Class 5 Steam Chemical Integrators: Reading the Window, Pack Counts and Load Release
How do you choose a Class 5 steam chemical integrator for a Canadian clinic?
The last load of the morning comes out and the assistant holds a pouch up to the light. There is a small strip inside, and one end of its window has moved. Whether that movement means the pack can go in the cupboard depends on one thing: whether the strip is an integrator that reads the critical parameters together, or a process indicator that only reports that the pack was in the chamber.
ISO 11140-1:2014 sorts chemical indicators by what they measure. Class 1 is a process indicator, the familiar tape or external square. Class 5 is the integrating indicator: time, temperature and saturated steam are read in a single window, and the accept endpoint is set so that passing corresponds to the lethality a biological indicator would demonstrate in the same cycle. That is the difference that matters in a clinic, and it is a difference in what the strip can be used for, not in how it looks.
Selection comes down to eight dimensions, each with a threshold you can read off the pack or the certificate.
| Dimension | What to check | Threshold to hold |
|---|---|---|
| Indicator category | Label and catalogue entry | Class 5 integrating indicator to ISO 11140-1:2014, stated, not implied |
| Parameters read | Product data | Time, temperature and saturated steam in one window, not one variable |
| Accept endpoint | A strip run in your own cycle | An unambiguous end state; a partial move must be readable as not accepted |
| Size against the pack | Physical fit inside your pouch or wrap | Fits flat in the centre of the pack without folding the window |
| Lot and expiry | Pack label | Lot number and date on the immediate pack, not only the carton |
| Pack count | Order arithmetic | A count that matches packs per week, so the box is finished inside its window |
| Storage behaviour | Product data and pack seal | Individually or strip-sealed against humidity until use |
| Recordability | Your own log | A field to write the strip result, lot and cycle against the load |
The third dimension is the one that produces arguments. A strip that is partly moved is not a pass, and a strip read at the wrong moment in a cooling chamber is not a reading at all. Buy from a supplier whose instructions say plainly what a partial response means, and write that into the clinic's own procedure so the decision does not depend on who is holding the pouch.
Which pack counts are available in Canada?
The integration format used in Canadian dental and medical settings is a paper strip with a printed response window, sealed against humidity until the pack is opened. Our 
CliniEco Class 5 steam chemical integrator, 100-pack carries the ISO 11140-1 Type 5 classification on the pack, with the lot number and expiry printed where the person opening the box will see them.
The strip itself carries the cycles it was set for, printed on the paper beside the window: 3 minutes at 134 C, 4 minutes at 132 C and 20 minutes at 121 C on the units in our catalogue, together with the reference, lot and expiry. That print is worth reading at the box, because it tells you whether the strip was built for the cycles your sterilizer actually runs rather than for one of them.
Three order shapes cover most needs:
- 100 strips at $19.99, which is $0.20 a strip and covers twenty packs a day for a working week.
- 200 strips at $32.99, which brings the strip to about $0.17 and suits a site running multiple sterilizers.
- Ten boxes of 100 at $159.92, a thousand strips at about $0.16 each, which is the shape a group purchasing for several locations orders in.
Two other formats get confused with this one. Class 4 indicators respond to two or more critical variables but are not calibrated to stand in for the biological outcome, and Class 6 emulators are designed to match a specific cycle's defined parameters rather than respond across a range. Neither is interchangeable with a Class 5 in a procedure that says Class 5.
Canada has no separate national standard for integrators; the classification comes from ISO 11140-1, and CSA Z314:23 governs the sterilization practice around it. What changes province to province is the monitoring frequency and the record, not the strip.
How does it compare with tape and with a biological indicator, and where does each fall short?
| Check | What it responds to | Where it sits in the pack | Where it falls short |
|---|---|---|---|
| Class 1 process indicator (tape, external square) | Exposure to the process | Outside, on the fold or the pouch face | Proves the pack went through the chamber, nothing about the inside of the pack |
| Class 4 multicritical indicator | Two or more critical variables | Inside the pack | Not calibrated to a biological outcome, so it cannot stand in for one |
| Class 5 integrating indicator | Time, temperature and saturated steam together | Inside the pack, at the slowest point | Reads the conditions it saw, not the kill inside the load; it cannot replace the spore test |
| Class 6 emulator | A defined cycle's parameters | Inside the pack | Tied to one cycle specification; less flexible across a mixed sterilizer schedule |
| Biological indicator | Lethality against a defined spore population | Inside the challenge pack | 24 hours to a result in the vapour format, so the load is held |
Read the table downwards and the procurement logic is visible. Tape answers a question about every pack and answers it cheaply. The integrator answers a question about the inside of the pack. The biological indicator answers the question the audit cares about most, and takes a day to do it. A clinic needs all three layers, and the failure mode is treating one of them as a substitute for another: autoclave indicator tape on the outside is not a substitute for a strip inside, and a strip inside is not a substitute for the spore test.
How do you use one correctly, step by step?
The strip is only as good as its placement and its record. The sequence that holds:
1. Check the strip before the pack is closed: pack seal intact, window unreacted, lot and expiry legible.
2. Place it inside the pack at the slowest point to reach temperature and steam. For a wrapped instrument set that is the geometric centre; for a pouch, flat against the paper face in the middle, not tucked in a corner behind an instrument.
3. Close and label the pack as usual, with the tape on the outside carrying the date and cycle number.
4. Run the cycle, and confirm the cycle parameters on the sterilizer printout or display rather than assuming them.
5. Read the strip after the pack has cooled enough to handle, against the manufacturer's reference, and decide acceptance on the endpoint, not on how much the window has moved.
6. Record it: date, sterilizer, cycle or load number, integrator lot, result, and the biological indicator line that covers that period. The RCDSO standard of practice for infection prevention and control asks for the daily operation of each sterilizer to be logged in a book kept at least 10 years from the last entry.
7. Hold or quarantine any pack whose strip did not reach the accept endpoint, and treat the cause before the next load.
Step five is where habits drift. A window that has moved two thirds of the way is not a pass, and a strip that somebody read after the pack sat in a warm room for an hour is not a reading of the cycle. The rule to write into the SOP is a decision rule, not a description.
What goes wrong most often — and how do you catch it early?
Six failures account for most of the unusable integrator records we see.
| Symptom | Root cause | How to check |
|---|---|---|
| Strips read accept on a load that later fails a spore test | Air removal or steam quality problem the strip cannot resolve on its own | Compare the integrator result with the biological result for the same period, and check the vacuum and trap records |
| Window partly moved on every load | Strip placed at the cold edge of the load, or the pack is too dense | Move the strip to the geometric centre and run a test pack in the same position |
| Strips that react before the cycle | Storage in a humid cupboard, or an opened box left loose | Inspect the pack seal and the storage spot; a strip that has partly reacted is not usable |
| Every strip passes, no strip has ever failed | Nobody has defined what a failed strip looks like | Ask three staff what they would do with a partial response; if the answers differ, the rule is missing |
| Lot number absent from the log | Lot recorded on the carton only, and the carton went in the bin | Write the lot on the first strip's log line when the box is opened |
| Integrator used as the release authority | The procedure collapsed three checks into one | Read the SOP: release should reference the biological result for the period, not the strip alone |
The first row is the one that ends an inspection badly, and it is not a defect in the strip. An integrating indicator is a well-designed proxy; it is still a proxy, and steam quality problems that the strip cannot see are exactly what the biological indicator exists to catch. A record that shows only one of the two is a record with a gap in it.
What does an unverifiable integrator cost you?
Follow the chain, step by step.
1. The strip's job is to tell the person holding the pack whether the conditions inside that pack reached the parameters that sterilize. It is the only check that sits inside every pack and reads the critical variables together.
2. If the strip is unreadable, mis-stored or read against no defined endpoint, the failure is quiet: a pack that has no usable internal result is released, and the only checks left are the ones on the outside.
3. An audit does not begin with the brand of the strip. It begins with whether the facility can show that the checks it relied on mean what the facility's own procedure says they mean.
4. When that chain breaks, packs released on the strength of those checks lose their evidential value for the period in question. The instruments were in all likelihood sterile; the record cannot demonstrate it.
5. Responsibility sits with the facility that released the load, not the supplier of the strip. Placement, reading, release and record are clinic decisions, and a purchase order proves what was bought, not what was verified.
6. That is why the buying criterion is not the cost of the strip. It is whether each pack carries an internal result the clinic can explain, backed by the spore test that covers the load.
Here is the list to run against the current box.
| What you have to be able to prove | How to check it | What it means if you cannot |
|---|---|---|
| The class is what the procedure says it is | Pack label: Class 5 integrating indicator, ISO 11140-1:2014 | A procedure that names Class 5 and a box that is not Class 5 is a documentation gap |
| The strip was inside its working life | Lot and expiry on the immediate pack, opening date on the log | Strips outside the window behave unpredictably, and the result is uninterpretable |
| Storage protected the chemistry | Storage below 30 C, sealed until use, away from sinks | A partly reacted strip reports on the cupboard, not the cycle |
| Placement was at the slowest point | Written placement rule, plus a check pack in the same position | A strip at the cold edge verifies the edge |
| The load has a biological result behind it | Biological indicator line for the day and sterilizer | The internal checks stand alone, which is not what the standards expect |
| Who imported and holds the licence | Health Canada MDALL search on the licence number | The Canadian status of the product rests on the seller's word |
Where the facility's own procedure requires the reference method behind the strip, the pairing is a strip in every pack and a 24-hour self-contained biological indicator, 25-pack in the challenge load. CliniEco Medical holds Health Canada establishment licence MDEL #35334 as an importer of medical devices; that is a fact a buyer can check in the public register, and it says nothing about anyone else's product.
What should you verify before you buy?
Work down this list once, before the first order.
- The class is printed on the pack, with the standard number, not described in a brochure.
- The product data states the parameters the strip reads, and what a partial response means.
- A strip fits flat in the centre of your own pack without folding the window.
- Lot and expiry sit on the immediate pack, so the log line can be written from the box in hand.
- Storage instructions are specific about humidity and temperature.
- The pack count matches your packs per week, so the box is finished inside its window.
- The clinic's procedure names the strip's endpoint and the action on a partial result.
- The biological indicator line behind the load is defined, with its own frequency.
Our 100-pack above is the shape most single-site clinics start with; a two-sterilizer site usually moves to the 200-strip box of the same strip once the weekly count is known. The rest of the range sits under Class 5 integrators, the air removal check that belongs beside it is the Class 2 Bowie-Dick test pack, 6-pack, and purchasing for more than one location is handled through wholesale terms. Reselling? become a distributor.
References
- ISO 11140-1:2014 — Sterilization of health care products, chemical indicators, general requirements — ISO, Geneva; clause 4, indicator categories including the integrating indicator; verified 2026-10-27
- ISO 11138-3:2017 — Biological indicators for moist heat sterilization processes — ISO, Geneva; §1 scope, the reference method the integrator is calibrated against; verified 2026-10-27
- ISO 11138-1:2017 — Sterilization of health care products, biological indicators, general requirements — ISO, Geneva; §7.3.2 reference incubation time; verified 2026-10-27
- RCDSO Standard of Practice — Infection Prevention and Control in the Dental Office — Royal College of Dental Surgeons of Ontario; monitoring of sterilization and record retention; verified 2026-10-27
- Public Health Ontario — Cleaning, Disinfection and Sterilization of Medical Equipment/Devices in All Health Care Settings, 3rd edition — Public Health Ontario, May 2013; monitoring of sterilization processes; verified 2026-10-27
Not sure how this applies to your own setup? Ask a sterilization compliance specialist — you’ll get a written answer specific to your equipment and province, with the regulation or standard cited.
Related Reading
- Class 5 Integrator Explained for Canadian Clinics
- Can You Reuse a Class 5 Chemical Integrator Between Loads
- Type 5 Integrators vs Type 6 Indicators: The Class System Explained
Frequently Asked Questions
What does a Class 5 integrator measure that tape does not?
Tape responds to exposure to the process: it tells you the pack went through a steam cycle. A Class 5 integrating indicator reads time, temperature and the presence of saturated steam together in one window, and the strip is designed so that an accept result corresponds to the lethality a biological indicator would show in the same cycle.
Does a Class 5 integrator replace the biological indicator?
No. The classification exists precisely to keep the two apart. An integrator is an in-pack check that can run on every pack, every cycle; the biological indicator remains the reference method, and it is the result an audit asks for when the question is whether the load was actually sterilized.
How many integrators does one pack need?
One per pack is the ordinary practice for a clinic that wants every instrument set to carry its own result. If the load is wrapped as a single large pack, one strip goes into the geometric centre, which is the slowest point to reach temperature and steam.
What does a pack count cost per strip?
At current catalogue prices, $0.20 on the 100-pack, $0.17 on the 200-pack and about $0.16 in the ten-box case of a thousand. A 100-pack covers a clinic running twenty packs a day for five days.
How should an integrator strip be stored?
Sealed in its original pack, below 30 C, out of direct sunlight and away from sinks or any source of steam. The chemistry is designed to respond once, in a sterilizer; a strip that has sat in a humid cupboard has already been partly exposed to the variable it measures.
What do you do if the window has not reached the accept end after a cycle?
Treat the pack as not verified and hold it. Recheck the load pattern, confirm the cycle parameters, then repeat the cycle with a strip in the same position and a biological indicator if the facility's policy requires it. Never re-read a strip later and call it a pass.
CliniEco Medical holds Health Canada establishment licence MDEL #35334 as an importer of medical devices, at 255 Duncan Mill Road, Suite 512, Toronto, ON M3B 3H9. Product specifications last verified against our live catalogue on 2026-10-27. Reviewed quarterly. Last review: 2026-10-27.
Last updated: October 2026.
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