Sterile drug production has always been a challenging task to perform in the pharmaceutical industry.
There are many requirements to fulfill: to assure product quality, to protect the operator when potent
compounds are present, to achieve high levels of efficiency,.…. And all of them must comply with the
existing pharmaceutical regulations. In Europe, the main directives to follow are 2001/83/EC and
2017/1572. Annex I of these guidelines for CGMPs was modified in 2022 and it has agitated the sector
as human intervention is explicitly not accepted at all under class A conditions. This article will analyse
how to address these challenges in different scenarios.
Related news
How to overcome choked flow limits in freeze-drying processes
In a freeze-drying process, one of the limiting factors in the duration of ...
New trends: Green Engineering, sustainability through a proper design
In today’s situation, sustainability is a more critical concept in engine...
Air flow smoke pattern testing: a new challenge in a subjective test in Annex 1 EU GMP
In the maintenance process of aseptic facilities, one of the tests of high importance is the ‘A...
Exploring sustainable cooling solutions for freeze dryers. A focus on natural gases
Mechanical refrigeration systems are an important factor against global cli...