Cleaning & Disinfection of GMP Cleanrooms in Pharmacies

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The "proper" cleanroom cleaning. How exactly this is done is a concern increasingly shared by pharmacy managers. According to the pharmacy operation regulations, they are responsible for their cleanroom hygiene – without necessarily being experts in cleanroom technology. This article provides an initial overview of cleaning and disinfection procedures as well as suitable solution concepts to assist with this challenge. Regular and professional cleaning and disinfection in cleanrooms are essential parts of operational hygiene. Numerous regulatory requirements dictate the processes in manufacturing pharmacies. But which materials should I use for cleaning and disinfection? What should I consider when choosing mops and cloths? In any case, special, cleanroom-compatible mops should be used that release only a minimal amount of particles and fibers. The same applies to cloths. It is also important that the cloths themselves are not a source of contamination. Depending on the purpose, either nonwoven cloths or knitted cloths are used. These can be pre-treated with the appropriate disinfectant to facilitate handling. Generally, GMP requires that multiple disinfectants (i.e., at least two) with different effective spectra be used, as well as a sporicide regularly. Cabinets and isolators, unlike surfaces, must be considered separately due to their hard-to-reach areas. Hydroflex offers an excellent solution for the safe cleaning of these GMP A areas with the ICT tool. During the entry procedure, contamination from introduced materials and raw materials must be excluded. Therefore, especially for non-sterile products, appropriate precautions for disinfection must be taken. Finally, the new GMP Annex 1 explicitly states that before each disinfection step, it must be ensured that the surface is free of contaminants (including invisible ones) to guarantee the success of disinfection. This also prevents residues on surfaces from causing unwanted chemical reactions with the sporicidal disinfectant. Detailed information on these points is available from Hydroflex in the CleanFacts "Cleaning & Disinfection of GMP Cleanrooms in Pharmacies" for download.