Biological and physicochemical autoclave controls ensure that every sterilization cycle reaches the required parameters. This guide details the different types of controls, their frequency, and documentation requirements under Romanian regulations.
Sterilization control operates at three complementary levels, as defined by Ordinul MS nr. 1761/2021. Physical indicators are the parameters displayed by the autoclave (temperature, pressure, duration) — they confirm the cycle ran according to the selected program. Chemical indicators (autoclave tape, chemical integrators) change color when exposed to sterilization conditions. Biological indicators (spore tests) are the most reliable: they confirm that the most resistant microorganisms have been destroyed.
The Bowie-Dick test (for pre-vacuum autoclaves) or Helix test (for hollow loads) verifies steam penetration into the load. It must be performed daily, before the first load of the day, in an empty autoclave.
A failed Bowie-Dick test indicates a steam penetration problem — it could be a leak, vacuum pump failure, or a worn gasket. The autoclave must not be used until the problem is resolved.
Biological indicators contain spores of Geobacillus stearothermophilus, the microorganism most resistant to saturated steam. If the sterilization cycle destroys them, it will destroy any other microorganism.
Recommended frequency varies: weekly according to best practices, after every new installation or repair, and whenever there are doubts about autoclave performance. Ordinul 1761/2021 Art. 65 requires archiving all biological test results.
Autoclave tape (Class 1 indicator) is placed on each pouch. It does not guarantee sterilization — it only indicates that the pouch passed through the autoclave. Chemical integrators (Class 4, 5, or 6) offer more thorough verification by measuring exposure to temperature, pressure, and time.
Ordinul MS nr. 854/2022 added the requirement for Class 5 chemical integrators for every batch. These are mandatory for all regulated practices and studios. The Class 6 integrator is the most reliable chemical indicator: it only changes color when all critical cycle parameters are met.
Under Ordinul 1761/2021, every biological and physicochemical control must be documented: date, test type, result (pass/fail), corrective action if applicable. Autoclave reports, Bowie-Dick test results, Class 5 integrators, and biological test results must be archived according to internal quality control procedures.
Digital traceability allows automatic archiving of control results and linking them to the relevant sterilization cycles, eliminating the risk of loss or oversight. For more details on the use-by date, see the dedicated guide.
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