Pharma Cleanroom Classifications: ISO & EU GMP Overview | SAKTHIVEL MURUGAN NATARAJAN posted on the topic | LinkedIn
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Pharma Cleanroom Classifications: ISO & EU GMP Overview | SAKTHIVEL MURUGAN NATARAJAN posted on the topic | LinkedIn
This video is intended for all departments within the pharmaceutical industry, including Quality Control, Manufacturing, Engineering, and Quality Assurance and etc. It provides an overview of cleanroom classifications (ISO & EU GMP) and their associated key parameters such as🔹ISO level🔹Area design & Accessibility🔹Air velocity & ACH🔹 ...
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Cleanroom classification in pharma is based on the size of particles and the number of particles per cubic meter of air. There are specified limits of particle count,microbial counts and air changes for the cleanrooms. Cleanroom classification in pharma is per following standards, 👉ISO 14644-1 👉Federal Standards (FS 209) 👉European Standards 👉Grade A is maintained under laminar airflow hood (LAF) and critical activities listed below are performed in this grade, 👉Filling 👉Sealing 👉Aseptic m
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