Biological Indicator - 24h Readout, 25-Pack

CliniEco Medical Biological Indicator — 24h Rapid Readout, 25-Pack

$59.99 CAD

$59.99 CAD $99.99 CAD

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CliniEco Medical Biological Indicator — 24h Rapid Readout, 25-Pack

Spore testing every day the sterilizer runs — 24-hour results, about $2.40 per test

G. stearothermophilus ATCC 7953 · ISO 11138-3

Spore testing every day the sterilizer runs — 24-hour results

$59.99 for 25 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 on every day the sterilizer is used; the CDC and AAMI ST79 weekly baseline is the floor in most US states. A 25-pack covers five weeks of daily testing (five days a week) for one sterilizer, or about six months of weekly testing.

🛡️ 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

How to Read Your 24-Hour Result

Negative — pass	The medium stays purple after 24 hours at 56–60°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 dry-block incubator; read at 24 hours (this indicator is rated for a 24-hour readout, not 48 hours).
Positive control	An unexposed indicator 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 — 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	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
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
✓ 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
CDC and AAMI ST79: 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) — 3-hour 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 25-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 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

Frequently Asked 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 five weeks of daily testing (five days a week) or about six 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 ISO 13485 factory certificates, ISO 11138-3 compliance documentation and batch certificates of analysis on request. Email alina@clinieco.ca.