放射性药物
制药
ATMP 细胞和基因治疗
服务
Speedy Glove是一款电池供电的手套测试仪，在隔离区域和外部环境需要严格隔离的情况下，设备可对安装在隔离器或RABS上的手套进行泄漏测试。系统遵照ISO 14644-7附录E.5的要求，执行压力衰减完整性测试。
Speedy Glove与目前所有可用的手套法兰兼容 ，配备可与手套一起使用的触摸屏，拥有极快的测试速度（比市场标准快30％）。
As we travel to industry events worldwide and present our Speedy Glove product, there are a few questions from booth visitors that generally come up. Here are the most common ones, with their answers.
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.
