cGMP defrosting booth

MONTANIER specializes in the design of cGMP thawing chambers. For the pharmaceutical sector, we develop ergonomic and highly efficient equipment for thawing bags of various products in record time. Thawing and drying the bags takes less than 2 hours, compared to often more than 12 hours with a water bath process. Montanier has mastered the process according to cGMP regulations, and our equipment is fully qualified. Our teams have extensive experience with the quality and organizational requirements imposed by these cGMP regulations. Our chamber is modular and customizable to suit the bags or types of components to be thawed. We create bespoke equipment, tailored to your specific needs.

Example of a defrosting booth:

• Process traceability: 21 CFR Part 11 and audit trail on the customer network
• Features: Programmable cycle in recipes, ensuring automatic operation:
  • EPU defrosting at 35°C in recirculation mode
  • Drying at 35°C
  • Maximum peak temperature: 37°C
  • Local recording of the cleaning report, and sending of the reports over the network as PDFs
  • very precise temperature control
• Equipment composition:
  • 1 Defrosting cabinet with 4 interlocking doors (2 by 2)
  • 1 technical skid attached to the cabin
  • 1 drying unit (CTA)
  • 1 Extraction circuit with extractor
  • 2 HMI operator boxes (1 at the cabin input and 1 at the cabin output)
• 1 main electrical cabinet

A selectable cycle within the recipes, on the input HMI, allows the operator to use the following functions:

• Defrosting cycle for bags in hot purified water, adjustable from 20 to 35°C in recirculation mode
• Pocket drying with adjustable warm treated air from 20 to 35°C
• User-friendly operator interface thanks to the monitoring of ongoing steps
• Validation of the defrosting and chamber cleaning process with the issuance of a report
• Removal of the 2 shelf support pockets, closing of doors, then locking of exit doors and unlocking of entry doors.
• Chamber washing cycle using hot purified water + disinfectant (in case of a punctured bag), temperature can be increased for rinsing. This cycle allows for internal cleaning of the pipes and the chamber interior.
• Use of a hygienic heat exchanger for heating water, and also for heating compressed air