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- Autoclave v. Rotoclave® by Dr. Gary Braedt of the University of New Orleans

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Home > Evaluation & Reports > Environmental Impact Statement by Tempico Medical Processing Co., Inc.(TMPC) >
Summary


Summary    

ENVIRONMENTAL IMPACT STATEMENT
Tempico’s Rotoclave® is a pre-vacuum-type autoclave with a patented internal rotating drum and the additional feature that the sterilizing steam is condensed and eliminated before the door can be opened. The Rotoclave® is a totally closed system with safety interlocks that insure that the vessel’s integrity cannot be breached until the conditions of time, temperature and pressure have been met, guaranteeing complete sterilization of the contents. Since the sterilizing steam must be evacuated and condensed before the door can be opened, the Rotoclave® emits no fumes or emissions of any kind which would endanger the health and safety of the operator. The outflows from the Rotoclave®, therefore, are as follows: solid waste discharged from the drum, water resulting from condensation of the sterilizing steam, which is routed to the sanitary sewer; and the air exhaust used to break the vacuum post-sterilization, which is vented outside of the building. The results of stringent tests of these outflows have shown them to be sterile, non-toxic and non-carcinogenic. Further tests have demonstrated the Rotoclave® to have a sterilization capacity that exceeds worldwide standards by several orders of magnitude. The following is a brief summary of the data we have provided in the accompanying document, "Treatment of Regulated Medical Waste in Tempico’s Rotoclave® produces an output that is sterile and non-carcinogenic", which serves to demonstrate the environmental safety of the Rotoclave®.  Please consult this document for further details.

Bacterial contamination of Rotoclave® outflows by source:
Aqueous
Floor drain, during a cycle
Floor drain, after a cycle
Sight glass
Air exhaust vent, during a cycle
Air exhaust vent, after a cycle

Assay limit: 10 bacteria/ml of sample.

Solid:
Assay limit: 1 bacterium/gram of sample


 
None Detected
None Detected
None Detected
None Detected
None detected


Results of a sterility Challenge:

Cell/Spore type

Log10Kill

Trial 1 Trial 2 Trial 3
Bacillus stearothermophilus
cells ----- 7.0 6.7
endospores 7.8 8.3 8.0
Bacillus subtilis
cells 9.1 7.8 7.4
endospores 9.1 9.5 9.1
Staphylococcus aureus 8.2 9.5 9.5
Mycobacterium smegmatis 8.6 9.6 9.6
Mycobacterium phlei 8.5 ----- -----
Pseudomonas aeruginosa 10 9.5 9.5
Candida albicans 9.5 10 10
*Log10Kill = Log10Input – Log10Recovered. Log10Recovered was set to 0 since the assay limit is 1 cell/ml, and no cells were recovered from any of the samples tested.

Carcinogenic and toxic potential of Rotoclave® outflows by source:
Aqueous extract from solid mass
Floor drain, during a cycle
Floor drain, after a cycle
Sight glass
Air exhaust vent, during a cycle
Air exhaust vent, after a cycle

Assay: Ames test

None detected
None Detected
None Detected
None Detected
None Detected
None detected


.

For complete copy of the Environmental Impact Statement, please contact Tempico for a downloadable Pdf file.


The author, Gary Braedt, Ph.D., was an Assistant Professor and Coordinator of the Microbiology Program at the University of New Orleans from 1989- 1995. In 1991 he founded MicroBio Services and has provided contract services for Tempico at various times since then.
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