What is the difference in cleanroom contamination concerns amongst the industries, and what is the best way to ensure compliance?
Contamination to the product in any cleanroom is very costly. Contaminated products can’t be sold, so the investment in raw materials and labor is completely lost, and starting over means duplicate costs.
The two sources of contamination are particulate and microbial. Most commonly, humans are the vehicle for contaminates. In any case, sources and entry paths don’t vary significantly by industry. What is different amongst the industries is tolerable versus intolerable levels of contamination.
A high-tech manufacturer makes microscopic products that can’t accept any particulate contamination at all. The tiniest speck of dust would look enormous on a microchip. However, the focus for these products is the sterility of the chip. Mold, fungus, and other forms of contamination are of no concern. A high-tech device only has to pass the company’s own internal checks. If a laptop of television works, it ships.
On the other hand, the pharmaceutical industry has to adhere to strict FDA and Good Manufacturing Practice (GMP) regulations. Pharmaceutical manufacturers don’t just need products to be microbial-free; they also have to verify their paper trail for everything. They can’t check their product by plugging it in and turning it on. That’s why it’s so important for these organizations to have, use, and document cleanroom procedures.
It is a wise idea to hire professional and experienced outside help to clean a cleanroom at the end of the day. The last thing that internal staff wants to do at the end of a long shift is painstakingly clean all of the equipment in their lab. With the right experts and equipment, your environment should exceed the highest regulations for contamination control, maintenance, cleanroom control, and safety.
If you need your cleanroom certified or validated, trust the experts at Gerbig Engineering Company. We have been working with cleanrooms since 1985. Call 888-628-0056 or email firstname.lastname@example.org.