The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have been published, there is no industry standard established that is based on empirical data or that has a justifiable scientific rationale. This paper published in the Journal of Pharmaceutical Sciences provides a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry. Using this information the BioPhorum team recommend a best practice for the lyophilizer leak rate test.
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The topic of campaign manufacture for lyophilization processes was discussed by the BioPhorum Lyophilization group. This member only publication is a summary of the approach taken by the major biopharmaceutical companies with experience of campaign manufacture who are members of the group.