This apprenticeship has options. This document is currently showing the following option:
Apply a process or processes to create products to a specification.
Science manufacturing technicians are found in the process manufacturing sector.
This is a core and options apprenticeship. An apprentice must complete the core and one option relevant to their occupation. The options are:
Biotechnology manufacturing technicians produce biological products such as proteins, antibodies, and DNA. These may be used in pharmaceuticals, agricultural products, food and feed, detergents, paper, textiles, and biofuels. The final product may be solid or liquid and may be filled into small volume bottles or large bulk containers. Typically, batch processing is used. They may work in a controlled environment, such as laboratory or clean room, or production facilities. Biotechnology has an important role to play in helping to address many global problems, such as climate change. For example, synthetic biology is already contributing to the development of many biological systems producing drugs, chemicals, and fuels without using fossil fuels.
Aseptic pharmaceuticals manufacturing technicians are involved in the manufacture of pharmaceutical products - medicines or drugs. They may be involved in part or all of the process including active pharmaceutical ingredients (API) production and final formulation. APIs are the medical ingredient that goes into medicines. Formulations typically involves the blending of the API and other ingredients. Production may be continuous or batch. Technicians work in highly controlled process areas. This could be in large process plant or small rooms depending on the type of medicine being made and the stage of the process. Typically, they will work in a clean room where air particulates are controlled to stop potential contamination of the product.
Both biotechnology and aseptic pharmaceuticals manufacturing technicians run and maintain the process or processes in line with operational parameters. They conduct quality assurance, resolving or escalating any issues, and complete records. Maintaining workplace safety by following health, safety and environmental risk and management systems is a vital part of the role. They also take part in risk assessment and improvement activities, and support audits.
On a daily basis, they work with other members of the process team. They also have contact with people in other teams for example, laboratory, maintenance, process engineering, supply chain, and warehouse. They may also have contact with external people such as, customers, service providers, and regulators.
They must ensure that the process and products meet quality specifications and are produced to schedule. They must work to external manufacturing regulations to protect the process, product, plant and equipment, company employees, and the environment. They must also consider sustainability. They may need to wear specialist PPE to protect the product or themselves. This may include, safety glasses, chemical resistant gloves, suits and footwear, and breathing apparatus. They may work alone or part of a team. They work with minimal supervision, taking responsibility for the quality and accuracy of their work.
This is a summary of the key things that you – the apprentice and your employer need to know about your end-point assessment (EPA). You and your employer should read the EPA plan for the full details. It has information on assessment method requirements, roles and responsibilities, and re-sits and re-takes.
An EPA is an assessment at the end of your apprenticeship. It will assess you against the knowledge, skills, and behaviours (KSBs) in the occupational standard. Your training will cover the KSBs. The EPA is your opportunity to show an independent assessor how well you can carry out the occupation you have been trained for.
Your employer will choose an end-point assessment organisation (EPAO) to deliver the EPA. Your employer and training provider should tell you what to expect and how to prepare for your EPA.
The length of the training for this apprenticeship is typically 36 months. The EPA period is typically 3 months.
The overall grades available for this apprenticeship are:
When you pass the EPA, you will be awarded your apprenticeship certificate.
The EPA gateway is when the EPAO checks and confirms that you have met any requirements required before you start the EPA. You will only enter the gateway when your employer says you are ready.
The gateway requirements for your EPA are:
Observation with questions
You will be observed by an independent assessor completing your work. It will last at least 3 hours. They will ask you at least 5 questions.
Interview underpinned by a portfolio of evidence
You will have an interview with an independent assessor. It will last at least 60 minutes. They will ask you at least 8 questions. The questions will be about certain aspects of your occupation. You need to compile a portfolio of evidence before the EPA gateway. You can use it to help answer the questions.
Multiple-choice test
You will complete a multiple-choice test. It will be closed book, meaning you will not have access to any books or reference materials.
In the test you can have:
The test will have 40 multiple-choice questions. You will have 60 minutes to complete it.
The EPAO will confirm where and when each assessment method will take place.
You should speak to your employer if you have a query that relates to your job.
You should speak to your training provider if you have any questions about your training or EPA before it starts.
You should receive detailed information and support from the EPAO before the EPA starts. You should speak to them if you have any questions about your EPA once it has started.
If you have a disability, a physical or mental health condition or other special considerations, you may be able to have a reasonable adjustment that takes this into account. You should speak to your employer, training provider and EPAO and ask them what support you can get. The EPAO will decide if an adjustment is appropriate.
This apprenticeship aligns with The Science Council for Registered Science Technician. Upon successful completion of the apprenticeship and upon receipt of the apprenticeship certificate, individuals are eligible to apply for RSciTech through a shortened application route. Individuals also need to be a member of a professional body that is licensed by the Science Council to be awarded this status. Further information is on the Science Council’s website.
Please contact the professional body for more details.
This apprenticeship aligns with The Institution of Chemical Engineers (IChemE) for Engineering Technician (EngTech). Upon successful completion of the apprenticeship and receipt of the apprenticeship certificate, individuals are eligible to apply for EngTech through a shortened application route. It will need to confirm that the EngTech requirements have been met. Individuals also need to be a member of a professional body licensed by the Engineering Council to be awarded this status. Further information is on the IChemE’s website.
Please contact the professional body for more details.
Science manufacturing technicians are found in the process manufacturing sector.
This is a core and options apprenticeship. An apprentice must complete the core and one option relevant to their occupation. The options are:
Biotechnology manufacturing technicians produce biological products such as proteins, antibodies, and DNA. These may be used in pharmaceuticals, agricultural products, food and feed, detergents, paper, textiles, and biofuels. The final product may be solid or liquid and may be filled into small volume bottles or large bulk containers. Typically, batch processing is used. They may work in a controlled environment, such as laboratory or clean room, or production facilities. Biotechnology has an important role to play in helping to address many global problems, such as climate change. For example, synthetic biology is already contributing to the development of many biological systems producing drugs, chemicals, and fuels without using fossil fuels.
Aseptic pharmaceuticals manufacturing technicians are involved in the manufacture of pharmaceutical products - medicines or drugs. They may be involved in part or all of the process including active pharmaceutical ingredients (API) production and final formulation. APIs are the medical ingredient that goes into medicines. Formulations typically involves the blending of the API and other ingredients. Production may be continuous or batch. Technicians work in highly controlled process areas. This could be in large process plant or small rooms depending on the type of medicine being made and the stage of the process. Typically, they will work in a clean room where air particulates are controlled to stop potential contamination of the product.
Both biotechnology and aseptic pharmaceuticals manufacturing technicians run and maintain the process or processes in line with operational parameters. They conduct quality assurance, resolving or escalating any issues, and complete records. Maintaining workplace safety by following health, safety and environmental risk and management systems is a vital part of the role. They also take part in risk assessment and improvement activities, and support audits.
On a daily basis, they work with other members of the process team. They also have contact with people in other teams for example, laboratory, maintenance, process engineering, supply chain, and warehouse. They may also have contact with external people such as, customers, service providers, and regulators.
They must ensure that the process and products meet quality specifications and are produced to schedule. They must work to external manufacturing regulations to protect the process, product, plant and equipment, company employees, and the environment. They must also consider sustainability. They may need to wear specialist PPE to protect the product or themselves. This may include, safety glasses, chemical resistant gloves, suits and footwear, and breathing apparatus. They may work alone or part of a team. They work with minimal supervision, taking responsibility for the quality and accuracy of their work.
Employers will set their own entry requirements. Typically, they require applicants to have GCSE science grade C or 4. An employer may require applicants to have a health screening to ensure suitability for working in some work environments.
Duty | KSBs |
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Duty 1 Conduct handover responsibilities - receiving information from or providing information to other shifts or maintenance teams. |
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Duty 2 Maintain the work area (housekeeping) following safety, environmental and risk management systems. |
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Duty 3 Undertake quality assurance processes. |
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Duty 4 Resolve and report, or escalate, process, quality, health and safety, environment, and operating environment issues when operating out of normal parameters. For example, out of specification parameter. |
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Duty 5 Complete process documentation - digital or paper based. For example, process and production records, traceability records, and quality assurance records. |
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Duty 6 Conduct first line routine maintenance and testing of process and plant equipment. |
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Duty 7 Participate in continuous improvement activities. |
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Duty 8 Participate in risk assessment activities. For example, task risk assessments and manual handling assessments. |
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Duty 9 Support audits - internal or external. For example, supply information, demonstrate and explain task. |
Duty | KSBs |
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Duty 10 Run and maintain biotechnology process, plant, and equipment in line with operational parameters. For example, temperature, pressure, pH, oxygen, and chemical and biological concentration. |
K26 K27 K28 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45 |
Duty 11 Conduct packaging of biotechnology intermediate or final processed product. |
K26 K27 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45 |
Duty 12 Conduct biotechnology equipment fault finding activities. For example, contamination investigation, and cleaning of failed equipment. |
K26 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45 |
Duty 13 Prepare biotechnology plant for maintenance, overhaul, or decommissioning. For example, decontamination, cleaning, isolation, segregation, and signage access restriction. |
K26 K30 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45 |
Duty 14 Establish new biotechnology equipment or new operating conditions. |
K26 K27 K28 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45 |
Duty | KSBs |
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Duty 15 Plan and run team working schedule to coincide with operational parameters, stakeholder requirements, and product limitations. For example, delivery time, maximised equipment set up and time, reduced product wastage, product expiration, and approvals. |
K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K63 K65 |
Duty 16 Start and maintain aseptic manufacturing process and equipment in line with operational parameters. |
K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K63 K64 K65 |
Duty 17 Conduct packaging, and transfer or dispatch of processed products for different product types and dispatch methods, including quality assurance checks. |
K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K64 K65 |
Duty 18 Conduct investigational activities. For example, room or operator environmental studies. |
K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K64 K65 |
K1: Science process manufacturing sector awareness: range of products, manufacturing environments, types of customers.
Back to Duty
K2: Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement.
Back to Duty
K3: Health and safety regulations, standards, and guidance: Control of Substances Hazardous to Health (COSHH), Dangerous Substances and Explosive Atmospheres Regulations (DSEAR), Electrical safety and compliance, Fire safety, Health and Safety at Work Act – responsibilities, incident and near miss reporting and investigation, Lifting Operations and Lifting Equipment Regulations (LOLER), Legionella, Lone working, Management of health and safety at work, Manual handling, Noise regulation, Permits to work, Provision and Use of Work Equipment Regulations (PUWER), Safety signage and purpose, Slips trips and falls, The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR), Working in confined spaces, and Working at height.
Back to Duty
K4: Science process manufacturing safety hazards – risks they pose and their management: temperature, pressure, and vapours. Risk assessment and safe systems of work. Personal Protective Equipment (PPE) requirements. Emergency procedures.
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K5: Health and safety management systems; key performance indicators (KPIs) and learning from incidents.
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K6: Environmental hazards that can arise from process. Hierarchy of control.
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K7: Environmental management systems standard. Environmental Protection Act. Environmental signage and notices.
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K8: Principles of sustainability and circular economy. Resource (energy, water, and waste) efficiency and reuse of materials. Principles of control and management of emissions and waste.
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K9: Continuous and batch techniques. Production requirements: product specification, processing specification, rate of production. Material safety data sheet, product labelling and product codes; the importance of identifying non-conforming materials and products. Overall Equipment Effectiveness (OEE). Stock control. Current Good Manufacturing Practice (cGMP).
Back to Duty
K10: Medicines and Healthcare products Regulatory Agency (MHRA): their role and requirements.
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K11: Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows.
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K12: Numerical approximations and unit conversion tables. Areas, volumes, and pressure and flow rates calculations. Statistical data.
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K13: Documentation requirements: documentation control, auditable records.
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K14: Requirements for a second person witness and second person checks.
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K15: How customer feedback can be used to assess quality performance. Purpose of audits. Non-conformance reports (NCR). Corrective Action Preventive Action (CAPA).
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K16: Principles of laboratory quality procedures: calibration requirements for quality control, representative sampling, and common methods of analysis.
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K17: Preventative and reliability maintenance practices.
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K18: Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors.
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K19: Problem solving and fault-finding techniques: root cause analysis, 5-Whys.
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K20: Continuous improvement (CI) systems and techniques.
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K21: Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR).
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K22: Verbal communication techniques.
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K23: Written communication techniques. Technical report writing techniques.
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K24: Principles of team working. Principles of equality, diversity, and inclusion in the workplace.
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K25: Planning, prioritising, and time management techniques.
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K26: Standard operating procedures (SOP) - what they are and why they are important.
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K27: Standard operating conditions (SOC) - what they are and why they are important.
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K28: Process control systems and their constituent components.
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K29: Quality standards. On-line and off-line quality control.
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K30: Requirements for shutting down and preparing for maintenance.
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K31: Main factors influencing quality assurance in biotechnology process industries.
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K32: Microbiology: classifications, characteristics. Sterility assurance.
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K33: Common contamination routes during biotechnology production.
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K34: The different types of cells that make up living organisms. The advantages and disadvantages of each cell type for commercial manufacturing.
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K35: Proteins: ammino acids, protein structures, and antibodies.
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K36: Molecular biology: DNA (deoxyribonucleic acid), RNA (ribonucleic acid), genetics, and methods of manipulation.
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K37: Chemistry and biochemistry: chemical bond types, acid and bases and conductivity.
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K38: Biotechnology processes: cell mass commercial manufacture, separation from the remaining cellular material, common methods of purification of product.
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K39: Immunology: diseases and body response and how these are used to create new medicines.
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K40: The thermal properties of solids, liquids, and gases.
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K41: The structure and properties of elements, mixtures, compounds.
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K42: Types of water and its use: cooling water, purified water, water for injection.
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K43: Purpose and operation of biotechnology equipment.
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K44: Utilities on site purpose and interaction with equipment: alarms, condensers, compressors, coolers, driers, electrical equipment, filters, heat exchange (heat transfer and fluid flow principles), heating services (steam generation and distribution principles), pipe work, plant control systems, pressure relief, process control instrumentation and their calibration requirements, pumps, reactors, receivers, vacuum pumps, and valves.
Back to Duty
K45: Conventions for drawings and graphical information.
Back to Duty
K46: Standard operating procedures (SOP) - what they are and why they are important.
Back to Duty
K47: Standard operating conditions (SOC) - what they are and why they are important.
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K48: Process control systems and their constituent components.
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K49: Start up and shut down procedures.
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K50: Main factors influencing quality assurance in pharmaceutical process industries.
Back to Duty
K51: Quality standards. On-line and off-line quality control.
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K52: Science in aseptic processing: microbiology, classifications and characteristics.
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K53: Sources, types and the impact of contamination.
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K54: Science in aseptic processing: chemistry principles.
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K55: Science in aseptic processing: biological principles.
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K56: Science in aseptic processing: anatomy and physiology.
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K57: Science in aseptic processing: pharmaceuticals and formulations, radio pharmacy and clinical pharmacy.
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K58: Aseptic manufacturing regulation and legislation; licensing regulations, Good Manufacturing Practice (GMP), Good Documentation Practise (GDP).
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K59: Manufactured products within a licensed aseptic environment; types, use, and classifications.
Back to Duty
K60: Manufactured products within a non-licensed aseptic environment; types, use, and classifications.
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K61: Materials within aseptic manufacturing; preparation, storage and stock management.
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K62: Pre and in-process checking within aseptic services.
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K63: Purpose and operation of aseptic pharmaceutical equipment.
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K64: Utilities on site purpose and interaction with equipment: alarms, facility monitoring systems, filters, heating, ventilation and air conditioning (HVAC), and electrical equipment.
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K65: Requirements for full equipment maintenance.
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S1: Review instructions or information to understand the task.
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S2: Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost.
Back to Duty
S3: Identify hazards and risks in the workplace and personal safety and mitigation measures.
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S4: Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance.
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S5: Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation.
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S6: Apply sustainability principles for example, minimising waste.
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S7: Segregate resources for reuse, recycling, and waste handling.
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S8: Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge.
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S9: Apply first line maintenance practices.
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S10: Store tools and equipment.
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S11: Conduct calculations for example, conversations, tare weight, charge weights, yield calculations.
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S12: Interpret data for example, process data, quality control and test procedure data.
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S13: Perform second person witness and second person checks for critical tasks.
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S14: Identify issues for example, defects, deviations, process variance, and maintenance requirements.
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S15: Apply problem solving and fault-finding techniques.
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S16: Escalate issues outside limits of responsibility.
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S17: Record or enter information - paper based or electronic.
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S18: Use information and digital technology for example, management information systems, human machine interfaces, word processing, spreadsheet, email, virtual learning platforms, document sharing platforms. Comply with cyber security requirements and GDPR.
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S19: Apply continuous improvement techniques. Make a suggestion for improvement.
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S20: Apply team working principles.
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S21: Communicate with others verbally for example, colleagues and stakeholders.
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S22: Produce written documents for example, handover notes or emails, non-conformances, design change requests.
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S23: Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities.
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S24: Apply standard operating procedures (SOPs).
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S25: Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation.
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S26: Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable.
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S27: Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic.
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S28: Operate biotechnology equipment for example, start-up, shut down, or cleaning mode.
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S29: Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time.
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S30: Check calibration and calibrate analytical equipment.
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S31: Conduct at point analysis of the product using laboratory techniques (bench top analysis) for example, pH, conductivity measurement, optical density measurements, and protein concertation.
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S32: Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing.
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S33: Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding.
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S34: Conduct aseptic method for example, aseptic technique or aseptic sampling.
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S35: Interpret drawings and graphs.
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S36: Apply standard operating procedures (SOPs).
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S37: Select, check, and prepare raw (incoming) materials for aseptic process for example, weighing, measuring, conditioning, dissolving, and sanitisation.
Back to Duty
S38: Conduct pre-checks of hand tools, equipment and machinery for aseptic process including calibration record where applicable.
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S39: Operate aseptic process equipment for example, start-up and shut-down.
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S40: Set aseptic process parameters such as temperature, and pressure.
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S41: Conduct pre and in-process checks such as environmental monitoring.
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S42: Make adjustments to aseptic process parameters.
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S43: Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing.
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S44: Clean equipment and process areas in-between production to avoid cross-contamination.
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S45: Conduct volume checks.
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S46: Calibrate analytical equipment.
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B1: Prioritise health, safety, and environment.
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B2: Consider sustainability when using resources and carrying out processes.
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B3: Team-focus to meet work goals including support for equality, diversity and inclusion.
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B4: Take responsibility for the quality of their own work.
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B5: Take responsibility for the quality of their own work.
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B6: Respond and adapt to work demands.
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B7: Committed to continued professional development.
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Apprentices without level 2 English and maths will need to achieve this level prior to taking the End-Point Assessment. For those with an education, health and care plan or a legacy statement, the apprenticeship’s English and maths minimum requirement is Entry Level 3. A British Sign Language (BSL) qualification is an alternative to the English qualification for those whose primary language is BSL.
This standard aligns with the following professional recognition:
V1.0
This document explains the requirements for end-point assessment (EPA) for the science manufacturing technician 2023 apprenticeship. End-point assessment organisations (EPAOs) must follow this when designing and delivering the EPA.
Science manufacturing technician 2023 apprentices, their employers and training providers should read this document.
This is a core and options apprenticeship. An apprentice must be trained and assessed against the core and one option. The options are:
A full-time science manufacturing technician 2023 apprentice typically spends 36 months on-programme. The apprentice must spend at least 12 months on-programme and complete the required amount of off-the-job training in line with the apprenticeship funding rules.
The EPA should be completed within an EPA period lasting typically 3 months.
The apprentice must complete their training and meet the gateway requirements before starting their EPA. The EPA will assess occupational competence.
An approved EPAO must conduct the EPA for this apprenticeship. Employers must select an approved EPAO from the apprenticeship provider and assessment register (APAR).
This EPA has 3 assessment methods.
The grades available for each assessment method are below.
Assessment method 1 - observation with questions:
Assessment method 2 - interview underpinned by a portfolio of evidence:
Assessment method 3 - multiple-choice test:
The result from each assessment method is combined to decide the overall apprenticeship grade. The following grades are available for the apprenticeship:
On-programme - typically 36 months
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The apprentice must:
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End-point assessment gateway
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The apprentice’s employer must be content that the apprentice is occupationally competent. The apprentice must:
For the interview underpinned by a portfolio of evidence, the apprentice must submit a portfolio of evidence.
Gateway evidence must be submitted to the EPAO, along with any organisation specific policies and procedures requested by the EPAO. |
End-point assessment - typically 3 months
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The grades available for each assessment method are below
Observation with questions:
Interview underpinned by a portfolio of evidence:
Multiple-choice test:
Overall EPA and apprenticeship can be graded:
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Professional recognition
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This apprenticeship aligns with:
This apprenticeship aligns with:
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Re-sits and re-takes
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The EPA is taken in the EPA period. The EPA period starts when the EPAO confirms the gateway requirements have been met and is typically 3 months.
The EPAO should confirm the gateway requirements have been met and start the EPA as quickly as possible.
The apprentice’s employer must be content that the apprentice is occupationally competent. That is, they are deemed to be working at or above the level set out in the apprenticeship standard and ready to undertake the EPA. The employer may take advice from the apprentice's training provider, but the employer must make the decision. The apprentice will then enter the gateway.
The apprentice must meet the gateway requirements before starting their EPA.
They must:
Portfolio of evidence requirements:
The apprentice must compile a portfolio of evidence during the on-programme period of the apprenticeship. It should only contain evidence related to the KSBs that will be assessed by this assessment method. It will typically contain 10 discrete pieces of evidence. Evidence must be mapped against the KSBs. Evidence may be used to demonstrate more than one KSB; a qualitative as opposed to quantitative approach is suggested.
Evidence sources may include:
This is not a definitive list; other evidence sources can be included.
The portfolio of evidence should not include reflective accounts or any methods of self-assessment. Any employer contributions should focus on direct observation of performance for example, witness statements rather than opinions. The evidence provided should be valid and attributable to the apprentice; the portfolio of evidence should contain a statement from the employer and apprentice confirming this.
The EPAO should not assess the portfolio of evidence directly as it underpins the interview. The independent assessor should review the portfolio of evidence to prepare questions for the interview. They are not required to provide feedback after this review.
Gateway evidence must be submitted to the EPAO, along with any organisation specific policies and procedures requested by the EPAO.
The assessment methods can be delivered in any order.
The result of one assessment method does not need to be known before starting the next.
In the observation with questions, an independent assessor observes the apprentice in their workplace and asks questions. The apprentice completes their day-to-day duties under normal working conditions. Simulation is not allowed. It gives the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method.
This assessment method is being used because:
The observation with questions must be structured to give the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method to the highest available grade.
An independent assessor must conduct and assess the observation with questions.
The independent assessor must only observe one apprentice at a time to ensure quality and rigour. They must be as unobtrusive as possible.
The EPAO must give the apprentice 2 weeks' notice of the observation with questions.
The observation must take 3 hours.
The independent assessor can increase the time of the observation with questions by up to 10%. This time is to allow the apprentice to complete a task or respond to a question if necessary.
The apprentice may choose to end any assessment method early. The apprentice must be confident they have demonstrated competence against the assessment requirements for the assessment method. The independent assessor or EPAO must ensure the apprentice is fully aware of all assessment requirements. The independent assessor or EPAO cannot suggest or choose to end any assessment methods early (unless in an emergency). The EPAO is responsible for ensuring the apprentice understands the implications of ending an assessment early if they choose to do so. The independent assessor may suggest the assessment continues. The independent assessor must document the apprentice’s request to end any assessment early.
The observation may be split into discrete sections held on the same working day.
The EPAO must manage invigilation of the apprentice during the assessment, to maintain security of the EPA, in line with their malpractice policy. This includes breaks and moving between locations.
The independent assessor must explain to the apprentice the format and timescales of the observation with questions before it starts. This does not count towards the assessment time.
The independent assessor should observe the following during the observation:
Core
Option 1. Biotechnology manufacturing technician
Option 2. Aseptic pharmaceuticals manufacturing technician
Activities may relate to the same process or product, or different processes or products.
These activities provide the apprentice with the opportunity to demonstrate the KSBs mapped to this assessment method.
The independent assessor must ask questions. Questioning can occur both during and after the observation.
The purpose of the questions is to assess the apprentice's level of competence against the grading descriptors.
The time for questioning is included in the overall assessment time. The independent assessor must ask at least 5 questions. To remain as unobtrusive as possible, the independent assessor should ask questions during natural stops between tasks and after completion of work rather than disrupting the apprentice’s flow. The independent assessor must use the questions from the EPAO’s question bank or create their own questions in line with the EPAO’s training. Follow-up questions are allowed where clarification is required.
The independent assessor must ask questions about KSBs that were not observed to gather assessment evidence. These questions are in addition to the above set number of questions for the observation with questions and should be kept to a minimum.
The independent assessor must make the grading decision. The independent assessor must assess the observation and responses to questions holistically when deciding the grade.
The independent assessor must keep accurate records of the assessment. They must record:
The observation with questions must take place in the apprentice’s normal place of work for example, their employer’s premises or a customer’s premises. Equipment and resources needed for the observation must be provided by the employer and be in good and safe working condition.
Questioning that occurs after the observation should take place in a suitable environment, for example a quiet room, free from distractions and influence.
The EPAO must develop a purpose-built assessment specification and question bank. It is recommended this is done in consultation with employers of this occupation. The EPAO must maintain the security and confidentiality of EPA materials when consulting with employers. The assessment specification and question bank must be reviewed at least once a year to ensure they remain fit-for-purpose.
The assessment specification must be relevant to the occupation and demonstrate how to assess the KSBs mapped to this assessment method. The EPAO must ensure that questions are refined and developed to a high standard. The questions must be unpredictable. A question bank of sufficient size will support this.
The EPAO must produce the following materials to support the observation with questions:
The EPAO must ensure that the EPA materials are subject to quality assurance procedures including standardisation and moderation.
In the interview, an independent assessor asks the apprentice questions. It gives the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method.
The apprentice can refer to and illustrate their answers with evidence from their portfolio of evidence.
This assessment method is being used because:
The interview must be structured to give the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method to the highest available grade.
An independent assessor must conduct and assess the interview.
The purpose of the independent assessor's questions is to assess the apprentice against the following themes:
Core
Option 1. Biotechnology manufacturing technician
Option 2. Aseptic pharmaceuticals manufacturing technician
The EPAO must give an apprentice 2 weeks' notice of the interview.
The independent assessor must have at least 2 weeks to review the supporting documentation.
The apprentice must have access to their portfolio of evidence during the interview.
The apprentice can refer to and illustrate their answers with evidence from their portfolio of evidence however, the portfolio of evidence is not directly assessed.
The interview must last for 60 minutes. The independent assessor can increase the time of the interview by up to 10%. This time is to allow the apprentice to respond to a question if necessary.
The apprentice may choose to end any assessment method early. The apprentice must be confident they have demonstrated competence against the assessment requirements for the assessment method. The independent assessor or EPAO must ensure the apprentice is fully aware of all assessment requirements. The independent assessor or EPAO cannot suggest or choose to end any assessment methods early (unless in an emergency). The EPAO is responsible for ensuring the apprentice understands the implications of ending an assessment early if they choose to do so. The independent assessor may suggest the assessment continues. The independent assessor must document the apprentice’s request to end any assessment early.
The independent assessor must ask at least 8 questions. The independent assessor must use the questions from the EPAO’s question bank or create their own questions in line with the EPAO’s training. Follow-up questions are allowed where clarification is required.
The independent assessor must make the grading decision.
The independent assessor must keep accurate records of the assessment. They must record:
The interview must take place in a suitable venue selected by the EPAO for example, the EPAO’s or employer’s premises.
The interview can be conducted by video conferencing. The EPAO must have processes in place to verify the identity of the apprentice and ensure the apprentice is not being aided.
The interview should take place in a quiet room, free from distractions and influence.
The EPAO must develop a purpose-built assessment specification and question bank. It is recommended this is done in consultation with employers of this occupation. The EPAO must maintain the security and confidentiality of EPA materials when consulting with employers. The assessment specification and question bank must be reviewed at least once a year to ensure they remain fit-for-purpose.
The assessment specification must be relevant to the occupation and demonstrate how to assess the KSBs mapped to this assessment method. The EPAO must ensure that questions are refined and developed to a high standard. The questions must be unpredictable. A question bank of sufficient size will support this.
The EPAO must ensure that the apprentice has a different set of questions in the case of re-sits or re-takes.
The EPAO must produce the following materials to support the interview underpinned by a portfolio of evidence:
The EPAO must ensure that the EPA materials are subject to quality assurance procedures including standardisation and moderation.
In the multiple-choice test, the apprentice answers questions in a controlled and invigilated environment. It gives the apprentice the opportunity to demonstrate the knowledge mapped to this assessment method.
This assessment method is being used because:
The multiple-choice test must be structured to give the apprentice the opportunity to demonstrate the knowledge mapped to this assessment method to the highest available grade.
The test can be computer or paper based.
The test will consist of 40 multiple-choice questions.
Multiple-choice questions must have four options, including one correct answer.
The apprentice must be given at least 2 weeks’ notice of the date and time of the test.
The apprentice must have 60 minutes to complete the test.
The test is closed book which means that the apprentice cannot refer to reference books or materials whilst taking the test.
The following equipment is allowed to be used during the test:
The test must be taken in the presence of an invigilator who is the responsibility of the EPAO. The EPAO must have an invigilation policy setting out how the test must be conducted. It must state the ratio of apprentices to invigilators for the setting and allow the test to take place in a secure way.
The EPAO must verify the apprentice’s identity and ensure invigilation of the apprentice for example, with 360-degree cameras and screen sharing facilities.
The EPAO is responsible for the security of the test including the arrangements for on-line testing. The EPAO must ensure that their security arrangements maintain the validity and reliability of the test.
The test must be marked by an independent assessor or marker employed by the EPAO. They must follow a marking scheme produced by the EPAO. Marking by computer is allowed where question types support this.
A correct answer gets 1 mark.
Any incorrect or missing answers get zero marks.
The EPAO is responsible for overseeing the marking of the test.
The apprentice must take the test in a suitably controlled and invigilated environment that is a quiet room, free from distractions and influence. The EPAO must check the venue is suitable.
The test could take place remotely if the appropriate technology and systems are in place to prevent malpractice.
The EPAO must develop a purpose-built assessment specification and question bank. It is recommended this is done in consultation with employers of this occupation. The EPAO should maintain the security and confidentiality of EPA materials when consulting with employers. The assessment specification and question bank must be reviewed at least once a year to ensure they remain fit-for-purpose.
The assessment specification must be relevant to the occupation and demonstrate how to assess the KSBs mapped to this assessment method. The EPAO must ensure that questions are refined and developed to a high standard. The questions must be unpredictable. A question bank of sufficient size will support this.
The EPAO must ensure that the apprentice has a different set of questions in the case of re-sits or re-takes.
The EPAO must produce the following materials to support the test:
The EPAO must ensure that the EPA materials are subject to quality assurance procedures including standardisation and moderation.
Fail - does not meet pass criteria
Theme
KSBs
|
Pass
The apprentice must demonstrate all of the pass descriptors for the core and their option
|
Distinction
The apprentice must demonstrate all of the pass and distinction descriptors for the core and their option
|
---|---|---|
(Core) Organise own work
K25 S1 S2 |
Reviews instructions or information to understand the task's requirements. (S1) Plans tasks and identifies and organises resources required to complete it using planning, prioritising, and time management techniques with consideration for safety, environmental impact, quality, and cost. (K25, S2) |
The balance of safety, environmental impact, quality, and cost factors in their planning decisions is justified. (K25, S2) |
(Core) Maintain the work area
K4 K6 S3 S4 S7 S10 B1 |
Identifies health and safety and environmental hazards and risks in the workplace, and personal safety and mitigation measures with consideration of hierarchy of control and emergency procedures. Prioritises and applies health, safety, and environmental procedures in compliance with regulations, standards and guidance mitigating against risks including use of personal protective equipment. (K4, K6, S3, S4, B1) Segregates resources for reuse, recycling, and waste handling in line with company procedures. (S7) Stores tools and equipment in line with company procedures. (S10) |
Explains the importance of applying health, safety and environmental procedures in their work. (K4, K6, S4) |
(Core) Apply control room procedures
K11 S5 |
Applies controlled environmental procedures in line with the need and requirements for clean rooms in manufacturing including protocols for entering, gowning, working in, exiting, and material flows. (K11, S5) |
None |
(Core) Conduct first line routine maintenance
K17 S9 |
Applies first line maintenance practices in line with their company's preventative and reliability maintenance practices. (K17, S9) |
Explains the benefits of applying preventative and reliability maintenance practices. (K17, S9) |
(Core) Communicate with others
K22 S21 |
Uses verbal communication techniques suitable for the context. (K22, S21) |
None |
(Core) Complete process documentation
K13 S17 |
Records or enters data for work tasks - paper based or electronic - in line with company procedures for documentation control and auditable records. (K13, S17) |
None |
(Biotechnology technician) Option 1. Run and maintain biotechnology process
K26 K27 K28 K43 S24 S25 S26 S27 S28 S29 S33 |
Selects, checks, and prepares raw materials for biotechnology process or processes in line with task requirements and standard operating procedures. Conducts pre-checks of hand tools, equipment, and machinery for biotechnology process or processes, including calibration record where applicable, required for task in line with standard operating procedures. Connects service connections for biotechnology process or processes in line with task requirements and standard operating procedures. Operates biotechnology equipment and sets and adjusts biotechnology process parameters using process control system and its constituent components to maintain standard operating conditions for the task in line with standard operating procedures. Removes and replaces disposable components and checks functionality to ensure no equipment errors. (K26, K27, K28, K43, S24, S25, S26, S27, S28, S29, S33) |
Justifies their approach to running biotechnology process in terms of effectiveness or efficiencies of practice and the impact of their actions on others. (K26, S24) |
(Biotechnology technician) Option 1. Conduct biotechnology quality assurance
K29 K31 S30 S31 S32 B4 |
Checks calibration and calibrates analytical equipment in line with standard operating procedures. Takes responsibility for the quality of own work by conducting at point analysis of product using laboratory techniques (bench top analysis) and applying quality assurance procedures in line with quality standards and on-line and off-line quality control requirements that take account of the main factors influencing quality assurance in biotechnology process industries. (K29, K31, S30, S31, S32, B4) |
None |
(Aseptic pharmaceutical technician) Option 2. Run and maintain aseptic pharmaceutical process
K46 K47 K48 K49 K63 S36 S37 S38 S39 S40 S42 |
Selects, checks, and prepares raw materials for aseptic process in line with task requirements and standard operating procedures. Conducts pre-checks of hand tools, equipment, and machinery for aseptic process, including calibration record where applicable, required for task in line with standard operating procedures. Operates aseptic process equipment and sets and adjusts aseptic process parameters using process control system and its constituent components to maintain standard operating conditions for the task in line with standard operating procedures and start up and shut down procedures. (K46, K47, K48, K49, K63, S36, S37, S38, S39, S40, S42) |
Justifies their approach to running aseptic process in terms of effectiveness or efficiencies of practice and the impact of their actions on others. (K46, S36) |
(Aseptic pharmaceutical technician) Option 2. Conduct aseptic pharmaceutical quality assurance
K50 K51 K62 S41 S43 S44 S45 S46 B5 |
Conducts pre and in-process checks in line with aseptic services checking requirements. Takes responsibility for the quality of own work by applying quality assurance procedures in line with quality standards and on-line and off-line quality control requirements that take account of the main factors influencing quality assurance in pharmaceutical process industries. Cleans equipment and process areas in-between production in line with standard operating procedures to avoid cross-contamination in line with company procedures. Conducts volume checks in line with company procedures. Calibrates analytical equipment in line with standard operating procedures. K50, K51, K62, S41, S43, S44, S45, S46, B5) |
None |
Fail - does not meet pass criteria
Theme
KSBs
|
Pass
The apprentice must demonstrate all of the pass descriptors for the core and their option
|
Distinction
The apprentice must demonstrate all of the pass and distinction descriptors for the core and their option
|
---|---|---|
(Core) Role and responsibilities
K2 K14 S13 S16 B6 |
Describes their role as a science manufacturing technician including their limits of responsibility, how they escalate issues, and how they respond and adapt to work demands in line with organisational requirements. Outlines the impact of an operator’s competence on product quality. Outlines change control requirements and why they are important. (K2, S16, B6) Describes how they perform second person witness and second person checks for critical tasks in line with company requirements. (K14, S13) |
Explains the importance of applying second person witness and second person checks for critical tasks and aseptic techniques in production. (K14, S13) |
(Core) In process or post manufacturing procedures
S8 |
Describes how they apply in process or post-process manufacturing procedures in line with task requirements. (S8)
|
None |
(Core) Sustainability
K8 S6 B2 |
Describes how they consider and apply the principles of sustainability and the circular economy when using resources and carrying out processes including resource efficiency, reuse of materials, and recycling and control of emissions and waste. (K8, S6, B2) |
Explains how they have supported the development or implementation of sustainability practice in the workplace beyond their role for example, through promoting good practice to others, identifying improvement to practice. (K6, S6, B2) |
(Core) Problem solving and fault finding
K18 K19 S14 S15 |
Describes how they identify issues and apply problem solving and fault-finding techniques to establish the root cause of common faults in processing including flow, blockages, instrumentation failures, seals, and human factors. (K18, K19, S14, S15) |
Assesses the value of specific fault-finding and problem solving techniques for different issues. (K18, K19, S14, S15) |
(Core) Continuous improvement
K20 S19 |
Describes how they have applied continuous improvement (CI) techniques and a made a viable suggestion for improvement in their work to support CI systems. (K20, S19) |
Justifies the potential impact of the improvement suggestion with consideration to benefits and any potential risks. (K20, S19) |
(Core) Written communication
K23 S22 |
Describes how they apply written communication and report writing techniques to produce communications in their work suitable for context. (K23, S22) |
None |
(Core) Information and digital technology
K21 S18 |
Describes how they use information and digital technology in work tasks in compliance with cyber security requirements and GDPR. (K21, S18) |
None |
(Core) Teamwork
K24 S20 B3 |
Describes how they apply team working principles to meet work goals in line with their company's policy on equality, diversity, and inclusion. (K24, S20, B3) |
Justifies how their team focus approach helped to achieve a positive outcome in a team activity. (K24, S20, B3) |
(Core) Continued professional development
S23 B7 |
Describes the planned and unplanned learning and development activities they have carried out and recorded to meet personal development needs, showing a commitment to future CPD. (S23, B7) |
None |
(Biotechnology technician) Option 1. Biotechnology process operations
K33 S34 |
Describes how they conduct aseptic method in line with task requirements to avoid common contamination routes in line with standard operating procedures. (K33, S34) |
None
|
(Biotechnology technician) Option 1. Shutting down and preparing for maintenance
K30 |
Explains their company's requirements for shutting down and preparing for maintenance. (K30) |
None |
(Aseptic pharmaceutical technician) Option 2. Requirements for maintenance
K65 |
Explains their company's requirements for full maintenance. (K65) |
None |
Grade | Minimum marks required | Maximum marks required |
---|---|---|
Fail | 0 | 27 |
Pass | 28 | 40 |
Performance in the EPA determines the overall grade of:
An independent assessor must individually grade the observation with questions and interview underpinned by a portfolio of evidence in line with this EPA plan.
The EPAO must combine the individual assessment method grades to determine the overall EPA grade.
If the apprentice fails one assessment method or more, they will be awarded an overall fail.
To achieve an overall pass, the apprentice must achieve at least a pass in all the assessment methods. To achieve an overall EPA merit, the apprentice must achieve a distinction in one assessment method (observation with questions, or interview underpinned by a portfolio of evidence), and a pass in the other two assessment methods. To achieve an overall EPA distinction, the apprentice must achieve a distinction in the observation with questions, a distinction in the interview underpinned by a portfolio of evidence, and a pass in the multiple-choice test.
Grades from individual assessment methods must be combined in the following way to determine the grade of the EPA overall.
Observation with questions | Interview underpinned by a portfolio of evidence | Multiple-choice test | Overall Grading |
---|---|---|---|
Any grade | Any grade | Fail | Fail |
Any grade | Fail | Any grade | Fail |
Fail | Any grade | Any grade | Fail |
Pass | Pass | Pass | Pass |
Distinction | Pass | Pass | Merit |
Pass | Distinction | Pass | Merit |
Distinction | Distinction | Pass | Distinction |
If the apprentice fails one assessment method or more, they can take a re-sit or a re-take at their employer’s discretion. The apprentice’s employer needs to agree that a re-sit or re-take is appropriate. A re-sit does not need further learning, whereas a re-take does. The apprentice should have a supportive action plan to prepare for a re-sit or a re-take.
The employer and the EPAO should agree the timescale for a re-sit or re-take. A re-sit is typically taken within 2 months of the EPA outcome notification. The timescale for a re-take is dependent on how much re-training is required and is typically taken within 4 months of the EPA outcome notification.
Failed assessment methods must be re-sat or re-taken within a 6-month period from the EPA outcome notification, otherwise the entire EPA will need to be re-sat or re-taken in full.
Re-sits and re-takes are not offered to an apprentice wishing to move from pass to a higher grade.
The apprentice will get a maximum EPA grade of if pass they need to re-sit or re-take one or more assessment methods, unless the EPAO determines there are exceptional circumstances.
Roles | Responsibilities |
---|---|
Apprentice |
As a minimum, the apprentice should:
|
Employer |
As a minimum, the apprentice's employer must:
|
EPAO |
As a minimum, the EPAO must:
|
Independent assessor |
As a minimum, an independent assessor must:
|
Training provider |
As a minimum, the training provider must:
|
Marker |
As a minimum, the marker must:
|
Invigilator |
As a minimum, the invigilator must:
|
The EPAO must have reasonable adjustments arrangements for the EPA.
This should include:
Adjustments must maintain the validity, reliability and integrity of the EPA as outlined in this EPA plan.
Special considerations
The EPAO must have special consideration arrangements for the EPA.
This should include:
Special considerations must maintain the validity, reliability and integrity of the EPA as outlined in this EPA plan.
Internal quality assurance refers to the strategies, policies and procedures that an EPAO must have in place to ensure valid, consistent and reliable EPA decisions.
EPAOs for this EPA must adhere to the requirements within the roles and responsibilities table.
They must also appoint independent assessors who:
Affordability of the EPA will be aided by using at least some of the following:
This apprenticeship aligns with:
This apprenticeship aligns with:
Knowledge | Assessment methods |
---|---|
K1: Core.
Science process manufacturing sector awareness: range of products, manufacturing environments, types of customers. Back to Grading |
Multiple-choice test |
K2: Core.
Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement. Back to Grading |
Interview underpinned by a portfolio of evidence |
K3: Core.
Health and safety regulations, standards, and guidance: Control of Substances Hazardous to Health (COSHH), Dangerous Substances and Explosive Atmospheres Regulations (DSEAR), Electrical safety and compliance, Fire safety, Health and Safety at Work Act – responsibilities, incident and near miss reporting and investigation, Lifting Operations and Lifting Equipment Regulations (LOLER), Legionella, Lone working, Management of health and safety at work, Manual handling, Noise regulation, Permits to work, Provision and Use of Work Equipment Regulations (PUWER), Safety signage and purpose, Slips trips and falls, The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR), Working in confined spaces, and Working at height. Back to Grading |
Multiple-choice test |
K4: Core.
Science process manufacturing safety hazards – risks they pose and their management: temperature, pressure, and vapours. Risk assessment and safe systems of work. Personal Protective Equipment (PPE) requirements. Emergency procedures. Back to Grading |
Observation with questions |
K5: Core.
Health and safety management systems; key performance indicators (KPIs) and learning from incidents. Back to Grading |
Multiple-choice test |
K6: Core.
Environmental hazards that can arise from process. Hierarchy of control. Back to Grading |
Observation with questions |
K7: Core.
Environmental management systems standard. Environmental Protection Act. Environmental signage and notices. Back to Grading |
Multiple-choice test |
K8: Core.
Principles of sustainability and circular economy. Resource (energy, water, and waste) efficiency and reuse of materials. Principles of control and management of emissions and waste. Back to Grading |
Interview underpinned by a portfolio of evidence |
K9: Core.
Continuous and batch techniques. Production requirements: product specification, processing specification, rate of production. Material safety data sheet, product labelling and product codes; the importance of identifying non-conforming materials and products. Overall Equipment Effectiveness (OEE). Stock control. Current Good Manufacturing Practice (cGMP). Back to Grading |
Multiple-choice test |
K10: Core.
Medicines and Healthcare products Regulatory Agency (MHRA): their role and requirements. Back to Grading |
Multiple-choice test |
K11: Core.
Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows. Back to Grading |
Observation with questions |
K12: Core.
Numerical approximations and unit conversion tables. Areas, volumes, and pressure and flow rates calculations. Statistical data. Back to Grading |
Multiple-choice test |
K13: Core.
Documentation requirements: documentation control, auditable records. Back to Grading |
Observation with questions |
K14: Core.
Requirements for a second person witness and second person checks. Back to Grading |
Interview underpinned by a portfolio of evidence |
K15: Core.
How customer feedback can be used to assess quality performance. Purpose of audits. Non-conformance reports (NCR). Corrective Action Preventive Action (CAPA). Back to Grading |
Multiple-choice test |
K16: Core.
Principles of laboratory quality procedures: calibration requirements for quality control, representative sampling, and common methods of analysis. Back to Grading |
Multiple-choice test |
K17: Core.
Preventative and reliability maintenance practices. Back to Grading |
Observation with questions |
K18: Core.
Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors. Back to Grading |
Interview underpinned by a portfolio of evidence |
K19: Core.
Problem solving and fault-finding techniques: root cause analysis, 5-Whys. Back to Grading |
Interview underpinned by a portfolio of evidence |
K20: Core.
Continuous improvement (CI) systems and techniques. Back to Grading |
Interview underpinned by a portfolio of evidence |
K21: Core.
Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR). Back to Grading |
Interview underpinned by a portfolio of evidence |
K22: Core.
Verbal communication techniques. Back to Grading |
Observation with questions |
K23: Core.
Written communication techniques. Technical report writing techniques. Back to Grading |
Interview underpinned by a portfolio of evidence |
K24: Core.
Principles of team working. Principles of equality, diversity, and inclusion in the workplace. Back to Grading |
Interview underpinned by a portfolio of evidence |
K25: Core.
Planning, prioritising, and time management techniques. Back to Grading |
Observation with questions |
K26: Biotechnology manufacturing technician.
Standard operating procedures (SOP) - what they are and why they are important. Back to Grading |
Observation with questions |
K27: Biotechnology manufacturing technician.
Standard operating conditions (SOC) - what they are and why they are important. Back to Grading |
Observation with questions |
K28: Biotechnology manufacturing technician.
Process control systems and their constituent components. Back to Grading |
Observation with questions |
K29: Biotechnology manufacturing technician.
Quality standards. On-line and off-line quality control. Back to Grading |
Observation with questions |
K30: Biotechnology manufacturing technician.
Requirements for shutting down and preparing for maintenance. Back to Grading |
Interview underpinned by a portfolio of evidence |
K31: Biotechnology manufacturing technician.
Main factors influencing quality assurance in biotechnology process industries. Back to Grading |
Observation with questions |
K32: Biotechnology manufacturing technician.
Microbiology: classifications, characteristics. Sterility assurance. Back to Grading |
Multiple-choice test |
K33: Biotechnology manufacturing technician.
Common contamination routes during biotechnology production. Back to Grading |
Interview underpinned by a portfolio of evidence |
K34: Biotechnology manufacturing technician.
The different types of cells that make up living organisms. The advantages and disadvantages of each cell type for commercial manufacturing. Back to Grading |
Multiple-choice test |
K35: Biotechnology manufacturing technician.
Proteins: ammino acids, protein structures, and antibodies. Back to Grading |
Multiple-choice test |
K36: Biotechnology manufacturing technician.
Molecular biology: DNA (deoxyribonucleic acid), RNA (ribonucleic acid), genetics, and methods of manipulation. Back to Grading |
Multiple-choice test |
K37: Biotechnology manufacturing technician.
Chemistry and biochemistry: chemical bond types, acid and bases and conductivity. Back to Grading |
Multiple-choice test |
K38: Biotechnology manufacturing technician.
Biotechnology processes: cell mass commercial manufacture, separation from the remaining cellular material, common methods of purification of product. Back to Grading |
Multiple-choice test |
K39: Biotechnology manufacturing technician.
Immunology: diseases and body response and how these are used to create new medicines. Back to Grading |
Multiple-choice test |
K40: Biotechnology manufacturing technician.
The thermal properties of solids, liquids, and gases. Back to Grading |
Multiple-choice test |
K41: Biotechnology manufacturing technician.
The structure and properties of elements, mixtures, compounds. Back to Grading |
Multiple-choice test |
K42: Biotechnology manufacturing technician.
Types of water and its use: cooling water, purified water, water for injection. Back to Grading |
Multiple-choice test |
K43: Biotechnology manufacturing technician.
Purpose and operation of biotechnology equipment. Back to Grading |
Observation with questions |
K44: Biotechnology manufacturing technician.
Utilities on site purpose and interaction with equipment: alarms, condensers, compressors, coolers, driers, electrical equipment, filters, heat exchange (heat transfer and fluid flow principles), heating services (steam generation and distribution principles), pipe work, plant control systems, pressure relief, process control instrumentation and their calibration requirements, pumps, reactors, receivers, vacuum pumps, and valves. Back to Grading |
Multiple-choice test |
K45: Biotechnology manufacturing technician.
Conventions for drawings and graphical information. Back to Grading |
Multiple-choice test |
K46: Aseptic pharmaceuticals manufacturing technician.
Standard operating procedures (SOP) - what they are and why they are important. Back to Grading |
Observation with questions |
K47: Aseptic pharmaceuticals manufacturing technician.
Standard operating conditions (SOC) - what they are and why they are important. Back to Grading |
Observation with questions |
K48: Aseptic pharmaceuticals manufacturing technician.
Process control systems and their constituent components. Back to Grading |
Observation with questions |
K49: Aseptic pharmaceuticals manufacturing technician.
Start up and shut down procedures. Back to Grading |
Observation with questions |
K50: Aseptic pharmaceuticals manufacturing technician.
Main factors influencing quality assurance in pharmaceutical process industries. Back to Grading |
Observation with questions |
K51: Aseptic pharmaceuticals manufacturing technician.
Quality standards. On-line and off-line quality control. Back to Grading |
Observation with questions |
K52: Aseptic pharmaceuticals manufacturing technician.
Science in aseptic processing: microbiology, classifications and characteristics. Back to Grading |
Multiple-choice test |
K53: Aseptic pharmaceuticals manufacturing technician.
Sources, types and the impact of contamination. Back to Grading |
Multiple-choice test |
K54: Aseptic pharmaceuticals manufacturing technician.
Science in aseptic processing: chemistry principles. Back to Grading |
Multiple-choice test |
K55: Aseptic pharmaceuticals manufacturing technician.
Science in aseptic processing: biological principles. Back to Grading |
Multiple-choice test |
K56: Aseptic pharmaceuticals manufacturing technician.
Science in aseptic processing: anatomy and physiology. Back to Grading |
Multiple-choice test |
K57: Aseptic pharmaceuticals manufacturing technician.
Science in aseptic processing: pharmaceuticals and formulations, radio pharmacy and clinical pharmacy. Back to Grading |
Multiple-choice test |
K58: Aseptic pharmaceuticals manufacturing technician.
Aseptic manufacturing regulation and legislation; licensing regulations, Good Manufacturing Practice (GMP), Good Documentation Practise (GDP). Back to Grading |
Multiple-choice test |
K59: Aseptic pharmaceuticals manufacturing technician.
Manufactured products within a licensed aseptic environment; types, use, and classifications. Back to Grading |
Multiple-choice test |
K60: Aseptic pharmaceuticals manufacturing technician.
Manufactured products within a non-licensed aseptic environment; types, use, and classifications. Back to Grading |
Multiple-choice test |
K61: Aseptic pharmaceuticals manufacturing technician.
Materials within aseptic manufacturing; preparation, storage and stock management. Back to Grading |
Multiple-choice test |
K62: Aseptic pharmaceuticals manufacturing technician.
Pre and in-process checking within aseptic services. Back to Grading |
Observation with questions |
K63: Aseptic pharmaceuticals manufacturing technician.
Purpose and operation of aseptic pharmaceutical equipment. Back to Grading |
Observation with questions |
K64: Aseptic pharmaceuticals manufacturing technician.
Utilities on site purpose and interaction with equipment: alarms, facility monitoring systems, filters, heating, ventilation and air conditioning (HVAC), and electrical equipment. Back to Grading |
Multiple-choice test |
K65: Aseptic pharmaceuticals manufacturing technician.
Requirements for full equipment maintenance. Back to Grading |
Interview underpinned by a portfolio of evidence |
Skill | Assessment methods |
---|---|
S1: Core.
Review instructions or information to understand the task. Back to Grading |
Observation with questions |
S2: Core.
Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost. Back to Grading |
Observation with questions |
S3: Core.
Identify hazards and risks in the workplace and personal safety and mitigation measures. Back to Grading |
Observation with questions |
S4: Core.
Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance. Back to Grading |
Observation with questions |
S5: Core.
Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation. Back to Grading |
Observation with questions |
S6: Core.
Apply sustainability principles for example, minimising waste. Back to Grading |
Interview underpinned by a portfolio of evidence |
S7: Core.
Segregate resources for reuse, recycling, and waste handling. Back to Grading |
Observation with questions |
S8: Core.
Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge. Back to Grading |
Interview underpinned by a portfolio of evidence |
S9: Core.
Apply first line maintenance practices. Back to Grading |
Observation with questions |
S10: Core.
Store tools and equipment. Back to Grading |
Observation with questions |
S11: Core.
Conduct calculations for example, conversations, tare weight, charge weights, yield calculations. Back to Grading |
Multiple-choice test |
S12: Core.
Interpret data for example, process data, quality control and test procedure data. Back to Grading |
Multiple-choice test |
S13: Core.
Perform second person witness and second person checks for critical tasks. Back to Grading |
Interview underpinned by a portfolio of evidence |
S14: Core.
Identify issues for example, defects, deviations, process variance, and maintenance requirements. Back to Grading |
Interview underpinned by a portfolio of evidence |
S15: Core.
Apply problem solving and fault-finding techniques. Back to Grading |
Interview underpinned by a portfolio of evidence |
S16: Core.
Escalate issues outside limits of responsibility. Back to Grading |
Interview underpinned by a portfolio of evidence |
S17: Core.
Record or enter information - paper based or electronic. Back to Grading |
Observation with questions |
S18: Core.
Use information and digital technology for example, management information systems, human machine interfaces, word processing, spreadsheet, email, virtual learning platforms, document sharing platforms. Comply with cyber security requirements and GDPR. Back to Grading |
Interview underpinned by a portfolio of evidence |
S19: Core.
Apply continuous improvement techniques. Make a suggestion for improvement. Back to Grading |
Interview underpinned by a portfolio of evidence |
S20: Core.
Apply team working principles. Back to Grading |
Interview underpinned by a portfolio of evidence |
S21: Core.
Communicate with others verbally for example, colleagues and stakeholders. Back to Grading |
Observation with questions |
S22: Core.
Produce written documents for example, handover notes or emails, non-conformances, design change requests. Back to Grading |
Interview underpinned by a portfolio of evidence |
S23: Core.
Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities. Back to Grading |
Interview underpinned by a portfolio of evidence |
S24: Biotechnology manufacturing technician.
Apply standard operating procedures (SOPs). Back to Grading |
Observation with questions |
S25: Biotechnology manufacturing technician.
Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation. Back to Grading |
Observation with questions |
S26: Biotechnology manufacturing technician.
Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable. Back to Grading |
Observation with questions |
S27: Biotechnology manufacturing technician.
Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic. Back to Grading |
Observation with questions |
S28: Biotechnology manufacturing technician.
Operate biotechnology equipment for example, start-up, shut down, or cleaning mode. Back to Grading |
Observation with questions |
S29: Biotechnology manufacturing technician.
Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time. Back to Grading |
Observation with questions |
S30: Biotechnology manufacturing technician.
Check calibration and calibrate analytical equipment. Back to Grading |
Observation with questions |
S31: Biotechnology manufacturing technician.
Conduct at point analysis of the product using laboratory techniques (bench top analysis) for example, pH, conductivity measurement, optical density measurements, and protein concertation. Back to Grading |
Observation with questions |
S32: Biotechnology manufacturing technician.
Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. Back to Grading |
Observation with questions |
S33: Biotechnology manufacturing technician.
Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding. Back to Grading |
Observation with questions |
S34: Biotechnology manufacturing technician.
Conduct aseptic method for example, aseptic technique or aseptic sampling. Back to Grading |
Interview underpinned by a portfolio of evidence |
S35: Biotechnology manufacturing technician.
Interpret drawings and graphs. Back to Grading |
Multiple-choice test |
S36: Aseptic pharmaceuticals manufacturing technician.
Apply standard operating procedures (SOPs). Back to Grading |
Observation with questions |
S37: Aseptic pharmaceuticals manufacturing technician.
Select, check, and prepare raw (incoming) materials for aseptic process for example, weighing, measuring, conditioning, dissolving, and sanitisation. Back to Grading |
Observation with questions |
S38: Aseptic pharmaceuticals manufacturing technician.
Conduct pre-checks of hand tools, equipment and machinery for aseptic process including calibration record where applicable. Back to Grading |
Observation with questions |
S39: Aseptic pharmaceuticals manufacturing technician.
Operate aseptic process equipment for example, start-up and shut-down. Back to Grading |
Observation with questions |
S40: Aseptic pharmaceuticals manufacturing technician.
Set aseptic process parameters such as temperature, and pressure. Back to Grading |
Observation with questions |
S41: Aseptic pharmaceuticals manufacturing technician.
Conduct pre and in-process checks such as environmental monitoring. Back to Grading |
Observation with questions |
S42: Aseptic pharmaceuticals manufacturing technician.
Make adjustments to aseptic process parameters. Back to Grading |
Observation with questions |
S43: Aseptic pharmaceuticals manufacturing technician.
Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. Back to Grading |
Observation with questions |
S44: Aseptic pharmaceuticals manufacturing technician.
Clean equipment and process areas in-between production to avoid cross-contamination. Back to Grading |
Observation with questions |
S45: Aseptic pharmaceuticals manufacturing technician.
Conduct volume checks. Back to Grading |
Observation with questions |
S46: Aseptic pharmaceuticals manufacturing technician.
Calibrate analytical equipment. Back to Grading |
Observation with questions |
Behaviour | Assessment methods |
---|---|
B1: Core.
Prioritise health, safety, and environment. Back to Grading |
Observation with questions |
B2: Core.
Consider sustainability when using resources and carrying out processes. Back to Grading |
Interview underpinned by a portfolio of evidence |
B3: Core.
Team-focus to meet work goals including support for equality, diversity and inclusion. Back to Grading |
Interview underpinned by a portfolio of evidence |
B4: Biotechnology manufacturing technician.
Take responsibility for the quality of their own work. Back to Grading |
Observation with questions |
B5: Aseptic pharmaceuticals manufacturing technician.
Take responsibility for the quality of their own work. Back to Grading |
Observation with questions |
B6: Core.
Respond and adapt to work demands. Back to Grading |
Interview underpinned by a portfolio of evidence |
B7: Core.
Committed to continued professional development. Back to Grading |
Interview underpinned by a portfolio of evidence |
KSBS GROUPED BY THEME | Knowledge | Skills | Behaviour |
---|---|---|---|
(Core) Organise own work
K25 S1 S2 |
Planning, prioritising, and time management techniques. (K25) |
Review instructions or information to understand the task. (S1) Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost. (S2) |
None |
(Core) Maintain the work area
K4 K6 S3 S4 S7 S10 B1 |
Science process manufacturing safety hazards – risks they pose and their management: temperature, pressure, and vapours. Risk assessment and safe systems of work. Personal Protective Equipment (PPE) requirements. Emergency procedures. (K4) Environmental hazards that can arise from process. Hierarchy of control. (K6) |
Identify hazards and risks in the workplace and personal safety and mitigation measures. (S3) Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance. (S4) Segregate resources for reuse, recycling, and waste handling. (S7) Store tools and equipment. (S10) |
Prioritise health, safety, and environment. (B1) |
(Core) Apply control room procedures
K11 S5 |
Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows. (K11) |
Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation. (S5) |
None |
(Core) Conduct first line routine maintenance
K17 S9 |
Preventative and reliability maintenance practices. (K17) |
Apply first line maintenance practices. (S9) |
None |
(Core) Communicate with others
K22 S21 |
Verbal communication techniques. (K22) |
Communicate with others verbally for example, colleagues and stakeholders. (S21) |
None |
(Core) Complete process documentation
K13 S17 |
Documentation requirements: documentation control, auditable records. (K13) |
Record or enter information - paper based or electronic. (S17) |
None |
(Biotechnology technician) Option 1. Run and maintain biotechnology process
K26 K27 K28 K43 S24 S25 S26 S27 S28 S29 S33 |
Standard operating procedures (SOP) - what they are and why they are important. (K26) Standard operating conditions (SOC) - what they are and why they are important. (K27) Process control systems and their constituent components. (K28) Purpose and operation of biotechnology equipment. (K43) |
Apply standard operating procedures (SOPs). (S24) Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation. (S25) Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable. (S26) Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic. (S27) Operate biotechnology equipment for example, start-up, shut down, or cleaning mode. (S28) Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time. (S29) Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding. (S33) |
None |
(Biotechnology technician) Option 1. Conduct biotechnology quality assurance
K29 K31 S30 S31 S32 B4 |
Quality standards. On-line and off-line quality control. (K29) Main factors influencing quality assurance in biotechnology process industries. (K31) |
Check calibration and calibrate analytical equipment. (S30) Conduct at point analysis of the product using laboratory techniques (bench top analysis) for example, pH, conductivity measurement, optical density measurements, and protein concertation. (S31) Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. (S32) |
Take responsibility for the quality of their own work. (B4) |
(Aseptic pharmaceutical technician) Option 2. Run and maintain aseptic pharmaceutical process
K46 K47 K48 K49 K63 S36 S37 S38 S39 S40 S42 |
Standard operating procedures (SOP) - what they are and why they are important. (K46) Standard operating conditions (SOC) - what they are and why they are important. (K47) Process control systems and their constituent components. (K48) Start up and shut down procedures. (K49) Purpose and operation of aseptic pharmaceutical equipment. (K63) |
Apply standard operating procedures (SOPs). (S36) Select, check, and prepare raw (incoming) materials for aseptic process for example, weighing, measuring, conditioning, dissolving, and sanitisation. (S37) Conduct pre-checks of hand tools, equipment and machinery for aseptic process including calibration record where applicable. (S38) Operate aseptic process equipment for example, start-up and shut-down. (S39) Set aseptic process parameters such as temperature, and pressure. (S40) Make adjustments to aseptic process parameters. (S42) |
None |
(Aseptic pharmaceutical technician) Option 2. Conduct aseptic pharmaceutical quality assurance
K50 K51 K62 S41 S43 S44 S45 S46 B5 |
Main factors influencing quality assurance in pharmaceutical process industries. (K50) Quality standards. On-line and off-line quality control. (K51) Pre and in-process checking within aseptic services. (K62) |
Conduct pre and in-process checks such as environmental monitoring. (S41) Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. (S43) Clean equipment and process areas in-between production to avoid cross-contamination. (S44) Conduct volume checks. (S45) Calibrate analytical equipment. (S46) |
Take responsibility for the quality of their own work. (B5) |
KSBS GROUPED BY THEME | Knowledge | Skills | Behaviour |
---|---|---|---|
(Core) Role and responsibilities
K2 K14 S13 S16 B6 |
Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement. (K2) Requirements for a second person witness and second person checks. (K14) |
Perform second person witness and second person checks for critical tasks. (S13) Escalate issues outside limits of responsibility. (S16) |
Respond and adapt to work demands. (B6) |
(Core) In process or post manufacturing procedures
S8 |
None |
Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge. (S8) |
None |
(Core) Sustainability
K8 S6 B2 |
Principles of sustainability and circular economy. Resource (energy, water, and waste) efficiency and reuse of materials. Principles of control and management of emissions and waste. (K8) |
Apply sustainability principles for example, minimising waste. (S6) |
Consider sustainability when using resources and carrying out processes. (B2) |
(Core) Problem solving and fault finding
K18 K19 S14 S15 |
Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors. (K18) Problem solving and fault-finding techniques: root cause analysis, 5-Whys. (K19) |
Identify issues for example, defects, deviations, process variance, and maintenance requirements. (S14) Apply problem solving and fault-finding techniques. (S15) |
None |
(Core) Continuous improvement
K20 S19 |
Continuous improvement (CI) systems and techniques. (K20) |
Apply continuous improvement techniques. Make a suggestion for improvement. (S19) |
None |
(Core) Written communication
K23 S22 |
Written communication techniques. Technical report writing techniques. (K23) |
Produce written documents for example, handover notes or emails, non-conformances, design change requests. (S22) |
None |
(Core) Information and digital technology
K21 S18 |
Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR). (K21) |
Use information and digital technology for example, management information systems, human machine interfaces, word processing, spreadsheet, email, virtual learning platforms, document sharing platforms. Comply with cyber security requirements and GDPR. (S18) |
None |
(Core) Teamwork
K24 S20 B3 |
Principles of team working. Principles of equality, diversity, and inclusion in the workplace. (K24) |
Apply team working principles. (S20) |
Team-focus to meet work goals including support for equality, diversity and inclusion. (B3) |
(Core) Continued professional development
S23 B7 |
None |
Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities. (S23) |
Committed to continued professional development. (B7) |
(Biotechnology technician) Option 1. Biotechnology process operations
K33 S34 |
Common contamination routes during biotechnology production. (K33) |
Conduct aseptic method for example, aseptic technique or aseptic sampling. (S34) |
None |
(Biotechnology technician) Option 1. Shutting down and preparing for maintenance
K30 |
Requirements for shutting down and preparing for maintenance. (K30) |
None |
None |
(Aseptic pharmaceutical technician) Option 2. Requirements for maintenance
K65 |
Requirements for full equipment maintenance. (K65) |
None |
None |
Contact us about this apprenticeship
Version | Change detail | Earliest start date | Latest start date | Latest end date |
---|---|---|---|---|
1.0 | Approved for delivery | 04/03/2024 | Not set | Not set |
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