The Solution

The Azzur team worked hand-in-hand with the client to develop a customized validation master plan, helped the manufacturing organization drive the schedule and project resources and clarified the qualification education strategy ensuring the implementation of a validated state.
 
Once commissioning was complete, the team of Azzur SMEs partnered cross-functionally on system testing and qualification, including, but not limited to:

• DQ/IQ/OQ for process equipment
• DQ/PQ for utilities, including purified water, steam in place, clean in place, ammonia, water for injection, compressed air, hydrogen, etc.
• Analytical Laboratory Instrumentation
• Controlled Temperature Units (CTUs)
• HVAC/Cleanroom Certification
• Buffer Generation
• Steam in Place (SIP)