1. Presented by: Healthmark Industries
Low Temperature Sterilization “Do you have Gas or are you just Vaping?”
Presented by:
Healthmark Industries
Presented by Fred Alston, CSPDT
Director of Clinical Sales and Services, Eastern Region
December 2, 2017

2. Disclosure
I am an employee of Healthmark Industries Fraser, Michigan USA
I am involved with the manufacture and distribution of medical products to healthcare facilities and healthcare professionals
No compensation has been received for this presentation or for travel to and from the seminar
All opinions are those of the presenter

3. Healthmark Policy
Healthmark’s Policy is to provide our customers and the healthcare community with the highest quality, state of the art medical products and support services in a timely and cost effective manner.
This goal is supported by a staff committed to individual accountability, professionalism, mutual respect, collaboration and service excellence. This presentation is part of that commitment, educating our customers.

4. Agenda Why Low Temp Brief History Low Temp Sterilization processes
Ethylene Oxide (EtO)
Vaporized Hydrogen Peroxide “VHP” (Plasma and Vapour)
Vaporized Hydrogen Peroxide and Ozone
Next?
Summary
Questions

5. Why Low Temp Steam Sterilization very effective and around for years.
Technology improvements
The expanded use of “PLASTICS”
Sensitive electronic components (Cameras)
Respiratory circuits
Material Compatibility

6. History
Plastic bag, crack the vial and throw into bag. Seal, Shake, Sit.
EtO discovered in 1859
Developed as a sterilant by the US Military during WWII.
Widespread use in Healthcare in the 80’s
Vaporized H2O2 with Plasma commercially used in the early 90’s
Additional VHP sterilizers in the later 90’s
VHP+O3 the latest process 2014

7. Low Temperature Sterilization Processes Pasturization/Sanitization
Liquid Chemical Disinfectants (LCD)
Ethylene Oxide (EtO)
Hydrogen Peroxide
Peracetic Acid
Ozone
Nitrogen Dioxide
Steam Formaldehyde
Microwave
??????

8. Low Temperature Sterilization
EtO

9. Low Temperature Sterilization
EtO
Used to be mixed gasses
(Penn Gas 80/20 then 88/12)
Now only 100% (boiling point around 51°F)
Full process must be completed in the same chamber
Aeration must be performed as part of the cycle, no goods transfer.
Great Material Compatibility.
Great Penetrant.
Kills by Alkylation.

10. Low Temperature alkylating agent noun (Medical Dictionary)
Definition
alkylating agent
noun    (Medical Dictionary)
Medical Definition of ALKYLATING AGENT
:  a substance that causes replacement of hydrogen by an alkyl group especially in a biologically important molecule; specifically :  one with mutagenic activity that inhibits cell division and growth and is used to treat some cancers

11. Low Temperature Sterilization
EtO
Biological testing uses bacillus atrophaeus.
Exposure time of 1-4 hours
Aeration time between 8-14 hours
Very effective process but does not keep up in the quick turn world we now live in.

12. Low Temperature Sterilization
EtO Pro’s and Con’s
PRO’s
Small Molecule
Excellent Penetrant
Compatible with most substrates and Packaging materials
Kills everything
CON’s
Kills Everything (including us)
Requires special ventilation and monitoring.
Leaves a Toxic Residue
Long complete process time
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13. Low Temperature Sterilization
Hydrogen Peroxide (H2O2)
VH2O2 Examples

14. Low Temperature Sterilization
Hydrogen Peroxide (Plasma)
ASP first to market with a H2O2 Plasma Sterilizer. (Early 90’s)
Much Safer than EtO
Process by-products are Oxygen and Water.
Much quicker process than EtO
Only utility needed was electrical power
(208 3Ø, CBA phasing. Had to be exact phasing)
H2O2 is a surface sterilant and does not penetrate as effectively as EtO.
Kills by Oxidation

15. Low Temperature Sterilization
Definition:
ox·i·da·tion
(ŏk′sĭ-dā′shən)n.1. The combination of a substance with oxygen.
2. A reaction in which the atoms in an element lose electrons and the valence of the element is correspondingly increased.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.

16. Low Temperature Sterilization
VH2O2
Shorter Cycle times (28 minutes to just over 1 hour)
No Aeration needed.
Biological used for testing is Geobacillus stearothermophilus
Sterilant is typically 59% hydrogen peroxide but can be as high as 90%
Comes in cartridge, Up to 5 cycles before exchanging cartridge.
Plasma Phase helps break down H2O2 and reduce residuals.

17. Low Temperature Sterilization
H2O2 (Plasma) Cycle Phase

18. Low Temperature Sterilization
H2O2 Pro’s and Con’s
PRO’s
Non-Toxic
Low Temp
Shorter complete process
CON’s
Not a great penetrant for lumens and cannulas
Not compatible with traditional packaging materials
Very, very moisture sensitive.
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