It can never be understated as to how important the cleanliness standard is in the cleanroom. If standards aren’t followed the consequences could be monumental. A Tennessee pharmacy cleanroom recently violated these cleanroom standards.
In addition to standard cleanliness regulations, cleanrooms that handle pharmaceutical compounding are also held to USP 797 regulations. These regulations are put into place with the intent of helping to protect the consumers of pharmacy products.
A Tennessee pharmacy was recently investigated by the FDA after several people had gotten sick from steroid injections produced in their laboratories. The FDA found terrible working conditions and a cleanliness standard that had long since vanished. The FDA findings included spiders, unclean and stained surfaces, improper handling of components and a machine leaking motor oil.
Many of these problems stem from a basic lack of written cleaning procedures. Keeping a cleanroom clean requires many steps, and having a written procedure will ensure that all areas of the room are properly cleaned. As seen in the Tennessee pharmacy mentioned above, cleaning procedures are vitally important.