CliniEco Medical Biological Indicator — 24-Hour Self-Contained, 25-Pack
Specifications
| Type | Self-contained biological indicator |
|---|---|
| Readout time | 24 hours |
| Pack quantity | 25 tests |
| Use | Steam autoclave sterilization monitoring |
| Result indication | Colour change |
| SKU | CLI-STER-BI-25 |
| Brand | CliniEco Medical |
Pricing
| Order | Unit price |
|---|---|
| 1 case | $69.99 CAD |
| 2–4 cases | Request quote |
| 5+ cases | Request quote |
Read the full product guide 19 sections · specs, use, compliance
What does 25 strips cover for a single-sterilizer clinic?
About a month of daily testing, plus the control vials the routine asks for. A practice that runs one autoclave on 22 use-days a month takes 22 indicators for the loads and adds one unexposed control from the same lot on each test day, which brings the month's draw close to the box. That is why 25 is the small format rather than the starter format: it is sized for one unit on a normal calendar, and a room that tests two units or runs six days a week outgrows it in a fortnight and should be looking at the 50-vial box instead.
How many 50-count boxes does a year of daily spore testing take?
Count test days first, then divide. At 22 use-days a month that is 264 test days a year, so ten or eleven 25-strip packs cover the loads, before the controls are counted; a clinic that keeps a monthly control ledger usually lands one box higher. The yearly figure is what makes the box-size choice worth ten minutes: the same 264 tests bought in 100-vial boxes means fewer orders, fewer lot numbers to file and one certificate to keep instead of four, while the smaller box keeps less capital sitting in a cupboard.
What has to be on the lot certificate before the box is accepted?
Three numbers and one organism. The certificate for the lot states the organism (Geobacillus stearothermophilus ATCC 7953), the spore population per vial (≥1.0 × 10⁶ CFU), the D-value and the Z-value — on the current lot, 2.0 minutes at 121 °C with a Z-value of 11.3 °C. Those are the figures an inspector or an accreditation reviewer asks to see beside the log, so the certificate is filed with the box rather than the invoice. The pack also ships with the daily and weekly log template, which is the second half of the same record.
| Attribute | Value as listed |
|---|---|
| Organism | Geobacillus stearothermophilus ATCC 7953 |
| Spore load | ≥1.0 × 10⁶ CFU per vial, typical 1.0–1.2 × 10⁶ |
| Readout | 24-hour rapid visual colour change |
| Cycles | 121 °C gravity and 132–135 °C vacuum-assisted steam |
| Format | Self-contained vial with growth medium, no transfer steps |
| Pack size | 25 indicators per pack, daily and weekly log template included |
| D-value / Z-value | Reported per lot on the CoA — current lot 2.0 min at 121 °C, Z 11.3 °C |
| Frequency | Ontario: each day the sterilizer is used; CDC / AAMI ST79 floor: at least weekly |
| Distribution | CliniEco MDEL #35334 |
Keep the paper side as tidy as the box: the printable daily and weekly spore-test log holds the lot code against each result, and the sterilization log generator on the same page produces the cycle sheet the indicator sits behind. Where the question is what a reviewer expects to see filed, the compliance documentation desk answers it against the current guidance.
CliniEco Medical distributes these indicators in Canada under MDEL #35334.
CliniEco Medical Biological Indicator — 24-Hour Self-Contained, 25-Pack
Spore testing every day the sterilizer runs — 24-hour results, with the per-test figure taken from the pack amount on this page
In-office monitoring — incubate and read on site; no need to send vials to an outside lab.
G. stearothermophilus ATCC 7953 · ISO 11138-3
Spore testing every day the sterilizer runs — 24-hour results
25 self-contained biological indicators, split from a 50-count box, priced on this page — the per-test figure is that amount divided by twenty-five. Each vial contains Geobacillus stearothermophilus ATCC 7953 spores (≥1.0 × 106 CFU per vial, typical 1.0–1.2 × 106, as stated on each lot CoA), the standard challenge organism for steam sterilization, in a self-contained vial with growth medium for a rapid visual readout in 24 hours instead of 48. In Ontario the RCDSO requires a biological indicator on every day the sterilizer is used; the CDC and AAMI ST79 weekly baseline is the floor in most US states. Each monitoring day uses two indicators — one test plus one unexposed positive control — so a 25-pack gives about 12 monitoring days, roughly two and a half weeks at five days a week.
🛡️ Where Your BIs Come From — Traceability You Can Verify
🏭 Factory Documentation on Request
Every lot ships with full manufacturer documentation available on request — the same supply chain used by established sterilization brands.
🧪 Standard Challenge Organism
Geobacillus stearothermophilus ATCC 7953 — the internationally accepted steam sterilization challenge organism, ≥1.0 × 106 CFU per vial (typical 1.0–1.2 × 106), verified per ISO 11138-1.
📋 Batch Traceability
Every pack carries lot-level traceability. Batch D-value and spore-count documentation available — ask us for the certificate of analysis for your lot.
🇨🇦 Canadian Import & Distribution
Imported and distributed by CliniEco Medical (MDEL #35334) — with English/French labeling and Toronto-based support.
📦 Importer & Regulatory Information
Imported and distributed by: CliniEco Medical (Ecology Source New Energy Technology Co., Ltd.)
255 Duncan Mill Road, Suite 512, Toronto, ON M3B 3H9, Canada
Storage: 15–30°C, away from direct sunlight and moisture. Shelf life: 24 months from manufacture; EXP printed on every vial. For professional use only. Do not use if damaged or expired.
Conforms to EN ISO 11138-3 (moist heat) and EN ISO 11138-1 — third-party test report XDX522601161208BST (BST Testing, EN ISO 11138-1:2017 and -3:2017) available on request. For steam sterilization only — not for dry heat, chemical vapour, ethylene oxide (EO) or other low-temperature processes.
How to Read Your 24-Hour Result
| Negative — pass | The medium stays purple after 24 hours at 56–60 °C (58 ± 2 °C): no spore growth. Release the load. |
| Positive — fail | The medium turns yellow: spores survived the cycle. Re-sterilize everything in that load and re-test before releasing instruments. |
| Incubation | 56–60 °C (58 ± 2 °C) dry-block incubator; read at 24 hours (this indicator is rated for a 24-hour readout, not 48 hours). |
| Positive control | Run one unexposed indicator from the same lot as a control on each day you test; it must turn yellow. If the control does not grow, the test run is not valid. |
| Reading is visual | No reader or UV lamp is needed. |
| Source | Manufacturer's instructions for use supplied with each lot. |
Product Specifications
| Brand | CliniEco Medical |
| Organism | Geobacillus stearothermophilus ATCC 7953 — ≥1.0 × 106 CFU per vial (typical 1.0–1.2 × 106) |
| Readout | 24-hour rapid visual readout (color change) |
| Cycles | 121°C gravity & 132–135°C vacuum-assisted steam sterilization |
| Format | Self-contained vial with growth medium — no transfer steps |
| Pack Size | 25 indicators per pack; daily and weekly log template included |
| Frequency | Ontario: each day the sterilizer is used (RCDSO) · CDC / AAMI ST79 floor: at least weekly |
| D-value / Z-value | Reported for every lot on the CoA — current lot: 2.0 min at 121 °C, Z-value 11.3 °C |
| Distribution | CliniEco MDEL #35334 |
Sample CoA from a production lot — the certificate issued with your shipment carries your lot number and the manufacturer's details.
Features
- ✓ G. stearothermophilus ATCC 7953 — the accepted steam sterilization challenge organism
- ✓ 24-hour result — results a day sooner than 48-hour vials
- ✓ Self-contained (SCBI) — ampoule and medium in one vial
- ✓ Daily + weekly record log template included — supports RCDSO daily and CDC/AAMI weekly monitoring
Compliance
- RCDSO (Ontario): one biological indicator each day the sterilizer is used — RCDSO IPAC standard 03/24_5542
- CDC and AAMI ST79: at least weekly per sterilizer (US baseline)
- Test organism: Geobacillus stearothermophilus ATCC 7953 (steam)
- Distributed by CliniEco Medical under MDEL #35334
- Manufactured to EN ISO 11138-3 and EN ISO 11138-1 — documentation available on request
Hardware is sold separately — buy only what you need
We do not bundle hardware into a plan. Prices:
- 24-Hour Dry-Block Incubator — $379
- Rapid Reader, 4-well fluorescence — $1,499 (3-hour results)
Both include free printable record sheets. No lock-in — our BIs work in any standard 56–60 °C (58 ± 2 °C) incubator.
Start BI Plan — Reserve Your Free Device →CliniEco Service Promise
- Free shipping on this 25-pack — anywhere in Canada
- In stock in Toronto — dispatched within 24h while this lot lasts
- Canadian-owned company
- Batch documentation available — CoA, D-value and spore count on request
Clinic & Volume Pricing
Contact us for volume pricing — email alina@clinieco.ca.
- Volume pricing for clinics, dental practices, LTC homes and distributors
- Free shipping on this item — anywhere in Canada
Why Buy CliniEco?
- 24-hour results, with the per-test figure shown on this page — priced below the equivalent 24-hour self-contained indicators sold in Canada — same challenge organism, same ISO 11138-3 basis
- Compliance built in — the log template supports RCDSO daily monitoring and CDC / AAMI ST79 expectations
- Complete reprocessing line — pairs with CliniEco pouches, rolls, tape and cleaning solution
- Full traceability — factory documentation, batch CoA, Canadian import
Related Reading
Related Guides
Learn how to choose and use this product correctly:
- Sterility Assurance Level (SAL) Explained: What 10-6 Means for Sterilization
- Biological Indicator Failure: Recall, Root Cause, and Re-Test Protocol
- Class 4 vs 5 vs 6 Sterilization Indicators: Which Do You Need?
- How Often Should You Run a Spore Test? Sterilizer Monitoring Schedules
- Free Sterilization Log Sheet Generator — printable, no login
Have a question about your own facility? Send it in and you will get a written answer specific to your setup, with the regulation or standard it is based on cited. Ask your compliance question.
Related tests in this BI line
- Clinic Starter Bundle — Gloves, Spore Testing & Sterilization Packaging
- CliniEco 24-Hour Biological Indicator Incubator — Precision Dry-Block, 24 Wells
- CliniEco Medical Biological Indicator — 1-Hour Rapid Readout, Fluorescence, 50-Pack
- CliniEco Medical Biological Indicator — 20-Minute Rapid Readout, Fluorescence, 50-Pack
- CliniEco Medical Biological Indicator — 24-Hour Self-Contained, 100-Pack
- CliniEco Medical Biological Indicator — 24-Hour Self-Contained, 50-Pack
- CliniEco Medical Biological Indicator — 3-Hour Rapid Readout, Fluorescence, 50-Pack
- Free Biological Indicator 5-Pack (clinics)
- CliniEco Medical Bowie-Dick Test Pack — ISO 11140-5 Type 2, Daily Vacuum Check, 6-Pack
- CliniEco Rapid Reader — 4-Well Fluorescence Biological Indicator Reader
Related supplies for the same workflow
Related articles
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- What Is a Biological Indicator? Definition, Core Organism, and Steam Autoclave Formats
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Common questions
How often should we run a spore test?
In Ontario, the RCDSO requires a biological indicator for each sterilizer on every day it is used — daily monitoring, not weekly. The weekly baseline is the CDC / AAMI ST79 standard in most US states. A 25-pack covers about 12 monitoring days (one test plus one control each day the sterilizer runs) or about three months of weekly testing.
How do I read the result?
After the cycle, activate the vial per the included instructions and incubate; read at 24 hours. No color change means no surviving spores (pass); a color change means failure — quarantine the load and re-test the sterilizer.
What organism is used, and why?
Geobacillus stearothermophilus ATCC 7953 — the standard biological challenge for steam because of its high heat resistance. A compact dry-block incubator is available on request.
Can I see the factory documentation?
Yes — we provide the test reports behind the standards listed above and batch certificates of analysis on request. Email alina@clinieco.ca.
Does it work with my autoclave cycle type?
This item is used with standard steam sterilization cycles; confirm the specific cycle against the manufacturer's instructions supplied with each lot.
How should it be stored, and how long does it keep?
Store between 15–30 °C at 30–65% relative humidity, keep away from sterilants, direct sunlight and UV, and do not crush the packaging. Shelf life is 24 months from the date of manufacture.
How often does a Canadian clinic need to run it?
In Ontario the RCDSO requires a biological indicator on every day the sterilizer is used.
Which standard does it meet?
Manufactured and tested to EN ISO 11138-1 and EN ISO 11138-3. Manufacturer documentation available on request.
How long does a 24-hour readout biological indicator take to incubate?
This is a self-contained 24-hour test: after the cycle the indicator is activated and incubated, and the readout is available at the time stated in the manufacturer's instructions for use — around 24 hours. Keep the activated indicator in the incubator for the full period before reading it, and read the result against the control.
Is a 24-hour biological indicator acceptable for RCDSO daily monitoring?
The requirement is about how often you test, not how fast the indicator reads. In Ontario the RCDSO expects a biological indicator for each sterilizer on every day the sterilizer is used — daily monitoring, not weekly — placed in a process challenge device and run for each type of cycle used that day. The weekly interval is the CDC / AAMI ST79 baseline in most US states. A 24-hour readout fits a daily schedule; where same-shift release is needed, a rapid-readout indicator is used instead.
How is this different from the 3-hour indicator and the 5-pack trial?
All three are biological indicators with the same pass-or-fail meaning; the difference is the readout time and the pack size. The 3-hour unit is a fluorescence test for same-shift release, this 24-hour unit suits a next-day schedule, and the 5-pack trial is a small pack to evaluate the routine before committing to a working size.
How many indicators does one test need, and how long should records be kept?
One indicator per sterilizer for each day it is used, plus a control. File the result in a log that matches your facility's records-retention policy, and note the sterilizer, the cycle type and the date alongside it.
