Telstar has integrated a new semi-automatic glove tester incorporating proprietary glove port recognition technology in the range of isolators designed by the company.
Developed by the Technology Centre for Barrier Isolation Systems of Telstar in the UK, the semi-auto tester has been designed and manufactured as a prototype for single use. It has been tested prior to standardising the product and expanding to a multi-glove tester and, from now on, future glove testers will be offered as an option to be integrated into the isolator/RABs control system.
The in-house 21 CFR compliant glove tester integrated in Telstar isolators provides the customer with a reliable, traceable means of testing gloves fitted to isolators or RABs in a working environment. The glove test parameters are adjustable to comply with the customer requirements and to compensate for different glove types and the system is rated for continuous use within the restrictions of normal life-cycle maintenance.
The system built up by Telstar has been recently implemented on an aseptic filling and closing isolator system and an aseptic vial filling & closing isolator, developed by the company for two international companies.
Richard Hanson, Technical Manager at the Technology Centre of Telstar in UK commented that “We are pleased to announce that the Telstar RFID glove leak testing system has been a success in both of our recent projects following months of intensive research at our facility in the United Kingdom. We now look forward to offering this system as an option on all isolator/RABs equipment”.
The glove tester consists of the glove test plug and umbilical lead fitted with quick release connections to enable one handed operation. All other components are mounted on-board the Isolator/RABs.
The design is an evolution of the semi-automatic system used on previous Telstar projects but now includes RFID recognition technology to identify the glove being tested, improving traceability and reducing the scope for operator error. From a QA perspective this is a significant technological advancement as without this technology the operator could test the same glove multiple times and the system would not know. In addition with CFR Part11 compliant software it will log up to 10 tests of each glove. The test results can be printed out for the client to keep as a hard copy.
When the tester is placed into a glove tester it reads the glove number by means of an RFID sensor in the glove port and automatically inflates the seal. The test is then started using the start pushbutton on the tester plug. After the seal has inflated to hold the tester plug in place, the glove is then inflated to a predetermined pressure.
The pressure is held at this level for a preset time and then the pressure is reduced until it reaches the required level when the test starts. If the pressure does not achieve the required pressure in a set period the test aborts or can be aborted at any time with the stop pushbutton. Operation of the start or stop pushbutton will illuminate the indication lamp around the relevant button.
The test is carried out for a preset length of time and the values monitored continuously. If the pressure drop is more than the allowed pressure the test fails but if the test runs the full time and the pressure drop is within the allowed tolerance then the test passes. At the end of the test the glove pressure is reduced and the seal deflates. Glove pressure is logged during the test and can be shown on the trend screens, either as live value or as historical data and can be printed or exported to a C.S.V file.
To help comply with CFR 21 Part 11 an audit trail is provided which logs all user logins, alarms and set point changes made on the glove tester and all user actions require a user to login to the system the user will automatically log out at a predetermined period. Finally, initial setup requires all tags to be allocated to a glove number in the setup screen to allow the system identify which glove is being tested.