Manufacture of sterile pharmaceutical products training course

14 – 15 November 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


 Workshop program:


10:00 – 11:15

Terms and definitions
Requirements for the production of sterile drugs
How to choose the sterilization method
Organization of production of liquid, sterile medicines: in aseptic conditions and with the use of finishing thermal sterilization.
GMP requirements and practical implementation of the process:
  •  solution preparation
  •  cooling water for injection,
     •  dispensing and loading of active pharmaceutical ingredients and excipients,
     •  mixing,
     •  sterilizing filtration,
  •  filling the primary packaging.

11:30 – 13:00

Wash of primary packaging.
Qualification of the car washer of primary packing.
Dry-heat sterilization and deproteinization. Qualification of the Depirogenation Tunnel.
Qualification of the depirogenation tunnel.

13:00 – 14:00

Lunch break

14:00 –17:00

Wet heat sterilization
Sterilization with superheated water
Monitoring of bioburden
Qualification and re-qualification of steam sterilizer
Data integrity on the production of sterile medicines


10:00 – 13:00

Validation of the sterilizing filtration:
  •  regulatory requirements for sterilization
  •  risk analysis during validation of the filtration process
  •  study of the viability of microorganisms
  •  bacterial retention
  •  chemical compatibility
      •  adsorption
      •  extractables and leachables
  •  product-wetted integrity testing
  •  toxicity testing

13:00 – 14:00

Lunch break

14:00 – 15:30

Intervention risk analysis
Qualification and validation as a tool to reduce the risks of drug non-sterility
Validation of Aseptic Processes (MFT)
Restricted Access Barrier Systems & Isolator

15:40 – 17:00

Practical workshops


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