Annex 1 has been in effect since August 22nd, 2022. Now we all know where we are likely to be on the important topic of Container Closure Integrity Testing (CCIT).

Or not? Do you use the blue bath test as a standard test for your packaging? What does that mean for you? Need to make changes? If so, by when, and if so, which ones? Are you already using a deterministic test, such as that proposed in USP 1207? Then you are now on the safe side! Or maybe not that?
I experience with my customers that there is still a lot of ambiguity. In this case you are in good company. Questions such as: "Can I use a deterministic test such as vacuum or pressure decay for all my products?" are the order of the day. If it doesn't work that way, what's wrong with it?

But if I can use the test technology, is it properly designed and qualified under the given Annex 1 requirements? Or do the new conditions require new attention and new measures? If YOU can answer all of these questions completely and confidently, then you most likely do not need our help. Or maybe it is, just to be completely sure? But if you get stuck with some of the questions, are unsure or don't have an answer, then the be integral team will be happy to help you.

Jens Höllein, as an independent consultant, will be happy to competently check with you whether you have already initiated or completed the right steps. If we come to the conclusion that your test system is not complete or not suitable for complying with Annex 1, integral GmbH will develop the right CCIT method with you, validate it for you and transfer it to your test systems. Competent, platform-independent and reliable. We develop the method in our laboratory, validate it either with you or with us and, if necessary, transfer the method to your test equipment.

You concentrate on the production of your parenteral products and we ensure that the regulatory requirements are fully met. If you have not yet decided on your CCIT technology, we will be happy to help you find the right provider with suitable test technologies. All from a single source. Feel free to contact us and let us guide you through this complex topic. #CCIT #Annex1 #labservices #consulting #parenteral #be_integral #info_at_beintegral_com