Prepare the biomanufacturing area and process equipment
Overview
This standard identifies the competences you need to prepare for biomanufacturing processing operations, in accordance with approved procedures. You are required to check the readiness of the manufacturing area and filling equipment that is 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 area and equipment are clear, cleaned and prepared correctly, and that the appropriate services are available, as stated in the instructions and standard operating procedures you are given. 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 the process preparation procedures. You will have an understanding of the readiness
preparations and the checking used, 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 check that the area and equipment are cleared and cleaned to the specified procedure
P4 check that the services required to start the operation are available
P5 check that the area and equipment have been prepared for use
P6 identify and deal with problems in accordance with departmental and organisational procedures
P7 complete all required documents with the specified information, in the required format and at the appropriate time
P8 record all information accurately and legibly
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’ 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 types of manufacturing process record used, and why they are important for the process quality, 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 area and the equipment to be prepared
K14 the specified procedures for clearing and cleaning
K15 how to confirm line clearance
K16 the services which are required to start the operation
K17 how to switch on the equipment
K18 the equipment to be used, and how it should be prepared
K19 the safety devices to be checked, and how to check them
K20 the documents to be completed, and when
K21 where to obtain the documents, and to whom they should be given the prescribed manner for making changes to documentation used in manufacturing
Scope/range
1. check the readiness of the area and equipment by carrying out all of the following:
1.1 observing the processing and packaging standard operating procedures
1.2 obtaining written and computer-based packaging instructions and records
1.3 identifying any problems associated with documentation, services, area and equipment and faults in production quality
1.4 making checks of the area, equipment and operating conditions
2. use three of the following types of protective clothing and equipment, as appropriate for the materials being handled:
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. check the readiness of equipment in one of the following types of manufacturing operation:
3.1 fully automated multi-stage operation
3.2 semi-automated multi-stage operation
4. record details of the preparation work, and communicate the details to the appropriate people, using:
4.1 verbal report
Plus one method from the following:
4.2 written or typed report
4.3 computer-based record
4.4 specific company documentation
4.5 electronic mail