Telstar has announced the integration of its new semi-automatic glove leak tester into a range of isolators.
Developed by the Technology Centre for Barrier Isolation Systems of Telstar in the UK, the semi-auto tester was designed and manufactured as a prototype for single use. This incorporated a proprietary glove port recognition technology, which has now been expanded to a multi-glove tester. Future glove testers will be offered the new system as an option for integration into the isolator/restricted access barrier (RAB) control system.
The in-house 21 Code of Federal Regulations (CFR) compliant glove tester integrated in Telstar isolators provides the customer with a reliable and traceable means of testing gloves fitted to isolators or RABs in a working environment. The glove test parameters are adjustable to comply with customer requirements and to compensate for different glove types. The system is rated for continuous use within the restrictions of normal life-cycle maintenance.
The system has recently been implemented on an aseptic filling and closing isolator system and an aseptic vial filling and closing isolator for two international companies.
Technical Manager at Telstar’s UK Technology Centre Richard Hanson commented: "we are pleased to announce that the Telstar radio frequency identification (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 UK. We now look forward to offering this system as an option on all isolator/RABs equipment".
The glove tester consists of a glove test plug and an 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 with previous Telstar projects. It now includes RFID recognition technology to identify a processed glove as having been tested, improving traceability and reducing the scope for operator error.
From a quality assurance (QA) perspective, this is a significant technological advancement because without this technology, the operator could test the same glove multiple times and the system would not know. In addition, CFR Part11 compliant software logs up to 10 tests of each glove. The test results can be printed out for the client to keep as a hard copy.
When a glove is placed into the tester, it reads its identification number by means of a 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.
This pressure is held at this level for a pre-set time and then the pressure is reduced. 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 pre-set length of time and the values monitored continuously. If the pressure drop is more than the expected amount, the test fails but if the test runs the full time and the pressure drop is within the allowed tolerance then it passes.
At the end of the test, glove pressure is reduced and the seal deflates. Pressure is logged and can be shown on the trend screens, either as a live value or as historical data, and can be printed or exported to a CSV 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. In addition, all user actions require a user to log in to the system. Finally, initial setup requires all tags to be allocated to a glove number in the setup screen for identification.