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Designing and building a new research laboratory is a challenging feat in itself, but when you are a company involved in manufacturing life-saving prognostic tests, the project becomes much more than just a challenge. This was the situation Aureon Laboratories faced six years ago.
Based in Yonkers, N.Y., Aureon develops personalized, predictive cancer tests and provides contract research services to assist biopharmaceutical companies in developing effective cancer treatments. Aureon incorporates a team of scientists and medical doctors who are specialized in molecular pathology, sophisticated image analysis and advanced mathematics in order to apply a systems pathology approach to better understand and determine which patients’ prostate cancer will recur, how aggressive their disease will be and patient response to treatment. Although Aureon’s initial tests focus on the prostate cancer market, future tests shall address other solid tumors such as breast, lung, colorectal and bladder cancer.
Testing the Water
The water used in clinical testing and research must be extremely pure. Tap water often contains particles, dissolved organics and dissolved inorganics that can have a negative effect on the results of critical laboratory test methods. In order to remove these contaminants, the water must be treated with a combination of technologies to meet the laboratory’s final purity level. Depending on the application, the water may require further treatment to establish an even greater level of purity.
Aureon’s laboratory water is used for research and development and it prognostic testing purposes, and must meet the American Society for Testing and Materials (ASTM) Type I reagent-grade water specifications. ASTM specifies that Type I water must have a resistivity of 18 megohm-cm, a maximum bacteria count of 10/1,000 mL and an endotoxin level less than 0.03 EU/mL. The water Aureon uses for general purposes, such as washing and rinsing glassware, can be ASTM Type II water quality.
“We require high-purity water for our many molecular pathology, DNA, RNA and protein applications, including the diverse tissue processing technologies,” said Dr. Charles J. DiComo, director of laboratories for Aureon. “We also carry out commercial processing and contract work, so we have to consistently hit our specifications.”
The Central System
Aureon purchased a complete laboratory water treatment system in August 2002 to meet its water specification requirements. Incoming city water is fed to a central treatment system that consists of multimedia, carbon and softening pretreatment systems, 1-micron filtration and a 75% recovery reverse osmosis system feeding a 250-gal storage tank.
The water from the tank feeds two 25-gpm distribution pumps and is then sent to two parallel (four total) mixed-bed tanks, a 25-gpm ultraviolet system (UV) and 0.2-micron filtration. The entire system is controlled and monitored by a central programmable logic controller that monitors all operational functions.
From the central treatment
system, the water is sent through a 1-in. polyvinylidene fluoride (PVDF) loop piping system, which feeds two glassware washers, a high-purity clean steam generator and 10 point-of-use (POU) faucets and laboratory water treatment systems located in various labs.
A PVDF gooseneck faucet is at the sink in each lab and supplies general-purpose deionized Type II water, while the POU system supplies Type I water. There also is a POU system installed in a walk-in freezer box where the temperature is only 33°F. An extended loop feeds tissue staining devices and a darkroom.
DiComo turned to Siemens Water Technologies to provide the entire treatment system. In addition to requiring a system that could produce the specified water quality, DiComo also needed equipment that could fit into a tight space. Of the 15,000 sq ft available, 8,500 sq ft was for lab space and even less room available for the central water treatment system.
The polishing systems are the compact PURELAB Ultra systems, designed to produce ASTM Type I ultrapure water for critical biological and analytical laboratory techniques. This system incorporates DI, UV and ultrafiltration (UF) technologies. Pretreated water from the central water treatment system enters the PURELAB system and flows through the DI cartridge pack, which consists of two DI cartridges. A dual-wavelength (185-nm and 254-nm) UV sterilizer between the two DI cartridges oxidizes the organics that made it through the first DI cartridge and kills bacteria and reduces the total organic carbon.
The water then enters a 5,000-nominal molecular weight UF cartridge that removes pyrogens. The quality of the water exiting the system is 18.2 megohm-cm. A PURELAB system was installed in the walk-in freezer box so that scientists performing nucleic acid- and protein-purification protocols would not have to leave the area to get high-purity water or worry about the water purity degrading in transit from another lab. To prevent the water from freezing, the system remains in recirculation mode at all times.
In order to ensure that the equipment performs at its peak level at all times, Aureon has a preventive maintenance agreement that covers the lab water equipment. “With a laboratory our size, which is the life blood of our business, we need to maintain these systems,” DiComo said. “Who better than the experts who designed and installed the system to come in and service it?”
Under this agreement, the services Siemens provides include system and loop sanitization, cartridge replacement and water quality testing. Aureon lab personnel, as well as an outside firm, test the final product water for bacteria in addition to the testing that Siemens does to ensure it consistently meets specification.
An article on Aueron’s laboratory appeared in R&D Magazine, December 2007.