IMA LIFE Freeze drying solutions can draw upon extensive, hands-on operations experience to help get new installation or freeze drying process up and running and qualified-on time and within budget.
Qualification documents and execution from IMA LIFE Freeze drying solutions will not only reduce the customer equipment validation time, but will provide multiple opportunities for the personnel to attend testing performed by trained technicians. This normally helps operators gain a better understanding and comprehension of the new machine and process.
IMA LIFE Freeze drying solutions can provide the customer with an omni-comprehensive package of documentation for on-site validation.
The package can include DQ, IQ, OQ and PQ protocols and support by specialists for execution.IMA LIFE Freeze drying solutions can support equipment qualification with a variety of different approaches:
| - |
Integration between commissioning and qualification. Based on written procedures, approved by the customer, IMA LIFE Freeze drying solutions defines rules (deviation management, project change control, etc.) to limit the duplication of effort between FAT/SAT and IQ/OQ/PQ. |
| - |
Risk analysis. Through the analysis of the critical process parameters and written rationale, IMA LIFE Freeze drying solutions supports the customer in defining the scope of the qualification, setting up initial and periodic qualification programmes, and integrating the commissioning and qualification efforts |
IMA LIFE Freeze drying solutions will frame the commissioning and qualification effort within the customer validation master plan. |
Solid Dose Processing / Manufacturing
Aseptic Processing & Freeze Drying
Recommend