Analytical services

Bioluz know-how and services

The Bioluz laboratory offers its services for the custom production of small and medium series of flexible containers between 20 ml and 5000 ml for industrial batches or pilot batches.

Bioluz supports its clients in:

  • Drafting of regulatory files:
    • Writing of validation file for analytical techniques
    • Writing of process validation file
    • Writing of sterilization validation file
  • The realization of pilot batches
    • Carrying out stability studies. We are equipped to achieve ICH stabilities at 25 ° C and at 40 ° C for semi-permeable containers
    • Industrialization and adaptations of manufacturing processes
  • Analyzes :

Microbiological controls are carried out internally: endotoxin control, sterility test, bioburden. The sterility test is performed in an isolator.

Chemical analyzes are also carried out internally (Titrator, HPLC, QDA, etc.). We carry out an analytical transfer or a complete validation depending on the needs and techniques.

Analytical services