Which Cleanroom Classification Level Do I Need?
We all like a simple answer but unfortunately, you might need different classification levels at various stages during the manufacturing of a product. For example to replace a screen on a mobile phone most of the procedure can be done in a workshop however the screen re-lamination is a particulate sensitive process and would need to be performed in a cleanroom and so in this example the phone would go from a non classified area to a classified area and then back to the non classified area for finishing.
Classification requirements are 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 industry has its own additional, industry-specific validation requirements. These could require additional certification by specialist agencies incurring costs of up to £10,000 for a small production or research facility.
Let us suppose that you have done your research and you have found that your process has a sensitive procedure that needs to be protected in an ISO class 6 cleanroom. That seems quite clear but be aware that 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.
During each of these states, the particulate will increase, degrading the room. It sounds obvious but if you put dirty equipment into your new ISO class 5 cleanroom it is not going to stay at ISO 5. If you don’t regularly clean your cleanroom it will not stay clean. If your operators wear the same clothes in your cleanroom as they do outside your cleanroom, it will not stay clean. Your requirement is for an ISO class 6 cleanroom ‘in operation’ and the way to ensure you maintain this level is through your standard operating procedures (sometimes referred to as SOP’s).
It’s important to review, as part of your SOP; the number of people that will be allowed in the cleanroom at any one time and the gowning protocols. The cleanliness of the equipment and products brought into the cleanroom along with the amount of equipment to be kept in the room will also have a strong influence. And of course, the regularity of the cleanroom wipe down procedure.