A glove leak tester plays an important role in managing contamination risks in aseptic processes.
The FDA requires glove management for isolators and RABS. This includes monitoring leak integrity and detecting holes. The FDA advises assessing old manufacturing equipment, and switching manual processes to automatic.
Our Automatic Glove Leak Testing System (AGLTS) is customizable and autonomous for isolators and RABS in the pharmaceutical industry. Automatic glove leak testing systems are highly sensitive and able to detect glove holes that are not visible to the human eye.
There are several benefits to using an automatic glove tester:
- Save production time in isolated filling lines, stand-alone isolator systems and RABS technology.
- Avoid operator mistakes.
- Detect small holes in the gloves (≥ 50 μm).
- Data consulting can be done outside the classified environment.
- Minimize personnel intervention to reduce the risk of contaminating sterile products and increase operator safety.
The AGLTS has advanced features to improve your experience of glove testing:
- Easy: user-friendly interface for operators
- Fast: Detection in less than 8 minutes
- Customizable: custom-designed glove port adaptor allows AGLTS to fit every kind of glove port.
- Manufacturing materials resistant to sanitizing agents and bio-decontamination processes.
Want to learn more about the AGLTS? Click here for more information.
References
- Our partner Tema Sinergie
- U.S. Food and Drug Administration. Guidance for Industry. (September 2004). Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice.
- U.S. Food and Drug Administration. Compliance Program Guidance Manual. (September 2015). Sterile Drug Process Inspections.
