Posted on 8/12/2024
With the review of GMP Annex 1, the bio-decontamination of barrier systems has certainly taken on a key role, but not all solutions available on the market offer the same answers in terms of results, process management and validation. In the article below, we are going to consider some aspects that should be evaluated before choosing the most suitable system for your aseptic process.
Almost a year after GMP Annex 1 came into force, there are still several open questions and problems to be solved. From one hand, there are some aspects whose interpretation gives rise to debate within the pharmaceutical industry but, on the other hand, some messages emerge with the utmost clarity.
One of them is certainly the need to use the most advanced technologies ...