Purified water is required for a wide range of ap-
plications within a facility, including cleanrooms. Water quality needs can range from laboratory grade to ultra-pure water, depending on the sensi- tivity of critical applications. The quantity of water needed from one point of use (POU) to another can vary from a few liters per day to several hun- dred liters per day. Understanding and then meet- ing these various requirements is a challenge but is critical in the design of a total water purification system for a cleanroom facility. Design process stages The design process can be broken down into four simple phases: in- vestigation, approach selection, loop design and finalization. Phase I: InvestigationA successful design outcome depends on the designers ability to establish precisely the needs at each POU in the facility. Although investigating a facilitys water requirements may appear straightforward, it is essential to have a well-defined plan. Understanding a facilitys water quality needs requires knowledge of various water quality standards and the organizations that pub- lish them. Determining the correct standards to follow depends on the regulatory environment in which the facility operates and the specific applications at each POU. Organizations such as the American Society for Testing and Ma- terials (ASTM), College of American Pathologists (CAP), Interna- tional Organization for Standardization (ISO), National Committee for Clinical Laboratory Standards (NCCLS), and United States Pharmacopeia (USP) all publish their own water quality standards. Typically, industries tend to follow the requirements of their affiliat- ed organizations. For instance, in the medical diagnostics field, labo- ratories usually follow CAP or NCCLS standards. USP is written and followed by the pharmaceutical industry, and ISO standards are fol- lowed by quality organizations across multiple industries. In certain areas, such as the pharmaceutical industry and medical diag- nostics, water quality standards are regulated and require compli- ance. To eliminate some confusion, we have defined water purifica- tion specifications that acknowledge regulatory agency standards (see Figure 1). After the water quality requirements have been established, the next step in the process is to determine the facilitys water quantity requirements and how the water will be accessed. If the facility will have multiple POUs, then it is important to determine how much water will be used at each POU. In facilities with glassware washers, autoclaves or other equipment incorporated in the loop, the neces- sary flow rates and pressure requirements for this equipment must be considered when determining the total quantity of water required. Correctly identifying these needs and locations will make the differ- ence in successfully designing a water purification system for a clean- room environment. Phase II: Approach selectionFor many years, the conventional approach has been to plumb water throughout a building or facility in a single-loop configuration with a single make-up system. Often, the loops can run for thousands of feet. If the loop becomes con- taminated or the make-up system fails, then the entire facility can be without water until the problem is resolved. Facilities can be shut down completely for several days due to water contamination issues. Using multiple make-up systems (duplex design) to feed a loop lowers the risk of potential damages from a single make-up system failure. The duplex system approach adds redundancy to the config- uration, but is similar to the conventional approach. If the loop be- Designing a water system Quality and quantity both matter in the design of water systems for clean scientific laboratory facilities BY DALE GORDON, MORGAN NORRI S AND GUY HART Water purification Parameter (units) Type I Type II Type III Contaminant Ions Resistivity M*cm >18.0 >1.0 >0.05 Silica (ppb) <10 <100 <1,000 TOC (ppb) Organics <20 <50 <200 <100 <1,000 Particles >0.2 m (units/mL) Particles <1 NA NA Bacteria (cfu/mL) Bacteria <1 NA NA Endotoxin (EU/mL) <0.001 Figure 1: Water purification specifications Reprinted with revisions to format, from the October 2004 edition of CLEANROOMS Copyright 2004 by PennWell Corporation comes contaminated, then all POUs are out of service until the loop can be decontami- nated completely. Another approach is to use several small- er loops feeding indi- vidual floors or de- partments. The added redundancy reduces the risk of a total facil- ity shut down. Having several smaller loops allows departments or individual floors to maintain and control their systems locally. Water is the most com- monly used reagent in most facilities, leading end users to become more involved in the maintenance of the systems. The localized loop approach begins to put some control back in the end users hands. A hybrid approach uses a small central system with polishers at each point of use. The advantage is the ability to plumb a lesser grade of water in the loop and then raise it to the desired quality level at the POU. Howev- er, there is still an inherent risk of loop con- tamination and downtime, which also can shut down a facility completely. When selecting an approach for getting water to multiple POUs with varying quan- tity and quality requirements, there are cer- tain rules that should be followed. For exam- ple, it is important that the system continuously circulates water through a fa- cility. The water must be kept moving con- tinuously as stagnant water is a source of bacterial proliferation. Without a properly designed loop, the water cannot be circulated endlessly. Therefore, dead-legs (areas where water sits in the system) must be kept to an absolute minimum. Failure to do so is invit- ing bacterial contamination. Lastly, shorter loops typically result in less contamination. Once an approach is selected that incorpo- rates one or more distribution loops, it is time to select the purification and monitor- ing equipment within the loop. Phase III: Loop designThe appropriate materials of construction for the piping in- frastructure and assembly are paramount in contributing to the preservation of the water quality within the loop. Identifying the most appropriate material and assembly method requires an analysis of the end users appli- cation(s), water quality needs and desired cleaning and/or sanitization protocol. Using the proper piping materials will minimize degradation of the purified water during distribution. There are a range of ma- terials to choose from, including PVC, stain- less steel, polypropylene and PVDF. Charac- teristics that differentiate the piping materials include material cost, installation cost, heat resistance and tendency to leach organic material into high-purity water. For the majority of applications found in the cleanroom environment, polypropylene serves as an excellent choice for loop piping. It is a relatively inexpensive piping material with low installation costs and poses mini- mal risk of leachable contamination into the high-purity water. Polypropylene is not a heat-resistant material and these loops can- not be heat sanitized. The presence of biofilm within a piping system is inevitable and exists to some degree in all water piping systems. A targeted flow ve- locity of 3-5 ft/s within the piping system is viewed as critical for minimizing the adverse effects of biofilm build-up and bacteria pro- liferation. This velocity effectively reduces biofilm because it creates a turbulent flow pattern within the piping. In turn, turbulent flow patterns make it difficult for bacteria to adhere to the piping walls. Flow rates well below this range create a laminar flow condi- tion, where water flows with minimal turbu- lence through the pipe. This makes it easier for bacteria to adhere to piping walls and con- tributes to biofilm development. In selecting the size and performance characteristics of the required distribution pump, one must balance the flow rate, pres- sure drop, pipe diameter of the distri- bution piping system, and targeted flow velocity of 3-5 ft/s. To do so re- quires the following actions: 1. Determine the expected distri- bution loop length (include fittings, valves, etc.) along with an accurate as- sessment of the number and flow rate requirements at each of the points of use. 2. Choose an initial pipe diameter (_, _, 1 1 _, etc) reflecting the length and point-of-use profile of the distribution loop as determined above. For smaller loop con- figurations with minimal points-of-use and flow requirements, a smaller pipe diameter may be anticipated. For larger configura- tions, a larger pipe diameter might be ex- pected. Keeping flow requirements and tar- get velocity in balance by increasing or decreasing the pipe diameter is an optimal way for reducing pressure losses (see Figure 2). 3. To calculate the required distribution pump pressure, begin with the minimum pressure needed at the most remote point of use. This can be achieved using a back pres- sure regulating valve at the end of the distri- bution piping. To this minimum pressure add the pressure loss through piping equip- ment and be sure to factor for piping eleva- tion changes. The ideal total target loop pres- sure is 55-75 psi (90 psi maximum). Loop monitoring components and devices should be incorporated within the loop design to verify and document performance. Conductivity or resistivity monitors should be used to measure ionic purity levels. Total Organic Carbon (TOC) monitors are used to measure the levels of organic carbon compounds present in the Water purification Investing in a total pure water solution is essential for any fully functioning cleanroom. In order to ensure success, we recommend a service plan that includes priority access to the service organization, routine validation and preventative maintenance visits. 3 to 5 ft/sec design target (~1 to 1.5 m/sec) Nominal size 1 /2 in. 20 mm (0.79 in.) 0.59 in. 2.6 3.4 4.3 3 /4 in. 25 mm (0.98 in.) 0.77 in. 4.4 5.8 7.3 1 in. 32 mm (1.26 in.) 1.02 in. 7.7 10.2 12.7 1 1 /4 in. 40 mm (1.57 in.) 1.28 in. 12.0 16.0 20.0 1 1 /2 in. 50 mm (1.97 in.) 1.61 in. 20.0 25.0 32.0 Outside diameter Inside diameter Flow rates (gpm) at velocity: 3 ft/sec 4 ft/sec 5 ft/sec Figure 2: Velocity through distribution pipe loop. The best designed make-up systems in- corporate these monitors. Sanitary sampling ports or valves provide standard and clean protocols for collecting purified water sam- ples to be tested and monitored. The water produced by the make-up sys- tem is typically stored in a reservoir or dis- tribution throughout the loop. Reservoirs are available in many sizes, configurations and materials of construction. Common practice is to use tanks con- structed of molded polyethylene because it produces a very smooth finish inside of the reservoir and minimizes biofilm growth. Well-de- signed reservoirs also have a conical bot- tom that allows them to be completely drained and ensures that the water within the reservoir is completely turned over. San- itary overflow devices, vent filters and CO 2 traps may be incorporated to sustain the de- sired water quality levels within the reservoir by preventing the ingress of airborne con- taminants. Properly sizing a reservoir re- quires selecting one large enough to meet peak demands during the day, but small enough that the water is completely turned over on a daily basis. Once a loop design has been completed along with an assessment of high purity water needs, select a make-up system that meets the quantity and quality needs determined in the previous steps. Next, a water chemistry analysis should be per- formed on the incoming feed-water. The re- sults of this analysis and the feed-water re- quirements of the make-up system will be used to determine the proper pretreatment needs. Phase IV: FinalizationFurther consid- erations when finalizing the design of the system include the physical facility, installa- tion, validation, and/or ongoing mainte- nance. In evaluating the facility it is impor- tant to recognize the available space and access limitations. Commonly overlooked is- sues include access to the room where the make-up system will reside, especially stairs and doors that need to be navigated when entering the area. As the size of the water pu- rification system increases, particularly the size of the reservoir, these issues become more important. The system designer also should check with the proper partieseither the facilities group or building architectto ensure that the location has the required electrical, drain and feed-water require- ments. If the system requires validation, then the manufacturer should be consulted. Manu- facturer validation packages tend to be more thorough and well designed because of their in-depth knowledge of the equipment. In most cases it is also a less expensive method because the manufacturer already has devel- oped the necessary protocols. Support services Ongoing maintenance and required service will be needed for many of the components in the system. The manufacturers service organ- ization is the best option for this work be- cause they know the system better than any- one else and have better access to spare parts and technical personnel that may be needed to maintain the system. Investing in a total pure water solution is essential for any fully functioning cleanroom. In order to ensure success, we recommend a service plan that includes priority access to the service organization, routine validation and preventative maintenance visits. This guarantees that your system produces a high quality of water to keep the facility working productively. Conclusion The design of a pure water system should be an initial consideration when building a cleanroom facility. As essential as overall sterility, it can often pose contamination, pro- ductivity and financial risks if not managed properly. Deploying the four simple phases of investigation, approach selection, loop design and finalization establishes a smooth and reli- able process. III DALE GORDON is regional business manager, MORGAN NORRI S is product mar- keting manager and GUY HART is regional custom systems specialist in the Lab Water Division, Millipore Corporation, 290 Concord Road, Billerica, MA 01821; for more informa- tion, call 781-533-6927 or e-mail dale_gor- don@millipore.com. Water purification A successful design outcome depends on the designers ability to establish precisely the needs at each POU in the facility. Although investigating a facilitys water requirements may appear straightforward, it is essential to have a well-defined plan. RP1549EN00
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