The Genesis Vera 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 6.47 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.

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.

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Features

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