Manufacturing Sterile Products

2 Day/s

CPD Hours: 14

Classroom, online, in-house

The long-awaited EU GMP Annex 1 update on sterile products has arrived. This update has an implementation date of 25th August 2023 for all but one clause. Companies manufacturing sterile products are expected to be fully compliant with this updated annex already, or at least by the time the remaining clause is implemented on 25th August 2024.

To help you with this implementation this two-day course has been updated to align with the updated Annex 1. It takes you through a sterile product lifecycle considering the aspects of formulation, manufacturing, and control of sterile products. Within this the areas of cleanroom design and operation are reviewed as are the controls around entry of materials, equipment and most importantly people.

Sterile product manufacturing should focus on terminal sterilization of the product and only when this is not possible is aseptic process permitted. Both these concepts are explored during the course. This course provides an extensive introduction to the regulatory requirements. 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 including sterile APIs and other sterile materials. It will be of benefit to those working in sterile products manufacturing, quality assurance and quality control as well as support areas such as engineering and training. You might be new to your team or experienced (looking for an update to your knowledge). Either way this course would be ideal for you.

This course includes the following topics:

  • Introduction to sterile product and why they are important 
  • Regulatory requirements and guidelines for manufacturing sterile products 
  • Formulation and primary packaging considerations 
  • An introduction to microorganisms 
  • Contamination control and clean room design  
  • Controls around people, materials and equipment  
  • Control of critical utilities including water 
  • Steam sterilisation processes and concepts of D and Z values  
  • Process lethality and the F0 concept 
  • Sterilization by dry heat, irradiation, gassing and filtration 
  • Disinfection and microbiological environmental monitoring 
  • Aseptic process simulations 
  • 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 controls needed for materials, equipment and utilities 
    • Understand the methods for terminal sterilisation and processes involved in aseptic product manufacture 
    • Understand the different types of sterilization and how they can be applied 
    • Appreciate the importance of people and the need for trained personnel 
    • Appreciate the role of product testing 

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Meet the tutors

Andy Martin

Andy has over 35 years of pharmaceutical industry experience, beginning at Smith and Nephew in 1985 as a microbiologist, progressing to QA Microbiology Manager in 1996. During that time, he gained experience in QA and QC activities of the manufacture of sterile eye drops (terminally sterilized and aseptically filled), aseptically filled sterile creams and non-sterile syrups. In 2003 he became the RSSL Pharmaceutical Training Manager with responsibility for providing commercial pharmaceutical training courses. In 2007, Andy moved to Catalent pharma Solutions, in Swindon, as Microbiology Manager leading a team responsible for microbiological control of freeze-dried tablets and soft gel capsules. Andy gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events. In 2012 Andy set up ABM Consulting Ltd which offers services specializing in Microbiology, QA and Good Manufacturing Practice. Andy is also treasurer for the UKs foremost microbiology organisation, Pharmig.

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