Monitor the routine maintenance, cleaning, disinfecting and calibration of biomanufacturing equipment
Overview
This standard covers the competences you need to monitor the routine maintenance, disinfecting, cleaning and calibration of equipment used for biomanufacturing processing operations. 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 be required to present records and details of your biomanufacturing work to the appropriate people.
On completion of the biomanufacturing activity, you will be required to return your immediate work area to an acceptable condition before undertaking further work. Use of SIP/CIP and autoclave 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 equipment maintenance, disinfecting and cleaning 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 maintenance, disinfecting and cleaning of equipment 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 maintenance, disinfecting and cleaning 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.
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 laboratory equipment is in a safe and effective condition according to established procedures
P4 identify and report any manufacturing equipment faults accurately to the appropriate person
P5 perform routine maintenance in accordance with manufacturer's instructions and relevant health and safety legislation
P6 adhere to the set-down hygiene regulations during the cleaning and disinfecting of biomanufacturing equipment
P7 confirm the correct operation and calibration of the manufacturing equipment 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 routine maintenance, disinfecting, cleaning and calibration of equipment used for biomanufacturing processes
K14 the manufacturers’ specifications and recommendations for the maintenance and calibration of the biomanufacturing equipment
K15 the methods used for visually checking and for the cleaning of biomanufacturing equipment
K16 the different types, condition and quantity of consumables required for the range of biomanufacturing equipment maintained
K17 the methods for maintaining personal health and safety during the maintenance of the equipment
K18 the methods for maintaining personal hygiene
K19 the organisational and departmental infection control policy, as applied to maintenance activities in the biomanufacturing environment
K20 how to check that the biomanufacturing equipment is working correctly and in accordance with the manufacturer’s specifications
K21 the common types of equipment fault, and how these must be dealt with
K22 the department or person to whom equipment faults should be reported
K23 the methods used for keeping records of maintenance, cleaning, disinfecting and calibration of biomanufacturing equipment, 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 ensure the safe isolation of the biomanufacturing equipment (such as electrical and fluids supply)
1.3 follow manufacturer's instructions, drawings and procedures for routine maintenance
1.4 check that the tools and equipment used are in a safe and usable condition
1.5 ensure that the biomanufacturing equipment is kept free from foreign objects, dirt or other contamination
1.6 carry out disinfection of biomanufacturing equipment in accordance with standard operating procedures
1.7 carry out auditory and visual check on the operation of the biomanufacturing equipment
1.8 confirm that the biomanufacturing equipment is calibrated correctly and ready for use
1.9 return all tools, equipment and waste to the correct location on completion of the maintenance activities
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 the maintenance, disinfection and cleaning operations on five of the following categories:
3.1 weighing and measuring equipment
3.2 temperature-controlled apparatus
3.3 water purification system
3.4 centrifuges
3.5 fermentation vessels
3.6 other (please specify)monitor the disinfection and cleaning activities with all of the following:
4.1 steaming in place/cleaning in place (SIP/CIP)
4.2 Autoclavingrecord details of the preparation 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