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| Steam Steriliser validation Datalogger |
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Steam Sterilization operates at high temperatures (typically 121°C) and pressure (typically 20PSIA) to achieve critical sterilization levels for the Medical, Dental and Pharmaceutical industries. Validation is necessary to assure that each process cycle is within the control limits, ensuring safety in processed products and tools. A MadgeTech line of data loggers has been developed exclusively to validate the entire Steam Sterilization cycle. The HiTemp150, Temp1000S and Temp1000FP data loggers measure temperatures up to 150°C. They can also endure the high pressure found in steam sterilizers. All the devices record measurements at periodic time intervals, validating the consistency during the entire sterilization cycle. Their standalone 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 sterilsation cycle, the MadgeTech software makes it simple to maintain records validating each successful sterilization cycle. MadgeTech Data Loggers have become the data loggers of choice in the sterilization industry. |
| Product Overview |
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| FDA Support |
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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 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 a 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. |
