What's New

The Second Generation


We've Improved the Residual Seal Force Tester in Every Way Possible

Modern System Controls

Modern System Controls

The control platform utilizes a reliable PLC for all data acquisition and resultant processing.

Modern Touchscreen Ineterface

Modern Touch Screen Interface

The tester now features a 10.1 inch Windows 10 based touchscreen system.

Adjustable Vial Rest

Adjustable Vial Rest

The vial rest is now adjustable to fit any vial size from 8mm to 88mm without having to change parts.

Dual Units

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

Graphical Data Display

The improved 10.1 inch screen allows for rich graphical data and reports to be displayed right on the tester.

Sample Labeling

Customizable Sample Labeling

The ability to add custom labels to your samples allows for more robust sample tracking.

Accurate

Improved Accuracy

The new RSF tester obtains several hundred force data points to allow for a more accurate analysis.

Gauge

Improved Force Calibration

The force feedback entails a step by step process with a three point final verification and date/time stamp.

Distance Calibration

New Distance Calibration

A distance calibration process has been added and includes a three point final verification with date/time stamp.

Spreadsheet Export

Spreadsheet Data Export

The ability has been added to now export reports and graphs to a Microsoft Excel spreadsheet. A licensed copy of Excel is included with the unit.

Periphables

Wireless Mouse & Keyboard Support

Wireless mouse and keyboard support is now built in to the embedded Windows 10 based PC.

Security Management

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.

CFR 21 Compliant

21 CFR Part 11 Capable

The Residual Seal Force Tester is now capable to be 21 CFR part 11 compliant.

VHP Certified

VHP Sterilization

The Residual Seal Force Tester has been certified for use with Vaporized Hydrogen Peroxide.

CE Compliant

CE Compliant

The Residual Seal Force Tester has been certified to be CE compliant.

The Residual Seal Force Tester
Residual Seal Force Tester
Residual Seal Force Tester
Residual Seal Force Tester

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 8mm to 88mm, and heights (including vial, stopper and cap) up to to 7.25 inches are accommodated. A wide variety of cap styles and sizes can be accommodated with specific cap anvils. Cap sizes including 7.5, 8, 10, 11, 13, 16.5, 17, 18, 20, 28, 30, 32, and 43 mm are supported. Residual seal forces in the range of 3 Lbf to 35 Lbf can be measured.

What is Residual Seal Force?

The force applied to deform the stopper creates a reciprocal force in the stopper. Once the applied force is released from the crimped stopper the reciprocal force created by the deformed elastomer becomes the Residual Seal Force (RSF) of the package. Residual Seal Force, then, is the stress an elastomeric closure will continue to exert against the glass vial finish and the overseal after the capping operation is complete.


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 automatically stored in a secure SQL database. The display includes a graph of captured data and analysis data points.

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, data is exported to a secure SQL server which is accessible using the Microsoft Excel program provided. The data reporting includes secured raw data and multiple graphical templates for easy data analysis.

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.

All manuals and validation documents are provided digitally as PDF files as well as on board in a HTML 5 searchable format.


Specifications

Vial Finish Diameter Vial Height Power Data Export Size Weight
8mm to 88mm Up to 7.25 Inches 110/220 VAC 2 USB, 1 Ethernet 13.7 [348mm] W x 18.4 [468mm] D x 29.3 [745mm] H  112 Lbf [50.8Kg]

Sample Reports & Graphs from the NEW Residual Seal Force Tester


Sample Report

Sample Report

A sample of the RSF Test Report that the tester exports to a Microsoft Excel file.


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Sample Graph

Sample Graph

A sample of the RSF Analysis that the tester exports to a Microsoft Excel file.


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User Interface

Operator Interface

A screen shot of the operator interface of the Residual Seal Force tester.


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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