CGMP thawing cabin

MONTANIER is a specialist in cGMP thawing cabin design. For the pharmaceutical sector, we develop ergonomic and very efficient equipment on the thawing of various product pockets in record time. Defrosting the pockets and drying takes less than 2 hours, compared to often more than 12 hours with a process per bath. Montanier masteres the process according to cGMP regulations and our equipment is qualified. Our teams have experience in the quality and organizational requirements imposed by these cGMP regulations. Our cabin is flexible and adaptable to suit pockets or types of thawing components. We make tailor-made equipment in accordance with your constraints.

Example of thawing cabin:

• Process Traceability: 21 CFR Part 11 and Audit Trail on Customer Network
• Features: Programmable cycle in recipes, ensuring in automatic mode:
  • UPR defrosting 35°C in recirculation
  • Drying 35° C
  • Maximum peak T°C: 37° C
  • Recording of cleaning report on site, and sending reports to network in PDF
  • Very precise temperature control
• Composition of equipment:
  • 1 Defrosting cabin with 4 interlocked doors (2 by 2)
  • 1 technical skid adjacent to the cabin
  • 1 drying plant (CTA)
  • 1 Extraction circuit with Extractor
  • 2 IHM operator sets (1 input and 1 cabin output)
• 1 general electrical cabinet

A selectable revenue cycle on the input IHM allows the operator to use the following functions:

• Defrost cycle of hot purified water pockets, adjustable from 20 to 35°C in recycling
• Drying pockets with hot treated air adjustable from 20 to 35° C
• Convenience of the operator interface by monitoring the current steps
• Validation of the thawing process and cleaning of the chamber with editing of a report
• Exit of the 2 shelves pocket supports, door closure, then lock doors exit and unlock doors entrance.
• Washing cycle of the chamber in hot purified hot water + disinfectant (in case of piercing of a pocket), temperature may be increased for rinsing. This cycle allows the inside washing of the pipes and inner washing chamber.
• Use of a hygienic exchanger for water heating and also for compressed air heating