Can an isolator handle an API that is both potent and sterile?

June 7, 2022

Last week we asked our followers: Can an isolator handle an API that is both potent and sterile? Let us explain.

If a powder is both sterile and toxic, the isolator will start working under sterile conditions. A VHP cycle will be run and the isolator will operate under positive pressure to keep the aseptic conditions (i.e. prevent any contamination from the environment). At the end of the process and when the product is securely packaged we have an isolator full of toxic product. At that point the goal becomes to protect the operator from the product and the mode of operation will switch to negative pressure to protect the operator from the toxic powder. The isolator can then be cleaned and when it is fully contaminated it can be used for the next product either in 100% aseptic conditions (if the product must be kept sterile but is not toxic) or in toxic conditions (if the product is potent but doesn’t need to be kept sterile) or are we saw in both conditions but one after another.

If you have further questions we would be happy to discuss further with you.

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