Glove Integrity Testing

The pharmaceutical and biotech industries constantly evolve to meet the highest quality and safety standards. The recent EU GMP Annex 1 update shows a significant shift in how we approach glove integrity testing in aseptic manufacturing environments.

A great example would be Tema Sinergie’s AGLTS 2, which goes beyond glove leak testing, featuring glove lifecycle management, integrated calibration, and RFID technology for automatic recognition. It also includes a user-friendly touch screen, and network integration via LDAP, and operates autonomously in classified environments without external power. 

1. Comprehensive Contamination Control Strategy

   To ensure every step is optimized for sterility. 

2. Increased Frequency and Rigor in Testing

   To detect even the smallest breaches.

   
   

3. Enhanced Training for Personnel

   To understand the nuances of glove integrity and be equipped to maintain the highest standards of sterility. 

   
   

4. Continuous Monitoring and Improvement

   Manufacturers are urged to conduct regular audits and leverage data analytics to identify trends and implement proactive measures.

   
   

5. Advanced Technologies and Materials

   Exploring new designs and materials that offer increased durability and resistance to contamination.