System Sterility

Initially, a system is sterilized by direct injection of low-pressure steam. Equipment, piping, and sterile barrier surface temperatures are checked and documented.

When necessary, a sterility challenge is performed. The system is inoculated with sterile media, and bacteria growth is monitored for several days. If contamination occurs, the system is completely disassembled and inspected to identify the root cause.

Sometimes, the system later shows evidence of contamination after a successful sterility challenge. AMG, Inc., can be called in to identify the source of contaminants and suggest actions that will prevent future contamination.