Critical Factors for Sterile Product Manufacture
Course
In Barnard Castle
Description
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Type
Course
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Level
Intermediate
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Location
Barnard castle
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Class hours
32h
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Duration
4 Days
The manufacture of sterile products is subject to special controls and relies heavily on the competence and knowledge of everyone involved in the process. This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.
New course topics include: RABS & Isolator Technology, Sterilisation Methods, Aseptic Processing & Process Simulation, HVAC, HACCP Principles, Cold Chain Transport, Risk Management Workshops.
Open discussion sessions on current best practices and regulatory trends in sterile product manufacture will be coupled with case studies to illustrate key points.
Important information
Documents
- Critical_Factors_for_Sterile_Product_Manufacture_V1.4.pdf
Facilities
Location
Start date
Start date
About this course
Key learning objectives are:-
- To review the key activities and processes which are critical to the success of sterile manufacturing operations
- To refresh delegates on the special nature of sterile products and understand the challenges involved in aseptic processing and the consequences of failure.
- To develop risk assessment methods and quantify risk
- To apply risk management techniques to control contamination in clean rooms
- Understand how the key aspects of the facility design, personnel, material flows, aseptic behaviours determine the success of aseptic processing.
- How to implement and perform a successful aseptic validation program including practical trail design
- To understand the current sterilisation & sanitisation processes and controls
- To understand the importance of critical utilities in sterile product manufacture including steam and high purity water.
- To understand the role of QC laboratories in sterile processes
- To understand the role of the QP in sterile manufacture
- To review the current regulatory requirements and trends in sterile manufacture
- To understand common GMP deficiencies and what inspectors are looking for.
Whether involved in Production, QA, QC, Engineering or Regulatory Affairs, this course will be relevant to you.
This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.
Reviews
Subjects
- Sterile Product Manufacture
- Microbiology
- Bio Burden
- Clean Rooms
- Aseptic manufacture
- Risk Management of Contamination
- Auditing QC Laboratories
- CAPA Systems
- Inspection Techniques
- Regulatory Trends
Teachers and trainers (1)
Marcus Booth
Director of Training and Consultancy
Over the last 27 years we have trained thousands of people within the pharmaceutical, biotech, medical device and health care industries. Honeyman courses continue to remain popular because they provide delegates with a sound understanding of the scientific principles associated with each technical discipline and the opportunity to put the principles into practice during interactive workshops, demonstrations and discussion sessions. We all actively work within industry and so provide pragmatic current best practice to allow companies to cGMP requirements and regulatory expectations.
Course programme
- Review of international regulatory guidelines related to sterile product manufacture
- Review of current deficiencies in sterile product manufacture
- Basic microbiology and sources of contamination
- Review of critical control points for bio burden control in a typical aseptic process
- Sterilisation steps including terminal sterilisation
- Sterilisation processes for irradiation of components
- Classification and functionality of clean rooms and cleanroom design principles
- Challenges in aseptic manufacture
- Risk management of contamination in cleanrooms
- Risk assessment method, quantification of risk and management
- Garment gowning procedures and garment management
- Cleanroom behaviour, personnel movements, disinfection procedures
- Regulatory expectations for aseptic validation
- Designing, performing media fills and interpreting results
- Key aspects of quality critical utilities, including design, testing and operation
- Filtration types and theory, filter selection and integrity testing
- Auditing pharmaceutical QC laboratories
- Understanding the role and responsibilities of the QP
- Effective CAPA systems in sterile product manufacture
- Sterile product inspection techniques including manual, automated and regulatory trends
Critical Factors for Sterile Product Manufacture