Sterilization Monitoring, Verified — Biological & Chemical Indicators

Sterilization monitoring, verified. CliniEco Medical is a Health Canada licensed importer and distributor (MDEL #35334) supplying biological and chemical indicators with published D-value reports, lot-level certificates of analysis, and four readout times — 20 minutes, 1 hour, 3 hours and 24 hours — for Canadian dental and medical sterilizers.

How our indicators compare, dimension by dimension

Dimension CliniEco 24-h self-contained 3M Attest system Typical online seller
Organism Geobacillus stearothermophilus ATCC 7953 ATCC 7953 often unstated
Population ≥1.0×10⁶ CFU/carrier, CoA matches the box stated “10⁵–10⁶”, vague
D-value at 121 °C 1.72 min measured (spec ≥1.50) — reports SCBI-24H-001 and SCBI-RAPID-001 report exists, not published not provided
Readout times 24 h · 3 h · 1 h · 20 min 24 h (fast read needs a dedicated reader) one option only
Dedicated reader required No — visual read, no equipment Yes (reader ≈ CA$555.99) usually not disclosed
Lot CoA every lot, with the measured ≥1.0×10⁶ value provided often absent, or a blank template
Not for use in stated: dry heat, chemical vapour (LTSF), ethylene oxide stated usually omitted
Packaging language English and French (Canadian requirement) EN / FR English only

Sources: D-value and population from the supplier certificate of analysis dated 28 October 2026 (lot ZJ1440) and D-value test reports dated 20, 21 and 22 October 2026; third-party report XDX522601161208BST, tested to EN ISO 11138-3:2017 and ISO 11138-1:2017. Reader price from a public Canadian listing. We do not claim to be more accurate than any other brand — we publish what we can point to.

Documents you can check

  • D-value report, 24-hour line — SCBI-24H-001, ISO 11138-1:2017. Available on request.
  • D-value report, rapid line — SCBI-RAPID-001, covering 20 min, 1 h and 3 h. Available on request.
  • Third-party test report — XDX522601161208BST, 12 pages, EN ISO 11138-3:2017. Available on request.
  • Certificate of analysis — a sample lot showing measured population, D-value and survive/kill times. Available on request.
  • Health Canada establishment licence — MDEL #35334 (importer and distributor), verifiable in the Health Canada database.

How many indicators do you actually need?

RCDSO Standard 5542 requires two indicators per sterilization cycle. Enter your workload and see what that means for a 25, 50 or 100 pack.

Method: monthly cycles = cycles/day × days/week × 52÷12 (≈4.333). Indicators = cycles × 2. Annual cost uses the current 25-pack price of $69.99 and scales pro rata for 50 and 100 packs. A dedicated reader is not required for this line.

What an inspector asks for — the three sheets

  1. Lot certificate of analysis for the box in use — population, D-value, survive and kill times, expiry.
  2. Incubator log — temperature and hold time for each readout (56–60 °C; 24 hours for the 24-hour line).
  3. Cycle record — cycle number, load, indicator result, initials.

We supply the first. Our compliance log centre generates the second and third from the RCDSO IPAC Self Audit field set, with no sign-up.

Where these indicators must not be used

  • Dry heat sterilization — use a dry-heat indicator.
  • Chemical vapour (LTSF / chemiclave) — different organism and carrier; not validated for this product.
  • Ethylene oxide — requires an EO-specific indicator.

Telling you where a product does not work is part of the specification, not a disclaimer.