Glove Integrity Testing, What Changes With The New EU GMP Annex 1 Revision

The revised Annex 1 of EU GMP introduces clearer expectations for sterile manufacturing, with a sharper focus on glove integrity testing in isolator environments. Defined testing intervals—now required at least at the start and end of each batch or production session—remove long-standing ambiguity and place greater operational demands on manufacturers. This shift makes testing frequency, consistency, and reliability central to compliant production. At the same time, equipment selection becomes more critical than ever. Factors such as minimizing false positives and negatives, reducing setup time, and ensuring ease of use and cleaning can directly influence production efficiency and risk management.

As the updated regulation takes effect, aligning testing strategies and technologies with these new requirements will be essential for maintaining compliance without compromising throughput.