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By Atlas High Purity Solutions team • October 12, 2020

USP Water System for Medical Device Manufacturer in Maine

Atlas High Purity Solutions summarizes the design and installation of a USP water system at a medical device manufacturer in Maine


Challenge

A multinational medical device manufacturer required a new USP ultrapure water system to support their production of a COVID rapid testing device. The testing device had been recently approved by the FDA and the company was mobilizing as quickly as possible to begin production. Due to the urgent nature of the situation, the project was to be initiated with extreme urgency.

Having recently installed several similar systems, Atlas High Purity Solutions was contacted to design, install, and commission the ultrapure water system. All stakeholders were aware of the urgency and importance of this installation. The customer's facilities team and contractors moved in lock step at an unprecedented pace, with the shared recognition that efficiency and speed from all parties involved would be critical to the project's success.

Solution

Atlas moved swiftly to respond to the customer's urgent timeline. By the time an order was placed for the system, Atlas had 6 weeks to complete the design, build, and installation of the equipment. Atlas pre-fabricated the system at its Boston-based facility. The customer's facilities team and contractors completed preparation of the room that was to house the water system on a Monday. The Atlas team was on site on Tuesday to install the USP water system. The ultrapure water system was commissioned immediately after installation, allowing the customer to move forward with next steps in ramping up their facilities for production.

Atlas is a regionally-focused company that differentiates from its competition with a combination of superior responsiveness and technical expertise. In this instance, it was a critical combination for the success of the customer's urgent project.

USP water quality criteria met by this water system included:

  • Bacteria [colony-forming units per milliliter (cfu/ml)] – less than 100 cfu/ml
  • Conductivity – less than 1.3 microsiemens/cm @ 25 C
  • Total Organic Carbon- less than 500 PPB
  • pH (relative to conductivity) – 5.0 to 7.0
  • Endotoxin – less than 0.25 EU/ml

 USP water system

 

USP water system 2

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Atlas High Purity Solutions has been designing, installing, and servicing ultrapure water systems for more than thirty years, and is the leading provider of reverse osmosis and DI water solutions in the northeast United States.

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