Sterile manufacturing and sterile filtration validation training course

16 July 2019


Denys Ostrovnoy


Course Objectives
  • To understand the mechanisms of contamination transfer from source to product and the protective measures in place to prevent product contamination
  • To have the opportunity to work with risk management techniques
  • To understand the key control measures and they impact the sterility assurance of the product
  • To introduce new thinking for qualification & validation based on risk assessment
  • To follow the EU GMP and cGMP regulations and guidelines for aseptic processing and to engage in discussions regarding industry changes and best practices


Target group
Anyone who wants to know more about GMP, such as quality control, quality assurance, and operations staff who perform GMP activities.



09:00 – 10:50

Validation of sterile filtration:
- analysis of risks when validating the filtration process;
- study of the vitality of microorganisms,
- bacterial retention

10:50 – 11.00

Coffee break

11.00 – 12.30

Validation of sterile filtration:
- chemical Compatibility,
- adsorption,
- extractables and leachables,

12:30 – 13:30

Lunch break

13:30 – 15:50

Validation of sterilizing filtration:
- testing of particles contamination,
- testing of bacterial endotoxins contamination,
- toxicity testing,
- determination of criteria forintegrity testing

15:50 – 16:00

Coffee break

16:00 – 17:30

Sterile manufacturing best practices
Answers to questions

17:30 – 18:00




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