A high-purity water system is a top priotory when designing a new research lab.
Designing, building and equipping a research lab is a challenge for any organization. But when you’re a company involved in manufacturing a potential life-saving prognostic test, it becomes a fast-track project.
That was the challenge Aureon Laboratories, Yonkers, N.Y., faced five years ago.
“Building a new lab from scratch is an interesting ballet,” comments Charles DiComo, Aureon’s director of laboratories. “The fact that we needed to complete everything in four months made it even more challenging.”
Aureon develops predictive tests for cancer recurrence and provides contract research services to assist biopharmaceutical companies in developing more effective cancer treatments. The company’s first commercially available prognostic test, Prostate Px, predicts prostate cancer recurrence and disease progression in patients who have had a prostatectomy.
Although Aureon’s initial tests focus on the prostate cancer market, future tests will predict cancer recurrence in other solid tumors such as lung, colorectal and bladder cancer.
The need for pure water
Aureon’s system processes city water into Type I and Type II water for use in their research laboratory. Click to enlarge.
The water used in research and clinical testing must be extremely pure. Tap water typically contains particles, dissolved organics, and dissolved inorganics that can negatively affect the results of critical laboratory test methods. To remove these contaminants, the water must be treated with a combination of technologies to meet the laboratory’s final purity level. This water may require further treatment or “polishing” to an even greater level of purity, depending on the specific application.
Aureon’s laboratory water used for research purposes 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 18.0 MV -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 glassware washing and rinsing, 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,” says DiComo. “We also carry out commercial processing and contract work. So, we have to consistently hit our spec.”
Designing the system
To meet these requirements, Aureon purchased a complete laboratory water treatment system in August 2002. Incoming city water is fed to a central treatment system that consists of multi-media, carbon, and softening pretreatment systems, 1.0-µm filtration, and a 75% recovery reverse osmosis (RO) system feeding a 250-gallon 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 (UV) system, and 0.2- µm filtration. The entire system is monitored and controlled by a central programmable logic controller (PLC) that monitors all alarm and operational functions.
From the central treatment system, the water is sent through a 2.5-cm PVDF loop piping system which feeds two glassware washers, a high-purity clean steam generator, and ten point-of-use faucets and laboratory water treatment systems located in various labs. At the sink in each lab is a PVDF gooseneck faucet that supplies general purpose, deionized (DI) Type II water, while the point-of-use system supplies Type I water. There is even a point-of-use system installed in a walk-in freezer box, where the temperature is only 4°C. An extended loop feeds tissue staining devices and a darkroom.
DiComo chose Siemens Water Technologies, Warrendale, Pa., to provide the entire treatment system. Besides requiring a system that could produce the specified water quality, he needed equipment that could fit into a tight space. Of the 15,000 ft2 available in the Phase I build-out, 8,500 ft of that was lab space, and even less was available for the central water treatment system.
The polishing systems are the compact PURELAB Ultra systems, designed to produce ASTM Type I ultra-pure water for the most critical biological and analytical laboratory techniques. The PURELAB Ultra incorporates DI, UV, and ultrafiltration (UF) technologies. Pre-treated 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 in between the two DI cartridges oxidizes the organics that made it through the first DI cartridge and also kills bacteria and reduces the total organic carbon (TOC). 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 MV-cm.
DiComo decided to have a PURELAB system installed in the 4°C 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. The system remains in recirculation mode at all times to prevent the water from freezing.
Guaranteeing purity in the future
To ensure that the equipment performs at its peak, Aureon has a preventive maintenance agreement that covers all lab water equipment.
“With a laboratory our size, which is the life blood of our business, we need to maintain these systems,” says DiComo.
The service Siemens provides under this agreement includes system and loop sanitization, cartridge replacement, and water quality testing. Since the central treatment system is remote from the laboratory area, an alarm on the central system automatically dials DiComo’s cell phone, as well as the cell phone of a Siemens representative, to alert them of a possible system problem.
Aureon lab personnel test the final product water for bacteria and also have an outside firm test the water to ensure it consistently meets specification. DiComo says the lab water equipment has performed very well over the past five years.
“All the Q.C. (quality control) on the equipment shows that the water quality is consistent. We’ve had no problems with the operation of the systems or the loop. Once in a while, a valve will go or something needs to be replaced, but that’s just normal wear and tear.”
DiComo adds, “The system is as rock solid as the day it was installed. I’m looking forward to getting many more years out of it.”
