This is a ready-to-use running log for recording physical integrity test results on the final sterilizing filter for every routine batch: the post-use test always, and the pre-use, post-sterilization (PUPSIT) result where it is performed. Replace every <<FILL: ...>> placeholder with your own specifics. A filled sample row follows.
Instructions
Log the integrity test result for every batch’s final sterilizing filter, referencing the validated production specification set in the filter validation protocol. A result at or above the validated limit is an integrity test failure regardless of whether the batch’s sterility test later passes; do not wait for the sterility result before opening a deviation. Retain per <<FILL: document retention period>>.
Field definitions
| Field | Format | Required | Who completes it | When |
|---|---|---|---|---|
| Batch number | <<FILL>> | Yes | Manufacturing | At filtration |
| Filter lot number | <<FILL>> | Yes | Manufacturing | At filtration |
| Wetting fluid used | <<FILL: product-wetted or water-wet; must match the validated basis>> | Yes | Manufacturing | At test |
| PUPSIT performed? | Yes / No, per the current PUPSIT risk-based justification | Yes | Manufacturing | Before product contact |
| PUPSIT result | <<FILL: reading and pass/fail>> | Yes, if PUPSIT performed | Manufacturing | Before product contact |
| Post-use test method | <<FILL: bubble point / diffusive flow / water intrusion>> | Yes | Manufacturing | After filtration |
| Post-use test reading | <<FILL>> | Yes | Manufacturing | After filtration |
| Validated specification | <<FILL: reference the filter validation protocol>> | Yes | Manufacturing | At test |
| Pass/Fail | <<FILL>> | Yes | Manufacturing | At test |
| Deviation reference, if failed | <<FILL>> | Yes, if applicable | Quality Assurance | At disposition |
| QA review | Initials and date | Yes | Quality Assurance | Batch release |
Log
| Batch | Filter lot | Wetting fluid | PUPSIT? | PUPSIT result | Post-use method | Post-use reading | Spec | Pass/Fail | Deviation ref | QA review |
|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
Sample rows from an example gene therapy drug product fill campaign. Company, product, and numbers are illustrative.
| Batch | Filter lot | Wetting fluid | PUPSIT? | PUPSIT result | Post-use method | Post-use reading | Spec | Pass/Fail | Deviation ref | QA review |
|---|---|---|---|---|---|---|---|---|---|---|
| ATX-DP-0231 | FL-88214 | Product-wetted | No, per PUP-2026-02 | N/A | Diffusive flow | 9.8 mL/min | Less than or equal to 12 mL/min | Pass | N/A | JS, 2026-08-14 |
| ATX-DP-0232 | FL-88215 | Product-wetted | No, per PUP-2026-02 | N/A | Diffusive flow | 14.6 mL/min | Less than or equal to 12 mL/min | Fail | DEV-2026-0209 | JS, 2026-08-15 |
| ATX-DP-0233 | FL-88216 | Product-wetted | No, per PUP-2026-02 | N/A | Diffusive flow | 8.1 mL/min | Less than or equal to 12 mL/min | Pass | N/A | JS, 2026-08-16 |
Batch ATX-DP-0232’s post-use test failure opened DEV-2026-0209 immediately, before the batch’s sterility result was available, consistent with the rule that an integrity test failure stands on its own regardless of a later sterility pass. The investigation traced the elevated reading to a filter handling error, not a manufacturing defect, and the batch was rejected rather than released on the strength of a passing sterility test alone.
Common inspection findings this log prevents
- A post-use integrity test failure not investigated because the batch’s sterility test came back clean.
- A wetting fluid recorded as “water” when the validated basis assumed product-wetted testing, or vice versa, invalidating the comparison to the specification.
- PUPSIT status not recorded per batch, so it cannot be confirmed the current risk-based justification was actually followed in practice.
- Gaps in the log where a batch’s integrity test result was never transcribed from the raw instrument printout.
- QA review recorded as complete with no initials or date tied to a specific reviewer.
How to adapt this log
- Set your retention period and reference your current filter validation protocol and PUPSIT justification document numbers.
- Make the wetting fluid field mandatory; a mismatch between validated basis and actual test fluid is a real, not cosmetic, defect.
- Require immediate deviation initiation on any Fail, decoupled from the sterility test timeline.
- Periodically trend the post-use readings across batches, not just check pass/fail, to catch a filter lot or process drift before it produces an outright failure.
- Confirm the log’s field set matches what your current filter validation protocol and PUPSIT justification actually require before first use.