Separate harvested biomaterial for biomanufacturing downstream processing using continuous flow centrifugation
Overview
This standard covers the competences you need to separate harvested biomaterial for biomanufacturing downstream processing operations using continuous flow centrifugation, in accordance with approved procedures. You are required to check the readiness of the manufacturing area and equipment to be used. You will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP). You will be required to present records and details of your biomanufacturing work to the appropriate people.
You will be required to check that the work area and equipment are ready for use, and that the appropriate resources and services are available, as stated in
the instructions and standard operating procedures you are given. You will separate biomaterial particles for downstream processing (DSP). You will be required to connect up the centrifuge in accordance with instructions and procedures. You will also complete all the required documents and paperwork in accordance with these same instructions and procedures.
Your responsibilities will require you to comply with health and safety requirements and organisational policy and procedures for the biomanufacturing work that is undertaken. You will be required to report any
problems with the health and safety procedures that you cannot personally resolve, or that are outside your permitted authority, to the relevant people.
Your underpinning knowledge will be sufficient to provide a sound basis for your work, and will enable you to adopt an informed approach to biomaterial harvesting procedures. You will have an understanding of the continuous flow
centrifugation process, in adequate depth to provide a sound background for carrying out the biomanufacturing activities to the required specification.
You will understand the safety precautions required when carrying out the biomanufacturing activities for scientific operations and processes. You will berequired 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 procedures
P2 wear the appropriate personal protection equipment (PPE) when working in a biomanufacturing environment
P3 prepare the centrifuge for separating biomaterial particles, in accordance with established practices and procedures
P4 harvest biomaterial particles in sealed aseptic containers for downstream processing (DSP), in accordance with established practices and procedures
P5 dispose of waste in the correct manner and location, and tidy and clean the work area, in accordance with established procedures
P6 communicate the required information about the work done, to authorised people, in accordance with departmental and organisational procedures
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 biomanufacturing activities
K2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting biomanufacturing activities
K3 the standard operating procedures, as set down in local
biomanufacturing operating manuals
K4 the importance of following equipment manufacturers’ operational instructions
K5 the principles of Good Manufacturing Practice (GMP) applied in the workplace
K6 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 them
K7 the biomanufacturing materials and batch process tracking and records system
K8 the types of handling and sorting system, and the procedures used for materials undergoing processing in the manufacturing facilities
K9 the importance of correct identification, and any unique organisational or manufacturing numbers
K10 the organisational requirements for maintaining the security of the workplace
K11 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K12 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K13 the main principles of operation for the different types of continuous flow centrifuge (disc stack, tubular centred, multi-chamber types)
K14 the main component parts of the centrifuge (including the different types of rotor and cores, the inlet/outlet connection points for the edge and centre of the centrifuge)
K15 how to distinguish between product and waste streams from the centrifuge
K16 how to dismantle and re-assemble a continuous flow centrifuge correctly (not appropriate for disc stack centrifuge)
K17 how to connect equipment and the centrifuge, for loading and unloading, cushion or step gradient
K18 how to connect equipment and the centrifuge for continuous flow centrifugation
K19 how to harvest particles where the required biomaterial in suspended in the liquid
K20 how to harvest particles where the required biomaterial in suspended in the solids
Scope/range
1. prior to entering the clean room, carry out all of the following:
1.1 use the correct issue of job instructions and specifications
1.2 follow risk assessment procedures and COSHH regulations
1.3 use personal protective equipment for the work being done
1.4 use the correct aseptic techniques and practices
1.5 operate the continuous flow centrifuge for separating operations
1.6 identify which centrifuge stream is biomaterial and which is waste
1.7 harvest biomaterial into sterile containers for downstream processing
1.8 store centrifuged biomaterial in the correct location for further processing
1.9 store records of your activities, in accordance with appropriate procedures
2. use three of the following types of protective clothing and equipment:
2.1 laboratory coat/overalls
2.2 gloves
2.3 head/hair covers
2.4 safety shoes/shoe covers
2.5 safety glasses/visors
2.6 other (please specify)
3. separate biomaterial particles by one of the following:
3.1 disc stack centrifuge
3.2 tubular centred centrifuge
3.3 multi-chamber centrifuge
4. separate biomaterial particles by one of the following techniques:
4.1 pelleting and clarifying
4.2 cushion sedimentation
4.3 banding in gradient
5. record details of the work done, and communicate the details to the appropriate people, using:
5.1 verbal report
Plus one method from the following:
5.2 written or typed report
5.3 computer-based record
5.4 specific company documentation
5.5 electronic mail