Monitor the filling of containers with processed biomaterials in secondary biomanufacturing operations using automated machinery
Overview
This standard covers the competences you need to monitor the filling of vials, syringes and other containers using automated machinery. 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 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.
On completion of the filling activity, you will be required to return your immediate work area to an acceptable condition before undertaking further work. Use of equipment 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 filling 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 monitoring of filling operations 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 filling 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 filling 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.
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 confirm that the equipment is set up and ready for operation
P4 follow the defined procedures for starting and running the equipment operating system
P5 deal promptly and effectively with error messages or equipment faults that are within your control and report those that cannot be solved
P6 monitor the filling process and ensure that the production output is to the required specification
P7 shut down the equipment to a safe condition on conclusion of the activities
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 filling operations using automated machinery
K14 the methods used for visually checking and for cleaning of the filling equipment
K15 the different types, condition and quantity of consumables required for the range of biomanufacturing equipment used
K16 the methods for maintaining personal health and safety during the filling operations
K17 the equipment operating programs, system and related specifications
K18 the equipment program retrieval and storage systems
K19 how to check that the filling equipment is working correctly and in accordance with the manufacturer’s specifications
K20 the common types of filling faults with the equipment, and how these must be dealt with
K21 the department or person to whom equipment faults should be reported
K22 the methods used for keeping records of filling operations, and why this is important
Scope/range
1. carry out all of the following operations:
1.1 adhere to procedures or systems in place for risk assessment, COSHH, personal protective equipment and other relevant safety regulations
1.2 check that all the equipment is in a safe and usable working condition (such as undamaged, safety devices in place and operational)
1.3 ensure that sufficient quantities of all required materials are obtained
1.4 obtain all the necessary data, documentation and specifications for the filling operations
1.5 check that filling operations are done in the required batch sizes
1.6 ensure that the work area is clear and tidy, and that waste is disposed of in the correct manner
1.7 ensure 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
2.2 gloves
2.3 head/hair covers
2.4 safety shoes/shoe covers
2.5 safety glasses/visors
2.6 other (please specify)monitor filling operation for two of the following types of equipment:
3.1 vial filling equipment
3.2 syringe filling equipment
3.3 other (please specify)monitor filled components to ensure that they comply with two of the following quality requirements:
4.1 correctly formed and sealed
4.2 free from filling defects
4.3 other (please specify)record details of the filling work, 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