§ 284.322. Autoclave validation testing requirements.
Autoclave operating parameters shall be established in accordance with the following:
(1) For facilities with one autoclave or multiple autoclaves that are not identical, each autoclave must have an initial validation test that establishes its operating parameters.
(2) For facilities with multiple autoclaves that are identical, one autoclave may have an initial validation test that establishes the operating parameters for all identical autoclaves at that facility.
(3) Autoclaves shall be tested using the manufacturer’s recommended vacuum pulse plan, operating temperature, operating pressure and residence time at the maximum weight and with the most difficult heat transfer challenge anticipated with the indicators located where disinfection would be most difficult to achieve.
(4) If multiple vacuum pulse plans, residence times, temperatures and pressures are recommended, the autoclave shall be tested to validate its performance at each recommended vacuum pulse plan, residence time, temperature and pressure. If a test fails, more stringent operating parameters shall be used incrementally until a satisfactory test and set of operating parameters is determined.
(5) Autoclave operating parameters must be validated to achieve a minimum of 250°F or 121°C measured at a point where disinfection would be most difficult to achieve.
(6) The residence time required to achieve a 6 log 10 reduction of mycobacteria and a 4 log 10 reduction of Geobacillus stearothermophilus spores for the level of heat transfer challenge selected shall be the residence time set into that autoclave’s controls.
(7) The vacuum pulse plan, residence time, operating temperature and operating pressure established in the validation test will form the permitted operating parameters for the autoclave tested.
(8) Instead of the temperature, residence time and other requirements of this section, manufacturers of vaccines or other biologics who satisfy the applicability criterion of § 284.321(p) (relating to regulated medical waste monitoring requirements) may establish and validate autoclave operating parameters and residence time based upon the requirements determined by the Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, as necessary to achieve the required disinfection under § 284.321(p)(5)(ii) for the specific infectious agent or biologic, or both, present in the wastes.
Source The provisions of this § 284.322 adopted November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021.
Cross References This section cited in 25 Pa. Code § 284.321 (relating to regulated medical waste monitoring requirements).
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