The cleanroom classification needed depends on specifications for operations to be conducted within. Research in your specific field will probably provide a specification or at least a general guideline.
FDA requirements cover several types of clean facilities, the most generally known being USP 797, specifying conditions for pharmaceutical compounding facilities.
Very generally speaking, simply keeping products “clean,” as in dust-free to the human senses during packaging and similar processes, probably fits within Class 10,000 or even Class 100,000. “Clean” storage of previously-packaged products usually fits in Class 100,000. Basically, if the operating staff wears frocks and possibly hairnets but not masks, bunny suits, booties and the like, these two classes probably fit.
If full suiting is required for more contamination-sensitive products or difficult contaminants, a Class 1,000 environment or cleaner will generally be required.
If your application requires a Class 100 or Class 10 environment, you already know it, or certainly should.
An important cost reduction potential is to design areas with different cleanliness levels for different operations. For instance, a gowning room for a Class 1,000 cleanroom could be effective at Class 10,000. This reduces the number of Fan-filter units (FFUs) and lowers operating costs.
These classes refer to environments with reduced particulate contamination, not to creating sterile environments. Consult your industry standards for sterile environments. The cleanroom is only part of the equation for a successful clean operation. Cleanroom garments such as frocks, coveralls, gloves, face masks, booties and head covers are often used because people are a major source of contamination.
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