Data Logging Solutions for Ethylene Oxide (EtO) Sterilization

Company Information •About Us Ethylene-Oxide •What is Ethylene-Oxide •Measurement requirements for EtO Processes The MadgeTech Solution •RHTemp1000IS •Temp1000IS •Benefits •21 CFR Part 11 Secure Software •Process Overview Table of Contents Using the System •Starting, stopping, and downloading from loggers Data Analysis •Graph, Data Table, and Statistics •Interface Customization •Timeslice •Math Channels Calibration and Maintenance •NIST Certificate Layout •The EtO Effect •User-Maintenance •MadgeTech EtO Servicing Customer Support and Contact Us 6 Warner Road, Warner NH 03278 • P: (603) 456.2011...

• MadgeTech, Inc. is a global company based in New England and founded on traditional principles, customer service, quality, and trust. • MadgeTech designs and manufactures all its data loggers at its USA headquarters facility. • MadgeTech is dedicated to providing customers with reliable, affordable products, hasslefree ordering, and excellent service, saving customers time and money. 6 Warner Road, Warner NH 03278 • P: (603) 456.2011 F: (603) 456

Ethylene Oxide (EO) is a gas widely used for the sterilization of healthcare devices and instruments. The process involves exposing products to a gas mixture of EO and nitrogen within a vacuum-filled chamber. The EO gas acts as a surface sterilant and the vacuum environment aids the gas to reach most aspects of the device requiring sterilization. 6 Warner Road, Warner NH 03278 • P: (603) 456.2011 F: (603) 456.2012

EO gas sterilization is dependent upon four parameters: EO gas concentration, temperature, humidity, and exposure time. In accordance with ANSI/AAMI/ISO 11135, it is required by the FDA that temperature and relative humidity be monitored at different intervals during process validations on routine EO processed medical devices. Periodic chamber mapping and cycle validations are required to be performed to ensure even distribution of temperature and humidity levels throughout the chamber. MadgeTech data loggers can aid in: • Facilitating Parametric Release • Product Qualification Runs • Chamber/Cycle...

• MadgeTech provides data logging solutions for temperature and humidity monitoring. • These solutions are intrinsically safe and designed specifically for use in EO environments. • MadgeTech data logging systems are designed to handle large numbers of data loggers, ensuring maximum efficiency. For a complete data logging system, the following is required: • Data loggers such as the RHTemp1000IS and Temp1000IS • IFC400 and/or IFC406 • Computer • MadgeTech 4 Secure Software • Free support is provided to ensure users feel comfortable and confident using the MadgeTech system. 6 Warner Road, Warner...

Humidity and Temperature Data Logger • Rated as Intrinsically Safe by FM Approvals for use in Class I, Division 1, Groups A, B, C and D and non-incendive for Class I, Division 2, groups A, B, C and D indoor and outdoor. • Utilizes a new thermoset-polymer capacitive sensor that provides the longest operating life in an ethylene-oxide based sterilization process • Maintains resistance against various chemical liquids and vapors like isopropyl, benzene, toluene, formaldehydes, oils and common cleaning agents Temperature Sensor: Resistance Temperature Detector (RTD) Temperature Response 10 Minutes...

How it M easures RHTemp1000IS A thin ≈ 1um plastic sheet with a porous platinum or gold metalization layer on each side. Water from the environment goes into the polymer and changes the dielectricity and thus the capacitance of the sensor. When used in an oscillator, the presence of water will change the outputfrequency. Output is proportional to relative humidity, rather than moisture content 6 Warner Road, Warner NH 03278 • P: (603) 456.2011 F: (603) 456.201

Temp1000IS Temperature Data Logger Temperature Sensor: • Rated as Intrinsically Safe by FM Approvals for use in Class I, Division 1, Groups A, B, C and D and nonincendive for Class I, Division 2, groups A, B, C and D indoor and outdoor. • Precision 100 ohm platinum RTD sensing element Resistance Temperature Detector (RTD) Temperature Range: Calibrated Accuracy: Start Modes: Software programmable immediate start or delay start, up to 2 years in advance Lethality Equations: Sterilization Units and Pasteurization Units are available in software with the click of a button • External RTD for fast...

• High-quality RTD temperature measurement element. • Uses 24-bit A! (sigma delta) ADC technology for best-in-class accuracy. • Specific one or two point adjustment can be requested to improve accuracy over varying ranges. 6 Warner Road, Warner NH 03278 • P: (603) 456.2011 F: (603) 456.2012

Benefits • Simply place the logger in the docking station to automatically establish communications • Download full memory in seconds • Multiplexer docking station allows for programming of up to 18 loggers at a time • Small size enables it to be placed easily into product packaging • Engraved label 6 Warner Road, Warner NH 03278 • P: (603) 456.2011 F: (603) 456.2012

MadgeTech 4 Software MadgeTech 4 Secure • MadgeTech 4 Secure aids in compliance with 21 CFR Part 11 requirements. • Full IQ/OQ/PQ validation documentation comes included • Quantity discounts are available • Don't need 21 CFR Part 11? MadgeTech has a standard version of this same software available for free. Features • Customizable Graphs • Exporting • Data Annotation • Digital Calibration • Automatic Statistics Calculation • Graph Overlays, Data Summary, Reports • Audit Trails • Electronic Signatures • Real time wireless alarming 6 Warner Road, Warner NH 03278 • P: (603) 456.2011 F: (603) 456.201...