Pharmaceutical and bioprocess equipment is accepted on cleanability as much as on strength: surface finish, material traceability, drainability and documentation are part of the acceptance criteria, and most of it is proved at the vendor during factory and pre-acceptance testing. A defect found after installation in a validated area is very costly to correct.

PSPP witnesses FAT and pre-FAT on bioreactors, purification skids and hygienic process equipment — riboflavin coverage, surface-roughness, passivation and dimensional checks — and reviews the material certificates and qualification records that the quality system will later audit.

Challenges

Hygienic design and surface finish

Cleanability depends on verified surface roughness, drainable geometry and correct passivation, all confirmed at FAT.

Material traceability

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

Equipment qualification

Bioreactors and purification skids need structured pre-FAT and FAT witnessing before they enter a validated environment.

Documentation rigor

Life-science projects demand traceable, audit-ready test records that stand up to GMP scrutiny.

Our Solutions

FAT / pre-FAT witnessing

Independent witnessing of factory and pre-acceptance testing for bioprocessing and production equipment.

Surface and coverage testing

Witness of riboflavin spray-coverage, surface-roughness and passivation verification.

Material and documentation review

Verification of product-contact material certificates and equipment qualification records.

Dimensional verification

Independent dimensional and completeness checks against the equipment specification.

Pharmaceuticals