Thorough technical documentation with installations
Renowned for the high-quality autoclavable bioreactors, fermentors and gas analyzers that provides to its clients, Kbiotech considers technical documentation for bioprocess equipments as an essential point in the validation approach, since all demonstrations must be carefully documented. Kbiotech delivers complete, “as built” documentation with its installations, which include all modifications that may occur after delivery on site. These modifications are subject to additional clauses for all relevant documents and are listed chronologically.
What does the technical documentation for bioprocess equipments includes?
Kbiotech documentation consist of main 4 files:
- Construction and Inspection Files
- Qualification Files (IQ,OQ,PQ)
- Operating File
- Preventive and Routine Maintenance File
Kbiotech and its partners are working to ensure that your facilities conform with standards and to industrialise your new processes, whilst complying with the latest applicable standards worldwide (BPF, GMP, GAMP…).
As International company operating worldwide Kbiotech provides multilingual technical documentation, including the User and Maintenance manuals available in English, German, French and Italian. Chinese, Russian and Japanese are available on request.
Please contact us for more detailed informations!