This is a ready-to-use record for a steam-quality test using the EN 285 triad: non-condensable gases, dryness value, and superheat, measured with a steam-quality test rig at the point of use. Condensate chemistry tells you the steam is clean; this test tells you it can sterilize, and the two are separate. Replace <<FILL: ...>> placeholders, read the acceptance limits off the current edition of EN 285, and file the completed record with the qualification or routine monitoring package. A filled specimen row follows. Confirm the standard against the current source before you rely on it.
Control header
| Field | Entry |
|---|---|
| Document title | Steam Quality Test Record (EN 285 Triad) |
| Document number | <<FILL: e.g. FRM-STM-002>> |
| System / generator ID | <<FILL>> |
| Point(s) of use tested | <<FILL>> |
| Test rig ID (calibrated) | <<FILL>> |
| Reason for test | <<FILL: qualification / periodic / post-maintenance / investigation>> |
| Retention | <<FILL: e.g. life of the system plus records-retention period>> |
Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Date / time | Date-time | Yes | Tester | At test |
| Point of use | Text / ID | Yes | Tester | At test |
| Non-condensable gases (NCG) result | % v/v | Yes | Tester | At test |
| NCG acceptance limit | % v/v (from current EN 285) | Yes | Tester | At test |
| NCG verdict | Pass / Fail | Yes | Tester | At test |
| Dryness value result | Fraction | Yes | Tester | At test |
| Dryness acceptance limit | From current EN 285 (note tighter value for dense metal loads) | Yes | Tester | At test |
| Dryness verdict | Pass / Fail | Yes | Tester | At test |
| Superheat result | deg C rise on expansion to atmospheric | Yes | Tester | At test |
| Superheat acceptance limit | deg C (from current EN 285) | Yes | Tester | At test |
| Superheat verdict | Pass / Fail | Yes | Tester | At test |
| Supply pressure | bar / kPa | Yes | Tester | At test |
| Overall verdict | Pass / Fail | Yes | Tester | At test |
| Tester | Name / signature | Yes | Tester | At test |
| Reviewer (QA/SME) | Name / signature / date | Yes | Reviewer | On review |
Instructions
- Use a calibrated steam-quality test rig; record its ID and confirm calibration is current before testing.
- Test at the point of use, not the generator outlet; steam quality degrades along the distribution.
- Read the acceptance limits for NCG, dryness, and superheat off the current edition of EN 285. The dryness minimum is tighter for dense metal loads; apply the value that matches your load.
- Record each of the three results, its limit, and its verdict. A single Fail among the three fails the overall test; investigate before use.
- Have QA or the SME review and sign. File with the qualification package (for a PQ point) or the routine monitoring record.
Test record
| Date / time | Point of use | NCG result | NCG limit | NCG verdict | Dryness result | Dryness limit | Dryness verdict | Superheat result | Superheat limit | Superheat verdict | Overall | Tester |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
The steam quality passes at a point of use when all three attributes are within their current EN 285 limits at that point. Any single Fail fails the test and triggers an investigation (feedwater, generator separation/carryover, trap performance, or distribution) before the steam is used for sterilization.
References
EN 285 (steam sterilization, large sterilizers) for the non-condensable gas, dryness, and superheat limits and the test method. EU GMP Annex 1 (2022) for the expectation that steam used for sterilization is of suitable quality. Related reading: clean utilities qualification, sterilization validation: moist heat.
Confirm the current version and clause numbers of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
Filled specimen
The following shows one completed row for an example pure-steam point of use serving an autoclave, so you can see how the three verdicts combine. The values are illustrative; take real limits from the current EN 285.
| Field | Entry |
|---|---|
| Date / time | 22 July 2026, 09:40 |
| Point of use | Autoclave AUT-02 chamber inlet |
| NCG result / limit / verdict | comfortably under the EN 285 cap / per current EN 285 / Pass |
| Dryness result / limit / verdict | above the minimum / per current EN 285 (standard load) / Pass |
| Superheat result / limit / verdict | well under the cap / per current EN 285 / Pass |
| Supply pressure | <<FILL>> |
| Overall verdict | Pass |
| Tester / Reviewer | J. Okafor / R. Gomez (QA), 22 July 2026 |
In this example all three attributes passed at the point of use, so the steam is fit to sterilize. Had the NCG result exceeded the cap, the overall verdict would fail even with dryness and superheat in range, because air pockets shield the load and defeat sterilization. Recording all three, at the point of use, with the load-appropriate dryness limit, is what makes the record defensible.
Common inspection findings this form prevents
- Steam judged acceptable on condensate chemistry alone, with no EN 285 triad record.
- Testing at the generator outlet instead of the point of use.
- Using the standard-load dryness limit for a dense metal load that needs the tighter value.
- A single failed attribute buried under an overall “acceptable,” with no investigation.
- An uncalibrated or unrecorded test rig, so the numbers cannot be trusted.
How to adapt this form
- Set your document number, generator ID, and test-rig ID in the header.
- Enter the EN 285 acceptance limits from the current edition, matched to your load type.
- Record every test at the point of use with all three verdicts.
- Route any Fail through your deviation process before the steam is used.
- Confirm the standard against the current published version before issue.