The decision always is from the final customer, that has to declare the applications and its requirements either in term of specification or clean room fabrication.
There are on the market different solutions for a clean room, currently the web is a good starting point to select “turnkey solution” clean room.
The norm ISO 14644-1 is defining the class difference, generally from class 1 to class 100.000, where these values define the maximum accepted level of dust particles above 0,5 micron for cubic meter of air.
Is quite important to select the right class, managing costs it will depends from the class, lower it is higher they will be.
Based on our experience, applications that require USP class VI are manufactured in clean rooms class 100.000 to 10.000 , based on the final use.
Workers selection and training, that need to be exposed on a different way of working in a clean environment with specific requirements and procedures, will be vital to succeed
The “Good Manufacturing Practices”, or good fabrication method, must be implemented into a clean room operation, and can be summarized in 5 elements in order to achieve a sustainable and quality consistent product: People, Working environment, Process, Procedures, Instructions.
Very generic enquires such as “I need a medical silicone rubber”, without being very specific on the norm, are not to be considered.