Speedy Glove is a battery-powered glove tester that performs leak testing on gloves installed on isolators or RABS where a strict separation between the isolated area and the external environment is required. The system performs pressure decay integrity tests that comply with the requirements of ISO 14644-7 Annex E.5.
Speedy Glove is suitable for all isolators equipped with glove flange such as those dedicated to aseptic processes, containment processes, the manipulation of API and HAPI and the manipulation of radiopharmaceuticals. Speedy Glove is compatible with all currently available glove flanges on the market.
The system boasts a number of peculiar and patented characteristics which make the Speedy Glove unique on the market in terms of performance and flexibility. There is, in fact, a unique system of rapid inflation of the glove that fills it with air in a few seconds during the leak test, saving between 3 and 5 minutes each test (approximately 30% of the total time) compared to the times usually required by similar devices on the market. It does not need to be connected to pneumatic circuits or compressed air tanks but can independently manage all the phases of the glove integrity testing process.
For the first time on the market the concept of “over-port” test is introduced in parallel with the classic “in-port” test that makes possible testing not only of the integrity of the glove but also of the entire mounting flange on which the glove is connected.
The system is also compatible with vaporised hydrogen peroxide, hence meaning it can be completely decontaminated. This important feature, together with the extremely compact dimensions, means it can be introduced through a pre-chamber into the isolator on the gloves to be tested. Once inside it is possible, with appropriate flanges arranged as in the Comecer isolators, to activate a glove testing process that inflates the glove from the inside outwards.
In the case, in fact, of critical processes to avoid breaking the class of isolator during the test it is possible to perform this test in reverse conditions compared to the classical approach, that is by inflating the glove inwards. To avoid fluctuations of pressures that could return false negatives or false positives, the isolator in fact in traditional tests of gloves is deactivated by turning off the ventilation and by normalising the pressure towards the environment. The Speedy Glove system offers the possibility of avoiding this temporary block of the isolator operation both through any test from the inside and through the real-time monitoring of the isolator pressure (if connected with Comecer machines) able to compensate for the effect of statistical fluctuation of the internal pressure thus avoiding false alarms.
1. Why is it important to test glove integrity in a RABs or Isolator?
Isolator integrity is a must to guarantee an aseptic working chamber. Tightness can be verified with a test on the entire isolator, but the leak test on the full chamber volume is not sensitive enough to find a microscopic leak in one of the gloves. That is why it is fundamental to perform a specific integrity test to verify each individual glove. This is done with a device specifically designed for this delicate task, like Speedy Glove.
2. When should one test glove integrity?
As specifically stated in the EU GMP Annex 1 revision, a glove integrity test is fundamental for the correct pre- and post-production qualification in an isolator. Since the glove is one of the main sources of risk in the process, it must be precisely controlled before and after each critical phase of the production process, compatibly with its Quality Risk management and therefore with the need to guarantee the quality of the medicinal product.
3. What norms and regulations apply to glove integrity testing?
At the regulatory level, the glove integrity test is described in ISO 14644-7 Annex E.5 where the use of the pressure decay test is identified as suitable for verifying any punctures or tears capable of determining a sealing problem on the isolator. However, this standard does not identify a precise set of parameters, given that times and pressure setpoints remain dependent on the type of equipment, the type of glove and the type of leak to be detected. Therefore since the standard identifies a generic method, it is necessary to support the measuring instrument with a suitable procedure development process and Performance Qualification.
4. How long does it take to recharge the Speedy Glove battery?
It takes 4 hours to recharge the battery. Batteries support approximately 20-30 consequential integrity tests.
5. Why and how is RFID used by Speedy Glove?
Speedy Glove can load the correct receipt using RFID. Each Speedy Glove is equipped with 20 RFID tags, and these are recognized up to a maximum distance of 20cm. RFID allows glove test tracing during analysis and therefore exclude operator human error.
6. Does Speedy Glove have internal memory?
Speedy Glove can archive around one thousand reports.
7. Does Speedy Glove support VHP?
Yes, Speedy Glove is compatible with VHP and can be introduced in the aseptic area.
8. How can test result reports be saved?
Reports are saved as CSV or PDF files using the USB port or a WiFi connection.
9. Is Speedy Glove CFR Part 11 compliant?
Yes, the Speedy Glove software is CRF Part 11 compliant. Additionally, you can add IOQ protocol execution that can verify and attest compliance with CFR part 11. The device is provided with access control and internal Audit Trail, which can be visualized and exported.
10. How can Speedy Glove adapt to different glove flanges?
Speedy Glove is easily adaptable to glove flanges of different dimensions thanks to an interchangeable standard device.
11. How is the recipe value identified for a test?
The recipe values are identified with Performance Qualification (PQ). PQ is able to verify, using a statistical analysis with a calibrated leak, the optimal parameters to be sure to avoid false-positive and false-negative results
12. How can you handle different Speedy Glove units inside a single production site?
Different units in a single production site can be managed with the Speedy Glove Manager software, which allows centralized reporting and simultaneous management of the recipes for different units.