Glove Integrity Tester for Isolators

Why is it Essential to Test the Integrity of Isolator Gloves?

Isolator gloves are a key component in maintaining a sterile environment in pharmaceutical production. Any defect, no matter how small, can lead to contamination, compromising the quality of medicines and patient safety.

There are multiple risks associated with defective gloves. In fact, even a microscopic perforation can allow microbial or chemical contaminants to enter, jeopardising the integrity of the manufacturing process. In addition, a leak can expose the operator to potentially hazardous substances, especially when handling highly active products.

It should be noted that current regulations, including Good Manufacturing Practices (GMP) and Good Manufacturing Practices (GMP) standards, require rigorous controls to ensure the sterility of production environments. The implementation of a glove integrity tester for isolators is therefore imperative to guarantee the compliance of facilities and avoid any risk of batch recalls or regulatory sanctions. By performing systematic tests, pharmaceutical manufacturers optimise their risk management and enhance the reliability of their production processes.

Gloves Integrity Tester for Isolators: Principles and Operation

The gloves integrity tester for isolators is based on proven methods that accurately identify defects that could affect the sterility of production environments. One of the most commonly used principles is the pressure test. This process involves blowing air into the glove and then measuring pressure variations. An abnormal drop in pressure indicates the presence of a leak. This type of test is fast, reliable and non-destructive, ensuring effective control without damaging equipment.

Conductivity testing and imaging-based technologies are other methods for detecting micro-leaks that are invisible to the naked eye. In this regard, modern integrity testers are generally equipped with high-precision sensors and analysis software, which provide detailed results in real time and facilitate the traceability of the checks carried out. By integrating these automated systems into isolators, regular tests can be carried out without interrupting production. This naturally helps to reduce downtime, improve productivity and ensure optimum safety for operators and the products being handled.

EREA Pharma: Recognised Expertise in Glove Integrity Testing for Isolators

EREA Pharma is a key player in the development of integrity testing solutions tailored to the requirements of pharmaceutical environments. Thanks to our expertise, we offer models of glove integrity testers for isolators that combine performance, reliability and ease of use. The systems we develop are based on cutting-edge technologies that ensure fast and accurate detection of defects. Designed to adapt to the constraints of clean rooms and sterile environments, these testers comply with standards and integrate seamlessly into existing manufacturing processes.

We also support manufacturers in implementing our tailor-made solutions, taking into account the specific characteristics of each installation. Our quality and innovation-focused approach enables pharmaceutical companies to secure their operations, reduce the risk of contamination and guarantee the compliance of their production. By choosing EREA Pharma, you benefit from a trusted partner capable of providing high-performance equipment and supporting you in optimising your integrity testing processes.

Would you like a quote for the installation of such a system? Contact us for a free, quick quote.