Maintain health and safety in a biomanufacturing environment
Overview
This standard covers the competences you need to maintain health and safety in a biomanufacturing environment. You are required to observe all legal, statutory and organisational requirements, and you must be able to identify any potential hazards and risks to health and safety. You must also know what actions to take in case of an emergency and, as well as ensuring your own safety, you must show responsibility towards your colleagues and others. You will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP).
Your responsibilities will require you to comply with health and safety requirements and organisational policy and procedures for the manufacturing work that is undertaken. You must be able to recognise the limitations of yourown competence with the manufacturing work, and ask for appropriate help and advice when it is needed. You will need to take responsibility for your own actions and for the quality and accuracy of the work that you carryout.
Your underpinning knowledge will provide an understanding of your manufacturing work, in order to apply safely the appropriate scientific principles and practices. You will be competent in the safe use of the materials, equipment, consumables and instruments used to perform the manufacturing operations, and with the procedures appropriate to your job.
You will understand the safety precautions required when carrying out the manufacturing activities for scientific operations and processes. You will be required to demonstrate safe working practices throughout, and will understand your responsibility for taking the necessary safeguards to protect yourself and others in the workplace.
This activity is likely to be undertaken by someone whose work role carries out Science/Bio manufacturing work activities. This could include individuals working in the following industries, Chemical, Pharmaceutical and Life Science industries.
Performance criteria
You must be able to:
P1 ensure that your work is carried out in accordance with standard operating proceduresP2 accurately assess health and safety in relation to your work and the biomanufacturing work environmentP3 use the appropriate personal protective clothing and equipment for the workP4 make safe any health and safety hazards, and report them to the appropriate person as soon as possibleP5 maintain the security of the biomanufacturing work environment, in accordance with organisational procedureP6 ensure that you maintain your work area to a standard of health and safety which is consistent with local policies and legal requirementsP7 maintain and use equipment and materials in accordance with manufacturers' instructions and local safety regulationsP8 dispose of hazardous materials, waste and waste containers, safely and correctlyP9 prepare, use and dispose of disinfectants, safely and correctlyP10 carry out decontamination of work surfaces and floors effectivelyP11 take the appropriate precautions to protect yourself and others during working hoursP12 follow the correct procedure, without delay, if an emergency arises or is suspected
Knowledge and Understanding
You need to know and understand:
K1 the health and safety requirements of the area in which you are carrying out the manufacturing activitiesK2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting manufacturing activitiesK3 the standard operating procedures, as set down in local manufacturing operating manualsK4 the importance of following manufacturers’ instructionsK5 the principles of Good Manufacturing Practice (GMP) applied in the workplaceK6 the importance of wearing protective clothing, gloves and eye protection when handling materials (including biochemical substances, biological pathogens and/or antigens), and the equipment used to contain and process themK7 the specific safety precautions to be taken when working with biomanufacturing equipment and computer-based systems (to include such things as safety guidance relating to the use of visual display unit (VDU) equipment and work station environment (including lighting, seating, positioning of equipment), and repetitive strain injury (RSI))K8 the identity of health and safety representatives (including the Manufacturing Safety Officer, Staff Health and Safety Representatives and First-Aiders)K9 the location and correct use of emergency equipment (including fire extinguishers, including the situations in which different types of fire extinguisher are used)K10 the organisational requirements for maintaining the security of the workplaceK11 the lines of communication and responsibilities in your department, and their links with the rest of the organisationK12 the limits of your own authority and to whom you should report if you have problems that you cannot resolveK13 why risks in the biomanufacturing work environment should be assessed, and the correct action to be takenK14 local procedures for escape (including escape routes and assembly points)K15 the location of fire alarms, and how to operate themK16 the location of spillage kits, and the procedures to follow in the event of spillages of chemicals and/or biological fluidsK17 the control of substances hazardous to health (COSHH) regulations, and their application in the biomanufacturing work environmentK18 the types of hazard which may occur in the manufacturing setting, and how these can be minimisedK19 the correct storage and disposal procedures for hazardous materials (including flammables, corrosive, harmful and toxic chemicals)K20 the hazards associated with disinfectants and other chemicals (including toxicity)K21 the meaning of the terms ‘disinfection’ and ‘decontamination’, and the use of disinfectantsK22 the reasons for disinfecting/decontaminating manufacturing surfaces and equipmentK23 why it is important to differentiate and segregate categories of waste (such as using waste colour-coding)K24 the correct procedures for the storage, transport and disposal of waste
Scope/range
identify health and safety standard operating procedures for all of the following:1.1 manufacturing hazards1.2 unsafe practices1.3 spillages1.4 manual handling1.5 VDU & RSI policies1.6 other (please specify)
handle safely three of the following hazardous substances, in accordance with approved procedures:2.1 flammables2.2 toxic chemicals2.3 corrosive chemicals2.4 biological materials
follow established procedures for all of the following emergencies:3.1 workplace fire3.2 gas escapes3.3 spillage of hazardous substances3.4 other emergencies (please specify)
dispose of, safely, two of the following, in accordance with approved procedures:4.1 sharps4.2 plastics4.3 confidential records4.4 biomaterials (solid and liquid)4.5 one-use modules/components4.6 other (please specify)4.7 metal4.8 cleaning wipes/tissues4.9 chemicals (solid and liquid)4.10 aerosol containers
5. dispose of waste in two the following categories, in accordance with approved practices:5.1 autoclave5.2 flushing5.3 solids for recycling5.4 addition of chemicals5.5 fluids for recycling5.6 other