Vera
Residual Seal Force Tester
The Vera 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.
Ensure Container‑Closure Integrity with Precision
The Vera has been designed to evaluate the critical seal tightness of parenteral vials sealed with stoppers and aluminum caps. By measuring Residual Seal Force (RSF) — the elastomeric force maintained after capping — it validates stopper compression and the integrity of the seal. This FDA‑recognized method is essential for establishing and controlling capping machine settings to ensure consistent container closure integrity.
RSF quantifies the stress a deformed stopper exerts post‑compression, which maintains the seal between the stopper and vial finish. Over time, RSF decays following a Maxwell curve, varying by rubber formulation and storage conditions. Proper RSF correlation with leak testing allows predictive assurance of seal integrity, even when glass defects exist.
The Genesis Vera® measures residual seal force on parenteral vials sealed with stoppers, lined seals, and aluminum caps. The aluminum caps may be either plain or fitted with plastic buttons; however, it is highly recommended that the plastic buttons be removed prior to testing. Other cap materials and styles can be accommodated as specialty applications, which should be submitted to Genesis Engineering for evaluation.
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.
Gallery
3D Model
Key Features
Modern System Controls
The control platform utilizes a reliable PLC and modern PC architecture for all data acquisition and resultant processing.
Modern Touch Screen Interface
The Vera features a high resolution 10.1 inch touchscreen.
Adjustable Vial Rest
The vial rest is adjustable to fit any vial size from 8mm to 88mm without having to change parts.
Dual SI & Imperial Units
Units for reporting can be switched between Imperial (Lbf Inches) and (Newtons mm). The selection becomes the default for future operation.
Graphical Data Display
The 10.1 inch screen allows for rich graphical data and reports to be displayed right on the tester.
Customizable Sample Labeling
The ability to add custom labels to your samples allows for more robust sample tracking.
Improved Accuracy
The Vera obtains several hundred force data points to allow for a more accurate analysis.
Improved Force Calibration
The force feedback entails a step by step process with a three point final verification and date/time stamp.
New Distance Calibration
A distance calibration process has been added and includes a three point final verification with date/time stamp.
Data Export
The ability to export reports and graphs to a Microsoft Excel spreadsheet or to Crystal Reports. A licensed copy of Excel is included with the unit.
Wireless Mouse & Keyboard Support
Wireless mouse and keyboard support is built in to the embedded PC.
User Security Management
Manage all users with fine grain security controls to restrict access and control use cases. Options are available to automatically obtain user credentials from a customer's secure server.
21 CFR Part 11 Capable
The Vera is capable to be 21 CFR part 11 compliant.
VHP Sterilization
The Vera has been certified for use with Vaporized Hydrogen Peroxide.
CE Compliant
The Vera has been certified to be CE compliant.
Operation & Vial Size Limits
- Measures residual seal force (RSF) for parenteral vials sealed with stoppers, lined seals, and aluminum caps.
- Supports aluminum caps with or without plastic buttons (button removal recommended for testing).
- Accommodates vial diameters from 8 mm to 88 mm and heights up to 6.47 inches.
- Compatible with a wide range of cap sizes, including 7.5, 8, 10, 11, 13, 16.5, 17, 18, 20, 28, 30, 32, and 43 mm.
- Measures residual seal forces from 3 lbf to 35 lbf with high repeatability.
- Specialty cap materials and styles available upon engineering evaluation.
Hardware Specifications
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. In this study we applied several methods—residual seal force tester, a self-developed system of a piezo force sensor measurement, and computed tomography—to characterize different container closure system combinations that had been sealed using different capping process parameter settings.
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Robert Ovadia, Philippe Lam, Oliver Stauch, Martin Vogt, Holger Roehl, Joerg Huwyler, Silke Mohl and Alexander Streubel