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| Ethylene Oxide validation Datalogger | ||
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Elapsed time recorders available in aluminum or stainless steel housings. High quality feel and performance comparable to that of much more expensive validation recorders. This blend has been the reason why the Madgetech dataloggers have become the new standard. |
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| OVERVIEW: | ||
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The ethylene oxide (EtO) industry demands the highest standards for temperature and humidity control. Medical and pharmaceutical instrumentation, hygiene, cosmetic and food products are compromised if not sterilized under the correct conditions. The proper sterilization of these products is vital to consumer safety. A MadgeTech line of data loggers has been developed exclusively to validate the entire EtO sterilization cycle. The Temp1000IS data logger measures temperature and the RHTemp1000IS measures temperature and humidity. Both devices record measurements at periodic time intervals, validating consistency during the entire EtO cycle. It’s stand alone operation and compact size permits the recorders to fit easily into the sterilization chamber with the product load. As federal regulations mandate records for each EtO sterilization cycle, these recorded readings can then be entered into validation documents within the software to validate a successful sterilization cycle. The MadgeTech 1000IS Series has become the data logger of choice among the EtO sterilization industry. The Temp1000IS and RHTemp1000IS, designed to be placed directly inside the sterilization chamber have been certified by FM Approvals as intrinsically safe for Class I, Division 1, groups A, B, C, D, and non-incendive for Class I, Division 2, groups A, B, C, D, hazardous environments. The Temp1000IS is water resistant. |
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| FDA Support | ||
| The task of meeting compliance regulations for the FDA’s 21 CFR Part 11 for electronic record keeping or the requirements set forth in Quality Plans has become complex. MadgeTech has simplified this process with our Secure Software. The MadgeTech Secure Software is documented validation software that includes Installation, Operation, and Performance qualification (IQ/OQ/PQ) protocols. This enormous time saver eliminates the need to develop inhouse software validation procedures. The MadgeTech IQ/OQ/PQ protocol assists in obtaining data security and integrity requirements as defined by 21 CFR Part 11 and are in support of FDA and cGMP guidelines. In addition, MadgeTech offers a Software Validation Workbook (SVW) to verify the functionality of the secure software. The workbook is not required to meet 21 CFR Part 11 or FDA requirements. Contact MadgeTech for more details. |
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| Software | ||
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The MadgeTech software interprets the temperature and humidity readings from the data loggers. This intuitive software and dependable data loggers optimize the sterilization process improving productivity and performance. Data collection is made simple and can record simultaneous process variables. The MadgeTech system can turn fundamental data logging into sophisticated results by offering several methods of data analysis. Validations runs of the EtO sterilization process can be generated with timestamps, reports, and printouts. Data can be interpreted in graphical, statistical, summary, or data formats. Effortlessly gather accurate data and create instant reports with fully traceable process records at your fingertips. |
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