Inactive
Notice ID:36C24922Q0509
The purpose of this amendment is to provide answers to the submitted questions. The response time and date for quotes remain unchanged - Tuesday, 26 July 2022 at 10:00 AM CT. Questions & Answers 1. Q:...
The purpose of this amendment is to provide answers to the submitted questions. The response time and date for quotes remain unchanged - Tuesday, 26 July 2022 at 10:00 AM CT. Questions & Answers 1. Q: Regarding spec 3. Provided sterilizers shall not exceed 40 in height.  The Amsco 250LS model is well over 40 tall is it feasible to provide a like for like autoclave to the Amsco 250LS that exceeds 40 ? A: The 40 height specification is referring to the interior chamber. 2. Q: Regarding spec 5. Effluent Decontamination Cycle; and 9. i. i. Contractor shall fully test effluent decontamination cycle.  Effluent decontamination is intended for passthru units only to avoid cross-contamination volumes of air from a contained area to a non-contained area. Single door units do not come equipped with this since loads are sharing the same space before and after sterilization (thus no cross-contamination is possible). As this is a single door unit, is it feasible to provide standard gravity, liquid, and prevacuum cycles as specified? What objectives are desired from an effluent decontamination setup that cannot be achieved through standard cycles? An explanation here could allow for the provision of a custom solution if needed. A: That description is not quite correct, the pass-thru configuration itself inhibits cross-contamination volumes of air from a contained area to a non-contained area. The effluent decontamination function ensures highly pathogenic biologic agents (Mad Cow virus, Tuberculosis, etc.) are not released in the vapor exhaust at the end of the sterilization cycle. The required cycles are included on the existing equipment in the Microbiology lab and necessary for routine laboratory processes. To ensure the safety of Microbiology staff when highly pathogenic biologic agents are present/suspected in laboratory specimens. This process is necessary to ensure the decontamination cycle performs as intended. 3. Q: Regarding spec 9. f.  USP 660 Cycle for sterilization test cycles for glassware.  Can you explain what is desired with this cycle over a standard gravity cycle? An explanation here could allow for the provision of a custom solution if needed. A: This cycle is for sterilization of lab glassware used for patient testing. 4. Q: Is the sterilizer intended for patient use or require 510k compliance? A: The requested equipment is intended for lab use (sterilization of lab glassware, biologically contaminated lab equipment, biohazardous patient samples, etc.).