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

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

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.

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

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

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

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

Low Temperature Sterilization EtO

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.

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

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.

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 Layout 1 Image + text

Low Temperature Sterilization Hydrogen Peroxide (H2O2) VH2O2 Examples

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

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.

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.

Low Temperature Sterilization H2O2 (Plasma) Cycle Phase

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. Layout 1 Image + text