EtO Off-Gasing in Supply Chain
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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