Duration: 2 days
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.
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.
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?
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
Who should attend:
More dates coming soon
For enquiries and details of the full agenda please email CPDNHC@tees.ac.uk