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A complete packaging process validation service that follows the guidelines presented in ISO 11607 is offered by a supplier of packaging machinery for medical device applications. The validation package, which features a risk-based approach that accords with the failure mode effects analysis method, includes documentation of all functions and potential risks, proof of process suitability, and software validation. The service provider carries out all of the test and protocol steps that are prescribed by the ISO standard for validation and qualification, some of them in its own plant and some at the customer’s site under actual production conditions. Besides using a black box approach for the protocol checking and traceable testing of all error messages, formula storage, and other software elements, the software validation explicitly describes all program components and the testing procedure for customer-specific modules. If the customer requests, the validation service can include a calibration of the packaging system’s features for measuring temperature, pressure/vacuum, and time values.

Multivac Sepp Haggenmüller GmbH & Co. KG

Wolfertschwenden, Germany

www.multivac.de