Active glove integrity testing
Radiopharmaceutical production must meet the strict requirements outlined in Annex 1, which include sterility, inspection, validation, risk control, and quality assurance. Active glove integrity testing is a crucial part of this process. Gloves are part of a physical barrier between the inside and outside of the hot cell; correct integrity is essential for both personal and product safety.
In collaboration with our partner MK Versuchsanlagen, Von Gahlen offers a compact system for active glove integrity testing. The solution is appreciated for its practical, user-friendly design and for meeting the EU GMP Annex 1 requirements for the manufacture of sterile medicinal products without production delays. In addition, the system is developed in accordance with GAMP 5 guidelines and fully supports 21 CFR Part 11 compliance to ensure validated processes and secure electronic data management.
Our partner
Powered by MK Versuchsanlagen and backed by more than 20 years of expertise in testing and measurement technology, the glove testers deliver a high-quality, accurate, and reliable solution for isolator and RABS applications. Their clients include globally recognized partners in the pharmaceutical and medical industries who rely on proven performance and consistent process integrity.
Automatic Glove Testing: integrated, proven, available
The Automatic Glove Testing device can be seamlessly integrated into our custom hot cell projects. It is easy to operate and can be implemented directly. Testing focuses on detecting leakage in the gloves using the pressure-decay method.
Functions include:
- Identification and Tracking: Ensures each glove and glove port is uniquely identified and traceable throughout the active glove integrity testing process, supported by RFID-enabled components.
- Automation and Efficiency: Wireless and software-assisted operations reduce human error and speed up the testing process.
- Data Logging: Facilitates accurate, efficient record-keeping of test results, with secure WLAN communication (WPA2 Personal/Enterprise).
- Quality Control: Enhance quality assurance by ensuring consistent tracking, testing, and documentation.
For the WLAN Glove tester with basic software, up to 4 test devices can be used; with an upgraded software version, up to 16 glove testers. And a solution for full integration with the customer's own network, with unlimited glove-testing devices.
- Recommendation: One glove tester per hot cell room/clean room.
- Calibration of glove tester: Yearly (by MK).
- Customizable to the required port size: Where other gloves than standard Von Gahlen gloves are used.
- Enterprise Integration: Optional connection to higher-level systems such as MES for seamless process integration.
- Certified Quality: Developed and manufactured under an ISO 9001 certified quality management system.
The integration with our hot cells
The hot cell models are designed for aseptic handling of sterile radiopharmaceutical solutions. The integrated laminar downflow system ensures a sterile environment that meets current Good Manufacturing Practices (GMP) Class A standards.
The hot cell features a shielded compartment with 50 mm lead shielding in all directions and an airtight stainless steel box with rounded corners. The box offers flexibility by allowing the addition of an airlock or a preparation glove box. These compartments help establish the required cascade design in accordance with GMP requirements.
Do you want more information about glove integrity testing? We can show you exactly how it works in practice. Please contact our sales team at sales@vongahlen.com.
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