Manufacturing sterile products with national horizons centre

2 Day/s

CPD Hours: 14


This interactive two day classroom only course is run at The National Horizons Centre (NHC), which is Teesside University's £22.3m centre of excellence for the biosciences and healthcare sector. The course makes extensive use of the facilities available and day two of the course incorporates several laboratory based exercises.

This 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.

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.

The following sessions/topics will be covered during the two days training:

  • Introduction to sterile products
  • Introduction to microorganisms
  • Lab Exercise - practical hand washing microbiological testing
  • Cleanroom design considerations
  • Air flow and particles
  • Practical Lab exercise- smoke air flow
  • Contamination control people and materials
  • Facility disinfection with on exercise what could go wrong
  • Control of Water and other utilities
  • Steam Sterilisation including kinetics
  • Other Sterilisation methods
  • Media filling / process simulation
  • Microbiological environmental monitoring
  • Practical feedback handwashing plates
  • Practical lab exercise - aseptic technique

    At the end of the course you will:

    • 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
Course dates TBC
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Meet the tutors

Sue Mann

Sue has worked in the industry for over 38 years, principally in quality and technical roles. She has a wealth of experience having held European Director & VP level positions at companies such as Eisai and Shire. For the last 11 years, Sue has been an independent consultant providing services across all major dosage forms and more recently ATMPs.

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