{"id":17812,"date":"2024-01-03T13:10:42","date_gmt":"2024-01-03T13:10:42","guid":{"rendered":"https:\/\/www.bdk.uk.com\/?p=17812"},"modified":"2024-01-03T13:11:21","modified_gmt":"2024-01-03T13:11:21","slug":"a-guide-to-cleanroom-manufacturing-process","status":"publish","type":"post","link":"https:\/\/www.bdk.uk.com\/2024\/01\/a-guide-to-cleanroom-manufacturing-process\/","title":{"rendered":"A Guide to Cleanroom Manufacturing Process"},"content":{"rendered":"
A cleanroom is a controlled environment with stringent regulations governing the levels of pollutants. These spaces are designed to maintain optimal conditions for the manufacturing process of sensitive products, such as medical devices. The medical industry demands unparalleled precision and hygiene. Cleanrooms ensure that medical devices are manufactured<\/a> in a sterile setting, minimising the risk of contamination and enhancing product safety.<\/p>\r\n Cleanrooms operate on the principles of controlled air flow and filtrations, using High-Efficiency Particulate Air (HEPA) filters. HEPA filters are comprised of thousands of fine fibres to capture close to 100% of particles in the air that are 0.3 microns or smaller. With constant monitoring, medical manufacturers<\/a> make sure the air is always sterile. At BDK, we undertake daily pressure checks to ensure the HEPA filters are operating efficiently and monthly Environmental Monitoring checks to assess the bio-burden.<\/p>\r\n The cleanroom classification system provides a standardised framework for evaluating and sustaining cleanliness within these controlled environments. They are classified according to number and size of particles permitted per volume of air.<\/p>\r\n Maximum concentration limits (particles\/m3 <\/sup>of air for <\/strong><\/p>\r\n particles equal to and larger than the sizes listed below)<\/strong><\/p>\r\n <\/strong><\/p>\r\nHow Does a Cleanroom Work?<\/h2>\r\n
Cleanroom Classifications<\/h3>\r\n