EtO Off-Gasing in Supply Chain

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11. Contact ChemDAQ to discuss your specific EtO monitoring and control needs. www.chemDAQ.com 412 - 787 - 0202 x110

1. Monitoring Ethylene Oxide Off - Gassing David M. Hilliker and P. Richard Warburton

10.  Some medical products continue to off - gas throughout the supply chain • Supply chain Companies are concerned about EtO exposure of their people • Time needed to off - gas depends on materials, packaging and environment (temperature, ventilation)  Need standardized EtO specific monitoring to avoid inconsistent and conflicting readings  ChemDAQ works with companies throughout the supply chain to provide EtO monitoring solutions that meet their specific needs  ChemDAQ is also in development an EtO absorber material that may help MDMs reduce EtO buildup in pallets, trailers and shipping containers Summary

3.  EtO penetrates materials very well, easily passing through paper and cardboard • Dissolves in certain materials such as plastics which takes a long time to come out again  Off - gassing is approx. exponential decay - no sharp endpoint • Rate depends on many factors including temperature, packaging, and ventilation  We do not measure the rate but rather the accumulated concentration of EtO that has off - gassed • Even a low emission product, if put into sealed container, can still reach high concentration The EtO Off - Gassing Problem

8.  The problem with a non - uniform approach • Inconsistent and Conflicting readings with EtO measurements  Need reliable results • ChemDAQ EtO sensor employs (patented) chemical filter to increase accuracy by filtering common interferents • ST2 displays and tracks below OSHA Action Level • “Impending” Alerts warn before reaching unsafe exposure levels • Sensor Calibration / Exchange (SXP®) service program ensures quality, accuracy and integrity in the EtO monitoring system Standardized EtO Monitoring

7. Create standard operating procedure for incoming and stored EtO sterilized medical products  SafeCide Portable Monitors • Testing trailers / containers before entry • Sampling pallets before they are broken down • Personal monitoring to measure individual’s exposure  Steri - Trac Area Monitors • Continuously monitor pallet staging and medical products storage areas • Automatically control ventilation to increase when needed Monitoring Applications

4.  1996 - ChemDAQ Corp. founded to address Ethylene Oxide monitoring need  2003 - ChemDAQ Corp. developed chemical filter that removes most VOCs - makes sensor more specific (patented 2009)  ChemDAQ Inc. founded in 2006, with outside investors. Steri - Trac® EtO monitoring system becomes market leader in Healthcare  2008 - Hydrogen Peroxide sterilization becomes widely used in healthcare; ChemDAQ develops H 2 O 2 monitoring system  2011 - Partnered with Large food company to develop Peracetic Acid (PAA) sensor and chemical filter (patent pending) for aseptic filling lines  2017 - SafeCide ™ portable monitor launched to address PAA exposure in Poultry Processing plants  2019 - Release of ChemDAQ’s 4 th Generation Steri - Trac 2+ EtO Gas Monitoring System ChemDAQ – a Brief History

2. Overview  Summary of Problem • Ethylene oxide (EtO) off - gassing of sterilized products is putting supply chain personnel at risk  Who is ChemDAQ ? • ChemDAQ designs, manufactures and sells gas monitors for specialty gases such as EtO  A Standardized Monitoring Solution is needed • Accurate monitoring and control of EtO gas vapors to ensure the safety of supply chain personnel  R&D – Solutions to EtO Off - gassing Problem • Development project for EtO absorber material • Manage EtO off - gassing throughout supply chain

5.  Simple to use: • Large display • Bluetooth connection between sensor and tablet • Automatically logs data, short and long term exposure TWAs • Export data to Excel or use built - in report and graphing functions  Two Sampling Modes: • Spot Sampling • Instantaneous alarms • Personal Monitoring • 15 min and 8 hour TWAs calculation and “Impending” alerts SafeCide ™ Portable Monitor for EtO

6.  ST2 Fixed Area Monitor • User adjustable high and low audible alarms • Large easy to read display, changes color with alarm status • Connects to DAQ® computer for data logging and TWAs • Relays triggered by alarms • Bluetooth or wired communication to E - Cell ® sensor.  ST2+ (Additional Features) • Built in data logging, TWAs, “Impending” Alerts, high and low alarms, etc. • Internal battery for power outages • Modbus, 4 - 20mA for connection to PLC Steri - Trac® EtO Area Monitor

9.  Increase aeration time at sterilization company • Challenge for medical device manufacturers (MDMs); affects throughput and lead time  Use more porous pallet wraps and create vent paths (chimneys) in pallets • Reduces build up in pallets, but potentially more EtO buildup in trailer  Increased ventilation in Trailer during shipment • Not always possible with many private trucks  ChemDAQ EtO Absorber – Prevent build - up of EtO • Treated filter material - placed in or around pallet AFTER sterilization • MDMs will decide if cost effective with or instead of other methods • Combine filter with fan (12V) to remove EtO from a trailer • Status: In R&D, prototype removes EtO Solutions to EtO Off - Gassing Problem

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