This is a ready-to-use summary report for a media fill, also called an aseptic process simulation (APS). It closes out one executed run: what was simulated against plan, whether the units reconciled and passed, and whether the line and crew are qualified as a result. Replace every <<FILL: ...>> placeholder, set your document numbers and dates, and route it through document control. It pairs with the media fill protocol. A worked filled specimen follows. This is general guidance to adapt and verify, not legal or regulatory advice; confirm each cited regulation against the current source before you rely on it.
Document control header
| Field | Entry |
|---|---|
| Document title | Media Fill (APS) Summary Report |
| Report number | <<FILL: RPT-ID>> |
| Version | <<FILL>> |
| Protocol executed | <<FILL: PROT-ID and version>> |
| Line / process | <<FILL: line ID and configuration>> |
| Run date(s) | <<FILL>> |
| Author | <<FILL: role>> |
1. Summary of activity
A media fill was executed on <<FILL: line ID>> per <<FILL: PROT-ID>> to <<FILL: initial qualification / semi-annual requalification / directed run for change>>. The run substituted <<FILL: soybean-casein digest medium (TSB)>> for product and reproduced the aseptic filling process, including the interventions and worst-case conditions defined in the protocol. This report presents the execution against plan, the results, and the qualification conclusion.
| Item | Entry |
|---|---|
| Purpose of run | <<FILL: initial (run x of 3) / requalification / change>> |
| Container-closure format | <<FILL>> |
| Barrier / technology | <<FILL: isolator / closed RABS / open RABS / conventional>> |
| Crew / shift simulated | <<FILL>> |
| Campaign duration simulated | <<FILL>> |
2. Intervention execution versus plan
Every intervention in the protocol was performed as planned; any deviation from the planned frequency or timing is noted and assessed. Unscripted interventions during the run are recorded here, because an unqualified intervention performed in a media fill is itself a finding.
| Intervention | Type | Planned count | Actual count | Notes |
|---|---|---|---|---|
<<FILL>> | <<FILL: inherent / corrective>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Unscripted intervention during run | Assessment |
|---|---|
<<FILL: none, or describe>> | <<FILL>> |
3. Unit reconciliation
| Line item | Count | Notes |
|---|---|---|
| Units filled | <<FILL>> | Per counter and physical count |
| Rejected at fill (no/low fill, cosmetic) | <<FILL>> | Documented, removed before incubation |
| Units incubated | <<FILL>> | Equals filled minus rejects |
| Units read | <<FILL>> | Must equal incubated |
| Positive (turbid) units | <<FILL>> |
The reconciliation must close: filled equals incubated plus rejects, and read equals incubated. Turbid units are never reclassified as cosmetic rejects.
4. Incubation and read
| Item | Entry |
|---|---|
| Incubation scheme | <<FILL: e.g. 7 days 20-25 C then 7 days 30-35 C, 14 days total>> |
| Reads performed | <<FILL: intermediate and final read dates, reader>> |
| Units accounted for at each read | <<FILL: 100% / explain>> |
5. Growth promotion
| Item | Entry |
|---|---|
| Challenge organisms (compendial + environmental isolates) | <<FILL>> |
| Challenge level | <<FILL: <=100 CFU>> |
| Growth within incubation | Pass / Fail |
A “no growth” result is uninterpretable unless growth promotion passed; a failed or late growth promotion invalidates the run.
6. Concurrent environmental and personnel monitoring
| Monitoring | Result versus limits |
|---|---|
| Grade A viable (air, settle, contact, glove) | <<FILL: no growth / list recoveries>> |
| Grade B viable | <<FILL>> |
| Non-viable particle counts | <<FILL>> |
| Personnel glove/gown prints | <<FILL>> |
Any grade A recovery or EM excursion during the run is cross-referenced to the investigation and to the isolate library.
7. Deviations
| Deviation | Description | Impact on run validity | Resolution |
|---|---|---|---|
<<FILL: none, or list>> | <<FILL>> | <<FILL>> | <<FILL>> |
8. Results versus acceptance
| Criterion | Result |
|---|---|
| Positive units | <<FILL>> (target zero) |
| Growth promotion | <<FILL: pass>> |
| Unit reconciliation closes | <<FILL: yes>> |
| All planned interventions performed | <<FILL: yes>> |
| Concurrent EM within limits | <<FILL>> |
Any single positive unit is a failed simulation and routes to the media fill failure investigation, not to this report’s conclusion.
9. Conclusion and qualification status
Based on the results above, this media fill <<FILL: passed / failed>>. As a result:
- Line
<<FILL: ID>>is<<FILL: qualified / not qualified>>for aseptic production of<<FILL: format>>until<<FILL: next-due date>>. - The crew and operators listed in the protocol are
<<FILL: media-fill-current / not current>>as of the read date. - Next requalification is due
<<FILL: date, per the six-month cadence>>.
10. References
FDA Guidance, Sterile Drug Products Produced by Aseptic Processing (2004). EU GMP Annex 1, Manufacture of Sterile Medicinal Products (effective 25 August 2023). USP General Chapters on sterility and microbiological control of aseptic processing environments.
Confirm the current version and clause numbers of each reference before issue.
11. Approvals
| Role | Name | Signature | Date | Meaning |
|---|---|---|---|---|
| Author (Process / Validation) | <<FILL>> | Report complete and accurate | ||
| Microbiology / QC | <<FILL>> | Results and growth promotion confirmed | ||
| Quality Assurance | <<FILL>> | Acceptance judged; qualification status granted |
Filled specimen
Illustrative, for a semi-annual requalification of a vial line inside a closed RABS.
Purpose: semi-annual requalification, day-shift crew, worst-case campaign duration 8 hours, maximum interventions.
Intervention execution: all 10 planned interventions performed at or above planned frequency; one unscripted event, an operator re-seated a fallen vial using the qualified fallen-vial procedure, recorded and assessed as within a qualified intervention type.
Reconciliation:
| Line item | Count |
|---|---|
| Units filled | 6,210 |
| Rejected at fill | 95 |
| Units incubated | 6,115 |
| Units read | 6,115 |
| Positive units | 0 |
Incubation: 7 days at 20-25 C then 7 days at 30-35 C; intermediate and final reads, 100% accounted for. Growth promotion: challenge organisms plus two in-house isolates grew within incubation, pass. Concurrent EM: grade A no growth; all counts within limits.
Conclusion: media fill passed. The vial line is qualified for aseptic production of the 2 mL format until the next requalification due in six months; the day-shift crew is media-fill-current as of the read date.
Every number ties out and the qualification conclusion is explicit, which is what lets a Qualified Person or quality unit rely on this report as a release condition.
Common inspection findings this report prevents
- A run reported as “passed” while growth promotion was never completed or failed.
- Reconciliation that does not close, or turbid units quietly moved to the reject pile.
- An unscripted intervention performed during the fill and never assessed.
- A conclusion that grants line qualification without stating the crew currency or the next-due date.
- Concurrent EM excursions during the fill left out of the report and the investigation.
How to adapt this report
- Set your report number and link the executed protocol.
- Carry the intervention list directly from the protocol so execution can be compared line for line.
- Complete the reconciliation so filled equals incubated plus rejects and read equals incubated.
- State the qualification outcome explicitly: which line, which format, which crew, and the next-due date.
- Confirm every regulation in section 10 against the current published version before issue.