cGMP thawing cabinet

MONTANIER is a specialist in the design of cGMP thawing cabins. For the pharmaceutical sector, we are developing ergonomic and highly efficient equipment for thawing bags of various products in record time. Thawing the pockets and drying takes less than 2 hours, compared to often more than 12 hours with a water bath process. Montanier controls the process according to cGMP regulations and our equipment is qualified. Our teams have experience of the quality and organizational requirements imposed by these cGMP regulations. Our cabin is modular and adaptable according to the bags or types of components to be defrosted. We produce tailor-made equipment, in accordance with your constraints.

Example of defrosting cabinet:

• Process traceability: 21 CFR Part 11 and audit trail on customer network
• Features: Programmable cycle in the recipes, ensuring in automatic mode:
  • EPU defrosting 35°C in recirculation
  • Drying 35°C
  • Maximum peak temperature: 37°C
  • Save the cleaning report locally, and send the reports in PDF over the network
  • Very precise temperature control
• Composition of equipment:
  • 1 Defrosting cabinet with 4 interlocking doors (2 by 2)
  • 1 technical skid adjoining the cabin
  • 1 drying plant (CTA)
  • 1 Extraction circuit with Extractor
  • 2 HMI operator boxes (1 at cabin input and 1 at cabin output)
• 1 general electrical cabinet

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

• Pouch thawing cycle in hot purified water, adjustable from 20 to 35°C in recycling mode
• Pocket drying with hot treated air adjustable from 20 to 35°C
• User-friendliness of the operator interface by monitoring the steps in progress
• Validation of the defrosting process and the cleaning of the chamber with edition of a report
• Exit of the 2 pocket support shelves, closing the doors, then blocking the exit doors and unlocking the entrance doors.
• Chamber washing cycle in hot purified water + disinfectant (in the event of a hole in a pocket), temperature that can be increased for rinsing. This cycle allows the interior washing of the pipes and the interior washing of the chamber.
• Use of a hygienic exchanger for heating water, and also for heating compressed air