READY FOR ANNEX1 ?
READY FOR ANNEX 1
On August 25, 2023, the new EU Annex 1 “Manufacture of Sterile Medicinal Products” will come into force.
Certainly, many companies already have such concepts and these can be supplemented accordingly.
Among other things, there is the requirement to determine changes in the microbiological flora in order to assess the effectiveness of the disinfectant used and the long-term effectiveness of the disinfection program. For this purpose, it is helpful to know which germs are present in one’s own cleanroom and form the so-called house flora.
Also in the course of establishing an environmental monitoring program, as required by the new Annex 1, the risk assessment should be based, among other things, on knowledge of the typical microbial flora isolated from the environment. This monitoring program is subject to ongoing observation and is used to establish trend analyses. Particular attention should be paid to organisms recovered that indicate loss of control, deterioration of cleanliness, or difficult to control organisms such as spore-forming microorganisms and molds. (Class A)
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We will be happy to assist you in identifying the germs present and likewise in storing them. The collected microorganisms should also be used for the nutrient testing of the monitoring plates used in the company in order to prove the fouling capability. We also offer in-house testing for fouling capability. Thus, it is not necessary to store and use the germs in the producing plant.
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