Manufacturing Sterile Products

2 Day/s

CPD Hours: 14

Classroom, online, in-house

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.

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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.

This course includes the following topics:

  • Preparing for regulatory inspection
  • Basic microbiology
  • Contamination control and clean room design 
  • Exercise
  • Steam sterilisation
  • Kinetics of steam sterilisation
  • Other sterilisation methods
  • Microbiological environmental monitoring
  • Media fills
  • Testing of sterile products

    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

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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Andy Martin

A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.

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Environmental monitoring with Cherwell laboratories

Run in partnership with Environmental Monitoring Process Validation Specialists, Cherwell Laboratories, the course addresses environmental monitoring for the manufacturing of both sterile and non-sterile products.