Challenge

A Biotech firm on the west coast needed to outsource the validation of its new USP Purified Water System. The firm needed to manage as few contractors as possible and needed to complete the qualification process as quickly as possible. The validation manager has a large workload, and found it increasingly challenging to rapidly manage multiple, complex projects with limited resources.

Solution

The Biotech firm found that using Siemens Water Technologies (formerly USFilter) to help validate their USP Purified Water System greatly facilitated the system qualification process.

• Siemens provides complete Factory Acceptance Tests (FAT), validation protocol packages and on-site execution to quickly complete the qualification process.
• We easily customize template protocols to make them “executable” by determining proper set points and operating conditions on a case-by-case basis.

Results

• The FAT saved at least a week in on-site execution time. The IQ and OQ both import testing data from the FAT. Also, much of the troubleshooting and fine-tuning is performed in the factory, not at the job site.
• By having the equipment expert involved with the execution, tasks are promptly completed.
• The equipment expert provides hands-on training for the end user during the qualification process.
• The enhanced speed and quality of the execution means that purified water is available for production weeks earlier than anticipated based on previous projects.