Monitor the measuring, weighing and preparation of compounds and solutions for biomanufacturing use
Overview
This standard covers the competences you need to monitor the measurement, weighing and preparation of solutions for biomanufacturing operations, in accordance with approved procedures. You are required to check the readiness of the manufacturing area and the measuring/weighing 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 also 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 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 applying the monitoring procedures. You will have an understanding of the preparations and checks 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 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 the biomanufacturing environment
P3 check that the quality and quantity of bulk compounds and solutions comply with manufacturing requirements
P4 ensure that equipment to be used is clean and calibrated for use
P5 use manufacturing scales for accurately weighing out materials, using metric/imperial measures
P6 accurately measure pH and conductivity of solutions in the laboratory, using correctly calibrated meters
P7 measure out aliquots of liquids into aseptic containers for manufacturing use and quality analysis
P8 measure liquids and solids for manufacturing use and analysis
P9 monitor and lead the quality and delivery of the above outcomes for yourself and your team
P10 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 measured, weighed and prepared solutions for a team in biomanufacturing operations
K14 how to calculate mass and volume in both metric and imperial measures
K15 how to convert metric measures to imperial measures and vice versa
K16 how to select the appropriate balance and scale for less than 100mg, 100 mg to 5g, and 5g and above
K17 how to weigh compounds and solutions using a balance and scale
K18 how to check that a pipette is clean, dry and ready for use
K19 how to measure out aliquots of solutions using a pipette for small quantities (less than 2ml) and large quantities (greater than 50ml)
K20 how to measure and calculate molarity/normality
K21 how to use the different types of pH meter to measure acidity and alkalinity
K22 how dissolved oxygen is measured, and its importance to the manufacturing process
K23 how pressure is measured, and its importance to the manufacturing process
K24 how temperature is measured, and its importance to the manufacturing process
Scope/range
1. use three of the following types of protective clothing and equipment:
1.1 laboratory coat/overalls
1.2 gloves
1.3 head/hair covers
1.4 safety shoes/shoe covers
1.5 safety glasses/visors
1.6 other (please specify)
2. monitor the weighing activities using balances (scales) to two of the following accuracies:
2.1 grams
2.2 kilograms
2.3 other (please specify)
3. monitor the measurement of solutions using four of the following:
3.1 automated pipettes
3.2 graduated cylinders/beakers/tubes
3.3 volumetric flasks
3.4 graduated/bulb pipettes
3.5 other (please specify)
3.6 syringes
3.7 burettes
4. monitor the measurement of pH and conductivity using two of the following:
4.1 handheld pH meter
4.2 combined pH/conductivity meter
4.3 conductivity meter
4.4 in-line pH meter
4.5 other (please specify)
5. calibrate or check the calibration for two of the following:
5.1 pH meter
5.2 conductivity meter
5.3 other (please specify)
5.4 balance
5.5 pipettes
6. monitor the making-up of specific volumes of solutions to a specified concentration, by both of the following:
6.1 creating a new solution by measuring and dissolving the correct amount of solute in the correct volume of diluents/solvent
6.2 dilution from a concentrated stock solution
7. monitor the weighing and preparation of two of the following types of compound and solution:
7.1 powers/granulations that do not readily lose or gain weight (moisture or solvent)
7.2 solids that readily lose or gain weight (moisture or solvent)
7.3 liquid samples (by difference)
7.4 liquid samples (direct)
8. record details of the work done, and communicate the details to the appropriate people, using:
8.1 verbal report
Plus one method from the following:
8.2 written or typed report
8.3 computer-based record
8.4 specific company documentation
8.5 electronic mail