I. PURPOSE

The purpose of the Autoclave Verification Program is to protect the public health, safety, welfare, and environment for the citizens of the Commonwealth of Kentucky. Implementation of this program by all research departments within the University of Kentucky will ensure that all potentially infectious waste or biohazardous waste as defined in the University of Kentucky Biosafety Manual (http://ehs.uky.edu/hmm/biosafety_manual.html) will be decontaminated prior to disposal as solid waste in a public landfill pursuant to guidelines set forth in Guidance for Evaluating Medical Waste Treatment Technologies , US. EPA, 1993. For this protocol, decontamination is defined as a log6 reduction in infective organisms, not sterilization. Sharps waste is not covered under this program.

II. PROGRAM DESCRIPTION

The Autoclave Verification Program depends on four core components:

• appropriate use of the autoclave,
• annual calibration,
• maintenance, and
• performance verification.

Individuals shall be designated within each department to ensure these four components are met and the corresponding documentation is recorded. Standard Operating Procedure ()shall be developed by the responsible department with consultation by the Biological Safety Office and approved by the Institutional Biosafety Committee. Proper documentation of this program is both essential and mandatory, and will be maintained by all users of the autoclaves. This documentation will be monitored in tandem by the Biological Safety Office and the Chemical Hygiene Office.

III. AUTOCLAVE USE

Equipment manuals shall be made available to all autoclave users and stored in the departmental office. In addition, a master copy of the equipment manual will be kept by the responsible department or individual.

Adherence to Autoclave Operation Policies is mandatory.

IV. LOGS

Several logs shall be kept relevant to each autoclave and will be crucial tools in ensuring proper use and care of the autoclave. These logs shall be kept on file in the departmental office or by the designated responsible individual for three years past the last entry. These logs will include a description of the equipment, each event relative to a piece of equipment, manufacturer’s instructions, results of monthly verification tests, and contact information for the calibration contractor, as follows:

• Name of the equipment
• Current location
• Manufacturer’s name
• Serial number
• UK inventory number
• Date received
• Date placed in service
• Condition when received (e.g. new, used, reconditioned; if known)
• Copy of the manufacturer’s instruction
• Contact information for the contractor (name, address, phone number)
• Dates and results of calibrations
• Date of next calibration
• Each event relative to the piece of equipment to include date, event, any corrective action taken, name or initials of the person completing the action, and
• Results of monthly verification tests.

V. ANNUAL CALIBRATION

All autoclaves are considered “pressure vessels” and must be calibrated annually to meet ASME pressure vessel code. Documentation shall be kept in the departmental office and entered into the Maintenance Log. Annual calibration is usually performed as part of the maintenance contract held by each department.

VI. PERFORMANCE VERIFICATION

Performance of the autoclave will be verified both monthly and with each load processed. These policies are based on the requirements for processing BSL2/RG2 agent as described in Biosafety in Microbiological and Biomedical Laboratories, fourth edition, HHS Publication No. (CDC) 93-8395.

• Monthly
  Each set of conditions (time, temperature, pressure) used to decontaminate biohazardous waste by each autoclave must be verified monthly using a Biological Indicator. Results are recorded in the Biological Indicator Test Results Log, listing the conditions, date, and initials of person performing the test.
• Each Load
  Each load of biohazardous waste processed in an autoclave must meet the operating conditions. Verification may occur two ways. First, newer autoclaves may have computerized control systems which monitor all physical parameters and can provide documentation, either printed on a continuous roll or as individual “per load” reports. Secondly, older autoclaves may not have this function available, so verification for each load must be performed manually.
  1. Autoclaves without automatic documentation
     For each and every autoclave run which processes biohazardous waste, the operator must incorporate a Chemical Integrator Test Pack (CITP), evaluate the performance of the autoclave based on color change results of the CITP, and document the run in the User’s Log for the autoclave. If it is determined from the CITP that the autoclave is not functioning properly, the operator will attach a sign reading “out of order” to the front of the autoclave and notify the responsible department or individual immediately. The waste must be autoclaved again, so that a CITP verifies it has reached the conditions necessary for safe disposal with the general trash.
  2. Autoclaves which provide documentation (printed report) of operating physical parameters
     These autoclaves may not require Chemical Integrator Test Pack evaluation for each load (confirm with Biological Safety Officer before implementing the following procedure). In lieu of using the CITP with each load, operators may use the printed report generated by the autoclave as verification that the load met appropriate operating conditions. The operator must review the printed report and sign initials, date, and log number (from User’s Log ) on document. If on a continuous roll, the entire roll will be archived with the User’s Log. If individual reports are generated, detach report and record data on User’s Log, saving individual readouts as documentation. These must be saved in a file/envelope and archived with the User’s Log. Computer monitors must be calibrated and checked yearly. Monthly biological testing must still be performed.

VII. DOCUMENTATION

Accurate and timely documentation is necessary to ensure proper decontamination of waste. Documentation procedures are mandatory and are included in each component of the autoclave verification program.

• Autoclave Insect Signage
• Autoclave Plant Signage
• Autoclave Waste Signage

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