Vials with lyophilized product

We offer standard and customized lyophilizer solutions from pilot models to large industrial scale. Together with our customers, we work closely with our research, validation, and production teams to provide the best machine layout and process that meet all customer requirements.

All freeze dryers in compliance with the international regulations including FDA, cGMP, ASME, GAMP5, 21 CFR Part 11, and PED.

Pilot Freeze Dryers
  • Compact design
  • Easy operation
  • Custom solutions
  • Suitable for R&D and laboratory settings
Industrial Freeze Dryers
  • User friendly, easy to operate
  • Compact design
  • Multiple door options, including single or double doors
  • Clean-in-Place (CIP): we offer several options to CIP, including using condensed steam, spray balls, or rotating nozzles. The cleaning medium drains fully from the drying and condensing chamber and the drain is easily accessed from the inspection door.
  • Sterilization-in-Place (SIP), filtration device, sanitary piping system.
  • All freeze dryers can be easily sterilized with sterilization medium (steam is the internationally preferred medium). Our validation staff can support our customers in any step of the O.Q. (Operation Qualification) and P.Q. (Performance Qualification) of the S.I.P. validation tests.
  • High-performance refrigeration system
  • Filter-integrity test: included in the standard package is an air/nitrogen inlet filter with valves manifold permitting in-situ integrity test after filter sterilization (SIP)
Loading and Unloading Systems(ALUS)
  • Loading systems for bulk products, vials, or ampoules
  • Shelf-by-shelf or all shelves at once
  • Intermediate storage before and after lyophilization
  • Protective environments during loading and unloading
Validation
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
  • Instructions, calibrations, and other documentation to assist client in starting production on time.