GMP Cleanrooms in Pharmacies
According to the pharmacy operating regulations the pharmacy managers are responsible for the hygiene within their cleanrooms. But they are often no experts in cleanroom technology.
Often, we get asked similar questions when it comes to the “correct” cleaning and disinfection of their different cleanroom areas. That a routine and reliable cleaning and disinfection in cleanrooms is an essential part of the operational hygiene is a matter of fact. The GMP guidelines are relevant for qualification and auditing by authorities as well as for the requirements of the processes in the pharmacy. But which materials do I use for cleaning and disinfection? What do I have to look out for in mops and wipes?
Special, cleanroom-suitable mops which only emit a low level of particles and fibers should be used. This also applies to special cleanroom wipes, which will not become a source of contamination themselves.
Depending on the intended use, either non-woven wipes or knitted wipes are used. These can be presaturated with the correct disinfectant as required to facilitate handling. In principle, GMP stipulates that several disinfectants with different activity spectrums must be used, as well as a sporicide on a regular basis.
In contrast to surfaces, workbenches and isolators must be considered separately due to their difficult accessibility. But here, too, there is an excellent solution for safe cleaning of these GMP A areas with the ICT tool.
Contamination by materials transferred into the cleanroom must be avoided. Therefore, an appropriate transfer disinfection, especially for non-sterile materials entering the cleanroom, is essential. In many cases, a separate cleaning step will not be performed, as long as the routine disinfection is effective at removing regular soiling. The new GMP Annex 1 (draft) however, explicitly refers to this process. BEFORE each disinfection step it must be ensured that the area is free of contamination (even non-visible) to guarantee an effective disinfection. At the same time, cleaning can prevent residue build up on surfaces which quickly lead to corrosion, especially with sporicidal agents.
Click here for download our Cleanfacts “Cleaning & Disinfection of GMP Cleanrooms in Pharmacies” to get more information!