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Your Autoclave Passed the Cycle. Did It Actually Sterilize?

  • Writer: Luo Yee, Heng (Ms.)
    Luo Yee, Heng (Ms.)
  • Jun 11
  • 2 min read

Most facilities log temperature, pressure, and cycle time but do you know? It's not a sterilization control programme.

The problem

  • Physical parameters confirm the cycle ran but not that sterilization was achieved

  • Dense or improperly loaded chambers can fail to sterilise even when readings look correct

  • Only a biological indicator placed at the hardest-to-reach load point gives direct organism kill evidence

Three gaps auditors find

  • No BI programme — organism kill never confirmed with a spore-based device

  • Wrong CI class — Class 1 only shows a pack went through a cycle; Class 5 or 6 is required for steam sterilization release

  • No validation records — no certified reference organism documentation to confirm the required sterility assurance level (SAL) is achieved


Biological Indicators vs Chemical Indicators — both are required in a complete programme. What an auditor checks (FSSC 22000 / ISO 17025 / GMP)

  • Written autoclave SOP

  • BI placed in the most challenging load position

  • CI used on every cycle with per-load records

  • BI results logged: lot number, placement, incubation temp, readout

  • Documented action protocol for BI/CI failures

  • Validation report confirming SAL achievement

  • Reference organism strains traceable to ATCC/NCTC


Genesis SSCS: five layers, one programme

Genesis SSCS closes all three gaps in a single structured system:



Ready to close the gaps?

  • No-obligation programme assessment needed just we review your setup and recommend the right tier

  • Equipment supply (Biobase autoclave) + rental available

  • Done-For-You Autoclave Validation Service — Genesis conducts placement, incubation, and issues the full EN ISO 11138-aligned validation report

Need Support With Sterilization Control?

 Request a free BI + CI starter pack with the subject line “SAMPLE KIT” from Genesis Bioscientific to test a biological indicator and chemical indicator on your next autoclave cycle.


Genesis Bioscientific Pte Ltd  |  Woodlands Square, Singapore  |  Microbiology Solutions for Food Manufacturers & Laboratories


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