Verify the quality of cleaning and sterilisation fluids

Prepare materials, equipment and solvents required for cleaning and sterilisation

Configure equipment systems for cleaning operations

Perform cleaning and clean-in-place operations for production equipment and materials in accordance to SOPs and CGMPs

Conduct sterilisation, and sterilise-in-place activities for relevant production equipment and materials in accordance with SOPs and CGMPs

Perform tests to verify cleaning and sterilising has been performed to the required standards

Document completion of cleaning and sterilising according to organisational procedures

Develop cleaning and sterilisation Standard Operating Procedures (SOPs)

Set timings and schedules for the cleaning and sterilising of production line components

Conduct training on requirements for cleaning and sterilisation of equipment and containers

Conduct inspections on cleaning and sterilisation procedures to ensure compliance

Review records of cleaning and sterilisation activities

Work with Quality Control department to ensure cleaning and sterilising is conducted to the required standards

Review cleaning and sterilisation Standard Operating Procedures (SOPs)

Integrate cleaning and sterilising activities with other systems and processes in the biopharmaceuticals manufacturing facilities

Review cleaning and sterilising activities

Identify improvements that can be made to cleaning and sterilising procedures and equipment

Perform root-cause analysis on contamination issues resulting from inadequate cleaning and sterilising

Develop follow-up actions to maintain cleanliness and sterility standards across product lines following lapses