Bioreactor Pre-FAT and Riboflavin Coverage Testing — Slovenia
PSPP provided independent Pre-FAT inspection and expediting support for four stainless-steel bioreactor vessels manufactured for an international pharmaceutical expansion project. The two-day assignment included riboflavin spray-coverage testing, dimensional spot checks, surface-roughness verification and readiness review before Final FAT.
- 4
- Stainless-steel bioreactor vessels included in the project
- 2 x 150 L
- Small-capacity bioreactor vessels
- 2 x 1000 L
- Large-capacity bioreactor vessels
- 2 days
- Pre-FAT inspection and expediting duration
The Challenge
Bioreactor vessels used in pharmaceutical production require reliable internal spray coverage, hygienic surface condition and dimensional conformity before acceptance. The assignment involved vessels at different stages of readiness, simultaneous test activities and repeated cleaning verification where fluorescent indications showed areas requiring corrective action.
Scope & Approach
PSPP attended the manufacturer facility to monitor Pre-FAT activities for two 150 L and two 1000 L stainless-steel bioreactor vessels. The work included review of vessel drawings, technical specifications, inspection protocols and operating parameters; confirmation of equipment readiness; and observation of riboflavin-based spray-coverage testing using UV inspection. Flow rate, pressure, spray sequence, agitator operation and drainage intervals were monitored against the approved test parameters. Where fluorescent residues indicated inadequate cleaning, localized corrective cleaning was performed and the spray cycle was repeated to confirm effective coverage. PSPP also carried out random dimensional verification, reviewed surface-roughness measurements performed with calibrated equipment, checked pressure-gauge traceability and recorded outstanding requirements for Final FAT.
The Outcome
The observed coverage tests achieved acceptable spray distribution after the required cleaning and re-verification activities. Three vessels were reported ready for Final FAT at the conclusion of the Pre-FAT visits, while the remaining vessel and outstanding detailed checks were clearly identified for comprehensive verification during the final acceptance stage.
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