From the Leader in Seal Integrity
The Genesis Residual Seal Force Tester measures residual seal forces on parenteral vials sealed with stoppers, lined seals and aluminum caps. The aluminum caps can be plain aluminum, or aluminum with plastic buttons, though it is highly recommended that the plastic buttons be removed prior to testing. Other cap materials and styles may be accommodated as specialty applications. Specialty applications should be submitted to Genesis engineering for evaluation. Vials with diameters of .5 inch to 3.5 inches, and heights (including vial, stopper and cap) from 1 inch to 7.25 inches are accommodated. A wide variety of cap styles and sizes can be accommodated with specific cap anvils. Cap sizes including 13, 16.5, 20, 28, 30 and 32mm are supported. Residual seal forces in the range of 3.0 Lbf to 50.0 Lbf can be measured.
What is Residual Seal Force?
Learn why Residual Seal Force is important.
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 residual seal force is measured by applying strain (compression) at a fixed rate to the cap/stopper/vial package and collecting strain (distance) vs. stress (force) data. This data is analyzed by a proprietary data analysis algorithm to determine the residual seal force.
The measured residual seal force is displayed on an operator interface on the front of the instrument and is made available on a serial port for automatically placing the data in a spreadsheet on a computer.
The residual seal force readings are completely objective (no operator subjectivity is involved in the measuring process) and consistent within +- 20%.
For research or validation purposes, a special mode is available that provides both raw and result data through the serial port. This allows the raw force data to be dumped directly into a spreadsheet. Software is available from Genesis that displays force and derivative data graphs based on the raw data.
The instrument includes a safety enclosure to protect the operator in the unlikely event of glass breakage or slippage, and to keep fingers away from the actuator assembly during the process of collecting data.
|Vial Finish Diameter||Vial Height||Power||Data Export||Size||Weight|
|8mm to 20mm||Up to 7.25 Inches||110V AC||USB, Ethernet||23" W x 19" D x 17" H"||100 lbs|
Impact of Vial Capping on Residual Seal Force and Container Closure Integrity | PDA Journal
The vial capping process is a critical unit operation during drug product manufacturing, as it could possibly generate cosmetic defects or even affect container closure integrity. Yet there is significant variability in capping equipment and processes, and their relation to potential defects or container closure integrity has not been thoroughly studied.
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Robert Ovadia, Philippe Lam, Oliver Stauch, Martin Vogt, Holger Roehl, Joerg Huwyler, Silke Mohl and Alexander Streubel