(1) the autoclave meets the criteria in this Subpart for effective treatment of RMW;

(2) loads contain only those items or types of RMW for which effective treatment has been demonstrated by validation testing; and exclude RMW for which effective treatment by the system has not been demonstrated or is prohibited;

(3) each load is treated using residence time, temperature and pressure, and with one or more vacuum cycles that have been validated as effective for the treatment of RMW, and conditions of treatment are monitored and documented for each load;

(4) the effectiveness of treatment is maintained, by including, as applicable, procedures for and frequency of: calibration verification and recalibration of parametric controls; monitoring by bio-challenge testing or other demonstration that treatment has been attained; and preventative maintenance of engineering controls (e.g., charcoal, HEPA filters, etc.) and diagnostic procedures for electronic controls (e.g., integrated computers and mechanical components, etc.);

(5) occupational exposure is minimized, and physical injury to operators is prevented during loading, the cycle, and unloading the autoclave; and

(6) personnel are provided training on the routine operation of the autoclave, are kept current with manufacturer recommendations for operation, and have been instructed in emergency procedures for handling malfunctioning systems and untreated RMW. Training programs must mandate initial training and retraining at least once per calendar year and as necessary for presenting updates on operational information.

(1) Parametric controls must be employed to monitor operating parameters automatically and continuously throughout the entire cycle, and generate a record of operating parameters for each cycle.

(2) Routine operational performance of an autoclave must be monitored by bio-challenge testing, conducted in accordance with subdivision (h) of this section using the validation protocol.

(3) If an autoclave fails to attain no growth in viable spores concentration upon bio-challenge testing or indicators fail to show expected results (i.e., a color change), the load shall be handled as untreated RMW, and the facility must demonstrate, through a repeat of bio-challenge testing, that the autoclave effectively treats RMW before resuming its use for treatment purposes.

(1) during the first 30 days of actual operation, the first and third load each day must include biological indicators placed in the waste;

(2) after 30 days of operation, one load each day must include biological indicators placed in the waste;

(3) after six months of successful operation with no failures in daily testing, bio-challenge testing may be conducted every 40 hours of operation. Any bio-challenge test failures will require repeat bio-challenge testing;

(4) bio-challenge testing must include at least one-third of the number of biological indicators that are required for validation or two indicators, whichever is greater;

(5) every 200 hours of operation, biological indicators used during bio-challenge testing must be evaluated by an independent laboratory; and

(6) bio-containment facilities at BSL 3 or 4 using pass-through treatment systems must conduct bio-challenge testing for each load of RMW.