NEW! Learn About the Importance of Pharmaceutical Glass Handling
PDA Technical Report No. 87 Current Best Practices for Pharmaceutical Glass Vial Handling and Processing
This technical report in which Genesis contributed to focuses on a technical understanding of glass, its strength, and its limitations, and provides guidance in best handling practices for glass vials throughout the pharmaceutical process — receipt, storage, preparation, filling, stoppering, freeze-drying, and capping. This document focuses on where surface damage may occur and where excess stresses may be applied during processing and handling.
This report also reviews typical pharmaceutical glass handling processes and identifies areas of concern. Points to consider are presented for line, material, and equipment enhancements as well as guidance and practical approaches for using procedural controls to better employ existing equipment.
The report is available to purchase at the PDA Website or you may read it for FREE if you are a PDA Member. Follow the link below for more information.
Residual Seal Force Tester
The Genesis Residual Seal Force Tester evaluate's seal tightness by measuring the Residual Seal Force in the stopper/seal combination of a parenteral package created as a result of the vial sealing process.
The FDA recognizes the use of RSF as a predictor of seal integrity.
The FDA in its Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products recognizes the usefulness of properly validated seal force testing. Most importantly, RSF is useful in the establishment, validation and control of capping machine settings.
The Integra Laboratory Vial Crimper
Small Package, Big Performance
The Integra Laboratory Crimper is a small vial crimper that is ideal for development, pre-clinical, clinical, pilot and compounding pharmacy operations. Available in four configurations the Integra can meet your small batch size needs assuring the best possible seal integrity.