Challenge

A major pharmaceutical manufacturer needed to expand a USP Purified Water distribution system with proper change control and validation procedures. The expansion had to be implemented with minimal system downtime.

Solution

Siemens Water Technologies implemented the system expansion on a total turnkey basis including engineering services.

• Demolition of obsolete equipment and piping was provided.
• The existing system was updated through addition of a steam sanitized activated carbon filter, ozone, conductivity and flow instrumentation, new ozone generation equipment, storage tank nitrogen blanketing, and increased pump capacity.
• Some distribution polishing equipment was moved into the generation system.
• Distribution capacity was increased through addition of a new distribution pumping system and installation of a new ---foot sanitary 316L SS distribution loop.
• The controls were modified in a validatable lifecycle methodology.
• All documentation was corrected with incorporation of the changes.
• The modified system was passivated, commissioned, and validated through the IQ and OQ protocols. SOP’s were provided for the new system and operator training was completed.
• Downtime was minimized through mechanical and electrical cut-in work during brief shutdowns prior to main project execution.  Piping installation was expedited with extensive prefabrication. 

Results

• By working with one water treatment company for the entire turnkey system, the company saved time and money, getting the facility’s system up and running all the faster.
• The facility now can deliver an additional 94,000 gallons per day.  
• The facility saved hundreds of thousands of dollars and many months of time with this expansion rather than through implementation of a complete new system. 
• The system produces water that easily exceeds all of the USP requirements for Purified Water.