SPMC's FAQs provide guidance for your technical challenges.
Validating Package Sealing Equipment
Can a packaging machinery manufacturer successfully offer a 'template' for validating their machine?
Last Updated On May 15, 2008
The machinery manufacturer is in the best position to provide the critical parameters for successful machine operation. Whether or not the machine manufacturer would provide a true validation template is probably dependent on how familiar they are with the medical device packaging market. In any case, it is important to get information from the machine manufacturer to successfully plan the IQ and OQ portions of a package manufacturing process validation.