The purpose of revising Annex 1 is to reflect the changes that have occurred in the legislation and production of sterile medicinal products since the first edition in 2007. The latest revised version of EU GMP Annex 1 starts from the chapter on isolator systems, specifically proposing the integrity testing of gloves on isolator devices. The new regulations involve the definition of the time intervals for glove testing, thus standardizing the usage criteria for manufacturers. In fact, the first edition of Annex 1 drafted in 2007 stipulated that glove leakage tests must be carried out frequently, but did not provide any further specifications. The newly released revised version precisely fills this gap, stating that for isolators, glove tests must be conducted at specified time intervals, at least at the start and end of each production batch.  

Original quotation: "Tests should be carried out at specified time intervals. Generally speaking, glove integrity tests should be carried out at a minimum frequency at the start and end of each batch or activity." "For manual aseptic processing activities producing single pieces or small batches, the frequency of integrity verification may be based on other criteria, such as the start and end of each manufacturing round." 

The above latest revised content stipulates that regardless of the size of the production batch, the glove integrity test must be strictly carried out in accordance with the regulations at the start and end of each production. 

Obviously, such changes in the regulatory framework will inevitably have an impact on the manufacturing process. Since August 25, 2023, when the new Annex 1 came into effect, pharmaceutical companies within Europe or those intending to sell their products in this market will actually face the need to increase the frequency of glove testing. 

Biodeconta has been committed to the research and development of glove integrity testing since 2019 in order to assist pharmaceutical factories in compliant production. Through the unremitting efforts of R&D personnel and the product iteration, Biodeconta launched the latest GISTOOL, a glove integrity tester with group control, in March 2024. Our latest model is lightweight and beautiful, weighing only 2.5 kg. It features a wireless group control design, supporting the management of multiple workshops and gloves across the entire factory. The software interface of the product is easy to operate, and the historical data is traceable, meeting the requirements of audit trails.

Reliability: Avoid False Alarms and Missed Alarms
As the number of tests increases depending on the production batches, the reliability of test results becomes even more crucial. If there are errors in the test results, such as false negatives or false positives, it will surely lead to production interruptions until the problem is identified and resolved. In the worst - case scenario, it may even be necessary to destroy the entire relevant batch. In this sense, thoroughly evaluating the reliability before choosing equipment can prevent potential problems that may be difficult to handle in the future.

Biodeconta has 5 years of R & D experience and has accumulated over 100,000 glove integrity test experiments. We have rich experience in the integrity testing of isolator gloves, and the 100% reliability ensures that customers don't need to worry about the test results before and after each production.

The Setup of Equipment Also Affects the Speed of Testing Activities
Undoubtedly, the speed during the testing process plays a key role in not slowing down the production cycle. But this is not the only parameter to consider: the instrument setup time is also important and can play a crucial role in simplifying procedures. Therefore, when evaluating equipment, it is recommended to consider this aspect as well, evaluating not only the actual testing time but also the time required to set up the equipment.

The Biodeconta GISTOOL glove integrity testing system of Biodeconta features custom - defined test formulas; the RFID identification at the cuff can automatically identify gloves, which is convenient and time - saving. The wireless group - control version can simultaneously control more than 200 devices, supporting the testing management of multiple workshops and gloves.

Ease of Use: Ease of Cleaning and Maintenance Should Not Be Underestimated
The last aspect that should not be underestimated is the ergonomics and user - friendliness of the equipment. Of course, a user - friendly instrument will enable operators to perform the required operations in the shortest possible time. But this is not the only aspect to consider. Maintenance is also important, especially cleaning. Since this is an instrument almost exclusively used in a clean environment, it is recommended to evaluate this aspect as well, because an instrument that is easy to clean will take less time to prepare for use, thus saving time and resources.

The Biodeconta GISTOOL glove integrity tester is lightweight and beautiful, weighing only 2.5 kg. The button design is ergonomic, and the product is easy to operate. The entire body is designed to be dust - free, which is convenient for cleaning. The product design is customer - oriented, facilitating customers' operation both in appearance and function.