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Quality control

Baccinex provides full quality control support at each step of projects:

  • Raw materials and packaging articles are sampled and analysed at reception and released for use
  • Specific In-process controls (IPC) per process can be performed: bioburden, conductivity, pH, osmolality, HPLC…
  • Release testing on the finished products

Quality control laboratory is used for testing and validation. It is divided in 2 parts:

  • Physico-chemical laboratory: Main physico-chemical analysis can be performed in this area: Endotoxins, HPLC, IR spectrophotometry, pH, osmolality, viscosity, conductivity, UV-visible spectrophotometry, sub-visible particles, loss on drying…
  • Microbiological laboratory : Bioburden, sterility tests (under grade A isolator), incubation and reading of media fill tests, environmental controls of classified facilities, germs identification… are carried out in this clean room

Pharmacopoeial methods can be carried out. For other tests, validation of analytical and microbiological methods (bioburden, sterility, endotoxins, HPLC…) can be performed and subsequently be used in routine.

In case some analysis couldn’t be performed internally, Baccinex qualified sub-contracting laboratories that are able to carry out every type of analysis.