Well it’s an interesting thesis. The problem with systems that are described as being closed (assuming that they really are closed – meaning gas-tight) is not what happens to the product or the API when the systems are closed, it is what happens when you have to either put the product or API into the system or take it out at the end. When this happens the system, by definition, can no longer be considered to be “closed” and it is in fact “open”. There are a variety of approaches that are possible to deal with this that include engineering controls, environmental controls, procedural controls. However there is no single right answer and whatever the solution it has to protect the process and product. I have to add however that it is difficult to say more in the absence of details about the individual facility and process.
