Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-8441
The Royal Decree 832/2014, on 3 October, which establishes the title of senior technician in manufacturing of pharmaceutical, biotechnological and related and fix their minimum educations, acts in accordance with the Royal Decree 1147 / 2011, July 29, which establishes general vocational education system management which it defines in article 9 the structure of titles of professional training and specialization courses, taking as a basis the national catalogue of professional qualifications, the guidelines laid down by the European Union and other aspects of social interest and implements the mentioned title of manufacturing of pharmaceutical, biotechnological and related.
The organic law 2/2006, of 3 may, education, establishes the educational administrations to develop the curriculum of the titles of professional training, starting from the basic curriculum and in the conditions laid down in article 6 bis 4. Schools will develop and complete, where appropriate and as established by the educational administrations, the curriculum of the different stages and cycles in use of their autonomy as set out in chapter II of title V of the aforementioned organic law.
The Royal Decree 832/2014, 3 October, in its first repealing provision, repeals the Royal Decree 1069 / 1993, of 2 July, which establishes the curriculum of the training cycle of top grade corresponding to the title of senior technician in manufacturing of pharmaceutical, biotechnological and related, established under the auspices of the organic law 1/1990 of 3 October , of General Organization of the educational system.
In accordance with the foregoing and after a Royal Decree 832/2014, October 3rd, has set the professional profile of the title of technician in manufacturing of pharmaceutical, biotechnological and related, the basics of the curriculum and other aspects of academic management that ensure a common training and guarantee the validity of the titles throughout the national territory now determine, in the field of management of the Ministry of education, culture and sport, the expansion and contextualization of the contents of the professional modules included in this title, respecting the professional profile of the same. It means 'pharmaceutical product', within the framework of this order, all those 'medicines and sanitary products"that are established as such in the current legislation on this matter.
The needs of a market of work integrated in the European Union require that the teachings of training pay special attention to the languages of the countries members, incorporating them into its training offer. In this sense, this training cycle includes in the curriculum for training in English language, in response to the provisions of the Royal Decree 1147 / 2011, July 29.
In addition, the curriculum of the training cycle is established since respect autonomy pedagogical, organisational and management of the centres that offer vocational training, promoting these teamwork of teachers and the development of plans of training, research and innovation in the teaching field and actions that promote the continuous improvement of the training processes.
On the other hand, professional training centres will develop the curriculum established in this order, taking into account the characteristics of the student body, with special attention to the needs of persons with disabilities.
Finally, it should be noted that this training cycle curriculum integrates scientific, technological and organizational aspects of the established teachings for the students to acquire a global vision of the productive processes of the professional profile of the technician in manufacturing of pharmaceutical, biotechnological and related.
In the process of elaboration of this order has issued report of the State School Board.
For all of the above, in virtue, I have: chapter I General provisions article 1. Object.
This order is intended to determine, from the basic curriculum established in Royal Decree 832/2014, on 3 October, which establishes the title of technician in manufacturing of pharmaceutical, biotechnological and related and fix their minimum educations, the curriculum of the training cycle of top grade corresponding to the aforementioned title.
Article 2. Scope of application.
The curriculum established in this order shall apply within the territorial scope of the Ministry of education, culture and sport management.
Chapter II article 3 curriculum. Curriculum.
1. the curriculum for the teaching of vocational training of the educational system corresponding to the title of senior technician in manufacturing of pharmaceutical, biotechnological and related, established in Royal Decree 832/2014, October 3rd, is determined in the terms set out in this order.
2. the professional profile of the curriculum, which is expressed by the general competence, professional, personal and social competences and qualifications and units of competence of the national catalogue of professional qualifications, is included in the title of technician in manufacturing of pharmaceutical, biotechnological and related, referred to in the preceding paragraph.
3. the General objectives of the curriculum of the training cycle, the objectives of professional modules expressed in terms of learning outcomes and assessment criteria are included in the title of technician in manufacturing of pharmaceutical, biotechnological and related, referred to in paragraph 1 of this article.
4. the contents of the professional modules that make up the present curriculum, adapted to the socio-economic reality as well as the prospects for 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 by this order is established taking into account the socio-economic reality and the geographical, socio-productive and labor characteristics of the environment's implementation of the title.
2 vocational training centres will benefit necessary autonomy pedagogical, organisational and economic management for the development of the teachings and its adaptation to the specific characteristics of the socio-economic, cultural, and professional environment.
3. the authorized to deliver this training cycle will realized and develop curricular and organisational measures that are most appropriate to the characteristics of its students and of their production environment, flexibly and in use of their pedagogic autonomy, within the general framework of the educational project, in the terms established by the organic law 2/2006, education.
4. the curriculum of the training cycle regulated by this order will take place in educational programs or curriculum development, enhancing or creating the culture of prevention of occupational hazards in the spaces where be given professional modules, as well as promoting a culture of environmental respect, excellence in work, compliance with standards of quality, creativity, innovation gender equality and respect for equality of opportunity, the 'design for all' 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 the students and the environment, attending especially to persons with disabilities, in terms of accessibility and support resources needed to ensure that this student can study these teachings in the same conditions as the rest.
2. in addition, the teachings of this cycle will be taught with a flexible and open methodology based on self-learning and adapted to the conditions, capabilities and needs of students, so as to enable reconciliation of learning with other activities and responsibilities.
Article 6. Duration and sequencing of professional modules.
1. the total duration of the teachings relevant to this training cycle, including the professional training module in workplace, is 2000 hours.
2. the professional modules of this training cycle, when they are offered on a face-to-face basis, will be organized in two academic years and shall be adjusted to the sequencing and weekly hourly distribution determined in annex II of this order.
3. the first academic year will take place entirely in the educational center. To be able to attend the second course, you will need to have passed the professional modules involving altogether, at least eighty percent of the hours of the first course.
4. ensure the right of registration of those who have completed a professional module in another autonomous community in the terms established in article 48.3 of the Royal Decree 1147 / 2011, July 29, which establishes the general management of the vocational training of the educational system.
5. in General, during the third quarter of the second year, and once achieved the positive assessment in all professional modules in the educational center, the professional training module will be developed in work centers.
6. exceptionally, and in order to facilitate the adjustment of the number of registered people to the availability of training posts in enterprises, approximately half of the second year students may develop module professional training in workplace during the second quarter of the second year, provided they have positively passed 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 that can prevent the development of professional training module in workplace can conform to previous assumptions, this will organize in other periods coincide with the development of the economic activity of the professional profile of the title.
8. in any case, the evaluation of the professional training module in workplace will depend to the positive evaluation of the rest of the professional modules of the training cycle.
Article 7. Professional project module.
1. the professional module 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 technician in manufacturing of pharmaceutical, biotechnological and related.
2. in General, this module will be taught by teachers who exerts the tutoring of training in workplace.
3. the professional module of project will be developed during the last period of the training cycle, combining the collective, and the individual tutoring so that at least 50% of the total length is carried out in person and complete with mentoring a distance in which information and communication technologies will be employed.
4. in any case, and before the start of the professional training module in workplace, responsible teachers must anticipate the teaching and learning activities that facilitate the development of the professional project module.
5. the evaluation of this professional module will depend to the positive evaluation of the rest of the professional modules of the training cycle, including training in workplace.
Article 8. Bilingual education.
1. the curriculum of the training cycle includes the English language in an integrated manner at least in two professional modules that make up the whole of the training cycle. These modules will be taught by teachers with teaching attribution in them and, in addition, having the linguistic qualification corresponding to level B2 of the common European framework of reference for languages.
2. in order to ensure that bilingual education is provided in two academic courses of the training cycle on an ongoing basis, professional modules of both courses will be chosen.
3. likely to be taught in English language modules are the designated annex III.
4. as a result of the greater complexity involved in the transmission and reception of teaching in a language other than the mother, the professional modules taught in English language increase their workload time, three hours per week for the set of modules that are taught in the first year and two hours for which develop during the second year. In addition, teachers who impart these professional modules will be assigned, in your individual schedule, at least three hours a week to prepare. These hours will be the same character as the hours.
5. on an exceptional basis and temporarily until 2020, when teachers with teaching attribution does not have the level of English required in these professional modules, you will share a total of three hours per week for the set of modules that are taught in the first year and two hours for which develop during the second course with a teacher or a teacher of English specialty. In this course, the programming of these modules will include, at least, a unit of work or teaching to be held exclusively in English language and the rest of didactic units will incorporate given teaching and learning activities exclusively in English at the assigned time.
6. on an exceptional basis, and upon request, in the case of students or students with disabilities that may present difficulties in its oral expression (cerebral palsy, deafness...) easing measures and/or alternatives will be established on the requirement of delivery of modules in English language, in a way that can take all the teachings of the professional modules in the Castilian language. These adaptations in no case shall be taken into account for lower the grades obtained.
Chapter III faculty, spaces and facilities article 9. Qualifications and accreditation of teachers requirements.
1. the specialties of faculty with teaching attribution in professional modules that constitute the teachings laid down for the title referred to in article 1 of this order, as well as equivalent qualifications for the purpose of teaching, are pick-ups respectively in annexes III A and III B of the Real Decree 832/2014, October 3rd.
2. with the aim of ensuring compliance with article 12.3 of the Real Decree 832/2014, on 3 October, for delivery of professional modules that comprise it, privately owned centres or public owned by other than the educational administrations, it must demonstrate that it complies with all the requirements established in that article, providing the following documentation (: a) certified photocopy of the official academic title demanded, according to the qualifications listed in annex III C of Royal Decree 832/2014, October 3rd. When the presented qualifications have direct correspondence with the professional module that you want to impart, deemed that it includes in itself the objectives of this module. Otherwise, in addition to the degree, the documents referred to in subparagraph (b) be provided) or c).
(b) in the event that want to justify that teachings leading to the qualification provided encompasses the objectives of professional modules that is intended to impart: personal academic certification of studies, original or authenticated, issued by official site, stating the teachings taken detailing the subjects.
Studies programs provided and completed by the person concerned, original or certified photocopy them, sealed by the University or corresponding official or authorized school.
c) where it is necessary to justify through work experience, at least for three years, has developed its activity in the sector linked to the professional family, its duration will be credited with the corresponding supporting official document, which will be: certification of the company or employer organization specifically indicating the activity carried out by the person concerned. This activity has to be implicitly related to the learning outcomes of the professional module which aims to impart.
In the case of those who work on their own, statement by the person concerned of the most representative activities related to learning outcomes.
Article 10. Spaces and facilities.
Spaces and facilities which must comply with the vocational training centres, to enable the development of teaching activities, are those set out in annex IV of this order and shall comply with the provisions of article 11 of Royal Decree 832/2014, October 3rd, as well as the legislation on equal opportunities, 'design for all' and universal accessibility , prevention of occupational health and safety in the workplace.
Chapter IV other offers and modality of these teachings article 11. Offer remote.
1. the professional modules offered to distance, when by its characteristics they required, ensure students the attainment of all the objectives expressed in the results of learning, through face-to-face activities.
2. the provincial directorates and the departments of education shall take the necessary measures and will give detailed instructions to centres authorized to deliver this training cycle in face-to-face mode, to start up and operation of the offer of the same distance.
3 authorised centres for imparting teachings of professional distance learning will have appropriate curriculum materials to be adapted to the provisions of the fourth additional provision of the organic law 2/2006 of 3 May.
Article 12. Combined offer.
In order to respond to the needs and personal interests and give the possibility to combine training with work, with other activities or situations, the offer of these teachings for adults and young people in special circumstances can be combined between regimes of classroom teaching and distance simultaneously, provided the same modules in two modalities do not take at the same time.
Article 13. Offer for adults.
1. the professional modules of this training cycle associated with units of competence of the national catalogue of professional qualifications may be a modular offer aimed at adults.
2. This training will be developed with an open and flexible methodology adapted to the conditions, capabilities and personal needs that allow them to reconciliation of learning with other activities and responsibilities, fulfilling the provisions of chapter I of title IV of the Royal Decree 1147 / 2011, July 29. In addition, this training will be capital to achieve a degree of professional formation, for which it will be necessary to prove the requirements of access.
3. with the aim of reconciling the learning with other activities and responsibilities, the provincial directorates and the departments of education may establish specific measures to fulfil the provisions of article 41 of the Royal Decree 1147 / 2011, July 29 and enable a range of face-to-face and distance simultaneously.
4. with the aim of promoting lifelong training, the Directorate-General of professional training of the Ministry of education, culture and sport may authorize the provincial directorates and the departments of education teaching, in the centers of their competence, professional modules organized in training units of shorter duration. In this case, each result of learning, with their criteria of evaluation and its corresponding block of content, will be the minimum and indivisible unit of partition.
First additional provision. Authorisation to impart these teachings.
Provincial and regional ministries of education processed authorization to the General Directorate of vocational training to be able to impart the teachings of this formative cycle of complete or partial form regime face-to-face and distance, of centres who request it and meet the requirements under the current legislation.
Second additional provision. Linguistic empowerment of teachers in bilingual education.
Teachers who go to provide teaching in English language must be in possession, before the date of beginning of each academic year, of the corresponding linguistic empowerment, for which purpose the Ministry of education, culture and sport will conduct a habilitation procedure before the beginning of each course.
Third additional provision. Training of teachers of bilingual education.
Provincial and regional ministries of education scheduled courses and English language training for all teachers of vocational training that will provide teaching in the subject to be taught in English language, professional modules who will be required to attend to them until they get the required habilitation. These measures shall apply, at least until the year 2020.
The training offered will be of three types: a) intensive training, through a course made, preferably in the modality, during the month of September.
(b) formation of long-lasting throughout the school year, through a course that combines face-to-face form and online, which will be held outside opening hours of forced stay in the training centre. During the period of preparation of the professional training module in workplace, this course will intensify and will be held, if possible, between the hours of forced stay in the Center.
(c) training in English-speaking country, through courses, which possibly will include cultural visits to institutions and attendance at conferences, and to be held at the end of the year once completed school activities in the training centres.
Sole transitional provision. Substitution of titles related to these teachings.
1. the students that, at the end of the school year 2015-2016, satisfying the conditions required to attend the second course of regulated title in Royal Decree 810/1993, of May 28, which establishes the title of technician in manufacturing of pharmaceutical products and related industries and the corresponding minimum teachings, under cover of the organic law 1/1990 , 3 October, General Organization of the educational system, and that has not passed any of the professional modules of the first course of the mentioned title, will have two calls in each of two successive years to overcome such professional modules. After this period, in the school year 2018-2019, apply you the validation, for modules overcome, laid down in article 15(1) of the Real Decree 832/2014, October 3rd, regulated by the organic law 2/2006 of 3 May.
2. to students who at the end of the school year 2015-2016, not satisfying the conditions required to attend the second course of the title of technician in manufacturing of pharmaceutical products and related, established by Royal Decree 810/1993, of 28 may, under cover of the organic law 1/1990 of 3 October, will apply the recognition set out in article 15(1) of the Royal Decree 832/2014 3 October, regulated by the organic law 2/2006 of 3 May.
3. the students that, at the end of the school year 2016-2017, does not meet the conditions required to obtain the title of technician in manufacturing of pharmaceutical products and related, established by Royal Decree 810/1993, of 28 may, under cover of the organic law 1/1990 of 3 October, will feature two calls in each of two successive years to overcome these professional modules , with the exception of the training module in workplace for which you will have an additional school year. To students who after that period had not obtained the title apply the validations for the overmatched modules set out in article 15(1) of the Real Decree 832/2014, October 3rd, regulated by the organic law 2/2006 of 3 May.
First final provision. Application of the order.
The Directorate-General of professional training, is authorized in the scope of their powers, to adopt measures and enact the necessary instructions for the application of the provisions of this order.
Second final provision. Implementation of these teachings.
1 during the 2015-2016 will be implemented the first year of the training cycle to which refers article 1 of this order and they will impart the teachings of first course covered by organic law 1/1990 of 3 October, corresponding to the Real Decree 810/1993 of May 28.
2 during the 2016-2017 will be implemented the second year of the training cycle to which refers article 1 of this order and they will impart the teachings of second year covered by organic law 1/1990 of 3 October, corresponding to the Real Decree 810/1993 of May 28.
Third final provision. Entry into force.
This order shall enter into force the day following its publication in the "Official Gazette".
Madrid, 21 July 2015.-the Minister of education, culture and sport, Íñigo Méndez de Vigo and Montojo.
Annex I professional modules 1. Professional module: Organization and management of the manufacture of pharmaceutical, biotechnological and related.
Contents: a) definition of the Organization and functional areas of a pharmaceutical or biotech company: classification of pharmaceutical laboratories: pharmaceutical laboratories of production.
Pharmaceutical laboratories of container.
Basic structure of the pharmaceutical and biotechnological industries.
Functions. Organization charts.
Analysis of process diagrams. Symbology.
Functional relationships of the different departments.
General aspects of facilities, buildings and spaces.
(b) characterization of the rules of good manufacturing and good practices of distribution of drugs and active ingredients: good manufacturing: objective. Scope. Guide to manufacturing.
Quality management. Responsibility of the unit's quality. Responsibility for production. Internal audits. External audits. Review of the quality of the product.
Staff. Training. Personal hygiene. Consultants.
Risks of contamination and cross-contamination.
Buildings and facilities. Design. Services. Dedicated areas. Lighting. Hygiene and maintenance. Water. Waste and wastewater.
Processing equipment and computer systems. Maintenance and cleaning of equipment. Calibration. Backup.
Raw materials management. Reception and quarantine. Sampling and analysis. Storage.
Production and process controls. Deadlines. Sampling and process controls. Mixing of batches. Pollution control.
Packaging, labelling, storage and distribution: packaging materials. Emission and control of tags. Packaging 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. Dates of expiry and reanalysis. Retention samples. Validation documentation. Validation of cleaning. Review of validated systems.
Rejection and re-use of materials: rejection. Reprocessing. Rework. Recovery of materials. Returns.
Claims and removed from the market.
Manufacturers and contracted Labs. Intermediate agents, brokers, traders, distributors, re-envasadores and re-etiquetadores.
(c) application of the guideline of manufacturing: manufacturing batch. The batch documentation. Traceability of the process.
Documentation systems. Specifications.
Records of use and cleaning of equipment.
Records of raw materials, intermediates, materials for packaging and labelling of active substances.
Method pattern (master production and control records). Formula pattern. Production instructions.
Production (production of batches and control records) Protocol. Identification of date, lot, results, used laboratory equipment and controls in process, appreciated deviations and result of the final analysis for lot release.
The laboratory control records: description of sample, date, analytical method, registration data and calculations and comparison with established acceptance criteria statement.
Revision of the Protocol of batch production. Compliance with the specifications for batch release.
(d) Organization of activities of an area of work: working methods. The improvement of methods.
Study and work organization. Programming of work methods. Task analysis and description of jobs in the pharmaceutical, biotechnology and related industries.
Elaboration of instructions for producing leaves.
Planning and control of continuous and discontinuous production.
Optimization of processes.
(e) characterization of authorisation, pharmacovigilance of medicinal products and confidentiality regulations: procedure for authorisation, registration and dispensation of medicines conditions. Requirements of the applicant. Evaluation of the documentation. Identification of the medicinal product guarantees. Authorization. Modifications of the conditions. Procedure for suspension and revocation. Community procedures.
Standards and analytical, pharmacotoxicological tests and clinical protocols relating to drug testing.
Pharmacovigilance of medicinal products. Sources of information. Agents of pharmacovigilance. Modification, suspension or revocation of the authorization. Studies postautorización.
Patents. Brands. Utility models. Industrial secrets.
Spanish and European legislation.
Rights and obligations. Advantages and disadvantages.
Confidential information. Protection. Contracts.
Limits of the obligation of confidentiality and secrecy.
2. professional module: Quality Control of pharmaceutical, biotechnological and related products.
Contents: a) implementation of quality control systems: elements of quality: quality assurance. Quality assurance plan.
Quality assessment. Inspection and audits. Documents.
Evaluation of the quality of the facilities: lighting, temperature, humidity, pressure, order and cleanliness, among others.
Inspection of the cleaning and disinfection operations: order of the process. Control of cleaning rooms and utensils. Cross-contamination. Control of disinfection of rooms and utensils. Registered biocides. Labelling of equipment and areas operations.
Evaluation of control on product process.
Control parameters: check-up of materials, sealing of blisters, integrity, closures, weight, print quality, focused and units per package or box.
Basic knowledge of the parameters that must be controlled. Methodology applied in each parameter.
Documents associated with process controls.
Registration and data collection.
Specifications and compliance with intervals. Deviations.
Inspection of measurement and process control equipment.
Types of equipment: magnifying glass, temperature, humidity, pressure, ammeters, registrars graphics and speed control.
Calibration of equipment. Maintenance. Systematic cleaning.
Application of computerized systems.
Process anomalies: types of anomalies and deviations. Corrective actions. Register of actions and shortcomings.
Evaluation of control of conditioning materials: types of materials. Characteristics of the packaging materials. Symbology. Filling, packaging and labeling. Modified atmospheres. Sealing of containers.
Standards of product finished according to their properties. Conditioning and storage.
(b) interpretation of the plan of testing and analysis of manufacturing processes: analysis and control plans. Quality of production. Planning of production quality control. Product verification. Control of inspection, measuring and test equipment. Quality in services. Selection of technical documentation.
Systems of quality control in production and laboratory.
Documents of quality systems.
Specifications of process control.
Most representative parameters of the production process. Methods manual, automatic, machine and others.
Standard operating procedures (SOP). Criteria and phases for its elaboration.
Establishment of tests to be performed. Physico-chemical tests on products in chemical plant. Physico chemical laboratory tests. Chemical analysis. Biochemical analyses.
Establishment of sampling frequencies.
Environmental risks and environmental protection.
Treatment of results: systems of registration of results of tests in the chemical industry. Specific software tools. Applied statistics. Statistical treatment of results in chemical industry. Analysis and representation of results.
(c) taking of samples: sampling Plan: sampling programmes. Plan of two classes and three classes. A sampling plan OC curves. Plans military Standard 105-D. levels of inspection. Single, double and multiple sampling. Table handling. Variables sampling plans. Military Standard 414 table handling.
Decision-making criteria for the interpretation of results.
Acceptable quality (NCA or AQL) level.
Standard sampling procedures. Organization of the sampling plan.
Official rules for the realization of sampling.
Sampling: in solid and liquid gas plant. Sampling procedure. Instruments and containers. Techniques of direct taking of samples of air, water, other liquids and solids.
Types of sampling: air, on surfaces, in liquid samples and in solid samples.
Conditions of handling, storage, transport and storage for various exhibitions.
Prevention of common mistakes in the handling of a sample and calculation of uncertainties in sampling.
Treatment of samples for testing.
(d) carrying out physical and physico-chemical tests: verification of organoleptic characteristics.
Physico-chemical tests on products in plant: concept, scales and methods. Used equipment. Calibration and contrast. PH. Density. Viscosity. Color. Refractive index. Specific rotation. Turbidity. Others.
Physicochemical tests in the laboratory: concept, scales, methods and equipment used. Standards: API, ASTM, BS, DIN, ISO. Trials of clean water. Trials of residual water. Trials of other liquids: density, viscosity, color, moisture, conductivity, heat capacity and corrosion. Sedimentation rate.
Physical tests: distillation range. Melting point. Solidification point. Hardness. Others.
Trials of solids: colour, particle size, moisture, bulk volume. Disintegration. Friability. PH. Others.
Trials of related products: specific weight. Size of the particles. Emulsion type. Dry residue. Others.
Accomplishment of tests on solid, semi-solid and liquid forms and others.
Measurement of physical and physicochemical variables: physical and physico-chemical parameters that must be controlled in manufacturing and finished product. Description of the procedure of trial, used equipment, processing and presentation of data obtained. Justification of results and conclusions.
(e) implementation of quantitative chemical analysis: General manipulation of matter and material techniques in the laboratory.
Cleaning of laboratory techniques.
Identification of chemical products.
Preparation of solutions and mixtures.
Normalization of reagents.
Basic operations for preparation of samples for analysis.
Standards of safety and environmental protection.
Fundamentals of the gravimetric analysis.
Gravimetric methods of analysis.
Types of chemical reactions and major applications.
Volumetric methods of analysis. Indicators.
Interpretation of analytical results. Errors.
Identification of organic compounds and formation of derivatives.
Organic elemental and functional analysis.
Selection of instrumental analytical techniques.
Identification and measurement of components by chemical or instrumental analysis techniques.
Analysis of samples by instrumental analytical techniques: application of electrochemical methods. Trials using optical methods. Application of spectroscopic techniques. Application of separation techniques.
Chemical parameters that must be controlled in the analysis and control of manufacturing and finished product.
Description of the procedure of trial, used equipment, processing and presentation of data obtained. Justification of results and conclusions.
(f) preparation of microbiological and biotechnological trials: making and preparation of samples of biological products: material used in sampling. Sampling techniques: liquid, solid, air, surfaces and environments. Identification, transport, preservation and storage of the sample. Working protocols established for the handling of samples. Reference samples.
Sterility controls. Sterilization procedures: filtration in lots, gas, dry heat, ionizing radiation or steam sterilization.
Kinds of substances on which testing of sterility: bacterial endotoxin, pyrogenicity and local tolerance.
Efficacy of sterilization methods: LAL techniques; self-sealing, turbidimetric, and chromogenic.
Antioxidant systems. Effects and types of antioxidants. Measurement.
Antimicrobial agents: classification according to their origin.
Efficacy of antimicrobial preservation agents: methods of evaluation of final and descriptive point.
Agents of stabilization and conservation: influence of container in contact with the product. Factors to be considered in stability tests: temperature, light and humidity. Criteria and determination of pharmaceutical stability tests.
Microbiological analysis in sampling: microbiological control in clean areas. Trials of detection and enumeration of microorganisms. Assessment and importance of bio-safety standards.
Verification of feasibility of inserts and vectors in genomic libraries and genetically modified micro-organisms.
DNA identification to ensure traceability in the industry.
Genetic constructions in a biotechnological process.
3. professional module: Basic operations in the pharmaceutical, biotechnology and industry.
Contents: a) characterization of separation by diffusion techniques: physico-chemical principles of the various operations. Parameters.
Phase diagram: reading and interpretation of graphs.
Diffusional separation operations: distillation, rectification, extraction, drying, humidifying, sublimation, crystallization, evaporation, absorption, adsorption and ion exchange.
Associated calculations: performance, balance of matter and energy.
Industrial applications of the diffusional operations.
Equipment and construction elements: distillers, extractors, dryers, humidifiers and evaporators, among others.
Association of equipment: series and parallel.
Start and stop operations.
Data logging. Anomalies.
Preparation of maintenance: cleaning, inerting, pressure tests, tests of vacuum, sealing and vaporized, among others.
(b) determination of operations of mechanical separation: physico-chemical principles of the various operations. Parameters.
Phase diagram: reading and interpretation of graphs.
Mechanical separation operations: sedimentation, filtration, centrifugation, precipitation, decanting, magnetic and electrical separation, concentration by flotation and spraying.
Equipment and installations of mechanical separation. Sedimentation tanks, centrifuges and decanters, among others.
Associated calculations: performance, balance of matter and energy.
Industrial applications of the mechanical operations.
Start and stop operations.
Anomalies. Data logging.
Preparation of maintenance: cleaning and inerting.
(c) determination of pharmaceutical technology operations: physico-chemical principles of the various operations. Parameters: fluency, particle size and rate of mixing, among others.
Pharmaceutical technology industrial operations: granulation, disintegration, grinding and sieving, freeze drying, mixing and dosing.
Dry and wet granulation.
Compression and coating.
Homogeneous dispersed systems. Stability of dispersed systems. Mixtures and solutions. Ways to express the concentration.
Agitation. Types of agitators. Types of impellers. Forms of agitation: axial, radial, and tangential.
Equipment and construction elements. Sieves, freeze drying and mixing equipment.
Start and stop operations. First level maintenance.
(d) operations with reactors: principles of chemical reaction. Types of chemical reactions.
Chemical kinetics. Speed of reaction. Chemical balance.
Balance of matter and energy in reactions.
Performance of the reaction.
Chemical reactors. Classification and design of reactors. Reaction variables.
Chemical catalysts. Types. Operating principles of the catalysts.
Regeneration of catalysts.
Start and stop operations. First level maintenance.
Anomalies. Data logging.
(e) prevention of occupational hazards and environmental protection: risks inherent in equipment and facilities. Pressure and vacuum equipment. Compression. Appliccation and mechanical operations teams.
Means of prevention.
Protection. Protection equipment: screens, torques of presence and others. Personal protective equipment.
Signaling and safety equipment. Safety data sheets.
Environmental protection: collection and waste selection.
Storage and removal of waste.
4. professional module: Principles of biotechnology.
Contents: a) determination of biotechnological interest organizations: 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.
Microorganisms of biotechnological interest. Diversity. Insulation. Selection. Security. Collections of microorganisms.
Properties of plant cells. Composition. Structural elements. Nutrition. Reproduction.
Properties of animal cells. Composition. Structural elements. Nutrition. Reproduction.
Plant and animal cells of biotechnological interest. Biobanks. Plant cell lines. Animal cell lines (human, primates, rats, mice, fish and insects). Hybridomas. Fabrics.
Properties and classification of viruses. Composition. Structural elements. Morphological forms. Reproduction. Habitat. Taxonomy.
Virus of biotechnological interest. Diversity. Insulation. Selection. Security.
Types of magnifiers. Conventional. Binoculars.
Types of microscopes microscope (field, field dark. contrast phase, interference, fluorescence and confocal). Electron microscope (transmission and scanning).
Laboratory materials used in microscopy. Fixing. Staining. Inclusion. Cuts. Supports. Grids. Microtomes.
Rules, use, maintenance and key parts of the optical microscope. Lenses and objectives. Increases. Resolution. Lighting. Filters. Adjustment. Cameras.
Identification, classification and quantification of microorganisms by microscope. Dilutions. Filtration. Counting Chamber. Viable cells. Time of generation.
(b) application of chromatographic techniques for the identification of cellular metabolites: definition of biochemistry. History.
The nucleotides. Structure. Nucleosides. Nomenclature. Function. Applications.
The amino acids. Structure. Classification. Function. Essential amino acids. Racemization. Applications.
Lipids. Structure. Classification. Function. Fatty acids. Phospholipids. Steroids. Saponification. Applications.
Carbohydrates. Structure. Nomenclature. Function. Stereoisomerism. Reducing sugars. Applications.
Vitamins and coenzymes. Structure of the vitamins. Types of coenzymes. Cofactors. Prosthetic group. Function. Applications.
Alcohols, organic acids, and antioxidants. Structure. Nomenclature. Function. Aromatic compounds. Acidity. Applications.
Antibiotics. Structure. Classes. Origin. Mechanisms of action. Applications.
Chromatographic techniques and equipment. Chromatographs. Detectors (UV, visible, fluorescence, electrochemical refraction, and masses). (Preparative and analytical) types. Terminology and concepts (analytes, effluents, phases, chromatograms, time of retention and baseline). Injectors. Pumps. Gradientadores. Heaters. Collectors.
The thin layer chromatography. Types of support. Types of eluent. Development and revealed. Constants for disabled (Rx-Rf). Applications.
The low pressure liquid chromatography. Types (exclusion, cast, adsorption, ion-exchange, and affinity). Properties of columns and fillers. Efficiency. Particle size. Types of Elution (isocratic and gradient). Applications.
The chromatographs for liquids of high pressure and its coupled detectors (HPLC). Types of HPLC. Types of detectors. High pressure pumps (mechanical and pneumatic). Filtration. Degassing. Quantitative and qualitative analysis. Applications.
The gas chromatographs and its coupled detectors. Chromatography, gas - liquid (GLC). (GSC) gas-solid chromatography. Types of detectors. Handling of gas. Quantitative and qualitative analysis. Applications.
(c) application of techniques of extraction and separation for the identification of cellular macromolecules: classification of the biomacromolecules. Concept of monomer and polymer.
Composition, physico-chemical properties, and functions of nucleic acids. Monomers. Links. DNA. RNA. Oligonucleotides. Denaturation. UV spectrum.
Biotechnological applications of nucleic acids. Sequencing. Genetic diagnosis. Phylogenetic trees.
Techniques of extraction, purification and quantification of nucleic acids. Cell lysis. Precipitation. Chromatography. Ultraviolet spectra and fluorescence. Staining.
Composition, physico-chemical properties and functions of proteins. Monomers. Links. (Primary, secondary, tertiary and Quaternary) structure. Types (fibrous and globular and conjugate). Structural proteins. Conveyors. Receivers. Enzymes. Peptides. Solubility. Denaturation. UV spectrum. Fluorescence spectrum. Circular dichroism.
Biotechnological applications of proteins. Proteins with pharmacological activity. Hormones. Antibodies. Vaccines. Industrial enzymes.
Techniques of extraction, purification and quantification of proteins. Cell lysis. Chromatography. Precipitation. Filtration. Crystallization. Chemical reactions of quantification (Biuret, Lowry, Bradford). Quantification espetrofotometrica (ultraviolet and fluorimetry). Sequencing.
Composition, physico-chemical properties and functions of the polysaccharides. Monomers. Links. Chemical classification (homopolisacarido and heteropolysaccharide). Functional classification (book, structural and recognition). Lipopolysaccharides.
Biotechnological applications of polysaccharides. Power. Medicine. Industrial.
Techniques of extraction, purification and quantification of polysaccharides. Treatment with solvents. Treatment with acids and alkalis.
Electrophoresis equipment. Power supplies. Cuvettes. Electrophoretic mobility. Electrophoresis buffers. Matrices. Patterns. Electrophoresis in plate (vertical and horizontal). Capillary electrophoresis. Isoelectric focusing.
Electrophoresis of proteins. Polyacrylamide matrix. Two-dimensional electrophoresis. Native and denaturing. Isoenzymatic. Immunoelectrophoresis. Staining and viewing. Applications. Western-blot.
Electrophoresis of nucleic acid. Pulsed field. Native and denaturing. Staining and viewing. RNA/DNA sequencers. Applications. Southern blot. Northern blot.
(d) identification of metabolic processes: cellular metabolism. Primary and secondary metabolism. Catabolism and anabolism. Aerobiosis and anaerobiosis. Metabolic pathways.
Metabolic regulation. Specific regulation and pleiotropic. Regulators of gene expression. Enzyme Regulation.
Replication, transcription and translation of the DNA. DNA polymerase. RNA polymerase. Ribosomes. Genetic code. Protein synthesis.
The cell membrane and transport. 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. Routes of biosynthesis and degradation (amino acids, lipids, sugars, and nucleotides).
Techniques of determination of enzyme activities. Concepts of maximum speed (Vmax) and Michaelis-Menten constant (Km). Concept of substrate and final product. Concept of enzyme inhibition. Reaction buffers. Effects of pH, temperature and ionic strength. Trials Spectrophotometric (Spectrophotometric). Trials with substrates radioactively marked (scintillation counters). International measurement of enzyme activity units. Endpoint and kinetic methods.
(e) application of genetic modification techniques: enzymes used in genetic engineering. Restriction enzymes. DNA ligase. Phosphatases. DNA polymerases.
Concepts of gene and chromosome. Chromosomes in prokaryotes and eukaryotes. Genes in prokaryotes and eukaryotes (exons and introns).
Procedures for the identification of genes. Reaction of the polymerase chain (analytical and quantitative). DNA hybridization.
Genetic transformation methods. Natural competition. Conjugation. Chemical transformation. Electroporation. Transfection. Lipofeccion. Microinjection.
Vectors for gene cloning and the creation of genetic libraries.
Gene expression systems. Host cells. Expression vectors. Transient and permanent expression.
Mutagenesis methods. Chemical mutagenesis. Physical mutagenesis. Site-directed mutagenesis. Random mutagenesis. Mutagenesis in vivo and in vitro.
The protein engineering methods.
Concept of metabolic engineering.
(f) application of basic techniques of Bioinformatics: concept of bioinformatics. Computers. Networks. Clusters. Programs. Biological data. Data mining.
Computer programs of interest in biotechnology. Operating systems. Languages. LIMS. EMBOSS. EMBASSY. EXPASY. CLUSTAL. BLAST. BioMoby.
Databases. Types of databases on biotechnology. Formats of 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. Comparison and annotation of proteins. Prediction of protein structure. Alignment of protein sequences. Phylogenetic trees.
Algorithms and strategies in statistical calculations. Measures of central tendency and dispersion. Probabilities and distributions. Analysis of variance. Regression and correlation. Graphics methods (of control charts). Frequency distribution. Statistics in Excel.
The storage. Terminology. Units of capacity. Storage devices. Data transfer. Backup.
5. professional module: Security in the pharmaceutical, biotechnology and industry.
Contents: a) characterization of the types of risks: determinants of the dangerousness of chemical products: toxicity, pathways of entry into the body, doses of contaminants, physical and chemical properties, physiological state and individual susceptibility.
Chemical contaminants. Nature and composition.
Classification of chemicals: explosive, oxidizing, flammable, toxic, harmful and others.
Physical contaminants. Location at the place of work and effects on the organism.
Biological agents. Classification according to their nature: viruses, bacteria, protozoa, fungi and helminths. Routes of entry.
Biological agents risk groups. Risks associated with biotechnology production plants.
Ionizing radiation. Sources.
Biological effects of radiation. Types: hereditary and somatic.
Magnitudes and radiological units. Activity. Absorbed dose. Equivalent dose.
Radiation detectors. Chamber gas, scintillation, semiconductor and thermoluminescence detectors.
Classification of detectors according to their use: personal, portable and non-portable measurement monitoring.
Commissioning, testing, process equipment and machinery: risk.
Risks in plants and biotechnological production equipment.
Risks of equipment and lines of work pressure or vacuum.
(b) characterization of security installations, equipment and risk prevention devices: safety devices. Facilities and equipment. Detectors, biosensors, alarms, actuators, and others.
Personal protective equipment. EPI.
Collective protective equipment. Showers, showers, campaigns and others.
Signs of safety facilities.
Pictograms. Prudence and risk phrases.
Characteristics of fire. Fire load.
Fire-fighting equipment. Extinction methods for different types of fire.
Elements of a production plant protection: purge systems and valves.
Systems of prevention of failures in the control system.
Prevention of industrial hazards: electrical power, maintenance of facilities and equipment with pressure.
Specific use of biological isolation: EPI, campaigns and cleanrooms.
Specific use of radiological risk: screens or protective shields, primary and secondary barriers, personal protection and access control systems.
Radiation protection. Protection techniques. Classification of the zones.
(c) implementation of security measures: hazardous substances.
Safety data sheets.
Safety in biotechnology, pharmaceutical and related facilities.
Hazardous chemical, physical and biological areas: detection and measurement devices.
Standard operating procedures for the reduction of risks.
Biological safety signage.
Standards of maintenance, order, cleaning and disinfection of the facilities, machines and equipment.
Preventive measures to different biological risk groups.
(d) implementation of environmental protection measures: regulations of environmental protection in the biotechnological, pharmaceutical and related processes: measurement of environmental parameters.
Types of pollution in the production process. Pollution due to emissions to the atmosphere, sewage and industrial waste.
Waste management: solids, liquids and gases. Treatment of waste water. Techniques of treatment and minimization of waste. Non-recyclable waste.
Precautions against pollution and spills. Biosafety laboratories.
Measurement of physical contaminants: noise. Moisture.
Reference of the polluting chemical, physical and biological values. Limits of toxicity, flammability.
Control of radiological contamination. Exposure limits. Management of radioactive waste. Transport of radioactive material.
(e) definition of actions in situations of emergency:
Emergency plan. Structure: assessment of risk, means of protection, emergency planning implementation.
Classification of emergencies. Actions.
Emergency equipment: name, composition and functions.
Instructions and slogans.
Evacuation plan: implantation, signage and drill.
Fire. Extinction methods.
Actions to spills and leaks of hazardous products.
First aid. Performance before injury, trauma, Burns, poisonings and contact with blood or organic liquids.
6. professional module: Areas and ancillary services in the pharmaceutical, biotechnology and industry.
Contents: a) characterization of a production plant areas: Areas. Cleanrooms. The cleanroom applications. Classification. Requirements and environmental conditions.
Ancillary services in a plant for production of pharmaceutical and related products. Definition. Its importance in the activity of a pharmaceutical plant.
Description of the equipment and auxiliary facilities.
Functionality of the equipment, auxiliary facilities and its constituent elements.
Interpretation of charts and diagrams of spaces, equipment and auxiliary facilities. Code of colors and symbols applied to equipment, apparatus and installations.
Legislation and occupational health and safety measures.
(b) operations with equipment and installations for the treatment of water: the water in nature: the water cycle.
Need for water in pharmaceutical manufacturing processes.
Types of waters.
Pharmaceutical quality water: purified water: PW, highly purified water: HPW, water for injection (WFI) and water for hemodialysis, among others.
Water treatment with pharmaceutical grade: separation of suspended solids.
Separation of dissolved ions: demineralization.
Separation of gaseous impurities.
Combined treatment of osmosis and exchange resins and reverse osmosis.
Combined treatment of osmosis with electrodeionization.
Determination of parameters. Physical, physicochemical, chemical, biological and microbiological parameters of water. Units. Measuring instruments.
Equipment and water treatment facilities. Start-up and shutdown.
Maintenance of first-level equipment and water treatment facilities.
Procedures of order and cleanliness in the equipment of water treatment.
Rules of safety, prevention and environmental.
(c) operations with supply air and other gas facilities: composition, characteristics and properties of air.
The air conditioning. Grade higronometrico. Dehumidification and humidification of air. Special areas.
Air sterilization. Clean areas. Maintenance and control of sterility.
Gases in the pharmaceutical industry. Medical gases.
Determination of parameters. Pressure. Relationship between pressure, volume and temperature. Measuring instruments.
The compressed air. Distribution of compressed air in the plant. Characteristics of compressed air: compressed air for operation of the equipment, air to process (in contact with the product and without contact with the product).
(d) operations with the equipment of pressure and vacuum: regulation of pressure equipment and its complementary technical instructions.
Pressure equipment: boilers, petrochemical, cryogenic tanks, bottles of autonomous respiratory equipment, transportable pressure vessels.
Vacuum systems. Production of vacuum.
Determination of parameters. Measuring instruments.
Vacuum production facilities and equipment. Vacuum pumps.
Start-up and shutdown.
First level of equipment and production of vacuum facilities maintenance.
Procedures of order and cleanliness in production vacuum facilities.
Rules of safety, prevention and environmental.
(e) management of the heating and cooling systems: concepts and units of heat and temperature. Measuring instruments. Transmission of heat.
Heat generation systems. Types. Equipment and installations of heat (heat exchangers and steam boilers: physical principles, performances of the equipment, operating parameters, steam distribution networks).
Pharmaceutical steam. Steam to air conditioning (HVAC). Steam service.
Cooling systems. Description. Equipment and facilities.
Balance of matter and energy.
Starting and stopping heating and cooling of a laboratory systems.
Maintenance of first level of equipment and installations for production of heat and cold.
Procedures of order and cleanliness in generation of heating and cooling equipment.
Rules of safety, prevention and environmental.
(f) management of equipment of transport of materials: liquid drive systems.
Fluid dynamics. Operation regimes. Loss of load.
Operations of transport and distribution of liquids. Installation of liquid transportation. Pumps. Types of pumps. Characteristic curves. Valves. Types of valves.
Gas drive systems.
Compressors. Types of compressors.
Operations of transport and distribution of gas. Equipment and installations of gas supply. Features, installation and accessories (valves and pipes, among others).
Transport of solids. Characteristics of solids: size, moisture and sensitivity to heat, among others.
Solids conveying systems: hydraulic, mechanical and pneumatic, among others.
Equipment for transportation of solids.
Symbolism, representation and nomenclature of transport of machines and equipment.
Symbolism, representation of pipeline elements: elbows, joints, union stands, brackets and expansion joints.
Start-up and shutdown.
First level of equipment and gas supply facilities maintenance.
Procedures of housekeeping facilities and equipment supply of air and gases.
Rules of safety, prevention and environmental.
(g) determination of sanitation, cleaning and disinfection processes: processes of cleaning, sanitization and disinfection. Definition of cleaning and disinfection processes. Stages. Frequency.
Types of products for cleaning, sanitizing and disinfectants. Factors that influence the effectiveness of disinfectants.
Sanitizers. Factors influencing the efficacy of sanitizers. Chemical compatibility.
Sanitizing processes: by heat, chemicals or radiation.
Cleaning systems-manual, semiautomatic and automatic (CIP, COP and SIP).
Cleaning, sanitization and disinfection regulations.
7. professional module: Biotechnological production techniques.
Contents: a) preparation of the facilities and equipment for biotechnological production processes: biotech production facilities. Types of rooms (fermentation. Sterilization. Conservation, separation. Gases. Final product). Stores. Environmental conditions (temperature, humidity, ventilation and lighting). GMP requirements.
Equipment of the biotechnical production plants. Reactors. Centrifuges.
Handling of biological samples. Regulations. Reception. Storage. Shipping. Packing. Blood. Human samples. Animal samples.
Materials, raw materials and reagents for the biotechnological production. Waste as raw material. Properties of the materials. Reactive hazardous. Radioactive substances. Reagents perishable. Storage.
Barriers for containment of microorganisms. Regulations. Environmental protection. Personal protection.
Methods of disinfection and sterilization of equipment. Chemical agents. Physical systems (heat and UV).
Disposal of biological waste. Classification of wastes (solids, liquids, bodies and special). Collection. Storage. Transfer. Recycled. Composting.
Maintenance of equipment and materials of the biotechnical production plant. Manuals. Cleaning. Calibration. Measuring equipment.
Diagram of biotechnological processes. Types of processes. Flowcharts.
(b) application of techniques of cultivation of microorganisms: facilities, equipment and materials for handling microorganisms. Autoclaves. Stoves of culture. Orbital agitators. Anaerobic chambers. Anaerobic jars. Laminar flow hoods. Material culture. Reagents. Incubators.
Basic operations for handling microorganisms. Sterilization. Cleaning materials. Sowing. Preparation of solutions. Cultures of pathogens.
Isolation and cultivation of microorganisms. Design of culture media. Liquid and solid media. Minimex and complexes. Preparation of inoculum. Incubators.
Aerobic and anaerobic cultures. Degassing. Catalysts. Microaerofilos.
Methods of maintaining the organisms. Freezing. Freeze drying. Short term storage.
Techniques for the identification of microorganisms. Stains. Mobility. Means of identification. Biochemical tests. PCR.
Cultivation of genetically manipulated microorganisms. Stability. Induction of the 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. Incubators roller. Laminar flow cabinet. Cryogenic freezers. Counter (coulter) cells.
Basic operations to manage animal and plant cells. Sowing. Insulation. Passes. Changes in environment. Asepsis.
Design of media for the cultivation of animal and plant cells. Components. Sera. Synthetic media. Preparation and control.
Cell lines and primary cultures. Types of cells. Tissue digestion methods. Adherent cells. Cells in suspension. Fabrics. Stands of cultivation (plates and bottles).
Methods of conservation of plant and animal cells. Criogenesis, 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 plant and animal cells. Inverted microscopes. Confocal microscopes.
Techniques for quantification of plant and animal cells. Flow cytometry. Stains. Analysis of image-based methods.
Cultivation of genetically modified plant and animal cells. Regulations. Precautions.
(d) characterization of bioreactors: General principles of production bioreactors. Design criteria. Scale.
Basic components of the bioreactors. Auxiliary devices. Instruments of measurement and control of bioreactors. Physical sensors. Chemical sensors. Biosensors. Control systems. Adding pumps. Sterilization systems. Supply of air and gases. Water supply. Power supply.
Models and configurations of the bioreactors. Stirred tank. Airlift. Fluid bed. Hollow fiber. Membrane. Photo-bioreactors.
Basic operations for the implementation of a bioreactor. Sterilization. Aeration. Agitation. Cooling. Heating. Preparation of Microcarriers.
Types of operation (continuous, semi-continuous and discontinuous). Transfer phenomena. Simulation.
Change of scale. Factors influencing the change of scale. Rescaling methods.
Calculation of performance, material balance and economy of the production process.
(e) characterization of Biocatalysis process: Fundamentals of enzymology. Structure and function of enzymes. History. Concept of enzyme. Classification. Nomenclature. Specificity. Chirality. Cofactors. Functions.
Fundamentals of the biotransformation. Enzymatic catalysis and cell. Enzyme assay. Concepts of kinetics. Michaelis-Menten kinetics. Kinetic constants and units. Inhibition. Alosterismo. Industrial enzymes. Extremophile enzymes.
Immobilization of biocatalysts. Enzymes. Cells. Types of immobilization.
Means of reaction engineering. Tampons. Pressure. Solvents. Temperature.
Improvement of biocatalysts. Protein engineering. Mutagenesis. Evolution.
Performance, balance of materials and economy.
(f) recognition of biotechnical production processes: General principles of operations processing of biological products. Break cell. Concentration. Centrifugation. Extraction. Freeze drying. Dialysis. Filtration. Evaporation. Distillation. Crystallization. Drying.
Production of bio-molecules of pharmaceutical interest through fermentation processes. Antibiotics. Carbohydrates. Amino acids. Vitamins. Organic acids. Antioxidants.
Production of recombinant proteins. Enzymes, hormones, growth factors.
Production of polysaccharides. Chitosan. Hyaluronic acid. Dextran. Alginate.
Production of antibodies and vaccines. Monoclonal. Recombinant.
Production of biomaterials. Polyhydroxyalkanoates. Polylactic.
Production of substances of pharmaceutical interest using biocatalysts. Steroids. Semi-synthetic antibiotics. Resolution of racemic mixtures.
Calculation of performance, material balance and economy of integrated separation and purification process.
8. professional module: Pharmaceutical production and related techniques.
Contents: a) characterization of pharmaceutical and related products: concept of medicinal product. Classification of medicaments.
Classification according to physicochemical properties: Basic, acid, fat-soluble and water-soluble drugs.
Depending on its complexity: simple and complex drugs.
Products of nutrition and dietetics, phytotherapy, homeopathy, dermopharmacy and cosmetics, health products.
Depending on your access: with and without prescription, prescription drugs, hospital specialties, they need visas for inspection. Unit dose.
According to their origin: synthesis, medicinal plants, radiopharmaceuticals, homeopathic, biotech, blood products, immunological.
Based on its pharmacological actions, therapeutic uses, and routes of administration.
Depending on the technique of elaboration: Magistral, Officinal, industrial or specialty pharmaceutical, research.
Biotechnology in the production of drugs.
Herbal-based medications. Classification and General characteristics.
Sanitary products. Classification and General characteristics.
Concept of formulation. Definition of dosage forms. Classification. Criteria for selection of a pharmaceutical form.
Route of administration of the pharmaceutical dosage forms: oral, topical, parenteral, and rectal.
Excipients. Requirements of the excipients. Selection criteria. Organoleptic characteristics, flavors, fragrances and dyes, among others. Propellants.
Preformulation concept. Physicochemical properties of an active principle: organoleptic, purity, solubility, size and particle shape and speed of dissolution, among others.
Instability in the drugs. Introduction. Causes of instability. Incompatibilities (humidity, temperature, microbial development, light, transportation and packaging, among others).
(b) characterization of the procedures and techniques of production of solid dosage forms: solid pharmaceutical forms.
Parameters of formulation of solid dosage forms: characterization, choice of excipient and formulation, among other technology.
Classification of solid forms: tablets, powders, granulates, capsules, tablets, suppositories and ovules, among others. Route of Administration: oral, topical (skin powders, sticks) rectal and vaginal.
Tablets. Coated types: tablets, tablets and tablets special. Types of coatings. Modified release tablets. Formulation. Release of the active ingredient.
Capsules. Types of capsules. General characteristics. Hard and soft gelatin capsules. Sizes and capacities.
Special solid oral forms. Forms of immediate release, regulated or controlled.
Characterization of solid forms: appearance.
Physical characteristics (uniformity of mass).
Chemical characteristics (richness and uniformity of content in single-dose preparations).
Mechanical properties (strength and disintegration time dissolution rate).
Formulation of solid forms technologies. Stages of development of solid forms.
Process diagrams. Types of process. Flowchart.
Pharmaceutical plants: horizontal and vertical, among others. Advantages and disadvantages.
Features of the rooms and the equipment and facilities in a pharmaceutical plant. Equipment for the production of solid forms (sieve shakers, mixers, dryers and elevators, among others), compressing machines and capping machines. Drums of coatings.
(c) characterization of the procedures and techniques of production of liquid, semi-solid pharmaceutical forms and others: liquid, semi-solid pharmaceutical and other dosage forms forms.
Classification of liquid forms: solutions, syrups, emulsions, suspensions, eye drops, among others. Route of Administration: oral, parenteral, and topical (airway).
Oral solutions, syrups, and other dosage forms. Formulation. Manufacturing solutions.
Oral emulsion. 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 delivery. Microemulsions. Liposomes. Characterization: appearance, organoleptic, physicochemical characteristics (wealth, uniformity of content in the single-dose preparations, features mechanical and microbiological.)
Formulation technologies. Stages. Preparation of liquid forms and other dosage forms.
Process diagrams. Types of process. Flowchart.
Equipment and facilities for the preparation of liquid forms and other dosage forms. Equipment solutions and syrups. Equipment for aerosol. Equipment for suspensions and emulsions. Equipment for creams, gels and pomades. Equipment for suppositories and ovules. Ophthalmic equipment. Equipment for transdermal patches.
(d) determination of the techniques of production of sterile: sterilization. Sterile drug manufacturing processes: parenteral, nasal, ophthalmic and otic.
Basic techniques of manufacture of sterile products.
Characteristics of the manufacture of sterile products. Injectables (cleaning, neutrality and isotony) requirements.
Principles in sterile manufacturing.
Diagram for sterilization and aseptic manufacturing. Symbolism of the equipment and its elements. Flowchart.
Special areas of production. Areas of sterile products. Areas of sterile products allergenic, oncology and biological, among others.
Sterile products processing facilities and equipment. Equipment for injection.
Control in the manufacture of sterile products.
(e) manufacture of pharmaceuticals and related products: phases of the manufacturing process. Manufacturing batch.
Operations in the manufacture of pharmaceutical and related forms.
Driving of a manufacturing of pharmaceutical and related forms.
Starting and stopping a line of pharmaceutical manufacturing.
Maintenance of equipment and installations in the production of pharmaceutical forms.
Good manufacturing standards. Cleaning and disinfection.
Guide to manufacturing. Sections. Filling.
Traceability of the process. The batch documentation.
9. professional module: Regulation and control in the pharmaceutical, biotechnology and industry.
Contents: a) definition of the parameters of the process control: classification of the control parameters.
Main control parameters: pressure, level, temperature and flow.
Pressure: units. Conversion factors. Physical basis of measurement.
Relative or gauge pressure, absolute pressure and differential pressure.
Flow: units. Direct and indirect measurement conversion factors. Physical basis of measurement.
Volume flow and mass flow.
Level: units. Measurement continuous and timely. Conversion factors. Physical basis of measurement.
Temperature: units. Conversion factors. Physical basis of measurement.
Heat and temperature.
Relationship between the variables.
(b) management of the measuring instruments: General characteristics of the measuring instruments: range, scope, sensitivity, dead zone, hysteresis, precision and accuracy.
Pressure transmitters: capacitive. Resistive. Piezoelectric. Piezoresistivos. Balance and forces.
Differential pressure flowmeters: Venturi tubes. Nozzles. Pitot tubes. Orifice plates.
Variable area meters: rotameters.
Measuring instruments of speed: turbine and ultrasonic.
Positive displacement meters.
Mass flow meters: meters Coriolis effect.
Level indicators: glass, magnetic, with pressure gauge, cord, tape and float.
Level transmitters: by gassing, by pressure hydrostatic and differential, conductive, capacitive, ultrasonic, radar, and radioactive.
Local indicators of temperature: thermometers.
Radiation pyrometers: optical and total radiation.
Temperature switches or thermostats.
Online Analyzers: biological and chemical probes of oxygen and CO2, among others.
Variable chemical and physicochemical susceptible of being tested online.
Systems of specimen in scanners online.
Toll booth scanners online.
Calibration of on-line analyzers.
Transmitters and transducers.
The response of the measuring instruments.
Standard signals. Signal 4-20 mA, 3-15 psi and others.
Detection of anomalies.
(c) application of basic control systems: symbolism of instruments and bows: norms and standards (ISA, IEEE, and others).
Open loop and closed loop.
Elements of a control loop: elements primary, transmitters, transducers, converters, controllers, end items, alarms, records, controlled variable, manipulated variable, disturbances and set points.
Final control elements.
Basic control types.
Proportional control, integral and derivative.
Manual or automatic control.
A PID control applications: distillation, boilers, preparation of mixtures and twinjet.
(d) characterization of advanced control systems: cascade Control.
•To control (feed-forward).
Split range control.
Control of maximum (override).
Distributed control systems.
Architecture of a distributed control system. Operator station. Control cabinets. A distributed control system levels: level 1, 2, 3 and 4.
Optimization of processes.
Control room: general description of a control room.
(e) preparation of basic programming of programmable logic controllers (PLC): elements of an electromechanical installation. Symbolism of actuators, elements of protection and maneuver.
Basic operation of electrical circuits.
PLC. Principles of operation.
Representation, Convention of symbols and colors.
Principles of logic. Logical equations.
Logic wired opposite logic of contacts.
Open and closed contacts.
Structure of a PLC: rack, frame or chassis, power supply, CPU (processor and operating system), modules (discrete and analog) inputs, outputs (analog and discrete), memory modules and Scan time.
Application of PLC in industrial control. Feedbacks, set in motion, stops. Motor control. Alarm and security systems. Batch manufacturing processes (batch).
10. professional module: Preparation and storage of pharmaceutical, biotechnology and related fields.
Contents: a) definition of conditioning operations: types of conditioning.
Rules for conditioning of pharmaceutical products.
Functions of the packaging.
Conditioning for protection against physical or mechanical risks: bumps, falls and pressures, among others.
Conditioning for protection against environmental risks: temperature, humidity, light and atmospheric gases.
Conditioning for protection against biological risks: attacks of animals and growth of bacteria or fungi, among others.
Passive protection: inviolability of the container and prevent the access of children, among others.
Packaging information: the immediate packaging and the secondary.
Rules on advertising of medicines.
(b) characterization of the main types of containers: features of the immediate packaging.
Characteristics of the secondary packaging.
Types of packaging depending on the status of the medicinal product: liquid forms: bottles, jars, vials, cartridges, syringes and bags.
Semi-solid forms: plastic pipes, with layers of different materials and plastic sheets or metal or metal.
Solid forms: blisters and bottles of plastic or glass, among others.
Types of packaging depending on the closing: container tightly closed.
Sealed container. Container with inviolable closure.
Characteristics of closures: test of air tightness, resistance and compatibility with the content, effectiveness to close it once opened, automation of the close, resistance to the opening by children, ease of dosing and the output of the product, among others.
Types of secondary packaging.
Information on the primary packaging.
Information in the secondary container.
Symbols and abbreviations used in the packaging of medicines.
Conditioning monodose and multidose.
Special arrangements: radiopharmaceuticals, advertising specialties, products for the care and maintenance of contact lenses, veterinary medicinal products.
(c) operations of the equipment and installations of dosing and packaging: packaging Guide.
Conditioning equipment: solid, semi-solid, dosage forms and liquid.
Printing and coding systems.
Dosing and packaging of sterile products.
First level of the equipment and facilities maintenance.
Procedures of order and cleanliness in conditioning primary teams. Despirogenar.
Risk prevention and environmental protection regulations.
(d) characterization of storage facilities: storage regulations.
Inside and outside the laboratory storage rooms.
General characteristics of a warehouse of pharmaceutical and related products.
Models of organization of the store. Store conventional and chaotic.
Basic rules of organization: stock reduction, separation products, isolation and confinement.
Types of storage.
Types of cabinets: flammable, corrosive, security, refrigeration and microbiological products.
Security in a laboratory storage elements.
(e) characterization of reception and dispatch operations: operations and General checks.
Verification of the material safety data sheet.
Input and output records.
Checks of the products.
Systems of wrapping, printing and encoding.
Measuring and weighing of quantities.
Systems for the protection of goods.
(f) implementation of the storage of pharmaceutical, biotechnological and related: rules of distribution of drugs and active ingredients.
Storage criteria: appropriate labels, material safety data sheet, registration, classification of products according to risk, stock, expiration, size, utility, among others.
Storage conditions: order cleaning: solids: temperature, humidity, level and height, among others.
Liquid: temperature, pressure steam and level.
Gases: maximum pressure and pressure-temperature relationship.
Conditions of conservation.
Isolation and confinement of products.
Stacking of materials: products in bulk, cans, boxes, bags, tubes, bottles, bottles and glassware.
Computer applications (calculation and specific programmes of warehouse management sheet).
Safety measures on storage: falls from products and crashes, among others.
Management of stocks.
11. professional module: Electromechanical maintenance in process industries.
Contents: a) identification of components of equipment and installations materials: materials and properties. Types of materials.
Nomenclature and commercial stands for materials.
Physical and physico-chemical properties: hardness, toughness, brittleness, stability, elasticity, malleability, thermal and electrical conductivity, density and viscosity, among others.
Treatments and tests of materials: non-destructive and destructive tests.
Corrosion of metals. Types of corrosion.
Degradation of non-metallic materials.
(b) characterization of the mechanical elements: principles of mechanics. Kinematics and dynamics of machines.
Machining techniques. Turning, milling and grinding.
Construction materials of mechanical elements. Types. Properties (optical, thermal, mechanical, chemical, magnetic and sensory). Forces/efforts (tensile, compression, bending, torsion, cut and buckling).
Elements of machines and mechanisms.
Transmission of the movement (direct and indirect) elements: description, performance, symbolism, first level maintenance.
Transformers elements of movement (circular in straight and vice versa): description, performance, symbolism.
(Fixed and removable) connecting elements: description, operation and maintenance of first level.
Auxiliary elements (batteries and energy dissipators, clutches, supports and bearings). Description, operation, maintenance of first level.
Techniques of lubrication: lubrication by fog.
Rules of safety and hygiene.
Assessment of mechanical components wear: lubrication and preventive maintenance.
(c) characterization of hydraulic and pneumatic machines: Fundamentals of pneumatic.
Properties of compressed air.
Pneumatic facilities: characteristics and field of application.
Production and treatment of the compressed air circuits. Symbols, and operating maintenance of first level.
Compressed air distribution networks. Features and construction materials.
Pneumatic elements of regulation and control. Description, performance, symbolism and first level maintenance.
Pneumatic elements of drive or actuators. Description, performance, symbolism and first level maintenance.
Interpretation of the documentation and diagrams. Symbology.
Analysis of the different sections that compose the pneumatic plants.
Efficient use of compressed air in the processes of preparation of food products.
Basics of hydraulics.
Hydraulic fluids: types and properties.
Fundamental principles of hydraulics.
Hydraulic unit: foundations, parts (tank, pump, drive motor, safety valves, pressure gauge, filter and radiator), operation, maintenance of first level and security measures.
Hydraulic elements of distribution and Regulation (throttles for flow and pressure, return ducts): description, performance, symbolism, maintenance of first level and security measures.
Hydraulic elements of work (cylinder and engine): description, performance, symbolism and first level maintenance.
Hydraulic systems: characteristics, scope.
Interpretation of the documentation and diagrams. Symbology.
Different operation of the hydraulic system and features.
Rules of safety and hygiene in hydraulic and pneumatic installations.
Environmental impact of hydraulic and pneumatic installations.
(d) identification of electric machines: principles of electricity. AC and DC current. Applications.
Fundamental electrical quantities (intensity and power, electrical resistance, voltage or difference of potential, energy and electric power): definition, units.
Principles of magnetism and electromagnetism.
Production and transport of electric power facilities. Types. High voltage networks: substations.
Electrical circuits. Elements of control and manoeuvre, protection and receivers. Description and operation.
Electric, static and rotating machines. Typology and classification of electric machines features: generators, transformers and motors. Types.
High voltage networks: substations.
Maneuver in high and low voltage equipment: disconnectors and switches.
Protective equipment: protective uninterruptible (UPS) systems.
Control cabinets. Typology. Features.
Electrical symbols. Normalization. Interpretation of wiring diagrams.
Rules of safety and hygiene in electric machines.
Safety of the electric circuits of low, medium and high voltage regulation.
(e) characterization of maintenance actions: functions and objectives of the maintenance.
Types of maintenance. Preventive maintenance, first level and corrective. Technical documentation.
The first level maintenance organization.
Equipment, tooling and tools employed in the maintenance of first level.
Signage of the area for maintenance. Application protocols.
Supervision of specific maintenance. Liability.
Signs of dysfunction of the equipment and facilities.
Documentation of interventions. Records.
Impact of improper maintenance of equipment and installation.
12 professional module: Project for the manufacture of pharmaceutical, biotechnological and related products.
Contents: a) identification of the needs of the productive sector and the Organization of the company: identification of job functions.
Structure and business organization of the sector.
Activity of the company and its location in the sector.
Organizational chart of the company. Functional relationship between departments.
Industry trends: productive, economic, organisational, employment and others.
Working in the field of company procedures. Systems and methods of work.
Determination of excluded labour relations and special labour relations.
Collective agreement applicable to the professional field.
The culture of the company: corporate image.
Systems of quality and security applicable in the sector.
(b) design of sector-related projects: analysis of the local situation, of the business sector in the area and offer the context in which will develop the professional training module in workplace.
Compilation of information.
General structure of a project.
Elaboration of a working script.
Planning of the implementation of the project: objectives, contents, resources, methodology, activities, timing and evaluation.
Feasibility and opportunity project.
Review of the applicable regulations.
(c) planning of the implementation of the project: sequencing of activities.
Elaboration of work instructions.
Development of a risk prevention plan.
Documentation for the planning of the implementation of the project.
Compliance with safety standards and environmental.
Indicators of the quality assurance of the project.
(d) a definition of procedures for monitoring and evaluation of the implementation of the project: proposal of solutions to the objectives of the project and justification of the selected.
Definition of the procedure of evaluation of the project.
Determination of the variables subject to evaluation.
Documentation required for the evaluation of the project.
Quality control of process and final product.
Registration of results.
13. professional module: Training and job counseling.
Contents: a) actively seeking employment: evaluation of the importance of ongoing formation for the employment and professional career of the technician in manufacturing of pharmaceutical, biotechnological and related.
Analysis of interests, skills, and personal motivations for the career.
Identification of learning paths related to the technician in manufacturing of pharmaceutical, biotechnological and related.
Responsibility for own learning. Knowledge of the requirements and the expected fruits.
Definition and analysis of the professional sector of the title of technician in manufacturing of pharmaceutical, biotechnological and related.
Own career planning: labour targets, medium and long term, consistent with needs and preferences.
Realistic and consistent with the current lineup and the projected targets.
The process of job search in small, medium and large companies in the sector.
Opportunities for learning and employment in Europe. Europass, Ploteus.
Job search tools and techniques.
Evaluation of the self-employment as an alternative for the professional insertion.
The process of decision-making.
Establishment of a list of personal consistency check between career, training plan and aspirations.
(b) management of the conflict and work teams: assessment of the advantages and disadvantages of teamwork for the effectiveness of the organization.
Kinds of equipment in the field of pharmaceutical and biotechnological production according to the roles played.
Analysis of the formation of the work teams.
Characteristics of an effective team.
Participation in the task force. Analysis of the possible roles of its members.
Definition of conflict: characteristics, sources and stages of the conflict.
Methods for resolution or deletion of the conflict: mediation, conciliation and arbitration.
(c) employment contract: the right to work.
Intervention by the public authorities in labour relations.
Analysis of the individual employment relationship.
Determination of excluded labour relations and special labour relations.
Modalities of work and measures of promotion of the procurement contract.
Rights and duties arising from the employment relationship.
Working conditions. Wages, working time and working rest.
Modification, suspension and termination of the employment contract.
Representation of male and female workers.
Collective bargaining as a means for the reconciliation of the interests of the staff of the company and the business community.
Analysis of a collective agreement applicable to the professional field of the technician in manufacturing of pharmaceutical, biotechnological and related.
Collective labour disputes.
New organization of work environments: outsourcing and teleworking, among others.
Benefits for workers in the new organizations: flexibility and social benefits, among others.
d) Social Security, employment and unemployment: the system of Social security as a basic principle of social solidarity.
Structure of the Social security system.
Determination of the main obligations of entrepreneurs and their staff in Social Security: affiliation, high, low, and quote.
The protective action of Social Security.
Classes, requirements and amount of benefits.
Concept and yielded situations by unemployment.
Systems of advice to the staff of the company regarding their rights and duties.
(e) evaluation of occupational hazards: importance of the culture of prevention at all stages of the professional activity.
Assessment of the relationship between work and health.
Analysis and determination of working conditions.
The concept of professional risk. Analysis of risk factors.
The evaluation of risks in the enterprise as the basic element of the preventive activity.
Analysis of risks linked to security conditions.
Analysis of risks linked to environmental conditions.
Analysis of risks linked to psychosocial and ergonomic conditions.
Specific risks in the sector of pharmaceutical and biotechnological production.
Determination of possible damage to the health of the worker or a worker that can arise from the detected risk situations.
(f) planning of prevention of risks in the enterprise: rights and duties in the area of occupational risk prevention.
Responsibilities in the area of occupational risk prevention.
Prevention in the company management.
Representation of male and female workers in prevention.
Public organisations related to the prevention of occupational risks.
Planning of prevention in the company.
Emergency and evacuation in environments of work plans.
Development of an emergency plan in a small or medium company in the sector.
(g) implementation of measures of prevention and protection in the enterprise: determination of individual and collective protection and prevention measures.
Protocol of action in a situation of emergency.
First aid. Medical emergency. Basic concepts.
Application of first aid techniques.
Training for the personnel of the company in the field of emergency plans.
Surveillance of the health of workers.
14. professional module: Enterprise and entrepreneurship.
Contents: a) entrepreneurship: innovation and economic development. Main features of innovation in the field of pharmaceutical and biotechnological production (materials, technology and organization of production, among others).
Entrepreneurial culture as a social need.
The enterprising character.
Key factors of entrepreneurial people: initiative, creativity and education.
The collaboration between entrepreneurs.
The performance of the enterprising people as employees of a company related to the manufacture of pharmaceutical, biotechnological and related.
The performance of the enterprising people as entrepreneurs in the sector of pharmaceutical and biotechnological production.
The risk in entrepreneurial activity.
Concept of entrepreneurship. Requirements for the exercise of the business activity.
Personal goals versus business objectives.
Business plan: business idea in the field of pharmaceutical and biotechnological production.
Good practices of entrepreneurial culture in the pharmaceutical, biotechnology and related products in local manufacturing activity.
(b) the company and its environment: basic functions of the company.
The company as a system.
The general environment of the company.
Analysis of the general environment of a company related to the manufacture of pharmaceutical, biotechnological and related.
The specific environment of the company.
Analysis of the specific environment of a company related to the manufacture of pharmaceutical, biotechnological and related.
Relations of a manufacturing company of pharmaceutical, biotechnological and related products with their environment.
A company of manufacture of pharmaceutical, biotechnological and related relations with the whole of society.
The culture of the company: corporate image.
The social balance.
Social responsibility and ethics of the companies in the sector of pharmaceutical and biotechnological production.
(c) creation and implementation of a company: company concept.
Types of company.
The responsibility of the owners of the company.
Taxation in enterprises.
Choice of the legal form. Size and number of partners.
Administrative procedures for the formation of a company.
Economic feasibility and financial viability of a company related to the manufacture of pharmaceutical and biotechnological products.
Analysis of the sources of financing and budgeting of a company related to the manufacture of pharmaceutical and biotechnological products.
Aid, grants and tax incentives for SMEs related to the manufacture of pharmaceutical and biotechnological products.
Business plan: choice of the legal form, study of economic and financial viability, administrative procedures and management of grants and subsidies.
(d) administrative function: concept of accounting and basics.
Accounting operations: registration of the economic information of a company.
Accounting as a true picture of the economic situation.
Analysis of accounting information.
Tax obligations of the companies.
Requirements and deadlines for the submission of official documents.
Administrative management of a company related to the manufacture of pharmaceutical, biotechnological and related.
15. professional module: Training in workplace.
Contents: a) identification of the structure and business organization: structure and enterprise organization in the sector of pharmaceutical and biotechnological production.
Activity of the company and its location in the sector of pharmaceutical and biotechnological production.
Organizational chart of the company. Functional relationship between departments.
Logistical organization of the company. Suppliers, customers and marketing channels.
Working in the field of company procedures. Systems and methods of work.
Human resources in the enterprise: requirements of training and professional, personal and social competences associated with different jobs.
Quality system established in the work center.
Security system established in the work center.
(b) application of ethical and work habits: personal attitudes: empathy, punctuality.
Professional attitudes: order, cleanliness, responsibility and security.
Attitudes towards the prevention of occupational and environmental hazards.
Hierarchy in the company. Communication with the team.
Documentation of professional activities: classification, coding, renewal and disposal methods.
Recognition and application of the internal rules of the company, work instructions and standard operating procedures.
(c) preparation of areas and ancillary services: selection of the areas of production in the pharmaceutical industry.
Assurance of the order and cleaning of working areas.
Verification of the correct operation of the equipment and auxiliary facilities.
Realization of the set-up and maintenance of facilities and ancillary equipment.
Realization of the start and stop of auxiliary equipment and facilities.
Selection and setting of the variables of operation of auxiliary equipment.
Verification of the correct operation of the equipment and auxiliary facilities.
(d) development of pharmaceutical, biotechnological and related: interpretation of the diagram of process and manufacturing Guide.
Selection of materials, equipment and production facilities.
Checking the correct conditions and proportions of materials in the process.
Realization of the set-up and maintenance of facilities and production equipment.
Realization of the start and stop of the equipment and facilities.
Selection and setting of the variables of operation of the equipment and facilities in the conditions laid down.
Assurance of the order and cleanliness in the production areas.
Completion of guide of manufacturing documents.
(e) packaging and storage of pharmaceutical, biotechnological and related products: analysis of the procedures of packaging products.
Selection of materials, equipment and facilities of conditioning.
Realization of the commissioning of facilities and equipment and facilities.
Realization of the start and stop of the equipment and facilities.
Selection and setting of the variables of operation of the equipment.
Realization of the packaging and labelling.
Realization of the storage, ensuring the quality of the product.
Assurance of the order and cleanliness in the areas of conditioning and storage.
Completion of manufacturing Guide documents and records of receiving and forwarding.
(f) participation in the implementation of the quality control of products: identification of quality parameters that have control in the preparation of pharmaceutical, biotechnological and related products.
Establishment of online analysis and the quality control for raw materials, intermediate and final products.
Establishment of sampling points.
Realization of the taking of samples and transfer, ensuring their representativeness, controlling pollution and alterations.
Selection of equipment of making sample and measurement, calibration and maintenance.
Realization of the quality controls in the product line.
Registration of the data obtained, ensuring the traceability of the product.
Preparation of technical reports for production and process control.
(g) application of the rules of risk prevention and environmental protection: identifying the types of risk in the production process.
Taking safety measures for the handling of substances.
Assurance of compliance with the rules of safety equipment and facilities.
Assurance of compliance with the rules of environmental protection in the production process.
Analysis of the actions corresponding to the company emergency plan.
Study of the protocols of action before an accident or incident at the company.
Realization of controls of contamination in the work environment.
Management of the waste generated in the production process.
Annex II sequencing and weekly hourly distribution of formative cycle of medium level professional modules: manufacture of pharmaceuticals, biotechnological and related module duration (hours) first professional (h/week) second year course 2 quarters (h/week) 1 quarter (hours) 1387. Organization and management of the manufacture of pharmaceutical, biotechnological and related 75 2 1388. Quality control of pharmaceutical, biotechnological and related 150 5 1389. Basic operations in the pharmaceutical, biotechnology and related 175 5 1390. 150 5 1391 biotechnology principles. Security in the pharmaceutical, biotechnology and related 75 2 1392. Areas and ancillary services in the pharmaceutical, biotechnology and related 155 5 1398. Training and labour orientation 90 3 hours reserved for the module given in English 90 3 1393. 110 5 1394 biotechnical production techniques. Techniques of pharmaceutical production and related 130 6 1395. Regulation and control in the pharmaceutical, biotechnology and related 90 5 1396. Packaging and storage of pharmaceutical, biotechnological and related 70 4 0191. Electromechanical maintenance in 100 5 1399 process industries. Enterprise and initiative entrepreneur 60 3 hours reserved for the module given in 40 2 1397 English. Manufacture of pharmaceuticals, biotech and related 40 40 1400 project. Training in workplace 400 400 2,000 30 30 440 formative cycle Total annex III susceptible modules to be taught in English language 1388. Quality control of pharmaceutical, biotechnological and related products.
1389 basic operations in the pharmaceutical, biotechnology and industry.
1390 principles of biotechnology.
1392 areas and ancillary services in the pharmaceutical, biotechnology and industry.
1393 biotechnical production techniques.
1394 pharmaceutical production and related techniques.
1395 regulation and control in the pharmaceutical, biotechnology and industry.
0191-electromechanical maintenance in process industries.
Annex IV spaces and equipment minimum spaces: space training surface m² 30 pupils or students 20 students or students classroom versatile 60 40 laboratory chemical analysis and physicochemical 120 90 laboratory of Microbiology and biotechnology 120 90 180 120 minimum equipment industrial chemistry lab: space training equipment multi-purpose classroom.
Computers installed in network, system imaging and internet.
Chemical and physico-chemical analysis laboratory.
Heating magnetic stirrer.
Safety Cabinet for reagents.
Equipment for the determination of boiling points.
Equipment for determination of melting point.
UV visible spectrophotometer.
Portable environmental measurement instruments.
Ice making machine.
General laboratory equipment.
Equipment and sampling tools.
pH meter field.
Laboratory of Microbiology and biotechnology.
Agents, equipment and approved cleaning and disinfecting instruments.
Heating magnetic stirrer.
Orbital agitators with speed and temperature regulations.
Specific computer applications.
75 L autoclave.
0.01 g precision electronic scale.
Bathrooms heating of microtubes and Microplates.
Laminar flow hood.
Campaign for PCR.
Centrifuge 20 000 to 40 000 rpm.
Freezer at - 40 ° C.
Binocular biological microscopy equipment.
Equipment for UV protection and accessories.
Colonies counter equipment.
Cell culture team.
Biotoxicidad test equipment.
Equipment and appliances devoted to micro-manipulacion of animals, plant cells and microorganisms.
Equipment for genetic transformation and microbial selection of animal and plant cells.
UV spectrophotometer with cuvettes.
Stoves of culture.
Refrigerator/freezer - 20 ° C.
Basic material of biotechnology.
General microbiology material.
Microcentrifuge with temperature regulation.
Binocular biological microscopes.
Pipettes of variables and serial volumes.
Vacuum filtration ramps.
20 L equipped laboratory reactor.
Thermal cycler with ramp temperature (PCR).
Transilluminator 312nm, with images, printers and monitor Analyzer.
Industrial chemistry lab.
Automatic analysers; Online analyzers.
Safety Cabinet for reagents.
Electronic balance scale.
Elements of regulation. With sensor, actuators, transmitters and controllers control loops. Control panel with programmable logical control devices.
Final control elements.
Plant trainer: a real industrial chemical/biochemical process Simulator.
Aerodynamic assessment team.
Team of permeability.
Equipment of regulation and control of processes (pH, flow rate, temperature, pressure, level).
Equipment breakdown of pharmaceutical forms.
Teams of hardness.
Teams of friability.
Witness line of a pharmaceutical plant: pressure systems, vacuum, heating, water vapor, inert gases, air conditioning, sterilization of air and water treatment.
Equipment for the manufacture of pharmaceutical dosage forms.
General material grinding for assemblies.
Chemical reactor / equipped biochemist.
Neural networks and expert systems.
Alarm systems, surveillance and communication.
Digital control systems. Modules control, calculation or recording and visualizacioń monitors.
Local control systems.
Registration systems, manual or computerised.
Supplies, tools and maintenance products.
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