Pharmaceutical Freeze Dryers
We offer standard and customized freeze dryer solutions from pilot models to large industrial scale from our partner Criofarma. Together with our customers, we work closely with our research, validation, and production teams to provide the best machine layout and processes that meet all customer requirements.
All freeze dryers are designed to meet strict FDA and cGMP requirements.
Criofarma’s advanced research plant performs pilot tests to confirm theoretical conditions of the clients’ processes before the installation of equipment. This process is done to ensure maximum results from every machine.
- Industrial Freeze Dryers
- Pilot Scale Freeze Dryers
- Automatic Loading and Unloading Systems (ALUS)
- Easy to operate units
- Designed according to meet FDA requirements
- Extensive and detailed documentation
- Preliminary validation carried out at the factory in the presence of the buyer’s expert personnel
- User friendly, tried, and tested control system
- Cleaning systems (CIP) reaching all areas
- Through steam sterilization (SIP) designed for easy validation
- Fabrication and finish quality to exceed cGMP.
- High performance refrigeration system
- Compact design
- Customised solutions from pilot plant (0.5 m2) up to industrial production plant of 60 sq. meters or more
Custom designed solutions for loading systems of bulk product, vials, or ampoules:
- Loading at constant level
- Loading shelf by shelf or all shelves at one time
- Double or single door solutions
- Intermediate storage before and after lyophilization
- Protective environments during loading and unloading
- Loading and unloading under LAF or isolator
Many of the CRIOFARMA freeze dryers are manufactured for high technology applications requiring sterilization. Designs are continually improving, supported by intensive validation studies. All freeze dryers can be easily sterilized with sterilization medium (steam is still 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.