Subchapter D. PROCESSING FACILITIES
Sec.
284.301. Scope.
284.310. Application requirements.
284.311. Plan for monitoring.
284.320. Operating requirements.
284.321. Regulated medical waste monitoring requirements.
284.322. Autoclave validation testing requirements.
Cross References This subchapter cited in 25 Pa. Code § 284.101 (relating to authorization for general permits).
§ 284.301. Scope.
This subchapter sets forth application and operating requirements for a person or municipality that operates a processing facility, other than a transfer or composting facility, for regulated medical or chemotherapeutic waste. The requirements in this subchapter are in addition to the applicable requirements in Chapter 271 (relating to municipal waste management—general provisions).
Source The provisions of this § 284.301 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (273304).
§ 284.310. Application requirements.
An application to operate a processing facility shall comply with § § 283.101—283.114 (relating to general provisions).
§ 284.311. Plan for monitoring.
An application for a processing facility for regulated medical waste shall contain a plan, including necessary designs, procedures and test protocols on forms provided by the Department, for meeting the requirements of § 284.321 (relating to regulated medical waste monitoring requirements), including the following:
(1) The method by which disinfection will be accomplished.
(2) A description of the monitoring and quality assurance program to ensure disinfection.
Source The provisions of this § 284.311 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (273304) and (281971).
§ 284.320. Operating requirements.
A person or municipality that operates a processing facility shall comply with Chapter 283, Subchapter C (relating to operating requirements).
Source The provisions of this § 284.320 corrected July 20, 2001, effective March 3, 2001, 31 Pa.B. 3942; amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial page (281971).
§ 284.321. Regulated medical waste monitoring requirements.
(a) A person or municipality that disinfects regulated medical waste shall monitor the waste to ensure the following:
(1) For thermal processing or incineration, the absence of anaerobic or aerobic bacterial growth in a composite sample of processing residue or ash.
(2) For other disinfection processes, both of the following are met:
(i) The process shall be capable of inactivating mycobacteria at a 6 log 10 reduction or greater.
(ii) The process shall be capable of inactivating Geobacillus stearothermophilus spores, Bacillus pumilus or Bacillus atrophaeus spores at a 4 log 10 reduction or greater.
(b) The operator of a facility that incinerates or thermally processes regulated medical waste shall submit to the Department a microbiological analysis of a composite sample of the processing or ash residue on forms provided by the Department, at a minimum, annually during the life of the facility.
(c) The operator of a facility that incinerates regulated medical waste shall submit to the Department, at least annually during the life of the facility, a chemical analysis of composite samples of the ash residue on forms provided by the Department.
(d) If the facility disinfects regulated medical waste by means other than incineration or thermal processing, the operator shall perform a microbiological analysis of indicators removed from the processed waste. The analysis shall be conducted, at a minimum, every 40 hours during the operational life of the facility, unless otherwise provided in a permit. The analyses shall be made available to the Department upon request.
(e) Unless the Department approves another indicator or test in writing, the following indicators shall be used to establish and verify the following processes:
(1) For autoclaving, spores of Geobacillus stearothermophilus.
(2) For dry heat, gas or chemical disinfection, spores of Bacillus atrophaeus variety niger (globigii). Ethylene oxide may not be used for gas disinfection.
(3) For ionizing radiation, spores of Bacillus pumilus.
(f) Indicators used for methods of disinfection other than incineration or thermal processing shall be located prior to disinfection at a point within the load where disinfection will be most difficult to achieve.
(g) Regulated medical waste will be considered to be infectious unless one of the following has occurred:
(1) For disinfection processes other than incineration or thermal processing, the indicator spores are determined by microbiological analysis to have been destroyed in accordance with subsection (a).
(2) For incineration or thermal processing using a test other than an indicator spore, a microbiological analysis determines that disinfection has occurred in accordance with subsection (a).
(h) The operator of the disinfection facility shall so certify that the requirements of subsection (a) have been met on a form provided by the Department.
(i) Ash or other processing residue shall be stored in accordance with § 284.418 or § 284.419 (relating to storage and containment of ash residue from regulated medical or chemotherapeutic waste incineration; and storage and containment of processing residue from a regulated medical or chemotherapeutic waste processing facility).
(j) Ash or other processing residue shall be transported in accordance with § 284.511 or § 284.514 (relating to transportation of ash residue from regulated medical or chemotherapeutic waste incineration; and transportation of processing residue from a regulated medical or chemotherapeutic waste facility).
(k) Compactors, grinders or similar devices may not be used to reduce the volume of regulated medical waste before the waste has been rendered noninfectious. If the volume reduction device is within a continuous, enclosed disinfection process and part of one processing system, then the reduction device may be used.
(l) The operator of a regulated medical waste processing facility shall dispose of ash or other processing residue from the facility in a landfill that has been approved by the Department to accept the waste, if the waste is disposed in this Commonwealth.
(m) An autoclave facility shall comply with all applicable requirements and is prohibited from processing pathological waste or chemotherapeutic waste.
(n) Unless otherwise approved in writing by the Department, an operator of an autoclave facility shall employ the procedures in § 284.322 (relating to autoclave validation testing requirements) to validate the operating parameters and protocols of the processing equipment. These procedures must be employed at an on-going frequency specified by the manufacturer of the autoclave and in the following circumstances:
(1) When a new autoclave is installed.
(2) When an autoclave is modified, repaired or has experienced a malfunction with respect to hardware, software, controls or ancillary equipment.
(o) The facility shall maintain a record of the autoclave validation testing protocols and procedures.
(p) For facilities engaged in the production or research and development of vaccines or other biologics that are classified under the North American Industrial Classification System as Code 325414—Biological Protocol (except Diagnostic) Manufacturing and who meet the following criteria may utilize the alternate disinfection requirements specified in paragraph (5) instead of the requirements of subsections (a)—(o) to process waste containing an infectious agent classified as Biosafety Level 2 or below, as determined by the protocols established in the most recent edition of the Centers for Disease Control’s Biosafety in Microbial and Biomedical Laboratories existing at the time the waste is generated:
(1) Utilize onsite processing facilities at which at least 50% of the waste processed is generated onsite.
(2) Operate in accordance with United States Food and Drug Administration good manufacturing practices or good laboratory practices.
(3) Employ a production process where the infectious agents or biological, or both, are known and well characterized, inactivation criteria are determined and bioburden is measured and controlled including screening for objectionable organisms.
(4) Specify and approve the decontamination process, method and monitoring, and validation procedures for each specific infectious agent in its waste by either of the following:
(i) Establishing and utilizing an Institutional Biosafety Committee constituted in accordance with the Centers for Disease Control and the National Institute of Health guidelines or composed in whole or in part of a panel of experts, a member of which is a biosafety officer certified by the American Biological Safety Association or the American Society for Microbiology or equivalent.
(ii) Retaining a contractor certified by the American Biological Safety Association or the American Society for Microbiology who accepts responsibility for the process, method and procedures that the contractor specified and approves (Independent Certified Biosafety Professional).
(5) The alternate disinfection process must be conducted as follows:
(i) Disinfection shall be conducted by inactivating all waste material in accordance with the practices, methods and minimum parameters for biological kill established by the facility’s Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, consistent with the Centers for Disease Control and the National Institute of Health guidelines or scientifically accepted protocols, or both.
(ii) Efficacy of the inactivation operations shall be demonstrated through review of decontamination cycle data by trained technicians or other testing methods or studies specified by the Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, as appropriate for the specific infectious agent or biologic, or both, present in the waste. The procedures for demonstrating the efficacy of the inactivation operations must be set forth in standard operating procedures or other written procedures maintained at the facility, or both.
(iii) Preventative maintenance and calibration programs for decontamination equipment consistent with generally accepted industry standards as specified by the Institutional Biosafety Committee or Independent Certified Biosafety Professional, or both, shall be established and routinely implemented.
(q) With the exception of used sharps, which remain subject to the additional requirements of this chapter, regulated medical waste that is generated by manufacturers of vaccines and other biologics who satisfy the criteria of subsection (p)(1)—(4) and decontaminated in accordance with the procedures specified in subsection (p)(5), may be managed, stored, transported and disposed of as ordinary municipal waste and is not subject to any of the additional restrictions or requirements pertaining to special handling waste or regulated medical waste.
Source The provisions of this § 284.321 amended November 7, 2014, effective November 8, 2014, 44 Pa.B. 7021. Immediately preceding text appears at serial pages (281971) to (281972).
Cross References This section cited in 25 Pa. Code § 271.1 (relating to definitions); 25 Pa. Code § 273.511 (relating to processed regulated medical waste disposal); 25 Pa. Code § 284.2 (relating to permits-by-rule for regulated medical or chemotherapeutic waste processing facilities; qualifying facilities; general requirements); 25 Pa. Code § 284.111 (relating to application for general permit); 25 Pa. Code § 284.311 (relating to plan for monitoring); and 25 Pa. Code § 284.322 (relating to autoclave validation testing requirements).
§ 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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