Initial Efficacy Testing of Autoclaves

Background
Argonne National Laboratory is seeking a qualified vendor to perform Initial Efficacy Testing (IET) on each autoclave model used for the on-site treatment of infectious waste. The goal of the contract is to verify and document that each autoclave effectively renders infectious waste non-infectious, ensuring its safe disposal. The results will also establish validated operating parameters for ongoing treatment.

Work Details
The selected vendor shall conduct Initial Efficacy Testing (IET) on up to eight autoclave models located at Argonne National Laboratory. An Argonne employee will operate the autoclaves under the vendor's direction. All testing must comply with 35 Illinois Administrative Code (IAC) 1422.124, under Subtitle M.

The eight autoclaves include:
- Getinge Vacuum Steam Sterilizer Model 533LS
- Tuttnauer Model 3870M
- Tuttnauer Model 3870EA
- Primus Model PSS8-B-MESD
- Tomy SX-7000
- Tomy SS325
- Hirayama HV-50 Upright Autoclave-50 Liters.

Key tasks include:
1) Preparation and Planning: Review regulatory requirements and evaluate Argonne’s IET report for compliance; revise if necessary.
2) Equipment and Materials: Provide necessary equipment including self-contained biological indicators (SCBIs) with Geobacillus stearothermophilus spores; collaborate with Argonne’s Biosafety Program Manager for SCBI approval.
3) Conducting the IET: Perform tests according to specified procedures and document results.
4) Reporting: Create a separate IET plan for each autoclave model tested and provide recommendations for adjustments to cycle settings as needed. Deliverables include an updated IET report compliant with regulatory requirements and fully documented IETs demonstrating successful validation.

Place of Performance
Argonne National Laboratory