Biological Indicator - 24h Readout, 50-Pack

CliniEco Medical Biological Indicator — 24h Rapid Readout, 50-Pack

$119.98 CAD

In stock

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CliniEco Medical Biological Indicator — 24h Rapid Readout, 50-Pack

Daily biological monitoring for Ontario clinics — 24-hour results at about $2.40 per test

G. stearothermophilus ATCC 7953 · ISO 11138-3

Daily spore testing in Ontario — 24-hour results

$119.98 for 50 self-contained biological indicators — about $2.40 per test. Each vial contains Geobacillus stearothermophilus ATCC 7953 spores (10⁵–10⁶ per vial), 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 for each sterilizer on every day that it is used — daily monitoring, not weekly. The weekly baseline is the CDC / AAMI ST79 standard in most US states. One 50-pack covers about two months of daily testing for one sterilizer.

🛡️ Where Your BIs Come From — Traceability You Can Verify

🏭 Sourced from Certified Manufacturers

Our BIs are manufactured by ISO 13485-certified facilities — the same supply chain used by established sterilization brands. Full factory documentation available on request.

🧪 Standard Challenge Organism

Geobacillus stearothermophilus ATCC 7953 — the internationally accepted steam sterilization challenge organism, 10⁵–10⁶ spores per vial, verified per ISO 11138-1/3.

📋 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. For professional use only. Do not use if damaged or expired.
Conforms to ISO 11138-1 / ISO 11138-3.

Factory Certificates — available for verification

ISO 13485:2016 quality system certificates (DNV GL · DAkkS · Bureau Veritas)

✅ ISO 11138-1/3 Compliant ✅ ATCC 7953 Challenge Organism ✅ ISO 13485 Certified Factory ✅ Batch Traceability

Product Specifications

Brand	CliniEco Medical
Organism	Geobacillus stearothermophilus ATCC 7953 — 10⁵–10⁶ spores per vial
Readout	24-hour rapid visual readout (color change)
Format	Self-contained vial with growth medium — no transfer steps
Pack Size	50 indicators per pack; monitoring log template included
Frequency	Daily per sterilizer in Ontario (RCDSO); at least weekly in most US states (CDC / AAMI ST79)
Classification	Canada Class I; US FDA Class II, 21 CFR 880.2800

Features

✓ G. stearothermophilus ATCC 7953 — the accepted steam sterilization challenge organism
✓ 24-hour rapid readout — results a day sooner than 48-hour vials
✓ Self-contained (SCBI) — ampoule and medium in one vial
✓ Monitoring record log template included — supports RCDSO daily documentation and CDC / AAMI ST79

Compliance

RCDSO (Ontario): a biological indicator for each sterilizer on every day that it is used — daily
CDC and AAMI ST79: spore test at least weekly per sterilizer (US baseline)
Test organism: Geobacillus stearothermophilus ATCC 7953 (steam)
Canada Class I; US FDA Class II, 21 CFR 880.2800
Manufactured to ISO 11138-1/3 — documentation available on request

🎁 Get an Incubator or Rapid Reader FREE with a 12-Month BI Plan

Commit to 12 months of CliniEco BI supply and get a device free:

12 months of 24h BIs ($605/year) → Free 24h Incubator ($279 value)
12 months of Rapid BIs ($1,053/year) → Free Rapid Reader ($1,799 value) — 20-30 min results

Both include free digital record software. No lock-in — our BIs work in any standard 55-60°C incubator.

Start BI Plan — Reserve Your Free Device →

CliniEco Service Promise

Free shipping on this 50-pack — anywhere in Canada
Orders dispatched within 24h (Toronto)
Canadian-owned company
Batch documentation available — CoA, D-value and spore count on request

Wholesale Pricing

Volume pricing for clinics, dental practices, LTC homes and distributors
Free shipping on this item — anywhere in Canada

Why Buy CliniEco?

24-hour results at about $2.40 per test — versus $2.50–$6.90 typical of leading SCBI brands
Compliance built in — the monitoring record log template supports RCDSO daily documentation 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

Frequently Asked Questions

How often should we run a spore test?

It depends on the jurisdiction. In Ontario, the RCDSO requires a biological indicator for each sterilizer on every day that it is used — daily monitoring. In most US states, the CDC and AAMI ST79 baseline is at least weekly. One 50-pack covers about two months of daily testing for one sterilizer.

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 ISO 13485 factory certificates, ISO 11138-3 compliance documentation and batch certificates of analysis on request. Email alina@clinieco.ca.