US Patent No.7,174,772

GIT-LCA

Cost effective solution to Glove Integrity Testing

Pressure threshold leak detection
Self-contained console design
Color touchscreen operator interface
Printing functionality
Programmable mode of operation and parameters
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System
Environment
Features
Specifications
Operation
Hardware
Reports
Documentation
Photo's

System Description

The GIT-LCA glove integrity tester is a state-of-the-art, cost effective, leak testing system for testing the integrity of glove/sleeves or gauntlets of isolator/RABS systems.

The GIT-LCA glove integrity tester consists of a clean room compatible control console that the operator places in proximity to the gloveport to be tested and an appropriate glove interface device that is specifically designed to interface with the glove system to be tested.

The GIT-LC system can operate in either positive or negative pressure mode depending on whether the glove system to be tested is part of an aseptic or a containment application. The test outcome is provided to the operator in the form of a Pass/Fail visual indicator and pressure/airflow values. If desired, test results can be printed for permanent record keeping.

System Environment

Typical aseptic system installation, shown with glove/cuff type of test part interface and negative pressure test mode for aseptic filling operations. The glove under test is placed inside a vacuum chamber via a leak tight connection at the cuff.

For containment applications, the glove/sleeve are tested while oriented inside the isolator chamber.

Features

Stainless steel welded base with four casters, two swivel and two fixed.
Slanted control panel, easily viewed and accessed.
Ergonomically placed moving handle
Clear Pass/Fail test outcome feedback to the operator.
Numeric feedback of tested item performance.
Print out of test result, parameters and calibration data.
Simple operation, validation and maintenance.
Individual testing of the glove and the sleeve.
Capable of testing single piece gauntlet.
Self test capability, available at all times.
In-Situ Calibration
Cost effective.

Specifications

Console width: 615mm / 24 inch.
Console length: 585mm / 23 inch.
Console Height: 1130mm / 44.5 inch.
Material of construction: Stainless steel.
Rugged construction.
Non-marking polyurethane swivel casters.
12 foot long power cord.
Retractable pneumatic connections to the gloveport interface hardware.
Internal compressed air/vacuum supply.
Input power: 115VAC, 60hz / 220 VAC/50hz.
Dual channel operation

Mode of Operation

Non-Sterile/Containment leak test (containment applications)

Glove/Sleeve is pressurized from outside the isolator.
In the event of a leak in the test item, positive pressure inside the test item causes airflow into the isolator system.

Sterile system leak test (aseptic applications)

Glove/Sleeve placed under vacuum from outside the isolator.
In the event of a leak in the test item, negative pressure outside the test item causes airflow out of the isolator system.

Gloveport Interface Hardware

The system connects to the test item by means of a gloveport interface device. A number of interface configurations are possible, depending on the application, mode of operation and gloveport manufacturer. Following are the basic categories of interface devices possible and diagrams that demonstrate the concept of each. (Click on link to view diagram)

Positive pressure/Containment applications.

Negative pressure/Aseptic applications.

Gloveport Interface Reports

A number of gloveport interface reports are available. Click on the link to download.

10 inch Walker Barrier round gloveport and gauntlet
10 inch Ergoclean oval Walker Barrier Glove port
10 inch Gauntlet Off-Line tester
Glove and cuff interface vacuum chamber
Performance limit report - Cuff and Glove leak test

Documentation

Each system is shipped with an operator and maintenance manual that includes the following sections:

Handling and transport
System set up for operation
System detailed description and operational instructions
Maintenance instructions
Validation support documentation such as Equipment, Functional and Design specification documents.
Executed Functional Test Protocol
List of recommended spare parts for two years of operation
Manufacturer's catalog cuts and instruction sheets for all commercial components.
Electrical, mechanical, P&ID's and assembly drawings