Sterilization Load Record Template for Medical Device Lots
A sterilization load record shows that a specific load went through a validated cycle and met release criteria. This template captures the load contents, cycle data, indicator results and disposition in one document.
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Sterilization Load Record Template
Sterilization Load Record SL-2610-044
Facility: Meridian Orthopedics Inc., Sterilization Suite Method: Moist heat (steam) Sterilizer: Autoclave AC-02 Validated cycle: Cycle 3, 121 C for 30 min, validation PV-2025-031 Run date: 2026-10-16
Load contents
Lot L2610-0417, 492 pouches Lot L2610-0422, 300 pouches
Load configuration
| Item | Requirement | Result |
|---|---|---|
| Load pattern matches validated pattern | Yes | |
| Packaging intact and labeled | Yes | |
| Chemical indicator on each tray or pallet | Changed color | |
| Product in qualified quantity range | Yes |
Cycle record
Peak temperature 122.4 C, exposure time 30 min, pressure within limits, no alarms. Chart recorder printout attached.
Indicators
BI lot 5518, 3 in load at worst case positions plus 1 positive control
Indicator results
| Indicator | Location | Result | Read by | Date |
|---|---|---|---|---|
| Biological indicator 1 | ||||
| Biological indicator 2 | ||||
| Positive control | ||||
| Chemical indicator |
Disposition
Load disposition: Hold pending BI result
Approvals
Starting point only, not legal advice. Tailor fields to your validated process and to the standards that apply to it, such as ISO 11135 for ethylene oxide, ISO 17665 for moist heat or ISO 11137 for radiation. Parameters must match the validated cycle.
Link sterilization loads to lot status
Optional: a short review of tying load results to lot release status in your ERP or MES.
Optional. The tool and every export work without this. No spam.
How to use this template
Enter the load number, method, sterilizer and validated cycle, list every product lot in the load, and note the biological indicator details. After the cycle, paste or summarize the recorded parameters and attach the chart or printout. Export to PDF or Word, fill in the indicator results and sign. Do not release product until every release criterion in the validated procedure is met.
- Match load pattern to the validated configuration
- List every lot so a failure can be traced back
- Attach original cycle printouts or electronic data
- Record who read the biological indicators and when
The standards behind the record
ISO 13485 clause 7.5.7 requires validation of sterilization processes and records of the results. Each method has its own standard: ISO 11135 for ethylene oxide, ISO 17665 for moist heat, and the ISO 11137 series for radiation. These describe validation, routine control and release. The load record is the routine control evidence that a given load ran within the validated limits and that the product can be released.
Release and indicators
Product release depends on your validated approach. Many ethylene oxide and steam loads wait for biological indicator incubation results, while some processes use parametric release based on cycle data once the process is shown to be reliable. Chemical indicators show exposure but do not prove sterility. A positive biological indicator in the load triggers a nonconformance and an investigation, and the load is held or rejected.
Common mistakes
Common problems are loads built differently from the validated pattern, missing lot numbers on the record, indicators read late or not signed, and release before incubation finishes. Another is ignoring changes in packaging or product density that may require requalification. Keep the sterilizer calibration and maintenance current, because a drift in sensors can invalidate every load run since the last good check.
Frequently Asked Questions
What must a sterilization load record contain?
At minimum the load identity, product lots, method and validated cycle, recorded cycle parameters, indicator results, deviations, disposition and signatures. Your validated procedure may add items such as chamber conditions or pre-conditioning data.
Can product be released before the biological indicator result?
Only if your validated process allows it, for example parametric release. Otherwise the load is held until the biological indicators incubate and read negative with a valid positive control.
Is a chemical indicator enough?
No. It shows the item was exposed to a process condition, not that sterility was achieved. Biological indicators and recorded cycle parameters provide the main evidence for release.
When must a sterilization process be requalified?
Periodically per your procedure, and after changes to equipment, load configuration, packaging, product or bioburden. Each change needs a documented assessment that decides how much requalification is needed.
If lots, work orders and release status live in your ERP or MES, Netray can help link sterilization loads to lot status on your own infrastructure, with a person approving each release.
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