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Autoclave SOP: A Standard Operating Procedure You Can Adapt

An SOP turns the manual and your infection-control policy into the steps your staff actually follow. Use this structure, fill in your own machine and people, and have it approved before use.

Also called Autoclave SOP, Sterilisation SOP, Standard operating procedure

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What the SOP should contain

Keep it short enough to follow and specific enough to audit. Name your machine, your cycles and your people — a generic SOP copied from elsewhere is one of the first things an auditor notices.

HeadingWhat to write
1. PurposeTo make sure every load released from the steriliser went through a cycle that met its set parameters, and that this is recorded.
2. ScopeWhich steriliser (make, model, serial number), which room, which loads — and which loads it must not be used for.
3. ResponsibilitiesWho may operate it, who releases loads, who runs and reads the tests, who calls the engineer and who reviews the SOP.
4. ReferencesThe manufacturer’s instructions for use, your infection-control policy and the standard the machine is declared to, such as EN 13060.
5. Equipment and materialsWater specification, pouches, indicators, test packs, spore tests, and the log book or software.
6. ProcedureStart of day, each load and end of day — the steps below.
7. Release criteriaWhat must be true before a load is used or stored.
8. FailuresWhat to do when a test, cycle or load fails, including recall.
9. RecordsWhat is recorded, where, and for how long.
10. ReviewWhen the SOP is reviewed, and who signs it.

Procedure: start and end of day

  • Check the door seal and chamber rim, and wipe them with a damp lint-free cloth.
  • Check the clean-water reservoir level and that the used-water tank is empty.
  • Switch on and let the machine reach its ready state.
  • Run the vacuum leak test if the manual calls for it at the start of the day.
  • Run the Bowie-Dick or helix test in an otherwise empty chamber (vacuum sterilisers).
  • Record and initial the results. Process no patient loads until both have passed.
  • At the end of the day, empty the used-water tank, take out the trays and leave the chamber to dry as the manual directs.

Read next Cleaning schedule to attach to the SOP

Procedure: each load

Prepare

Only clean, dry, inspected instruments go in. Pack them in pouches or wraps as the load requires, with an internal indicator where your policy specifies. Label each pack with the date, the cycle or load number and the contents.

Load

Follow the loading pattern set for each load type: a single layer, pouches on edge or as the manual shows, nothing touching the chamber walls and weight within the cycle’s limit.

Select and run

Choose the cycle the SOP names for that load — for example 134 °C for wrapped instruments and 121 °C for heat-sensitive items. Do not interrupt the cycle or open the door early.

Check and release

Compare the printout or display with the release criteria. Check that each pack is dry and intact and its indicator has changed. Release it, or quarantine and reprocess.

Read next Loading patternsPouches and indicators

Release criteria

Write these as a checklist the operator completes for every load. If any line fails, the load is not released.

CheckPass
Cycle recordTemperature, pressure and hold time within the cycle’s limits; no alarms
Process indicatorsFully changed on every pack
Internal indicatorsPassed in the packs where the SOP places them
PacksDry, sealed, undamaged and labelled
Daily testsToday’s air-removal and leak tests passed
Spore testNo positive result outstanding for this steriliser

Failures, records and review

  • Failed test: stop patient loads and repeat once. If it fails again, take the machine out of use and call the engineer.
  • Failed load: quarantine it, reprocess it once the cause is fixed, and record what happened.
  • Positive spore test: stop using the steriliser, recall loads processed since the last negative test as your policy sets, inform the infection-control lead and record the corrective action.
  • Records: cycle printouts or logs, test and spore results, the cleaning log and service reports, kept together for the period your policy and licensing require.
  • Training: list who has been trained and signed off on the SOP, and retrain after changes.
  • Review: at least yearly, and after a new machine, a repair that affects the cycle, a new load type or a failure.

Read next Troubleshooting faultsValidation and requalificationCara guna autoclave (Bahasa Malaysia)

Related guides

Autoclave Testing: Bowie-Dick, Indicators and ValidationThe daily, weekly and yearly checks that prove your autoclave is sterilising — and what autoclave tape and pouches can and cannot tell you.Cara Guna Autoclave: Panduan Langkah demi LangkahAutoclave hanya mensteril alat yang telah dibersihkan, dibungkus dan dimuatkan dengan betul. Ikuti langkah ini setiap hari di klinik anda.Autoclave Troubleshooting: What to Check, and When to StopA symptom-by-symptom guide to the faults clinic autoclaves show most often — what staff can safely check, and when the machine must come out of use until an engineer has seen it.

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Frequently asked questions

What is an autoclave SOP?
A written standard operating procedure that tells staff exactly how to run, test and record your steriliser, and what to do when something fails. It is based on the manufacturer’s instructions and your infection-control policy.
Who should approve an autoclave SOP?
The person responsible for infection control or the clinic’s person in charge, after checking it against the manufacturer’s instructions. Staff who use the machine should sign that they have read it.
How often should an autoclave SOP be reviewed?
At least once a year, and whenever the machine, cycles, load types or packaging change, or after a failure.
Can I copy another clinic’s autoclave SOP?
Only as a starting point. The SOP must name your machine, your cycles, your loading patterns and your staff, or it will not match what actually happens.

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