Why Cleanroom facilities for Medical Devices processing?
Processing and packaging of materials carried out across the industries for many different industrial applications; Engineered products stands as an example of a global industry that incorporates various materials, processes, parts and packaging styles. However, medical device processing and manufacturing falls under greater scrutiny for safety, performance, cleanliness, and in some cases, sterility.
The controlled environment of a cleanroom can help ensure that dust and other viable particulate matter do not contaminate materials that will form parts of medical devices during making and packaging. Regulatory Authorities specify the infrastructure and work environment requirements needed to achieve conformity to the product including monitoring and controlling plans to produce a quality product.
‘What is Cleanroom?’
‘Manufacturing Processes and QMS’
‘All about Packaging System Design’