Lyophilizer Leak Rate Testing - An Industry Survey and Best Practice Recommendation.

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 article provides a review of the scientific literature in the public domain and most importantly, a perspective from 14 Pharmaceutical companies on the leak rate specifications commonly used in industry.

Evaluation of the Robustness of A Novel NIR-based Technique to Measure the Residual Moisture In Freeze-dried Products.

(Bio)pharmaceutical products freeze-dried in vials must meet stringent quality specifications: among these, the residual moisture (RM) is crucial. The most common techniques adopted for measuring the RM are destructive, e.g.

Application of Near-Infrared Spectroscopy to statistical control in freeze-drying processes.

Batch freeze-drying of pharmaceutical products in vials may result in a high degree of intra-batch variability due to several reasons, e.g. non uniform heating rate in the drying chamber.