Bioprocess Facilities

Bioreactors, fermenters and the clean utilities around them, where Pre-FAT coverage testing and dimensional verification precede Final FAT.

Pilot-scale bioprocess hall with stainless-steel bioreactors, process skids and mezzanine platforms — Industries

Bioprocess facilities turn on cleanability and traceability: bioreactors, fermenters and the clean utilities around them are accepted on surface finish, drainability and documentation, most of which is proven at the vendor before Final FAT. A defect found after installation in a classified area is costly to correct.

PSPP witnesses Pre-FAT and FAT on bioreactors and fermenters — riboflavin coverage, surface-roughness, passivation and dimensional checks — and reviews the material and qualification records the quality system will later audit.

Challenges

Hygienic design & surface finish

Cleanability depends on verified surface roughness, drainable geometry and correct passivation.

Pre-FAT coverage testing

Riboflavin spray-coverage and readiness checks must pass before Final FAT is scheduled.

Material traceability

Product-contact materials require complete, audit-ready certificates tied to the installed component.

Our Solutions

Pre-FAT / FAT witnessing

Independent witness of coverage, surface and dimensional testing before Final FAT.

Surface & passivation verification

Witness of surface-roughness and passivation results.

Documentation review

Verification of material certificates and equipment qualification records.