Manufacturing Sterile Products

Duration: 2 days
Price: £1,799+VAT

Delivered in partnership with RSSL this two-day course provides an extensive introduction to the regulatory requirements governing pharmaceutical clean room operation and details the aseptic filling and terminal sterilisation methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient and understand why there is intensive regulatory interest worldwide in the control of sterile product manufacture.

    Training partners

  • RSSL

The programme includes an introduction to sterile products, an introduction to microorganisms, sources of contamination, facility design and personal behaviours as contamination mitigation strategies, considerations for water and utilities, sterilisation methods plus practical exercises in aseptic technique, handwashing and environmental monitoring.

Module 1

o Introduction to sterile products
o Introduction to Microorganisms
o Practical hand washing microbiological testing
o Clean room design considerations
o Air flow and particles
o Practical exercise - smoke air flow
o Contamination control people and materials,
o Facility disinfection
o Exercise what could go wrong
o What have we learned?

Module 2

o Control of water and other utilities
o Steam sterilisation including kinetics
o Other sterilisation methods
o Media filling / process simulation
o Microbiological environmental monitoring
o Practical feedback handwashing plates
o Practical exercise - aseptic technique
o End of course questions and feedback

Learning outcomes:

  • Understand the risks associated with sterile products
  • Appreciate the requirements for contamination control and how this links to clean room design
  • Understand the methods for terminal sterilisation and processes involved in aseptic product manufacture
  • Appreciate the importance of people and the need for trained personnel

Who should attend:

  • This course will provide valuable underpinning knowledge to all personnel working for companies responsible for the manufacture of sterile products. It will be of benefit to those working in sterile products manufacturing, QC (especially environmental monitoring personnel), QA personnel as well as support engineers.

Course dates

More dates coming soon

For enquiries and details of the full agenda please email CPDNHC@tees.ac.uk

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