Monitor the separation of harvested biomaterial in biomanufacturing downstream processing using normal filtration
Overview
This standard covers the competences you need to monitor the separation of harvested biomaterial in biomanufacturing downstream processing operations using normal filtration, in accordance with approved procedures. You are required to check the readiness of the manufacturing area and equipment that is used. You will be required to work to the relevant standard operation procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP). You will also 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 from cell debris for downstream (DSP) processing. You will be required to separate biomaterial using filtration 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 biomanufacturing activities 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 the application different filtration procedures. You will have an understanding of the harvesting by the normal filtration 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 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 procedures
P2 wear the appropriate personal protection equipment (PPE) when working in the biomanufacturing environment
P3 prepare the filter unit and connect to the biomaterial source for downstream processing (DSP), in accordance with established practices and procedures
P4 pump biomaterial through the filter unit, monitoring and adjusting flow-rate according to specification
P5 collect filtered biomaterial in the correct aseptic containers and quantities
P6 perform a filter unit integrity test, in accordance with established practices and procedures
P7 dispose of waste in the correct manner and location, and tidy and clean the work area, in accordance with established procedures
P8 monitor and lead the quality and delivery of the above outcomes for yourself and your team
P9 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’ operating 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 how to monitor and lead the quality and delivery of separated harvested biomaterial in biomanufacturing downstream processing using normal filtration
K14 the different types of filter units, with and with-out pre-equilibrate, that are used in biomanufacturing
K15 how to assemble and disassemble filter units for biomaterial processing
K16 how to switch on the pump, vent air from the filter unit and monitor the flow-rate during processing
K17 the maximum flow rate for the common filter units used in biomanufacturing
K18 how to recognise the signs of filter blocking
K19 how to recover biomaterial from the filter unit by buffer solution washing
K20 the main differences between a disposable filter unit and a filter unit with module interchange
K21 how to store filled biomaterial containers for further processing
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 assemble and disassemble the filter unit to/from the fermentation vessels or biomaterial containers
1.6 switch on the pump, vent air and collect biomaterial in a sterile container
1.7 monitor flow-rate, pressure and output of biomaterial
1.8 wash the filter unit with buffer solution to recover biomaterial
1.9 store filled biomaterial containers in the correct location and quantities for further processing
1.10 store records of your activities, in accordance with appropriate procedures
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)control the separation of biomaterial by one of the following filter types:
3.1 disposable complete filter unit
3.2 filter unit with module interchangemonitor the use of both of the following types of filter unit:
4.1 filters with pre-equilibrate
4.2 filters without pre-equilibraterecord 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