Bring Your System Online
Our Process
Commissioning & Start-up Preparation
- Equipment
- Piping
- Valves
- Instrumentation
Piping Check-Out
- Caustic wash/surfactant to remove oil, grease, & other contaminants
- Detergent flush
- Acid wash to complete the cleaning process & remove elemental iron from stainless steel surfaces
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.
What can cause repeated contamination of a previously sterilized production system? Examples include:
Mechanical Completion Audits
Electrical & Instrumentation Calibration & Check-out
- AMG, Inc., written documentation and/or
- Client-written documentation reviewed by AMG, Inc.
Perform turn-over