This is a ready-to-use qualification protocol for a clean or pure steam system, covering installation, operational, and performance qualification. Pure steam that sterilizes parenteral-contact surfaces has to be both chemically clean and physically capable of sterilizing, so the protocol tests condensate chemistry and the EN 285 steam-quality triad, not one or the other. Replace every <<FILL: ...>> placeholder, read the numeric limits off the current editions of the cited standards and your specifications, and route it through your validation lifecycle. A filled specimen follows. Confirm each cited standard and monograph against the current source before you rely on it.
Approval page
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Validation / C&Q) | <<FILL>> | ||
| Reviewer (Engineering / SME) | <<FILL>> | ||
| Reviewer (QC / Microbiology) | <<FILL>> | ||
| Approver (Quality Assurance) | <<FILL>> |
| Field | Entry |
|---|---|
| Protocol number | <<FILL: e.g. QUAL-STM-001>> |
| Version | <<FILL>> |
| System name / ID | <<FILL>> |
| Steam grade | <<FILL: clean steam / pure steam (WFI-quality condensate)>> |
1. Objective
Demonstrate through documented IQ, OQ, and PQ that the steam system is installed correctly, operates reliably, and consistently delivers steam meeting its defined quality attributes at every point of use: additive-free condensate of the specified chemical quality, and, for pure steam, condensate meeting the Water for Injection quality bar, together with steam quality (non-condensable gases, dryness, superheat) adequate to sterilize.
2. Scope
Covers the generator <<FILL: generator ID>>, the distribution system, and the points of use listed in Attachment A. It covers clean/pure steam only; plant (black) steam is out of scope. Sterilizer cycle development and biological-indicator qualification are covered separately in <<FILL: sterilization validation protocol ID>> (see sterilization validation: moist heat).
3. System description
<<FILL: describe the feedwater source and quality, generator type and separation design, distribution material (for example 316L, orbital-welded, sloped to drain, surface finish), points of use, steam traps, and instrumentation.>>
4. Prerequisites
- Approved URS and risk assessment for the system.
- Commissioning and TAB complete and documented (system balanced, traps functional).
- Calibration of all measuring instruments current and traceable (the EN 285 steam-quality rig, conductivity, TOC, temperature, pressure); see calibration and metrology program.
- Feedwater system qualified and within specification.
- Test methods for condensate chemistry, endotoxin, and microbial available and validated.
5. Acceptance criteria (system level)
The system meets qualification when IQ, OQ, and the three-phase PQ each pass their defined criteria, with every point of use meeting the acceptance table in section 8 across the study, and all deviations closed.
6. IQ test cases
| ID | Verification | Expected result | Actual | Pass/Fail |
|---|---|---|---|---|
| IQ-01 | P&ID matches the installed system | As-built matches approved P&ID | <<FILL>> | <<FILL>> |
| IQ-02 | Material certificates for product-contact lines | 316L (or specified) mill certs and surface-finish records present, meeting the URS (for example Ra <<FILL: limit>>) | <<FILL>> | <<FILL>> |
| IQ-03 | Weld documentation | Weld log, boroscope/radiography records complete and acceptable | <<FILL>> | <<FILL>> |
| IQ-04 | Slope and dead-leg check | Piping sloped to drain; no dead leg beyond the design rule (<<FILL: e.g. no more than 2 to 3 pipe diameters>>) | <<FILL>> | <<FILL>> |
| IQ-05 | Instrument calibration | All GxP instruments calibrated and traceable | <<FILL>> | <<FILL>> |
| IQ-06 | Sample valves at each point of use | Present and correctly located for representative sampling | <<FILL>> | <<FILL>> |
7. OQ test cases
| ID | Verification | Expected result | Actual | Pass/Fail |
|---|---|---|---|---|
| OQ-01 | Generator reaches and holds steady state | Pressure/temperature stable within <<FILL: range>> within <<FILL: time>> | <<FILL>> | <<FILL>> |
| OQ-02 | Pressure control and alarms | Setpoint held; high/low alarms function | <<FILL>> | <<FILL>> |
| OQ-03 | Initial steam quality at worst-case point (EN 285 triad) | NCG, dryness, and superheat each within the current EN 285 limit | <<FILL>> | <<FILL>> |
| OQ-04 | Initial condensate chemistry at worst-case point | Conductivity and TOC within specification | <<FILL>> | <<FILL>> |
| OQ-05 | Failure/recovery behavior | System responds correctly to a simulated fault | <<FILL>> | <<FILL>> |
8. PQ: the three-phase sampling study
Sample at the points of use, not the generator outlet. Choose worst-case points per the protocol rationale and rotate the remainder through Phase 3.
- Phase 1 (intensive,
<<FILL: e.g. 2 to 4 weeks>>): every point of use, every operating day, for condensate chemistry (conductivity, TOC), endotoxin and microbial (pure steam), and steam quality (EN 285 triad) at worst-case points. Do not release the system on Phase 1 alone. - Phase 2 (
<<FILL: e.g. 2 to 4 weeks>>): same testing under the operating SOPs; interim production release may be supported under a documented rationale. - Phase 3 (remainder of about a year): reduced-frequency monitoring, rotating points, to capture seasonal feedwater variation.
PQ acceptance table (per point of use)
| Attribute | Method / standard | Acceptance limit | Result | Verdict |
|---|---|---|---|---|
| Conductivity | USP 645 | <<FILL: within Stage 1 table for temperature>> | <<FILL>> | <<FILL>> |
| TOC | USP 643 | <<FILL: e.g. <= 500 ppb>> | <<FILL>> | <<FILL>> |
| Endotoxin (pure steam) | USP 85 (BET) | <<FILL: < 0.25 EU/mL for WFI>> | <<FILL>> | <<FILL>> |
| Microbial (condensate) | Membrane filtration | <<FILL: site alert/action, WFI-based>> | <<FILL>> | <<FILL>> |
| Non-condensable gases | EN 285 (test rig) | <<FILL: NCG % v/v cap from current EN 285>> | <<FILL>> | <<FILL>> |
| Dryness value | EN 285 (test rig) | <<FILL: dryness minimum from current EN 285>> | <<FILL>> | <<FILL>> |
| Superheat | EN 285 (test rig) | <<FILL: superheat cap (deg C) from current EN 285>> | <<FILL>> | <<FILL>> |
9. Deviation handling
Record each discrepancy as a numbered deviation, assess impact, determine root cause, resolve, and re-test. QA approves each deviation and the final disposition.
10. Summary and conclusion
| Field | Entry |
|---|---|
| IQ result | <<FILL>> |
| OQ result | <<FILL>> |
| PQ result (all phases) | <<FILL>> |
| Deviations raised / closed | <<FILL>> |
| Conclusion | <<FILL: system qualified / not qualified>> |
| Approved by (QA) | <<FILL: name, signature, date>> |
11. Attachments
Attachment A: point-of-use list and worst-case rationale. Attachment B: calibration certificates. Attachment C: raw data and certificates of analysis.
12. References
USP <643> Total Organic Carbon, <645> Water Conductivity, <85> Bacterial Endotoxins Test; the Water for Injection monograph. European Pharmacopoeia “Pure steam” (its condensate meets Water for Injection requirements). EN 285 (steam sterilization, large sterilizers) for the non-condensable gas, dryness, and superheat limits and test method. EU GMP Annex 1 (2022); 21 CFR 211.48, 211.63, 211.67. Related reading: clean utilities qualification, water system validation per USP 1231.
Confirm the current version and clause numbers of each reference before issue.
13. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
Filled specimen
The following shows a completed PQ acceptance row for an example pure steam point of use serving an autoclave, so you can see how the table reads. The values are illustrative; take your real limits from the current standards.
| Attribute | Method / standard | Acceptance limit | Result | Verdict |
|---|---|---|---|---|
| Endotoxin | USP 85 (BET) | < 0.25 EU/mL (WFI) | < 0.05 EU/mL | Pass |
| Non-condensable gases | EN 285 (test rig) | per current EN 285 NCG cap | comfortably under the cap | Pass |
| Dryness value | EN 285 (test rig) | per current EN 285 minimum | above the minimum | Pass |
| Superheat | EN 285 (test rig) | per current EN 285 cap | well under the cap | Pass |
In this example the point of use passed both the WFI-quality endotoxin bar and the three EN 285 steam-quality attributes. A common failed protocol tests condensate chemistry and endotoxin but never runs the EN 285 triad, so it proves the steam is clean but not that it sterilizes. Testing both, at the point of use, is what makes the qualification complete.
Common inspection findings this protocol prevents
- Steam qualified on condensate chemistry alone, with no EN 285 steam-quality testing.
- Sampling at the generator outlet only, not at the points of use.
- Endotoxin not tested on pure steam condensate that sterilizes parenteral-contact surfaces.
- Dead legs and poor slope found only after qualification, on a later walkdown.
- A single intensive phase mistaken for a full PQ, with no seasonal (Phase 3) coverage.
How to adapt this protocol
- Set your protocol number, generator ID, and steam grade on the approval page.
- Read the EN 285 numeric limits and your condensate chemistry limits off the current standards and specifications; do not carry remembered numbers.
- List your real points of use and worst-case rationale in Attachment A.
- Align the microbial and endotoxin limits with the WFI monograph and your site alert/action regime.
- Confirm every standard and monograph against the current published version before issue.