Validation Testing
DaRob will use an independent laboratory to perform validation testing to determine the capability of the autoclave to achieve the performance standard of a minimum four log10 reduction of Bacillus Sterothermophilus spores or a similar alternative offered by the independent testing laboratory. The validation testing for autoclaves shall be performed in accordance with the following provisions:

Perform validation testing to ensure that the autoclave, using combinations of temperature, pressure, and time other than the minimums specified in paragraph (D)(1)(a) of this rule, is capable of achieving the performance standard of a minimum four log10 reduction of Bacillus Sterothermophilus spores or a similar alternative offered by the independent testing laboratory;

Use a challenge population of spores as either spore strips with a population of at least 1.0 X 10 (4) Bacillus Sterothermophilus, ampules containing at least 1.0 X 10 (4) Bacillus Sterothermophilus spores per milliliter or a commercially available steam pack which contains a population of at least 1.0 X 10 (4) Bacillus Sterothermophilus spores or a similar alternative offered by the independent testing laboratory. The owner or operator shall ensure that the Bacillus Sterothermophilus spore testing methodology does not result in the denaturation of the proteins within the inoculating media;

Compose the Validation testing waste load of containers of non-infectious
wastes. The waste load for testing shall consist of materials other than infectious wastes, such as newspaper, plastic backed absorbent pads, or general refuse placed into boxes, bags, or sharps containers which are representative of the normal or anticipated use for that autoclave unit. A challenge population of spores shall be placed in the center of each test container;

Treat the waste load containing the challenge population of spores in the same manner as the autoclave will be used during daily operations for the treatment of infectious wastes. This would include the same temperature, pressure, time, and total treatable volume;

Record the following information during the validation testing:
Arrow Graphic A written statement indication the autoclave pressure, temperature, and treatment cycle time that the facility owner or operator is attempting to validate for the treatment of infectious wastes;
Arrow Graphic The date;
Arrow Graphic The time the treatment cycle started, as specified in paragraph (D)(1) of this rule;
Arrow Graphic The time the treatment cycle ended, as specified in paragraph (D)(1) of this rule;
Arrow Graphic The chart or graph of the chamber temperature produced by the permanently connected temperature recording device;
Arrow Graphic The name of the person who loaded the autoclave and the name of the person performing laboratory analysis of the challenge population of spores;
Arrow Graphic A diagram depicting the pattern of infectious waste loading and location of the challenge population of spores during the validation testing. Those units which have rotating treatment chambers are not required to diagram the pattern of waste loading;
Arrow Graphic The total treatable volume of infectious wastes used during the validation testing as defined in paragraph (D)(1) of this rule. Once a total treatable volume of infectious wastes that an autoclave has been validated to treat has been established, infectious waste loads of lesser that the established total treatable volume may be treated without further validation;
Arrow Graphic The autoclave chamber pressure, as recorded by the permanently connected gauge, during the treatment cycle as specified in paragraph (D)(1) of this rule;
Arrow Graphic The challenge population of spores shall be incubated in accordance with the manufacturer's recommendation for optimal growth; and
Arrow Graphic The results of spore growth during incubation shall be recorded daily, for a period of seven days or for the maximum period of time as

Remove and incubate the challenge population of spores used in the validation testing for either seven days or for the maximum period of time as specified by the manufacturer of the spore test. If any of the challenge population of spores used to perform the testing is positive for growth at any time during the incubation period, the unit has failed to achieve the performance standard required for treatment of infectious wastes. In order to utilize the autoclave for the treatment of infectious wastes using combinations of temperature, pressure and time other than the minimums specified in paragraph (D)(1) of this rule, the operator shall either;

Arrow Graphic Change the treatment cycle temperature, pressure, and/or time requirements and again perform the validation testing until the performance standard is achieved. Rectification may require the operator to increase the minimum treatment cycle temperature, pressure and/or time requirements; or
Arrow Graphic Operate the autoclave at the minimum operation parameters of one
hundred twenty-one degrees Centigrade or two hundred fifty degrees
Fahrenheit, fifteen pounds per square inch gauge pressure for sixty
minutes.

Perform validation testing, upon request by, and in the presence of, the
Kentucky EPA or approved Health Department to verify that the written operating procedures as located in the Facility Management Plan are sufficient to meet the performance standard of a four log10 reduction in Bacillus Sterothermophilus spores. If so directed, the owner or operator shall use twice as many spore tests in the same location in the autoclave and permit the Kentucky EPA or approved Health Department to remove and separately incubate one-half of the spore tests.

 

 

Site Designed by Manhattan Trio Design, Inc.