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Weiss Gallenkamp supply complete Pharmaceutical Stability solution.

16 October 2007

Weiss Gallenkamp have supplied a major international company with a comlpete solution to their pahrmaceutical stability testing needs.

Steris develops and creates products that are used around the world to prevent infection and contamination in critical environments where the highest levels of sterility are required to ensure successful outcomes.  These include hospitals, outpatient clinics, pharmaceutical manufacturing operations, research labs, and other industrial environments.  Weiss Gallenkamp supplied a PSC 059 Pharmaceutical Stability Chamber to the company, who use the chamber with the Pharmasafe Remote Monitoring System.

Both the chamber and the remote monitoring system were validated by Weiss Gallenkamp thus providing a complete solution to the company's need.  Weiss Gallenkamp representative Martin Hughes was responsible for the proposal and subsequent sale, despite strong competition from other companies.  Martin said "It was fantastic that once again the customer recognised the benefits that Weiss Gallenkamp provide through superior quality products & service.  Our ability to offer an integrated package including both product & validation was a major factor in influencing the decision.  Steris represent the type of customer who are a pleasure to deal with and I sincerely hope that we will be at the forefront of their minds in the future should they need further controlled environment facilities."

The Daqstation DX-P Remote Monitoring System can be fitted to PSC units in place of the Independent Monitoring Centre or used as a remote monitoring system which allows the user to view the screen using a web browser.  The DX-P also has the benefits of having no multi-licence costs, being simple to use, cost effective, and is password protectable.  The Daqstation is compliant with 21 CFR pt 11, & covers electronic records and signatures. It is capable of batch functionality or continuous monitoring, with a clear, bright TFT LCD screen with an internal flash memory & removable storage media.  Each batch or continuous data file produced by the DX-P contains recorded data, configuration, audit trail, alarm log/acknowledgement, message log & calibration data.  In terms of validation, documents only or full, on-site validation by a Weiss Gallenkamp specialist is available.  This feature was key to the successful approach from Weiss Gallenkamp as we could offer a complete solution comprising the chamber with validation and also the remote monitoring system complete with validation.  Steris chose the option of on site validation, something which was designed to provide a documented audit trail of the installation, commissioning & performance of the new equipment by ensuring that the product complies with the order and product specifications.  For further information regarding Pharmaceutical Stability & validation please visit www.weiss-gallenkamp.com


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