Also, the lessons of this cycle will be taught with a flexible and open methodology, based on self-learning and adapted to the conditions, abilities and personal needs of the students, in order to allow the reconciliation of the learning with other activities and responsibilities.

Article 6. Duration and sequencing of professional modules.

1. The total duration of the lessons for this training cycle, including the vocational training module in the workplace, is 2000 hours.

2. The professional modules of this training cycle, when offered under face-to-face arrangements, will be organised in two academic courses and will be in line with the weekly hourly sequencing and distribution set out in Annex II of this order.

3. The first academic year will be fully developed in the educational center. In order to be able to pursue the second course, it will be necessary to have completed the professional modules which, as a whole, are at least 80% of the hours of the first course.

4. The right of registration of those who have passed any professional module in another Autonomous Community shall be guaranteed in the terms laid down in Article 48.3 of Royal Decree 1147/2011 of 29 July 2011 establishing the general vocational training of the educational system.

5. In general, during the third quarter of the second year, and once the positive evaluation has been achieved in all the professional modules carried out in the educational centre, the vocational training module will be developed in job.

6. Exceptionally, and in order to facilitate the adaptation of the number of persons registered to the availability of training positions in enterprises, approximately half of the second-year students will be able to develop this vocational training module. Training in workplaces during the second trimester of the second year, provided they have positively overcome all the professional modules of the first academic year.

7. Without prejudice to the foregoing and as a result of the temporality of certain economic activities which may prevent the development of the vocational training module in the workplace from being in conformity with the above assumptions, the latter may be organise in other periods coinciding with the development of the economic activity of the professional profile of the title.

8. In any case, the evaluation of the vocational training module in the workplace will be conditional on the positive evaluation of the rest of the professional modules of the training cycle.

Article 7. Project Professional Module.

1. The professional module of the project has an interdisciplinary character and incorporates the technological and organizational variables related to the essential aspects of the professional competence of the title of Superior Technician in Manufacturing of Products Pharmacists, Bitechnologicals and Purposes.

2. In general, this module will be taught by the teachers who are tutoring training in job centers.

3. The project professional module will be developed during the last period of the training cycle, combining individual and collective tutoring, so that at least 50% of the total duration will be carried out in an in-person manner and completed with remote tutoring in which information and communication technologies will be used.

4. In any case and prior to the start of the vocational training module in the workplace, the teaching and learning activities to facilitate the development of the project professional module should be anticipated by the responsible teacher.

5. The evaluation of this professional module will be conditional on the positive evaluation of the rest of the professional modules of the training cycle, including the training in job centers.

Article 8. Bilingual teaching.

1. The curriculum of this training cycle incorporates the English language in an integrated way, at least in two professional modules, from among those that make up the whole of the training cycle. These modules will be taught by teachers with teaching assignment in them and, in addition, they will have the language enablement corresponding to level B2 of the Common European Framework of Reference for Languages.

2. In order to ensure that bilingual education is delivered in the two academic courses of the training cycle on an ongoing basis, professional modules of both courses will be chosen.

3. The modules which may be imparted in the English language are those listed in Annex III.

4. As a result of the greater complexity of the transmission and reception of teaching in a language other than the mother tongue, professional modules taught in the English language will increase their time load in three hours a week. for the set of modules that are delivered in the first year and two hours for which they are developed during the second course. In addition, the teachers who provide these professional modules will be assigned, in their individual hours, at least three hours a week for their preparation. These hours will have the same character as the reading hours.

5. Exceptionally and on a transitional basis up to the year 2020, when teachers with teacher allocation do not have the level of English required in these professional modules, they will share a total of three hours per week for all the teachers. modules to be delivered in the first year and two hours for those who develop during the second course with a teacher or a teacher of the English specialty. In this case, the programming of these modules will include at least one unit of work or didactics which will be developed exclusively in the English language and the other teaching units will incorporate teaching activities exclusively in English at that time allocated.

6. Exceptionally, in the case of students or students with disabilities who may have difficulties in their oral expression (cerebral palsy, deafness ...), more flexible and/or alternative measures will be put in place. the requirement for the provision of modules in the English language, so as to enable all the teaching of professional modules in the Spanish language. These adaptations shall in no case be taken into account in order to undermine the qualifications obtained.

CHAPTER III

Teachers, spaces and equipment

Article 9. Qualifications and accreditation of teacher requirements.

1. The specialties of teachers with teaching assignment in the professional modules which constitute the teachings established for the title referred to in Article 1 of this order, as well as the equivalent qualifications for the purposes of teaching, are the entries respectively in Annexes III A and III B to Royal Decree 832/2014 of 3 October 2014.

2. In order to ensure compliance with Article 12.3 of Royal Decree 832/2014 of 3 October 2014, for the delivery of the professional modules that make up the company, in private or public ownership centers of other administrations other than education, it must be established that all the requirements laid down in that Article are met, with the following documentation:

(a) Photocopy of the official academic title required, in accordance with the qualifications included in Annex III C of Royal Decree 832/2014 of 3 October. Where the certificate submitted has direct correspondence with the professional module to be delivered, it shall be deemed to include in itself the objectives of that module. Otherwise, in addition to the titration, the documents referred to in subparagraph (b) or (c) shall be provided.

(b) In the event that it is necessary to justify that the teachings leading to the titration provided encompass the objectives of the professional modules that are intended to be taught:

Personal academic certification of studies performed, original or photocopied, issued by an official center, in which the teachings are recorded detailing the subjects.

Programs of the studies provided and submitted by the person concerned, original or photocopy of the studies, sealed by the corresponding official or authorized official or official University or Center.

c) Where it is necessary to justify by means of the work experience which, at least for three years, has developed its activity in the sector related to the family, its duration shall be credited by the appropriate supporting official document, which shall be added to:

Certification of the employer or employer in which the activity developed by the person concerned is specifically recorded. This activity must be implicitly related to the learning outcomes of the professional module that is intended to be delivered.

For those who are self-employed, a statement of the person concerned with the most representative activities related to learning outcomes.

Article 10. Spaces and equipment.

The spaces and facilities to be assembled by the vocational training centres, in order to enable the development of teaching activities, are those set out in Annex IV of this order and must comply with the Article 11 of Royal Decree 832/2014 of 3 October, as well as the rules on equal opportunities, "design for all persons" and universal accessibility, prevention of occupational risks and safety and health at the workplace.

CHAPTER IV

Other offerings and mode of these teachings

Article 11. Distance offering.

1. Professional modules offered at a distance, when required by their characteristics, will ensure that students achieve all the objectives expressed in learning outcomes, through face-to-face activities.

2. The Provincial Directorates and the Board of Education shall take the necessary measures and shall give the precise instructions to the centres which are authorized to provide this training cycle under pressure for implementation and operation of the offer from the same distance.

3. Centres authorised to provide vocational training lessons at a distance shall have appropriate curriculum materials which will be adapted to the provisions of the fourth additional provision of the Organic Law 2/2006 of 3 May.

Article 12. Combined offering.

In order to respond to personal needs and interests and to provide the possibility to reconcile training with work activity, with other activities or situations, the offer of these teachings for people adults and young people in special circumstances may be combined between face-to-face and distance learning systems at the same time, provided that the same modules are not cured in both modes at the same time.

Article 13. Offer for adults.

1. The professional modules of this training cycle associated with the competence of the National Catalogue of Professional Qualifications may be the subject of a modular offer for adults.

2. This training will be developed with an open and flexible methodology, adapted to the conditions, capabilities and personal needs that enable them to reconcile learning with other activities and responsibilities, in compliance with the Chapter I of Title IV of Royal Decree 1147/2011 of 29 July 2011. In addition, such training shall be capitalizable in order to obtain a professional training certificate, in order to obtain evidence of the established access requirements.

3. In order to reconcile learning with other activities and responsibilities, the Provincial Directorates and the Board of Education may establish specific measures to comply with the provisions of Article 41 of Royal Decree 1147/2011, July 29 and enable a face-to-face and remote offering simultaneously.

4. In order to promote training throughout life, the Directorate-General for Vocational Training of the Ministry of Education, Culture and Sport may authorise the Provincial Directorates and the Education Ministry to give the training, in the centres of their competence, of professional modules organised in training units of shorter duration. In this case, each learning result, with its evaluation criteria and its corresponding block of contents, will be the minimum and indivisible unit of partition.

Additional disposition first. Authorization to impart these teachings.

The Provincial Directorates and the Board of Education will deal with the Directorate-General for Vocational Training with the authorization to provide the teaching of this training cycle, in full or in part, in In-person and distance-based arrangements, of the institutions that request it and comply with the requirements required under the current legislation.

Additional provision second. Linguistic enablement of bilingual teaching faculty.

Teachers who are to be taught in English must be in possession, before the date of commencement of each academic year, of the relevant language qualification, to which the Ministry of Education, Culture and Sport will carry out an enabling procedure before the start of each course.

Additional provision third. Training of bilingual teaching staff.

The Provincial Directorates and the Board of Education will schedule courses and training activities in the English language for all teachers of vocational training to be taught in professional modules. which may be taught in the English language, who will have the obligation to assist them until they obtain the required qualification. These measures shall apply until at least the year 2020.

The training to be offered will be three types:

a) Intensive training, through a course, preferably in face-to-face mode, during the month of September.

b) Long-term training throughout the school year, by means of a course that combines in-person and online form, which will be performed outside of the mandatory time in the training center. During the period of completion of the vocational training module in the workplace, this course will be intensified and will be carried out, as far as possible, within the required time of stay in the centre.

(c) Training in English-speaking country, through courses, which will be possible to include cultural visits and conferences, and which will be carried out at the end of the course after the completion of school activities in the training centres.

Single transient arrangement. Replacement of titles related to these teachings.

1. The student who, at the end of the school year 2015 -2016, meets the conditions required to pursue the second course of the title regulated in Royal Decree 810/1993, of 28 May, for which the title of Superior Technician is established in Manufacture For the purposes of the Directive, the Commission is to be required to provide the Commission with a view to the application of the provisions of this Directive, in particular to the provisions of the Directive. of this title, will have two calls in each of the two successive years for power exceed those professional modules. After that period, in the 2018-2019 school year, the convalidations will apply to the superimposed modules, as set out in Article 15.1 of Royal Decree 832/2014 of 3 October, regulated by the Organic Law 2/2006 of 3 May.

2. The students who, at the end of the school year 2015 -2016, do not meet the conditions required to pursue the second course of the title of Superior Technician in Manufacturing of Pharmaceutical Products and Aends, established by Royal Decree 810/1993, 28 In May, under the Organic Law 1/1990, of October 3, the convalidations established in article 15.1 of the Royal Decree 832/2014, of 3 October, regulated by the Organic Law 2/2006, of 3 May, will be applied.

3. The students who, at the end of the school year 2016-2017, do not meet the conditions required to obtain the title of Superior Technician in Manufacturing of Pharmaceutical Products and Aends, established by Royal Decree 810/1993, of 28 May, to the Under the Organic Law 1/1990 of 3 October, it will have two calls in each of the two successive years in order to be able to overcome these professional modules, with the exception of the training module in the centre of work for which a Supplementary school year. The students who have passed that period have not obtained the title will be applied to the convalidations, for the modules surpassed, established in article 15.1 of the Royal Decree 832/2014, of October 3, regulated by the Law of Organic 2/2006, May 3.

Final disposition first. Application of the order.

The Directorate-General for Vocational Training, in the field of its powers, is authorised to take the measures and to issue the necessary instructions for the implementation of the provisions of this order.

Final disposition second. Implementation of these teachings.

1. In the course of 2015-2016, the first course of the training cycle referred to in Article 1 of this order will be implemented and the lessons of the first course covered by the Organic Law 1/1990 of 3 October will cease to be taught. corresponding to Royal Decree 810/1993 of 28 May.

2. In the course of 2016-2017 the second course of the training cycle referred to in Article 1 of this order will be implemented and the second course teachings covered by the Organic Law 1/1990 of 3 October will cease to be taught. corresponding to Royal Decree 810/1993 of 28 May.

Final disposition third. Entry into force.

This order will take effect the day following your publication in the "Official State Bulletin".

Madrid, 21 July 2015.-The Minister of Education, Culture and Sport, Iñigo Méndez de Vigo and Mr Mondez.

ANNEX I

Professional Modules

1. Professional Module: Organization and management of the manufacture of pharmaceutical, biotechnological and related products.

Code: 1387.

Contents:

a) Defining the organization and functional areas of a pharmaceutical or biotechnology company:

Classification of pharmaceutical laboratories:

Pharmaceutical production laboratories.

Pharmaceutical packaging laboratories.

Basic structure of the pharmaceutical and biotechnology industries.

Functions. Organizational charts.

Analysis of process diagrams. Symbology.

Functional relationships of the different departments.

General aspects of installations, buildings, and spaces.

b) Characterisation of the rules of correct manufacturing and good practices for the distribution of medicinal products and active substances:

Good Manufacturing Rules: Target. Scope. Manufacturing Guide.

Quality management. Responsibility for the quality unit. Production responsibility. Internal audits. External audits. Review of product quality.

Personal. Training. Personal hygiene. Consultants.

Pollution and cross-contamination risks.

Buildings and installations. Design. Services. Dedicated areas. Lighting. Hygiene and maintenance. Water. Waste water and waste.

Process teams and computer systems. Maintenance and cleaning of equipment. Calibration. Backups.

Managing raw materials. Reception and quarantine. Sampling and analysis. Storage.

Production and processing controls. Deadlines. Sampling and controls in process. Batch mixture. Pollution control.

Packaging, labeling, storage and distribution: conditioning materials. Issue and control of labels. Conditioning and labelling operations. Storage and distribution procedures.

Laboratory and validation controls: analysis of intermediates and active substances. Validation of analytical methods. Certificates of analysis. Stability controls. Expiration and reanalysis dates. Samples of retention. Validation documentation. Cleaning validation. Review of validated systems.

Control of changes.

Rejection and reuse of materials: rejection. Reprocess. Rework. Recovery of materials. Returns.

Claims and withdrawals from the market.

Manufacturers and contracted laboratories. Intermediate agents, brokers, marketers, distributors, re-enpackers and re-labels.

c) Application of the manufacturing guide:

Batch manufacturing. Documentation of the lot. Process traceability.

Documentation systems. Specifications.

Equipment usage and cleanup records.

Records of raw materials, intermediates, packaging materials, and active substance labeling.

Pattern method (production and control master records). Pattern formula. Production instructions.

Production protocol (batch and control production records). Date identification, batch, equipment used, laboratory results and controls in process, deviations assessed and final analysis result for batch release.

Control lab records: Sample description, date, analytical method, data record, and calculations and comparison declaration with established acceptance criteria.

Review of the batch production protocol. Compliance with the specifications for batch release.

d) Organization of the activities of a work area:

Working methods. Improving methods.

Study and organization of work. Working programming methods. Job analysis and job description in pharmaceutical, biotechnology and related industries.

Producing instruction sheets for production.

Planning and control of continuous and discontinuous production.

Process optimization.

e) Characterisation of the regulations on authorisation, pharmacovigilance of medicinal products and obligation of confidentiality:

Procedure for authorization, registration, and conditions for dispensing of medicinal products. Requirements of the applicant. Evaluation of the documentation. Guarantees of identification of the medicinal product. Authorisation. Changes to the conditions. Procedure for suspension and revocation. Community procedures.

Analytical, pharmacotoxicological and clinical standards and protocols for the conduct of drug testing.

Pharmacovigilance of medicinal products. Sources of information. Pharmacovigilance agents. Amendment, suspension or revocation of the authorisation. Post-authorisation studies.

Patents. Brands. Utility models. Industrial secrets.

Spanish and European legislation.

Rights and obligations. Advantages and disadvantages.

Confidential information. Protection. Contracts.

Limits of confidentiality and secrecy obligation.

2. Professional module: Quality control of pharmaceutical, biotechnology and related products.

Code: 1388.

Contents:

a) Application of quality control systems:

Quality items: quality assurance. Quality assurance plan.

Quality assessment. Inspection and audits. Documents.

On-premise quality assessment: lighting, temperature, humidity, pressure, order and cleaning, among others.

Inspection of cleaning and disinfection operations: order of the processes. Control of cleaning of rooms and utensils. Cross-contamination. Control of disinfection of rooms and utensils. Registered biocidal products. Team and area tagging operations.

Evaluation of the in-process control of the product.

Control parameters: materials check, blister tightness, lock integrity, weight, print quality, focus and units per package or box.

Basic Notions of the parameters to be controlled. Methodology applied on each parameter.

Documents associated with process controls.

Logging and collecting data.

Specifications and compliance intervals. Deviations.

Inspection of the measurement and control equipment of the process.

Equipment types: magnifying glass, temperature controllers, humidity, pressure, amperimeters, graphic loggers, and speed control.

Calibration of equipment. Maintenance. Systematic cleaning.

Application of computer systems.

Process Failures: Failure types and deviations. Corrective actions. Record of actions and defects.

Evaluation of the control of conditioning materials: types of materials. Characteristics of the packaging materials. Symbology. Filling, packaging and labelling. Modified atmospheres. Packaging tightness.

Rules for finished products based on their properties. Conditioning and storage.

b) Interpretation of the test plan and analysis of manufacturing processes:

Analysis and control plans. Quality of production. Planning of quality control in production. Product verification. Control of inspection, measurement and testing equipment. Quality in services. Selection of technical documentation.

Quality control systems in production and laboratory.

Quality systems documents.

Process control specifications.

More representative parameters of the production process. Manual, automatic, machine-foot, and other methods.

Normalized work procedures (PNT). Criteria and phases for their preparation.

Establishment of tests to be performed. Physico-chemical tests of products in chemical plant. Physico-chemical tests in chemical laboratory. Chemical analysis. Biochemical analysis.

Setting the sampling frequencies.

Environmental risks and environmental protection.

Environmental records.

Results treatment: Test result recording systems in the chemical industry. Specific IT tools. Applied statistics. Statistical treatment of results in chemical industry. Analysis and representation of results.

Reporting techniques.

c) Sample Take:

Sampling Plan: Sampling programs. Plan of two classes and three classes. PO curves of a sampling plan. Standard 105-D Military Plans Inspection levels. Single, double and multiple sampling. Table handling. Sampling plans by variables. Standard 414 Military Table Handling.

Results interpretation decision-making criteria.

Acceptable quality level (NCA or AQL).

Standard sampling procedures. Organization of the sampling plan.

Official rules for the taking of samples.

Sampling: in liquid and solid gases plant. Procedure for taking samples. Instruments and containers. Techniques for direct sampling of air, water, other liquids and solids.

Types of sampling: from air, on surfaces, on liquid samples and on solid samples.

Conditions for handling, storage, transport and storage for different samples.

Prevention of common errors in the manipulation of a sample and calculation of uncertainties in sampling.

Treatment of samples for trials.

d) Realization of physical and physico-chemical tests:

Verifying organoleptic characters.

Physico-chemical tests of plant products: concept, scales and methods. Equipment used. Calibration and contrast. PH. Density. Viscosity. Color. Refractive index. Specific rotation. Turbidity. Others.

Physico-chemical tests in the laboratory: concept, scales, methods and apparatus used. Standards: API, ASTM, BS, DIN, ISO. Clean water tests. Waste water tests. Tests for other liquids: density, viscosity, colour, humidity, conductivity, calorific value and corrosion. Sedimentation rate.

Physical Tests: Distillation interval. Melting point. Point of solidification. Hardness. Others.

Solids tests: color, granulometry, humidity, apparent volume. Disintegration. Friability. PH. Others.

Related product trials: specific weight. Particle size. Type of emulsion. Dry residue. Others.

Conducting tests on solid, semi-solid, liquid, and other forms.

Measure of physical and physicochemical variables: physical and physicochemical parameters to be controlled in manufacturing and finished product. Description of the test procedure, equipment used, presentation of data obtained and treatment thereof. Justification for results and conclusions.

e) Realization of quantitative chemical analysis:

General materials handling techniques and materials in the laboratory.

Laboratory material cleaning techniques.

Identification of chemicals.

Preparation of solutions and mixtures.

Normalization of reagents.

Basic sample preparation operations for analysis.

Safety and environmental protection rules.

Fundamentals of gravimetric analysis.

Gravimetric methods of analysis.

Types of chemical reactions and more important applications.

Volumetric methods of analysis. Indicators.

Interpretation of analytical results. Errors.

Identification of organic compounds and formation of derivatives.

Elementary and organic functional analysis.

Selection of instrumental analytical techniques.

Identification and measurement of components by chemical or instrumental analysis techniques.

Sample analysis by instrumental analytical techniques: application of electrochemical methods. Tests using optical methods. Application of spectroscopic techniques. Application of separation techniques.

Chemical parameters to be controlled in the analysis and control of manufacture and finished product.

Description of the test procedure, equipment used, presentation of data obtained and treatment thereof. Justification for results and conclusions.

f) Realization of microbiological and biotechnological trials:

Taking and preparing samples of biological products: material used in sampling. Sampling techniques: liquid, solid, air, surfaces and environments. Identification, transport, conservation and storage of the sample. Established work protocols for the handling of samples. Reference samples.

Sterility controls. Sterilisation procedures: batch filtration, gas sterilisation, dry heat, ionising radiation or water vapour.

Classes of substances on which sterility tests are performed: bacterial endotoxins, pyrogens, and local tolerance.

Efficacy tests of sterilization methods: LAL techniques; gelidification, turbidimetric, and chromogenic.

Antioxidant systems. Effects and types of antioxidant agents. Measurement.

Antimicrobial agents: classification according to origin.

Antimicrobial conservation agent efficacy trials: methods of endpoint and descriptive evaluation.

Stabilisation and storage agents: influence of the container in contact with the product. Factors to be considered in the stability tests: temperature, light and humidity. Criteria and tests for the determination of stability in pharmaceutical products.

Microbiological analysis in samples: microbiological control in clean areas. Test for detection and counting of micro-organisms. Assessment and importance of the biological safety standards.

Feasibility verification of inserts and vectors in genomic libraries and genetically modified microorganisms.

DNA identification to ensure traceability in the industry.

Genetic constructs in a biotechnological process.

3. Professional Module: Basic operations in the pharmaceutical, biotechnology and related industries.

Code: 1389.

Contents:

a) Characterization of Diffusion Separation Techniques:

Physico-chemical principles of the different operations. Parameters.

Phase diagram: graphic reading and interpreting.

Difusion separation operations: distillation, rectification, extraction, drying, humidification, sublimation, crystallization, evaporation, absorption, adsorption and ion exchange.

Associated calculations: Performance, matter and energy balance.

Industrial applications of the difuser operations.

Equipment and construction elements: distillers, extractors, dryers, humidifiers and evaporators, among others.

Association of teams: series and parallel.

Start and stop operations.

Data Log. Failures.

Maintenance preparation: cleaning, innertizing, pressure testing, vacuum testing, tightness and vaporization, among others.

b) Determination of mechanical separation operations:

Physico-chemical principles of the different operations. Parameters.

Phase diagram: graphic reading and interpreting.

Mechanical separation operations: sedimentation, filtration, centrifugation, precipitation, decantation, magnetic and electrical separations, flotation concentration and spraying.

Equipment and mechanical separation facilities. Sedimenters, centrifuges and decanters, among others.

Associated calculations: Performance, matter and energy balance.

Industrial applications of mechanical operations.

Start and stop operations.

Failures. Data logging.

Preparing maintenance: cleaning and inerting.

c) Determination of galenic operations:

Physico-chemical principles of the different operations. Parameters: fluency, granulometry and mixing index, among others.

Industrial galenic operations: granulation, disgorging, grinding and sifting, lyophilization, mixing and dosing.

Dry and wet granulation.

Compression and coating.

Homogeneous dispersed systems. Stability of the dispersed systems. Mixtures and solutions. Ways to express concentration.

Agitation. Types of agitators. Types of rodetes. Forms of agitation: axial, radial, and tangential.

Teams and constructive elements. Sieves, lyophilization equipment and mixers.

Start and stop operations. First-level maintenance.

d) Reactor operations:

Principles of chemical reaction. Types of chemical reactions.

Chemical Kinetics. Speed of reaction. Chemical balance.

Matter and energy balances in reactions.

Performance of the reaction.

Chemical Reactors. Classification and design of reactors. Reaction variables.

Chemical Catalysts. Types. Principles of operation of the catalysts.

Regeneration of catalysts.

Start and stop operations. First-level maintenance.

Failures. Data logging.

e) Prevention of occupational hazards and environmental protection:

Risks inherent in equipment and facilities. Pressure and vacuum equipment. Compression. Equipment for mechanical and difusing operations.

Prevention media.

Protection. Protection of equipment: screens, presence limiters and others. Personal protective equipment.

Signage and equipment security. Security tokens.

Environmental protection: collection and selection of waste.

Storage and removal of waste.

4. Professional Module: Principles of Biotechnology.

Code: 1390.

Contents:

a) Determination of organisms of biotechnological interest:

Properties and classification of prokaryotic microorganisms. Composition. Structural elements. Morphological forms. Nutrition. Reproduction. Habitat. Taxonomy.

Properties and classification of eukaryotic microorganisms. Composition. Structural elements. Morphological forms. Nutrition. Reproduction. Habitat. Taxonomy.

Micro-organisms of biotechnological interest. Diversity. Isolation. Selection. Security. Micro-organism collections.

Plant cell properties. Composition. Structural elements. Nutrition. Playback.

Animal cell properties. Composition. Structural elements. Nutrition. Playback.

Plant and animal cells of biotechnological interest. Biobanks. Plant cell lines. Animal cell lines (human, primate, rat, mouse, fish, and insects). Hybridomas. Tissues.

Properties and classification of viruses. Composition. Structural elements. Morphological forms. Reproduction. Habitat. Taxonomy.

Virus of biotechnological interest. Diversity. Isolation. Selection. Security.

Types of magnifiers. Conventional. Binoculars.

Optical Microscope Microscope Types (light field, dark field. phase contrast, interference, fluorescence, and confocal). Electron microscope (transmission and scanning).

Laboratory materials used in microscopy. Fixing. Staining. Inclusion. Cuts. Supports. Grilles. Microtomes.

Rules, use, maintenance, and fundamental parts of the optical microscope. Lenses and lenses. Increases. Resolution. Lighting. Filters. Adjustment. Photo cameras.

Identification, classification and quantification of microorganisms by microscope. Dilutions. Filtration. Counting chamber. Viable cells. Generation time.

b) Application of chromatographic techniques for the identification of cellular metabolites:

Definition of Biochemistry. History.

Nucleotides. Structure. Nucleosides. Nomenclature. Function. Uses.

Amino acids. Structure. Classification. Function. Essential amino acids. Racemisation. Uses.

Lipids. Structure. Classification. Function. Fatty acids. Phospholipids. Steroids. Saponification. Uses.

Carbohydrates. Structure. Nomenclature. Function. Stereoisomeria. Reducing sugars. Uses.

Vitamins and coenzymes. Structure of vitamins. Types of coenzymes. Cofactors. Prostetic group. Function. Uses.

Alcohols, organic acids and antioxidant substances. Structure. Nomenclature. Function. Aromatic compounds. Acidity. Uses.

Antibiotics. Structure. Classes. Origin. Mechanisms for action. Uses.

Chromatographic equipment and techniques. Chromatographers. Detectors (ultraviolet, visible, fluorescence, refraction, electrochemicals and masses). Types (preparatory and analytical). Terminology and concepts (analytes, effluents, phases, chromatograms, retention time and baseline). Injectors. Bombs. Gradients. Heaters. Collectors.

Thin-layer chromatography. Types of support. Types of eluent. Development and development. Mobility constants (Rx and Rf). Applications.

Low pressure liquid chromatography. Types (exclusion, distribution, adsorption, ion exchange and affinity). Column properties and fillers. Effectiveness. Particle size. Types of elution (isocratic and gradient). Applications.

High Pressure Liquid Chromatographers and their Coupled Detectors (HPLC). HPLC types. Types of detectors. High pressure pumps (mechanical and pneumatic). Filtration. Degassing. Quantitative and qualitative analysis. Applications.

Gas Chromatographers and their Coupled Detectors. Gas-liquid chromatography (GLC). Gas-solid chromatography (GSC). Types of detectors. Gas handling. Quantitative and qualitative analysis. Applications.

c) Application of extraction and separation techniques for the identification of cell macromolecules:

Classification of biomacromolecules. Concept of monomer and polymer.

Composition, physicochemical properties, and functions of nucleic acids. Monomers. Links. DNA. RNA. Oligonucleotides. Denaturation. Ultraviolet spectrum.

Biotechnology applications of nucleic acids. Sequencing. Genetic diagnosis. Phylogenetic trees.

Techniques for extraction, purification and quantification of nucleic acids. Cell lysis. Precipitation. Chromatography. Ultraviolet and fluorescence spectrometry. Staining.

Composition, physicochemical properties, and protein functions. Monomers. Links. Structure (primary, secondary, tertiary and quaternary). Types (fibrous, globular and conjugate). Structural proteins. Transporters. Receivers. Enzymes. Peptides. Solubility. Denaturation. Ultraviolet spectrum. Fluorescence spectrum. Circular dichroism.

Biotechnology applications of proteins. Proteins with pharmacological activity. Hormones. Antibodies. Vaccines. Industrial enzymes.

Techniques for the extraction, purification and quantification of proteins. Cell lysis. Chromatography. Precipitation. Filtration. Crystallization. Chemical quantification reactions (Biuret, Lowry, Bradford). Spectrophotometric quantification (ultraviolet and fluorimetry). Sequencing.

Composition, physicochemical properties and functions of polysaccharides. Monomers. Links. Chemical classification (homopolysaccharide and heteropolysaccharide). Functional classification (reserve, structural and recognition). Lipopolysaccharides.

Biotech applications of polysaccharides. Power. Medicine. Industrial.

Techniques for extraction, purification and quantification of polysaccharides. Solvent treatments. Treatments with acids and alkalis.

Electrophoresis equipment. Power supplies. Buckets. Electrophoretic mobility. Electrophoresis tampons. Matrices. Patterns. Plate electrophoresis (vertical and horizontal). Capillary electrophoresis. Isoelectrofocus.

Electrophoresis of proteins. Polyacrylamide matrices. Two-dimensional electrophoresis. Native and denaturant. Zimograms. Immunoelectrophoresis. Staining and visualisation. Applications. Western-blot.

Nucleic Acid Electrophoresis. Field pressed. Native and denaturant. Staining and visualisation. RNA/DNA sequencers. Applications. Southern blot. Northern blot.

d) Identification of metabolic processes:

Cellular metabolism. Primary and secondary metabolism. Catabolism and anabolism. Aerobiosis and anaerobic. Metabolic routes.

Metabolic regulation. Specific and pleiotropic regulation. Regulators of gene expression. Enzymatic regulation.

The replication, transcription and translation of DNA. DNA polymerase. RNA polymerase. Ribosomes. Genetic code. Protein synthesis.

The cell membrane and transportation. Membrane structure. Active and passive transport. Osmosis. Endocytosis. Exocytosis.

Energy metabolism. Glycolysis. The Krebs cycle. Oxidative phosphorylation. Photosynthesis. Free energy.

The biosynthesis and degradation of the major cellular metabolites. Biosynthesis and degradation routes (amino acids, lipids, sugars and nucleotides).

Techniques for determining enzymatic activities. Concepts of maximum speed (Vmax) and constate of Michaelis-Menten (Km). Concept of substrate and final product. Concept of enzymatic inhibition. Reaction tampons. Effects of pH, temperature and ionic strength. Spectrophotometric tests (spectrophotometers). Tests with radiolabelled substrates (scintillator counters). International units of measurement of enzymatic activity. Kinetic and endpoint methods.

e) Application of genetic modification techniques:

Enzymes used in genetic engineering. Restriction enzymes. DNA ligase. Phosphatases. DNA polymerases.

Gene and chromosome concepts. Prokaryotic and eukaryotic chromosomes. Prokaryotic and eukaryotic genes (exons and introns).

Procedures for the identification of genes. Chain polymerase reaction (analytical and quantitative). DNA hybridization.

Methods of genetic transformation. Natural competition. Conjugation. Chemical transformation. Electroporation. Transfection. Lipofection. Microinjection.

Vectors for gene cloning and the creation of gene libraries.

Gene expression systems. Host cells. Expression vectors. Transient and permanent expression.

Mutagenesis methods. Chemical mutagenesis. Physical mutagenesis. Directed mutagenesis. Random mutagenesis. In vivo and in vitro mutagenesis.

Methods of protein engineering.

Concept of metabolic engineering.

f) Application of basic bioinformatics techniques:

Concept of bioinformatics. Computers. Networks. Clusters. Programmes. Biological data. Data mining.

Computer programs of interest in biotechnology. Operating systems. Languages. LIMS. Ambushes. EMBASSY. EXPASY. Clustal. BLAST. BioMoby.

Databases. Types of databases in biotechnology. Formats of the information. Genbank, ENSEMBL. KEGG. NCBI. Swisprot. PFAM. Prosita. PDB.

Navigation tools. Internet browsing programs. Modems. Suppliers. Telephone access. WiFi. Search engines. FTP servers. Interfaces. Videoconferencing.

Bioinformatics techniques for genomic analysis. Gene prediction. Alignment and comparison of gene sequences.

Bioinformatics techniques for proteomic analysis. Protein comparison and annotation. Protein structure prediction. Alignment of protein sequences. Phylogenetic trees.

Algorithms and strategies in statistical calculations. Measures of central tendency and dispersion. Odds and distributions. Analysis of variance. Regression and correlation. Graphic methods (control letters). Frequency distribution. Statistics in Excel.

Storage of information. Terminology. Capacity units. Storage devices. Transfer of data. Backups.

5. Professional module: Safety in the pharmaceutical, biotechnology and related industries.

Code: 1391.

Contents:

a) Characterization of risk types:

Determinants of the hazard of chemicals: toxicity, pathways in the body, dose of contaminant, physical and chemical properties, physiological status and individual susceptibility.

Chemical Contaminants. Nature and composition.

Classification of chemicals: explosives, oxidants, flammable, toxic, harmful and others.

Physical Contaminants. Location in the workplace and effects on the body.

Biological agents. Classification according to its nature: viruses, bacteria, protozoa, fungi and helminths. Input paths.

Risk groups for biological agents. Risks associated with biotechnology production plants.

Ionizing radiation. Sources.

Biological effects of radiation. Types: hereditary and somatic.

Measures and radiological units. Activity. Absorbed dose. Equivalent dose.

Radiation Detectors. Gas, scintillator, semiconductor and thermoluminescence chamber detectors.

Classification of detectors according to their use: Personal monitoring, portable and non-portable measurement.

Commissioning, testing, processes in equipment and machines: risks.

Risks in biotechnology production plants and equipment.

Risks of equipment and lines of work under pressure or in a vacuum.

b) Characterization of security installations, equipment, and risk prevention devices:

Security devices. Installations and equipment. Detectors, biosensors, alarms, actuators and others.

Personal protection equipment. PPE.

Collective protection teams. Wash eyes, showers, bells and others.

Installations security signs.

Pictograms. Risk phrases and prudence.

Characteristics of the fire. Load of fire.

Fire equipment. Extinction methods for different types of fire.

Protection items in a production installation: Purge and Valve systems.

Control system failure prevention systems.

Prevention of industrial risks: electrical current, maintenance of facilities and pressure equipment.

Specific use of biological isolation: PPE, campaigns, and white rooms.

Specific use of radiological risk: protection screens or shields, primary and secondary barriers, access control systems and personal protection.

Radiological protection. Protection techniques. Classification of zones.

c) Application of security measures:

Hazardous substances.

Security Tokens.

Risk analysis.

Extinction of fires.

Security in biotechnology, pharmaceutical and related facilities.

Industrial hygiene.

Areas with chemical, physical and biological risk: detection and measurement devices.

Standard procedures for risk reduction work.

Biological safety signage.

Standards for maintenance, order, cleaning and disinfection of installations, machines and equipment.

Preventive measures for different biological risk groups.

d) Application of environmental protection measures:

Environmental protection regulations in biotechnological, pharmaceutical and related processes: measurement of environmental parameters.

Types of pollution in production processes. Pollution due to emissions into the atmosphere, waste water and industrial waste.

Waste management: solids, liquids and gases. Waste water treatment. Waste treatment and minimisation techniques. Non-recyclable waste.

Precautions against pollution and spills. Biosafety laboratories.

Measure of physical pollutants: noise. Humidity.

Reference values for chemical, physical and biological contaminants. Limits of toxicity, flammability.

Control of radiological contamination. Exposure limits. Management of radioactive waste. Transport of radioactive materials.

e) Defining action in emergency situations:

Emergency Plan. Structure: risk assessment, means of protection, emergency planning and implementation.

Classification of emergencies. Actions.

Emergency teams: naming, composition, and functions.

Instructions and slogans.

Evacuation plan: implantation, signage, and drill.

Fires. Methods of extinction.

Performances of spills and leaks of dangerous products.

First aid. Acting with injuries, trauma, burns, poisoning, and contact with blood or organic liquids.

6. Professional Module: Auxiliary areas and services in the pharmaceutical, biotechnology and related industries.

Code: 1392.

Contents:

a) Characterizing the areas of a production site:

Areas. White rooms. Applications of the white rooms. Classification. Environmental requirements and conditions.

Auxiliary services in a production plant of pharmaceutical and related products. Definition. Its importance in the activity of a pharmaceutical plant.

Description of auxiliary equipment and facilities.

Functionality of equipment, auxiliary installations, and their constituent elements.

Interpretation of diagrams and schemas of auxiliary spaces, equipment, and facilities. Colour code and symbology applied to equipment, appliances and installations.

Regulations and measures for the safety and prevention of occupational risks.

b) Operations with water treatment equipment and facilities:

Water in nature: water cycle.

Need for water in pharmaceutical manufacturing processes.

Water types.

Pharmaceutical quality water: purified water: PW, highly purified water: HPW, water for injection (WFI) and water for hemodialysis, among others.

Water treatment with pharmaceutical quality:

Separation of suspended solids.

Separation of dissolved ions: demineralization.

Separation of gaseous impurities.

Distillation.

Nanofiltration.

Reverse osmosis and combined osmosis treatments and exchange resins.

Electrodeionization.

Combined Osmosis Treatments with Electrodeionization.

Determination of parameters. Physical, physicochemical, chemical, biological and microbiological parameters of the water. Units. Measuring instruments.

Water treatment equipment and facilities. Start and stop.

First level maintenance of water treatment equipment and facilities.

Order and cleaning procedures in water treatment equipment.

Safety, prevention and environmental regulations.

c) Operations with air and other gas supply facilities:

Composition, characteristics, and properties of air.

Air Conditioning. Hygronometric grade. Dehumidification and air humidification. Special areas.

Sterilization of air. Clean areas. Maintenance and control of sterility.

Gases in the pharmaceutical industry. Medicinal gases.

Determination of parameters. Pressure. Relationship between pressure, volume and temperature. Measuring instruments.

The compressed air. Distribution of compressed air in plant. Compressed air characteristics: compressed air for the operation of the equipment, air for process (in contact with the product and no contact with the product).

d) Operations with pressure and vacuum equipment:

Pressure equipment regulation and its accompanying technical instructions.

Pressure equipment: boilers, petrochemical plants, cryogenic tanks, self-contained respiratory equipment bottles, transportable pressure vessels.

Empty systems. Production of vacuum.

Determination of parameters. Measuring instruments.

Equipment and vacuum production facilities. Vacuum pumps.

Start and stop.

First-level maintenance of vacuum production equipment and installations.

Order and cleanup procedures in vacuum production facilities.

Safety, prevention and environmental regulations.

e) Handling of heating and cooling systems:

Concepts and units of heat and temperature. Measuring instruments. Heat transmission.

Heat generation systems. Types. Heat equipment and installations (heat exchangers and steam boilers: physical principles, equipment functions, operating parameters, steam distribution networks).

Pharmaceutical vapor. Steam for air conditioning (HVAC). Service Steam.

Cooling systems. Description. Equipment and facilities.

Matter and energy balances.

Energy efficiency.

Commissioning and stopping a lab's heating and cooling systems.

First-level maintenance of heat and cold production equipment and facilities.

Order and cleaning procedures on heat and cold generation equipment.

Safety, prevention and environmental regulations.

f) Handling of material transport equipment:

Liquid drive systems.

Fluid static.

Fluid dynamics. Operating regimes. Load losses.

Transportation and distribution operations for liquids. Installation of liquid transport. Bombs. Types of pumps. Characteristic curves. Valves. Types of valves.

Gas driving systems.

Compressors. Types of compressors.

Transportation and gas distribution operations. Gas supply equipment and facilities. Features, installation and accessories (valves and pipes, among others).

Transportation of solids. Characteristics of solids: size, humidity and sensitivity to heat, among others.

Solid transport systems: hydraulic, mechanical and pneumatic, among others.

Solid transport equipment.

Symbology, representation and nomenclature of machine and equipment of transport of materials.

Symbology, representation of pipe elements: elbows, join elements, join supports, supports, and expansion joints.

Start and stop.

First-level maintenance of gas supply equipment and facilities.

Order and cleaning procedures in air and gas supply installations and equipment.

Safety, prevention and environmental regulations.

g) Determination of sanitization, cleaning, and disinfection processes:

Cleaning, sanitizing, and disinfection processes. Definition of cleaning and disinfection processes. Stages. Frequency.

Types of cleaning, sanitizing, and disinfectant products. Factors that influence the effectiveness of disinfectants.

Chemical compatibility.

Sanitizer. Factors that influence the effectiveness of the sanitizers. Chemical compatibility.

Sanitization processes: by heat, with chemical agents or by radiation.

Manual, semi-automatic and automatic cleaning systems (CIP, COP, and SIP).

Cleaning, sanitization, and disinfection regulations.

7. Professional Module: Biotechnology production techniques.

Code: 1393.

Contents:

a) Preparation of facilities and equipment for biotechnology production processes:

Plant installations of biotechnology production. Types of rooms (Fermentation. Sterilisation. Conservation, Separation. Gases. Final product). Warehouses. Environmental conditions (temperature, humidity, ventilation and lighting). GMP requirements.

Equipments of the plants of biotechnological production. Reactors. Centrifuges.

Handling of biological samples. Regulations. Reception. Storage. Shipping. Packaging. Blood. Human samples. Animal samples.

Materials, raw materials and reagents for biotechnology production. Waste as raw material. Properties of the materials. Hazardous reagents. Radioactive substances. Perishable reagents. Storage.

Microorganisms containment barriers. Regulations. Environmental protection. Personal protection.

Methods of disinfection and sterilization of facilities and equipment. Chemical agents. Physical systems (heat and UV).

Elimination of biological waste. Classification of wastes (solids, liquids, organisms and special). Collection. Storage. Transfer. Recycling. Composting.

Maintenance of equipment and materials from the biotechnology production plant. Manuals. Cleaning. Calibration. Measuring equipment.

Diagram of biotechnological processes. Types of processes. Flowcharts.

b) Application of micro-organism culture techniques:

Facilities, equipment and materials for handling microorganisms. Autoclaves. Culture stoves. Orbital stirrers. Anaerobic cameras. Anaerobic jars. Laminar flow campaigns. Cultivation materials. Reagents. Incubators.

Basic operations to handle microorganisms. Sterilisation. Cleaning of materials. Sows. Preparation of solutions. Crop of pathogens.

Isolation and cultivation of microorganisms. Culture media design. Solid and liquid media. Minimum and complex means. Preparation of inoculum. Incubators.

Aerobic and anaerobic crops. Degassing. Catalysts. Microaerophils.

Methods of conservation of microorganisms. Freezing. Lyophilisation. Short-term conservation.

Techniques for the identification of microorganisms. Tintions. Mobility. Means of identification. Biochemical tests. PCR.

Cultivation of genetically engineered microorganisms. Stability. Induction of production. Regulations. Precautions.

c) Application of plant and animal cell culture techniques:

Facilities, equipment and materials to handle animal and plant cells. Culture chambers. Growing rooms. CO2 incubators. Roller incubators. Laminar flow booths. Cryogenic freezers. Cell counter (coulter).

Basic operations to manage animal and plant cells. Sows. Isolation. Passes. Medium changes. Asepsis.

Media design for the cultivation of animal and plant cells. Components. Serums. Synthetic media. Preparation and control.

Primary crops and cell lines. Cell types. Methods of tissue digestion. Adherent cells. Cells in suspension. Tissues. Culture supports (plates and bottles).

Methods of conservation of animal and plant cells. Cryogenesis, Cell Banks. Blood banks.

Techniques for the characterization of animal and plant cells. Karyotypes. Selective antibodies. PCR. Hybridization. DNA Fingerprint. Analysis of Isoenzymes.

instrumental techniques for the visualization of animal and plant cells. Inverted microscopes. Confocal microscopes.

Techniques for quantification of animal and plant cells. Flow cytometry. Tintions. Methods based on image analysis.

Genetically engineered animal and plant cell culture. Regulations. Precautions.

d) Characterization of bioreactors:

General principles of production operations with bioreactors. Design criteria. Scale.

Basic components of bioreactors. Auxiliary devices. Measuring instruments and monitoring of bioreactors. Physical sensors. Chemical sensors. Biosensors. Control systems. Addition pumps. Sterilization systems. Supply of air and gases. Water supply. Electrical supply.

Models and configurations of bioreactors. Tank agitated. Airlift. Fluid bed. Hollow fiber. Membrane. Photobioreactors.

Basic operations for the commissioning of a bioreactor. Sterilisation. Aeration. Agitation. Cooling. Heating. Preparing Microcarriers.

Types of operation (continuous, semi-continuous, and discontinuous). Transfer phenomena. Simulation.

Change of scale. Factors involved in the change of scale. Scale-change methods.

Calculating the performance, material balance and economics of the production process.

e) Characterization of biocatalysis processes:

Fundamentals of the Enzyme. Structure and function of enzymes. History. Concept of enzyme. Classification. Nomenclature. Specificity. Chirality. Cofactors. Functions.

Fundamentals of biotransformation. Enzymatic and cellular catalysis. Enzyme assay. Concepts of kinetics. Kinetics by Michaelis-Menten. Kinetic constants and units. Inhibition. Allosterism. Industrial enzymes. Extreme enzymes.

Quiesce biocatalysts. Enzymes. Cells. Types of quiesce.

Reaction media engineering. Tampons. Pressure. Solvents. Temperature.

Enhancement of biocatalysts. Protein engineering. Mutagenesis. Evolution.

Performance, balance of materials and economics.

f) Recognition of biotechnology production processes:

General principles of biological product processing operations. Cell breakage. Concentration. Centrifugation. Extraction. Lyophilisation. Dialysis. Filtration. Evaporation. Distillation. Crystallization. Drying.

Production of biomolecules of pharmaceutical interest by means of fermentative processes. Antibiotics. Carbohydrates. Amino acids. Vitamins. Organic acids. Antioxidants.

Production of recombinant proteins. Enzymes, hormones, growth factors.

Polysaccharide production. Chitosan. Hyaluronic acid. Weird. Alginate.

Production of antibodies and vaccines. Monoclonal. Recombinant.

Production of biomaterials. Polyhydroxyalkanoates. Polylactic.

Production of substances of pharmaceutical interest by biocatalysts. Steroids. Semi-synthetic antibiotics. Resolution of racemic mixtures.

Calculation of performance, material balance, and economics of the integrated separation and purification process.

8. Professional Module: Pharmaceutical and related production techniques.

Code: 1394.

Contents:

a) Characterization of pharmaceutical and related products:

Concept of medication. Classification of the medicinal products.

Classification according to physicochemical properties:

Hydrosoluble, liposoluble, acidic, and basic drugs.

Depending on your complexity:

Simple and complex drugs.

Generics.

Citroasts.

Nutrition and dietary products, phytotherapy, homeopathy, dermopharmacy and cosmetics, sanitary products.

Depending on your access:

Medicines with and without prescription, advertising, hospital specialties, which need inspection visas. Unit dose.

Depending on your source:

Of synthesis, of medicinal plants, radiopharmaceuticals, homeopathic, biotechnological, blood products, immunological.

Depending on your pharmacological actions, therapeutic uses, and routes of administration.

Depending on the processing technique:

Masterful, official, industrial or pharmaceutical specialty, research.

Biotechnology in the production of medicines.

ATC code.

Medicinal products based on medicinal plants. Classification and general characteristics.

Healthcare products. Classification and general characteristics.

Homeopathy.

Veterinary products.

Concept of formulation. Definition of pharmaceutical forms. Classification. Selection criteria for a pharmaceutical form.

Way of administration of pharmaceutical forms: oral, topical, parenteral and rectal.

Active Principles.

Excipients. Requirements of the excipients. Selection criteria. Organoleptic characteristics, flavorings, flavourings and colorants, among others. Propellant gases.

Preformulation concept. Physico-chemical properties of an active substance: organoleptic characteristics, purity, solubility, size and shape of the particle and speed of dissolution, among others.

Instability in medications. Introduction. Causes of instability. Incompatibilities (humidity, temperature, microbial development, light, transport and packaging, among others).

b) Characterization of the production processes and techniques of solid pharmaceutical forms:

Solid pharmaceutical forms.

Formulation parameters of solid pharmaceutical forms: characterization, choice of excipients, and formulation technology, among others.

Classification of solid forms: tablets, powders, granules, capsules, tablets, suppositories and eggs, among others. Routes of administration: oral, topical (dermal powders, sticks) rectal and vaginal.

Tablets. Types: coated tablets, grageas and special tablets. Types of coatings. Modified release tablets. Formulation. Release of the active substance.

Capsules. Types of capsules. General characteristics. Soft and hard gelatin capsules. Sizes and capabilities.

Special solid oral forms. Forms of immediate, regulated or controlled release.

Characterization of solid forms:

Look.

organoleptic characters.

Physical characteristics (mass uniformity).

Chemical characteristics (richness and uniformity of content in single-dose preparations).

Drug characteristics (resistance, disaggregation time, and dissolution rate).

Microbiological characteristics.

Strong form formulation technologies. Stages of making solid forms.

Process Diagrams. Process types. Flowchart.

Pharmaceutical plants: horizontal and vertical, among others. Advantages and disadvantages.

Features of rooms and equipment and facilities in a pharmaceutical plant. Equipment for the production of solid forms (mixers, sieves, dryers and elevators, among others), compressing machines and capsulators. Coatings of coatings.

c) Characterisation of the production processes and techniques of liquid, semi-solid and other pharmaceutical forms:

Liquid, semi-solid and other pharmaceutical forms.

Formulation parameters.

Classification of liquid forms: solutions, syrups, emulsions suspensions, eye drops, among others. Routes of administration: oral, parenteral and topical (airway).

Oral solutions, syrups and other pharmaceutical forms. Formulation. Manufacturing solutions.

Oral Emulsions. Components of a suspension. Manufacturing.

Classification of semi-solid pharmaceutical forms. Ointments, pastes and creams, among others. Suspensions for topical application. Specifications. Creams. New dosage forms. Transdermal administration. Microemulsions. Liposomes. Characterization: appearance, organoleptic characteristics, physico-chemical characteristics (richness, uniformity of content in single-dose preparations, pharmacological and microbiological characteristics.

formulation technologies. Stages. Manufacture of liquid forms and other pharmaceutical forms.

Process Diagrams. Process types. Flowchart.

Equipment and facilities for the manufacture of liquid forms and other pharmaceutical forms. Equipment for solutions and syrups. Equipment for aerosols. Equipment for suspensions and emulsions. Equipment for creams, gels and ointments. Equipment for suppositories and eggs. Ophthalmic equipment. Equipment for transdermal patches.

d) Determination of sterile product production techniques:

Sterilization. Sterile drug manufacturing processes: parenteral, ophthalmic, nasal and otic.

Basic sterile product manufacturing techniques.

Production characteristics of sterile products. Requirements for injectables (cleaning, neutrality, and isotony).

Performance principles in sterile manufacturing.

Aseptic manufacturing and sterilization diagram. Symbology of the equipment and its elements. Flowchart.

Special areas of production. Areas of sterile products. Areas of allergenic, oncology, and biological products, among others.

Equipment and facilities for the production of sterile products. Equipment for injections.

Control in the manufacture of sterile products.

e) Manufacture of pharmaceutical and related products:

Phases of the manufacturing process. Batch manufacturing.

Operations in the manufacture of pharmaceutical and related forms.

Flow diagram.

Driving a manufacturing line of pharmaceutical and related forms.

Commissioning and stopping a pharmaceutical product manufacturing line.

Maintenance of equipment and facilities in the production of pharmaceutical forms.

Rules of correct manufacturing. Cleaning and disinfection.

Manufacturing Guide. Paragraphs. Fulfillment.

Traceability of the process. Batch documentation.

9. Professional Module: Regulation and control in the pharmaceutical, biotechnology and related industries.

Code: 1395.

Contents:

a) Defining process control parameters:

Classification of control parameters.

Main control parameters: pressure, level, temperature, and flow.

Pressure: drives. Conversion factors. The physical foundation of the measure.

Relative or manometric pressure, absolute pressure and differential pressure.

Flow: units. Direct and indirect measure Conversion factors. The physical foundation of the measure.

volumetric flow rate and mass flow rate.

Level: units. Continuous and timely measurement. Conversion factors. The physical foundation of the measure.

Temperature: units. Conversion factors. The physical foundation of the measure.

Heat and temperature.

Relationship between the variables.

b) Handling of measuring instruments:

General characteristics of measuring instruments: range, range, sensitivity, dead zone, hysteresis, accuracy and accuracy.

Pressure Transmitters: capacitors. Resistive. Piezoelectric. Piezoresistives. Balance and strength.

Differential Pressure Flow Meters: Venturi tubes. Toboeras. Pitot tubes. Hole plates.

Variable Area Meters: Rotamemeters.

Speed Meters: Turbines and ultrasounds.

Electromagnetic Meters.

Positive Displacement Meters.

Mass Flow Meters: Coriolis effect meters.

Level indicators: glass, magnetic, manometer, tape, float, and string.

Level switches.

Level Transmitters: by bubbly, by hydrostatic and differential pressure, conductive, capacitive, ultrasonic, by radar and radioactive.

Local temperature indicators: thermometers.

Thermocouples.

Termorresistors.

Thermistors.

Radiation pyrometers: optical and total radiation.

Temperature switches or thermostats.

Online analyzers: biological and chemical, oxygen probes, and CO₂, among others.

Chemical and physicochemical variables that can be analyzed online.

Sample take systems in online parsers.

Online Parsers Cassette.

Calibration of online probes.

Transmitters and transducers.

Measure ties.

Response of measurement instruments.

Normalized signals. Signal 4-20 mA, 3-15 psi and others.

Data Log Techniques.

Failure detection.

c) Application of basic control systems:

Instruments and bonds symbology: standards and standards (ISA, IEEE, and others).

Loops of control.

Open loop and closed loop.

Elements of a control loop: primary elements, transmitters, transducers, converters, controllers, final elements, alarms, records, controlled variable, manipulated variable, disturbances, and watchpoints.

Final control elements.

The driver.

Basic control types.

All/Nothing Control.

Proportional, integral, and derivative control.

Manual or automatic control.

Applications of a PID control: distillation, boilers, preparation of mixtures and birreactors.

Dashboards.

d) Characterization of advanced control systems:

Cascading control.

Forward control (feed-forward).

Adaptive control.

Predictive control.

Multivariable Control.

Relationship control.

Match range control.

Control of maximums (override).

Distributed control systems.

Architecture of a distributed control system. Operator station. Control cabinets. Levels of a distributed control system: level 1, 2, 3, and 4.

SCADA.

Process optimization.

Hart Protocol.

Control rooms: overview of a control room.

e) Realization of basic programmable logic controller (PLC) programming:

Elements of an electromechanical installation. Symbology of actuators, elements of protection and maneuver.

Basic operation of electrical circuits.

PLC. Operating principles.

Representation, symbol convention, and colors.

Hardware PLC.

PLC software.

Principles of logic. Logical equations.

Logical wired versus contact logic.

Contacts open and closed.

Programming Language.

Structure of a PLC: rack, rack or chassis, power supply, CPU (Operating System and Processor), input modules (discrete and analog), output modules (discrete and analog), memory, and Scan time.

PLC applications in industrial control. Regenerations, put in place, stops. Engine control. Alarm and security systems. Discontinuous manufacturing processes (batch).

Interlocks.

10. Professional Module: Packaging and storage of pharmaceutical, biotechnological and related products.

Code: 1396.

Contents:

a) Defining the conditioning operations:

Conditioning types.

Primary conditioning.

Secondary conditioning.

Pharmaceutical product conditioning regulations.

conditioning functions.

Conditioning as protection against physical or mechanical risks: bumps, falls and pressures, among others.

Conditioning as protection against environmental risks: temperature, humidity, light and atmospheric gases.

Conditioning as protection against biological risks: animal attacks and growth of bacteria or fungi, among others.

Passive protection: Inviolability of the container and prevent access of children, among others.

Conditioning as information: on the primary and secondary packaging.

Drug advertising regulations.

b) Characterisation of the main types of packaging:

Characteristics of the primary conditioning.

Secondary conditioning features.

Types of primary packaging based on the status of the product:

Liquid form: bottles, vials, vials, cartridges, syringes, and bags.

Semi-solid shapes: plastic, metallic or layered tubes of various plastic or metal materials and sheets.

Solid forms: blisters and plastic or glass bottles, among others.

Primary packaging types based on closure:

Container tightly closed.

Hermetic Canister.

Sealed Container. Container with tamper-evident closure.

Characteristics of the closures: tightness test, resistance and compatibility with the contents, effectiveness when closing it once opened, automation of the closure, resistance to the opening by children, ease of dosage and output of the product, among others.

Types of secondary packaging.

Primary pack information.

Information on the secondary packaging.

Batch number.

Expiration date.

Barcode.

Symbols and acronyms used in the packaging of medicines.

Single-dose and multidose conditioning.

Special conditioners: radiopharmaceuticals, advertising specialties, products for the care and maintenance of contact lenses, veterinary medicinal products.

Prospectus.

c) Operations of equipment and facilities for dosing and conditioning:

Conditioning Guide.

Conditioning equipment: in solid, semi-solid, and liquid pharmaceutical forms.

Dose equipment.

Printing and coding systems.

Smart tags.

Dosage and conditioning of sterile products.

First-level maintenance of equipment and installations.

Order and cleaning procedures on primary conditioning equipment. Despyrogate.

Cross-contamination.

Risk prevention and environmental protection regulations.

d) Characterization of storage facilities:

Storage regulations.

Storage rooms inside and outside the lab.

General features of a pharmaceutical and related product store.

Warehouse Organization Models. Conventional and chaotic warehouse.

Distribution of the storeroom.

Storage criteria.

Basic Organization Standards: Stock Reduction, Product Separation, Isolation, and Confinement.

Storage types.

Types of cabinets: for flammable, corrosive, safety, fridges, and microbiological products.

Security items in a lab store.

e) Characterisation of reception and dispatch operations:

General operations and checks.

Checking the security tab.

Input documentation.

Output documentation.

Input and output records.

Product checks.

Retracting, printing, and coding systems.

Batch classification.

Measurement and weighing of quantities.

Goods protection systems.

Computer applications.

f) Realization of the storage of pharmaceutical, biotechnological and related products:

Drug distribution regulations and active principles.

Storage criteria: appropriate labels, security token, record, product classification based on risk, stock, expiration, size, utility, among others.

Storage conditions: cleanup order:

solids: temperature, humidity, level, and height, among others.

liquids: temperature, steam pressure, and level.

Gases: maximum pressure and pressure-temperature ratio.

Conservation conditions.

Isolation and confinement of products.

Signaling.

Storage documents.

Materials stacked: bulk products, drums, boxes, sacks, tubes, carafe, bottles, and glass material.

Inventory.

Computer applications (spreadsheet and warehouse management specific programs).

Storage security measures: product drops and crashes, among others.

Stock management.

11. Professional Module: Electromechanical maintenance in process industries.

Code: 0191.

Contents:

a) Identification of equipment and plant components:

Materials and Properties. Types of materials.

Material nomenclature and acronyms.

Physical and physicochemical properties: hardness, toughness, fragility, stability, elasticity, malleability, thermal and electrical conductivity, density and viscosity, among others.

Treatments and testing of materials: non-destructive testing and destructive testing.

Corrosion of metals. Types of corrosion.

Oxidation.

Degradation of non-metallic materials.

b) Characterization of mechanical elements:

Principles of mechanics. Cinematics and dynamics of the machines.

Machining techniques. Turning, milling and grinding.

Constructive materials of mechanical elements. Types. Properties (optical, thermal, mechanical, chemical, magnetic and sensory). Forces/efforts (traction, compression, bending, torsion, cutting and buckling).

Elements of the machines and mechanisms.

Movement transmission elements (direct and indirect): description, operation, symbology, first-level maintenance.

Moving elements of movement (circular in rectilinear and vice versa): description, operation, symbology.

Join elements (detachable and fixed): first-level description, operation, and maintenance.

Auxiliary elements (accumulators and energy sinks, clutches, supports and bearings). Description, operation, first-level maintenance.

lubrication techniques: fog lubrication.

Transmission elements.

Safety and hygiene regulations.

Valuation of mechanical elements wear: lubrication and preventive maintenance.

c) Characterisation of hydraulic and pneumatic machines:

Fundamentals of pneumatics.

Properties of compressed air.

Pneumatic installations: features and application field.

Compressed air production and treatment circuits. First-level operation, symbology, and maintenance.

Compressed air distribution networks. Constructive characteristics and materials.

Regulatory and control tires. Description, operation, symbology and first-level maintenance.

Drive pneumatic elements or actuators. Description, operation, symbology and first-level maintenance.

Interpretation of the documentation and schemas. Symbology.

Analysis of the different sections that make up the pneumatic installations.

Efficient use of compressed air in food processing processes.

Hydraulic fundamentals.

Hydraulic fluids: types and properties.

Fundamental principles of hydraulics.

Hydraulic unit: fundamentals, elements (reservoir, pump, drive motor, safety valves, pressure gauge, filter and radiator), operation, first level maintenance and safety measures.

Water distribution and regulation elements (flow and pressure regulatory valves, return conduits): description, operation, symbology, first level maintenance and safety measures.

Hydraulic work items (cylinder and engine): description, operation, symbology, and first-level maintenance.

Hydraulic installations: features, application field.

Interpretation of the documentation and schemas. Symbology.

Different operation of the hydraulic system and features.

Safety and hygiene regulations in hydraulic and pneumatic installations.

Environmental impact of pneumatic and hydraulic installations.

d) Identification of electric machines:

Principles of electricity. Current and alternating current. Applications.

Fundamental electrical magnitudes (intensity and current, electrical resistance, voltage or difference of potential, energy and electrical power): definition, units.

Principles of magnetism and electromagnetism.

Electromagnetic Components.

Electrical energy production and transportation facilities. Types. High voltage networks: substations.

Electrical Circuits. Control and manoeuvring elements, protection elements and receivers. Description and operation.

Electrical, static and rotary machines. Typology and features

Classification of electric machines: generators, transformers and motors. Types.

High voltage networks: substations.

High and low voltage maneuvering equipment: dryers and switches.

Relays.

Protective equipment: Uninterruptible protection systems (SAI).

Maneuver cabinets. Typology. Features.

Electrical symbology. Standardisation. Interpretation of electrical schemes.

Safety and hygiene regulations on electric machines.

Safety regulations for low, medium and high voltage electrical circuits.

e) Characterization of maintenance actions:

Maintenance functions and objectives.

Maintenance types. Preventive, first-level and corrective maintenance. Technical documentation.

Organization of first-level maintenance.

Teams, tools, and tools used in first-level maintenance.

Signage for the area for maintenance. Application protocols.

Monitoring specific maintenance. Responsibility.

Dysfunction signs of equipment and installations.

Documentation of the interventions. Records.

Impact of incorrect equipment maintenance and installation.

12. Professional Module: Manufacturing project for pharmaceutical, biotechnology and related products.

Code: 1397.

Contents:

a) Identification of the needs of the productive sector and the organization of the company:

Identification of job roles.

Industry structure and organization.

Company activity and its location in the industry.

Organization chart of the company. Functional relationship between departments.

Industry trends: productive, economic, organizational, employment and other.

Work procedures in the company scope. Systems and methods of work.

Determination of excluded labor relations and special labor relations.

Collective agreement applicable to the professional field.

Company culture: corporate image.

Quality and security systems applicable in the industry.

b) Design of projects related to the sector:

Analysis of the local reality, the business offer of the sector in the area and the context in which the professional training module will be developed in the workplace.

Collecting information.

The overall structure of a project.

Crafting a work script.

Project execution planning: objectives, content, resources, methodology, activities, timing, and evaluation.

Project Feasibility and Opportunity.

Review of applicable regulations.

c) Planning for project execution:

Sequencing of activities.

Elaboration of work instructions.

Making a risk prevention plan.

Documentation required for project execution schedule.

Compliance with safety and environmental standards.

Project quality assurance indicators.

d) Defining control and evaluation procedures for project execution:

Proposal for solutions to the objectives outlined in the project and justification of the selected ones.

Defining the project evaluation procedure.

Determining the variables that can be evaluated.

Documentation required for project evaluation.

Process and end product quality control.

Log of results.

13. Professional module: Training and employment orientation.

Code: 1398.

Contents:

a) Active job search:

Valuation of the importance of permanent training for the career and professional career of the superior technician in the manufacture of pharmaceutical, biotechnological and Finnish products.

Analysis of personal interests, skills and motivations for the professional career.

Identification of training itineraries related to the top technician in Manufacturing of Pharmaceutical, Biotech and Purposes Products.

Responsible for learning itself. Knowledge of the requirements and expected fruits.

Definition and analysis of the professional sector of the title of Superior Technician in Manufacturing of Pharmaceutical, Biotech and Purposes Products.

Planning your own career:

Setting work goals, in the medium and long term, compatible with needs and preferences.

Realistic and consistent goals with current and projected training.

Job search process in small, mid-sized, and large companies in the industry.

Learning and employment opportunities in Europe. Europass, Ploteus.

Job search techniques and instruments.

Self-employment assessment as an alternative for professional insertion.

The decision-making process.

Setting a personal checklist of consistency between career plan, training, and aspirations.

b) Conflict management and work teams:

Valuation of the advantages and drawbacks of the team work for the organization's effectiveness.

Equipment classes in the pharmaceutical and biotechnology production sector according to the functions they perform.

Analysis of the training of work teams.

Features of an effective work team.

The participation in the work team. Analysis of the possible roles of their members.

Conflict definition: features, sources, and stages of the conflict.

Methods for conflict resolution or suppression: mediation, reconciliation, and arbitration.

c) Job Contract:

The right of the job.

Intervention of public authorities in industrial relations.

Analysis of the individual labor relationship.

Determination of excluded labor relations and special labor relations.

Hiring contract modes and promotion measures.

Rights and duties arising from the employment relationship.

Working Conditions. Salary, work time and work rest.

Modifying, suspending, and extinguishing the work contract.

Representation of workers and workers.

Collective bargaining as a means of reconciling the interests of the business and business staff.

Analysis of a collective agreement applicable to the professional scope of the superior technician in the manufacture of pharmaceutical, biotechnological and Finnish products.

Collective conflicts of work.

New work organization environments: subcontracting and teleworking, among others.

Benefits for workers and workers in new organizations: flexibility and social benefits, among others.

d) Social Security, Employment and Unemployment:

The Social Security System as a basic principle of social solidarity.

Structure of the Social Security system.

Determination of the principal obligations of the business and its staff in the field of Social Security: membership, high, low and contribution.

The protective action of Social Security.

Classes, requirements, and benefits.

Concept and situations that are protected by unemployment.

Systems of advice to the company's staff regarding their rights and duties.

e) Professional risk assessment:

Importance of preventive culture at all stages of professional activity.

Assessment of the relationship between work and health.

Analysis and determination of working conditions.

The concept of professional risk. Risk factor analysis.

Risk assessment in the company as a basic element of preventive activity.

Risk analysis linked to security conditions.

Risk analysis linked to environmental conditions.

Risk analysis linked to ergonomic and psychosocial conditions.

Specific risks in the pharmaceutical and biotechnology production sector.

Determination of the possible health damage to the worker or worker that may arise from the identified risk situations.

f) Planning for risk prevention in the enterprise:

Rights and duties in the field of occupational risk prevention.

Responsibilities in the field of occupational risk prevention.

Managing prevention in the enterprise.

Representation of workers and workers on preventive matters.

Public bodies related to the prevention of occupational risks.

Planning for prevention in the enterprise.

Emergency and evacuation plans in work environments.

Elaboration of an emergency plan in a small or medium enterprise in the sector.

g) Application of prevention and protection measures in the enterprise:

Determination of individual and collective prevention and protection measures.

Action protocol in an emergency situation.

First aid. Medical urgency. Basic concepts.

Application of first aid techniques.

Training the company's personnel in the field of emergency plans.

Monitoring the health of workers and workers.

14. Professional module: Enterprise and entrepreneurial initiative.

Code: 1399.

Contents:

a) Entrepreneurship Initiative:

Innovation and economic development. Main features of innovation in the field of pharmaceutical and biotechnology production (materials, technology and production organisation, among others).

Entrepreneurial culture as a social need.

The entrepreneurial character.

Key factors for entrepreneurial people: initiative, creativity and training.

Collaboration between entrepreneurs.

The performance of entrepreneurs as employees of a company related to the manufacture of pharmaceutical, biotechnology and related products.

The performance of entrepreneurs as entrepreneurs in the pharmaceutical and biotechnology production sector.

The risk in entrepreneurial activity.

Concept of entrepreneurship. Requirements for the exercise of business activity.

Personal goals versus business goals.

Business Plan: the business idea in the field of pharmaceutical and biotechnology production.

Good practices of entrepreneurial culture in the manufacturing of pharmaceutical, biotechnology and related products at the local level.

b) The company and its environment:

Basic company functions.

The enterprise as a system.

The overall business environment.

Analysis of the overall environment of a company related to the manufacture of pharmaceutical, biotechnology, and related products.

The company's specific environment.

Analysis of the specific environment of a company related to the manufacture of pharmaceutical, biotechnological and related products.

Relationships of a pharmaceutical, biotech, and related manufacturing company with its environment.

Relations of a company manufacturing pharmaceutical, biotechnology and related products with the whole of society.

Company culture: corporate image.

Social responsibility.

The Social Balance.

Business ethics.

Social and ethical responsibility of companies in the pharmaceutical and biotechnology production sector.

c) Creating and starting a company:

Company concept.

Enterprise Types.

The responsibility of the owners of the business.

Taxation in companies.

Choice of the legal form. Dimension and number of partners.

Administrative formalities for the formation of a company.

Economic Viability and financial viability of a company related to the manufacture of pharmaceutical and biotechnology products.

Analysis of sources of financing and budgeting of a company related to the manufacture of pharmaceutical and biotechnology products.

Aid, grants and tax incentives for SMEs related to the manufacture of pharmaceutical and biotechnology products.

Business plan: choice of legal form, economic and financial feasibility study, administrative procedures and management of grants and grants.

d) Administrative function:

Concept of basic accounting and notions.

Accounting operations: recording the economic information of a company.

Accounting as a true picture of the economic situation.

Analysis of accounting information.

Corporate Tax Obligations.

Requirements and deadlines for the filing of official documents.

Administrative management of a company related to the manufacture of pharmaceutical, biotechnological and related products.

15. Professional module: Training in job centres.

Code: 1400.

Contents:

a) Identification of the structure and business organization:

Structure and business organization of the pharmaceutical and biotechnology production sector.

Company activity and its location in the pharmaceutical and biotechnology production sector.

Organization chart of the company. Functional relationship between departments.

The company's logistics organization. Suppliers, customers, and marketing channels.

Work procedures in the company scope. Systems and methods of work.

Human resources in the enterprise: training requirements and professional, personal and social skills associated with different jobs.

Quality system set in the job center.

The security system set in the job center.

b) Application of ethical and labour habits:

Personal Attitudes: empathy, punctuality.

Professional attitudes: order, cleanliness, responsibility and security.

Attitudes to the prevention of occupational and environmental risks.

Hierarchy in the enterprise. Communication with the work team.

Documentation of professional activities: methods of classification, coding, renewal and elimination.

Recognition and application of internal company rules, work instructions, standard work procedures, and others.

c) Preparation of auxiliary areas and services:

Selection of production areas in the pharmaceutical industry.

Securing the order and cleaning of work areas.

Checking the proper operation of auxiliary equipment and facilities.

Realization of the tuning and maintenance of auxiliary facilities and equipment.

Performing the commissioning and stopping of auxiliary equipment and facilities.

Selecting and adjusting the operating variables of the auxiliary equipment.

Verifying the proper functioning of auxiliary equipment and facilities.

d) Elaboration of pharmaceutical, biotechnology and related products:

Interpretation of the process diagram and the manufacturing guide.

Selection of materials, equipment and production facilities.

Checking the correct conditions and proportions of the process materials.

Realization of the installation and maintenance of production facilities and equipment.

Performing the commissioning and stopping of equipment and installations.

Selecting and adjusting the operation variables of the equipment and installations under the conditions set out.

Order and cleanup assurance in production areas.

Completing the documents in the manufacturing guide.

e) Packaging and storage of pharmaceutical, biotechnological and related products:

Analysis of product conditioning procedures.

Selection of materials, equipment, and conditioning facilities.

Realization of the installation and installation of equipment and installations.

Performing the commissioning and stopping of equipment and installations.

Selecting and adjusting the operation variables of the teams.

Completion of packaging and labeling.

Performing storage by ensuring product quality.

Order assurance and cleaning in the areas of conditioning and storage.

Fulfillment of the documents in the manufacturing guide and the receipt and dispatch records.

f) Participation in the realization of quality control of products:

Identification of the quality parameters to be controlled in the manufacture of pharmaceutical, biotechnological and related products.

Establishment of online and quality control analysis for raw materials, intermediate and final products.

Setting the sampling points.

Performing the sampling and transfer, ensuring its representativeness, controlling the contamination and alterations.

Selection of sample and measurement equipment, checking their calibration and maintenance.

Performing the product online quality controls.

Record the data obtained, ensuring product traceability.

Elaboration of production and process control technical reports.

g) Application of the rules on risk prevention and environmental protection:

Identifying the risk types of the production process.

Take appropriate safety measures for substance handling.

Securing compliance with security regulations on equipment and installations.

Securing compliance with environmental protection regulations in the production process.

Analysis of the actions corresponding to the company's emergency plan.

Study of action protocols in the event of an accident or incident in the company.

Performing pollution controls in the workbench.

Managing the waste generated in the production process.

ANNEX II

Sequencing and weekly hourly distribution of professional modules

Mid-Grade Forming Cycle: Manufacturing of Pharmaceutical, Biotech, and Purposes Products

1395. Regulation and control in the pharmaceutical, biotechnology and related industries

1399. Enterprise and entrepreneurship

in the formative cycle

	Module	Duration (hours)	First Course (h/week)	Second
				2 Quarters (h/week)	1 quarter (hours)
1387. Organization and management of pharmaceutical, biotechnological and related products manufacturing	75	2
1388. Quality control of pharmaceutical, biotech and related products	150	5
1389. Basic operations in the pharmaceutical, biotechnology and related industries	175	5
1390. Principles of Biotechnology	150	5
1391. Safety in the pharmaceutical, biotechnology and related industries	75	2
	1392. Ancillary areas and services in the pharmaceutical, biotechnology and related industries	155	5
1398. Job training and guidance	90	3
reserved for the English imparted module	90	3
1393. Biotechnology production techniques	110		5
1394. Pharmaceutical and related production techniques	130		6
90		5
1396. Conditioning and storage of pharmaceutical, biotechnological and related products	70		4
0191. Electromechanical maintenance in process industries	100		5
60		3
reserved for the imparted module in English	40
1397. Pharmaceutical, biotech and related products manufacturing project	40			40
1400. Job center training	400			400
2,000	30	30	440

ANNEX III

Modules capable of being imparted in the English language

1388. Quality control of pharmaceutical, biotechnology and related products.

1389. Basic operations in the pharmaceutical, biotechnology and related industries.

1390. Principles of biotechnology.

1392. Ancillary areas and services in the pharmaceutical, biotechnology and related industries.

1393. Biotechnology production techniques.

1394. Pharmaceutical and related production techniques.

1395. Regulation and control in the pharmaceutical, biotechnology and related industries.

0191. Electromechanical maintenance in process industries.

ANNEX IV

Minimum spaces and equipment

Spaces:

Form Space

Surface
30 pupils or students	20 pupils or students
	60	40
Analysis Lab and physicochemical	120	90
and biotechnology lab	120	90
chemistry lab	180	120

Minimum Equipment:

Forative Space

-purpose Aula.	Computers installed in network, projection system, and internet. Audiovisual media. Application computer programs
and physicochemical analysis lab.	Calefactor magnetic Agitator. Humidity Analyzer. Security Armarium for Reagents. Balance analytics. granary balance. Thermostatic Bath. Empty pump. Centrileak. Column deminerator. Compressor. Destimator. Boiling point determination equipment. Electrophoresis equipment. The sieve team. Team for the determination of the melting point. Espectrotocolorimeter. Infrared Spectrophotometer. Visible ultraviolet spectrophotometer. Desiccation study. The rotating Evaporator. Horno. Portable instruments for measuring environmental conditions. Game densimeters. Ice making machine. General lab material. Ball mill. Teams and Sample Take Tiles. Portable Oximeter. field pHmr. Polimeter. Polimeter. Potentiometer. Abbe. Immersion Termostat. Portable Turbimeter. Viscosim
Microbiology and Biotechnology Lab.	Approved cleaning and disinfection agents, equipment, and instruments. Calefactor magnetic Agitator. Orbiting Agitators with Regulation Image Analyzer. Specific computer applications. 75 L. AutoKey Balance precision electronics 0.01 g. Balances. Ultrasound Bath. Bans microtube and microplate heaters. Empty pump. Laminar Flow Campaign. Campaign for PCR. Centriescape from 20 000 to 40 000 rpm. Freezer at -40ºC. Binocular biological microscopy equipment. UV protection equipment and accessorials. Colony counter equipment. Cell culture equipment. electrophoresis. Extraction equipment. HPLC equipment. Immunodetection equipment. Test teams biotoxicity. Equipment and apparatus dedicated to micro-manipulation of animal, plant and micro-organism cells. Equipment for genetic transformation and microbial selection of animal and plant cells. UV spectrophotometer with buckets. Drying Study. Crop stoves. Sterilization studies. Refrigerator with freezer -20ºC. Homogenizer. UV-Lamp. UV Lamp. Binocular Lupas. Basic biotechnology material. General Microbiology Material. Microflow with temperature regulation. Binocular biological microscopes. Pipettes automatic variable and serial volumes. Calefactor Plates. Empty filtering ramps. 20 L lab reactor equipped. Gel dryer. Termocycler with temperature ramp (PCR). Immersion thermostats. 312nm transient, with image analyzer, video printer, and monitor. Vortex
Industrial Chemistry Lab.	Automatic Analyzers; Online Parsers. Security Armarium for Reagents. Analytics Balance. Electronic granary balance. Regulatory items. Control loops with sensor, actuators, transmitters and controllers. Control panel with programmable logic control devices. Control final elements. Plant trainer: simulator for a real industrial chemical/biochemical process. < Aero-table_body_body. Permeability equipment. Regulatory and process control equipment (pH, flow, temperature, pressure, level). Siking Equipment. Pharmaceutical Forms Disgregation Equipment. Dissolution Teams. Hardship Equipment. Friability Equipment. Auxiliary line of a pharmaceutical plant: pressure systems, vacuum, heating, water vapor, inert gases, air conditioning, air sterilization, and water treatment. Equipment for the manufacture of pharmaceutical forms. < Zant_table_to_izq"> Conditioning Lines. General material esmeriled for mounts. Chemical/biochemical reactor equipped. Neural Networks and expert systems. Alarm, surveillance and communication systems. Digital control systems. Control, compute, or log modules and display monitors. Local control systems. Log, manual, or computer systems. Utiles, tools, and maintenance products.