Carry out sampling operations in a biomanufacturing environment
This standard covers the competences you need to collect product samples from the biomanufacturing process. Prior to undertaking the activity, and in accordance with approved procedures and practices, you will be required to carry out all the necessary preparations, within the scope of your responsibility. This may include preparing the work area, ensuring that it is in a safe condition to carry out the intended activities, and that any materials, equipment or other resources required are available and are in a safe and usable condition. 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 be required to present records and details of your biomanufacturing work to the appropriate people.
On completion of the sampling activity, you will be required to return your immediate work area to an acceptable condition before undertaking further work requirements. Use of the correct operating procedures and techniques is an important function in this role. Returning and/or storing any materials and equipment in the correct area, identifying any waste and arranging for its disposal, and reporting any defects or damage to the materials and equipment used are also part of this function.
Your responsibilities will require you to comply with organisational policy and procedures for the sampling operations undertaken, and to report any problems with the activities, materials or equipment that you cannot personally resolve, or that are outside your permitted authority, to the relevant people.
Your underpinning knowledge will provide a good understanding of your work, and will provide an informed approach to the completion of the sampling operation in a biomanufacturing environment. You will understand the importance of doing this work efficiently and effectively, and will know what to consider when preparing and tidying up the work area before and after the sampling activities. You will also know how to deal with problems, and how to achieve your work objectives and targets, in adequate depth to provide a sound basis for carrying out the activities safely and correctly.
You will understand the safety precautions required when carrying out biomanufacturing activities. You will be required to demonstrate safe working practices throughout, and will understand the responsibility you owe to 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.
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 ensure that the correct equipment and materials for the sampling process are available for use
P4 collect samples in the parameters specified in the standard operating procedure
P5 label and identify collected samples correctly
P6 maintain the condition of the samples and store in the correct location
P7 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 sampling methods and procedures used in the biomanufacturing environment
K14 the range of equipment and materials used for sampling in the biomanufacturing environment
K15 the principles and techniques of maintaining the sample integrity following collection
K16 how to identify defective sampling equipment, and the actions to be taken
K17 the methods used for the handling, storage and disposal of materials
K18 the cleaning materials and methods used in the sampling process
K19 the documentation and labelling systems that should be used to ensure sample traceability after sampling
K20 the methods used for keeping records of sampling operations, and why this is important.
1. collect samples following of all of the following operations:
1.1 adhering to procedures or systems in place for risk assessment, COSHH, personal protective equipment and other relevant safety regulations
1.2 checking that all the equipment is in a safe and usable working condition (such as undamaged, safety devices in place and operational)
1.3 ensuring that sufficient quantities of all required materials are obtained
1.4 obtaining all the necessary data, documentation and specifications for the sampling process
1.5 collecting and labelling samples in the required quantities
1.6 cleaning/disposing of sampling equipment and materials appropriately
1.7 ensuring that the work area is clear and tidy, and that waste is disposed of in the correct manner
1.8 ensuring that safe working practices and procedures are applied at all times
- use three of the following types of protective clothing and equipment:
2.1 laboratory coat/overalls
2.3 head/hair covers
2.4 safety shoes/shoe covers
2.5 safety glasses/visors
2.6 other (please specify)
3. collect samples at five of the following parameters:
3.1 location for sampling
3.2 sampling access points
3.3 sampling duration
3.4 sample cycle time
3.5 sampling frequency
3.6 other (please specify)
maintain the condition of samples by two of the following:
4.3 aseptic container
4.4 other (please specify)
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