Metrolab Blog

Particle Counters keep in mind 9

𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗻𝗴 𝗮 𝗣𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝗻 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗭𝗼𝗻𝗲𝘀

According to EU GMP Annex1 and ISO 14644-1, selection of sampling locations inside critical zones are defined as;

𝗘𝗨 𝗚𝗠𝗣 𝗔𝗡𝗡𝗘𝗫𝟭 𝟮𝟬𝟮𝟬 (𝗗𝗿𝗮𝗳𝘁)
«4.30 : …for the aseptic processing room and the background environment (Grade A zone and Grade B area, respectively), sample locations should also consider all critical processing zones such as the point of fill and stopper bowls. Critical processing locations should be based on a documented risk assessment and knowledge of the process and operations to be performed in the area»

𝗜𝗦𝗢 𝟭𝟰𝟲𝟰𝟰-𝟭:𝟮𝟬𝟭𝟱
A4.2 Positioning the sampling locations « c) select within each section a sampling location considered to be representative of the characteristics of the section, and… d) at each location, position the particle counter probe in the plane of the work activity or another specified point»
For non-unidirectional airflow cleanrooms or clean zones, locations may not be representative if they are located directly beneath non-diffused supply air sources.

Selecting sampling locations in cleanroom critical zones