What classification level do I need?
Classification requirements can be tricky to pin down. Many different classification levels can be required through out the process of manufacturing just one product, dependant on the process you are performing at that time. Classification requirements are therefore mostly product driven through approved manufacturing guidelines. You will need to research your specific manufacturing cleanliness requirements to create your user requirement specification (sometimes abbreviated to URS).
We work to the internationally recognised ISO 14644-1 standards (ISO class 5, 6, 7 etc) but you may find that your process has its own additional, industry specific validation requirements. These are carried out by specialist agencies and cost up to £10,000 for a small production or research facility .
There are 3 different states that cleanroom suppliers and your manufacturing guidelines will refer to when specifying your cleanliness levels;
- As built. This is how we will supply your environment, it will be tested without any equipment or personnel inside.
- At rest. This is when the environment has been populated with any furniture and machinery or equipment but is not in operation, i.e. the machines are not running and there are no personnel inside.
- In operation. This is when the personnel are going about their daily duties.
With most cleanroom operations, the majority of particulate is generated by personnel working within the room. It’s important to review the number of people that will be in the cleanroom, the gowning protocols, and the number of people per shift or the number of hours of operation per day.