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Title: Section 70-3.2 - Operational requirements

Effective Date


70-3.2 Operational requirements.

(a) Each facility seeking to operate an autoclave shall develop an operation plan, and shall submit such plan to the Department for review and approval prior to using the autoclave to treat regulated medical waste. Any change in procedures related to the operation of the autoclave shall be reflected in a modified plan, which shall be dated with each revision.

(b) No autoclave shall be used to treat regulated medical waste without Department approval of the facility's operation plan and any modifications made to such plan on or after the effective date of this regulation.

(c) The operation plan shall be designed to promote safe and effective operation of the autoclave. The operation plan shall include, minimally, procedures to ensure:

(1) the autoclave meets Department criteria for effective treatment of regulated medical waste (i.e., the protocol for validation testing and a summary of the results);

(2) loads contain only those items or types of waste for which effective treatment has been demonstrated by validation testing; and exclude waste materials for which effective treatment by the system has not been demonstrated and/or is prohibited pursuant to section 70-2.3 of this Subpart, and, as applicable, materials expressly excluded in the Commissioner’s notice of approval;

(3) each load is treated using residence time, temperature and pressure that have been validated as effective for the treatment of regulated medical waste, 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 challenge testing or other demonstration that treatment has been attained; and preventative maintenance of engineering controls (e.g., charcoal and/or HEPA filters) and diagnostic procedures for electronic controls (e.g., integrated computers and mechanical components);

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

(6) personnel are knowledgeable about 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 waste. Training programs shall mandate initial training and retraining at least once per calendar year and as necessary for presenting updates on operational information.


Any modification of an approved operation plan with potential to substantially alter treatment efficacy shall be submitted to the Department for approval. Prior to approving a modified plan, the Department may require that validation testing be conducted again by the facility, and the results submitted for Department review.

(e) Whenever an autoclave fails to operate in accordance with pre-established operating parameters, the facility shall:

(1) discontinue use of the autoclave, using emergency shutdown procedures if appropriate, until corrective action has been taken and validation testing has verified that effective treatment can resume;

(2) handle as untreated all regulated medical waste processed by the system since the last previous run under documented compliance with such requirements;

(3) document the failure, including date and autoclave identifier;

(4) document the facility response, including corrective action; and

(5) whenever a facility has reason to believe untreated waste certified as treated waste has left the facility, notify the waste transporter as soon as practicable, and notify the Department within seventy-two (72) hours of the waste’s leaving the facility.

(f) Monitoring autoclave operation.

(1) parametric controls shall be employed to monitor operating parameters automatically and continuously throughout the entire cycle, and generate a record of operating parameters for each cycle; or

(2) in the absence of parametric controls, routine operational performance of an autoclave shall be monitored by: (i) challenge testing, conducted every forty (40) hours of autoclave operation or once a week, whichever occurs first, using the same protocol as was approved by the Department for validation testing, and (ii) time/temperature-sensitive materials used in each load. No autoclave that fails to attain 4 log 10 reduction in viable spores concentration upon challenge testing shall be used to treat regulated medical waste. Whenever time/temperature-sensitive materials fail to show expected results (i.e., a color change), the load shall be handled as untreated waste, and the facility shall demonstrate, through a repeat of validation testing, that the autoclave effectively treats regulated medical waste before resuming its use for treatment purposes.

(g) Containment of regulated medical waste for treatment by autoclaving shall be by a container or containment system designed to withstand the temperature and pressure of autoclaving, and may, except for sharps, consist solely of a red bag.

(h) If the container or containment system does not, by design, allow steam to come into direct contact with waste material, the operator shall take action to ensure such contact.

(i) Sharps treated by autoclaving shall be destroyed prior to disposal.


VOLUME A-1a (Title 10)