MATCHING CUSTOMERS REQUIREMENTS - Our very long term experience since 1962 is so high that every CRIOFARMA freeze-drying system is a totally engineered solution to customers processing needs. Working closely with our customers and with our research, validation and production personnel we are able to provide the better layout and processing solutions for the customers requirements.
Custom Made Systems
A wide range of machines are customised to meet customers requirements. Experience in design for sterile applications according to meet cGMP and all regulatory guidelines. Customised solutions from pilot plant (0,5 sq. m) up to industrial production plant of 60 sq. m. or more.
Loading And Unloading Systems
CRIOFARMA is able to provide custom designed solution for loading systems of bulk product, vials or ampouls:
- 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
Naturally we have a deep sense of accountability towards safety and the environment. This manifest itself in every aspects of our work from the SIP and OP device to our imaginative control system concept design for which both operators and products in process are always safety conditions.
Sterilization in Place (S.I.P.)
Many of the CRIOFARMA freezedryers are manufactured for high technology applications requiring sterilization. Designs are continually improving supported by intensive validation studies. All the CRIOFARMA 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.
CRIOFARMA philosophy is not only to sell machines, but also to study with the customers all the production's problems and to suggest the possible solutions for the best results. CRIOFARMA can assist the customers in any step of the development of the technology related to the freeze-drying process.
Cleaning In Place (C.I.P)
CRIOFARMA offers several option to CIP using condensing steam alone, spray balls or rotating nozzles. The cleaning medium drain fully from the drying and condensing chamber and the drain is easily accessed from the inspection door.
Filter Integrity Test
Included in the standard package is an air/nitrogen in let filter with valves manifold permitting in-situ integrity test after filter sterilization (SIP).
CRIOFARMA support our customers in the:
- I.Q. (Installation Qualification),
- O.Q. (Operation Qualification) phase or even in parts of the
- P.Q. (Performance Qualification) phase providing the drawings,
Product Main Features:
- 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
Qualification and Compliance
Product Main Qualifications and Compliance:
- cGMP Guidelines
- CE / GAMP 4 / 21 CFR Part 11 Guidelines
- FDA Compliance
- Pressure Compliance: GB 150-1998 / PED / ASME Code