Operational qualifications for the validation of bioreactors

Kbiotech has integrated operational qualifications according to very demanding requirements applicable to methods involving design, inspection and validation of bioreactors and bioprocess equipments. They have been extended to include equipment qualification protocols, both for preliminary tests conducted in the workshop and for on-site tests prior to production.

Additionally, total control over product traceability enables identification of components, subassemblies materials and after-sales stages, as well as the origin and characteristics of raw materials used in manufacturing.

Validation of bioreactors and bioprocess equipments

Kbiotech’s goal is to help with the validation process in the following areas:

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT)
• Performance Qualification (PQ)