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Skills and Expertise

 
Processes validation

Let’s hold up as examples :

  • Sterile drugs production processes validation according to aseptic or terminal sterilization processes.
  • Radioactive drugs production processes validation according to remote handling processes.
  • Cleaning validation of the equipments in contact with the drug but also of the formulation tanks.
  • Transfer validation of components necessary for an aseptic production through the different pharmaceutical classifications (from non-classified areas to the sterile area).
  • Classification of the pharmaceutical production areas (grade D -> A) including a control of cleaning conditions depending on the level of classification.
  • Visual inspection before conditioning.

 

It also implies the writing of the complementary documents as well as the respect of the protocols that support the validation of a sterile drug production process.

  • Validation with Media Fill Test (MFT).
  • Container Closure Integrity Test (CCIT).
  • Sterile filtration validation.
  • Study of the « Leachables – Extractables ».
  • Stability study.
  • Capability study.
  • Transport validation.
  • Writing of the “Process Validation Master Plan” and of the different procedures (environmental controls, cleaning validation, areas and equipments cleaning, production procedure and adjoining Master Batch Record, etc.).
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