In 2012, there was an outbreak of fungal meningitis because of poor handling at a compounding lab for a pharmaceutical company. The source was an injection epidural steroid that was then sent out to 23 different states. Because the guidelines for safe handling within a clean room were not followed, 14,000 patients were exposed to the contaminated drug and at a recent count 64 people have died and 751 have been treated for persistent infections.
Unfortunately, this is possible if the guidelines in a clean room facility are not strictly adhered to. Clean rooms are set up with strict regulations to maintain the cleanliness during the manufacturing process of materials. The clean room exists to help keep contamination from happening. The newest standards for the USP 800 will help to insure that the handling of hazardous drugs will be kept in compliance for utmost safety of the handlers and those who benefit from the end product.
At Travis Clean Air, we strive to create the best product possible for your facility so you stay in compliance with the federal standards. We can build the clean room according to the USP 800 standards for handling hazardous drugs in a healthcare setting, but it’s up to you to remain compliant to the standards. Contact us for more information or to get started on designing a room for your facility. Our rooms are guaranteed in writing to pass certification according to USP 797 standards, however, we are now consulting on USP 800 standards.
(Click here for more info from the CDC on the fungal meningitis.)