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Abstract: Shanghai Lefeng Marketing Department described the requirements of CLSI clinical laboratory reagent pure water CLRW in this paper. It compared CLRW with Chinese Pharmacopoeia water for injection, and introduced the maintenance and management of pure water by CLSI. SRW, IFW and other concepts are briefly described.
CLSI is the English abbreviation of the Clinical and Laboratory Standards Institute. CLSI provides accurate application guidelines and treatment recommendations for a variety of clinical medicine programs, including C3-A4, which is a document on pure water quality standards. For clinical laboratory reagents pure water CLRW, CLSI is defined as follows:
At present, China's domestic clinical laboratory pure water uses the standard of purified water or water for injection as described in the Pharmacopoeia. However, with the deepening of internationalization, more and more medical institutions are in the process of complying with internationally accepted standards. CLSI related standards have been used.
What are the similarities and differences between CLRW and Chinese Pharmacopoeia (2015 edition)?
1. Different test items The Chinese Pharmacopoeia (2015 edition) water for injection test includes pH value, conductivity (25 ° C), total organic carbon, and microorganisms. The CLRW test items are resistivity (25 ° C), microorganisms, total organic carbon and particulate matter.
2. The resistivity requirement is greatly improved. The Chinese Pharmacopoeia (2015 edition) requires a conductivity of ≤1.3 μS/cm for water for injection, which is equivalent to a resistivity of ≥7.7 MΩ•cm. Compared with CLRW, the requirements are greatly improved. This requires that the pure water machine can not only use RO technology, but should also use DI or EDI technology for further purification.
3. Bacterial microbial requirements Different Chinese Pharmacopoeia (2015 edition) requires a bacterial content of < 1 cfu/mL for water for injection. CLRW requires a bacterial content < 10 cfu/mL.
4. TOC requirements are consistent. The limits for both TOC are < 500 ppb.
Lefeng's Super-Genie Central Pure Water System and Genie Pure Water System produce and deliver clinical laboratory reagent pure water that meets CLRW requirements. Lefeng uses IonPure's EDI technology to provide pure clinical laboratory reagents with constant flow rate, stable performance and reliable water quality, cost-effective and annual maintenance costs. 
What are the requirements for CLSI for purified water manufacturers?
In addition to the regulation of the water quality of CLRW, C3-A4 also lists the purification techniques applicable to clinical laboratory water, the requirements for equipment and routine maintenance, and how to conduct water quality testing and management. Therefore, effective water quality analysis and quality control methods are as important as excellent quality pure water. In particular, instrument water supply, regular inspection and analysis of water quality, regular maintenance, verification and verification of system operation, recording and archiving of all relevant data are essential for the quality assurance of pure water in clinical laboratories.
Therefore, pure water equipment manufacturers should not only be able to provide 3Q verification services, help clinical laboratories pass ISO15189 medical laboratories - special requirements for quality and capability; also help users to establish appropriate management practices, provide regular maintenance, record Related data information.
Lefeng's Super-Genie Central Pure Water System and Genie Pure Water System can record more than two years of data and export unmodifiable files to ensure record fairness. Lefeng can not only provide Chinese and English 3Q certification and complete verification procedures for various standards: IQ (installation confirmation), OQ (operation confirmation), PQ (performance confirmation) and maintenance procedures in ISO15189 environment; Customer requirements, providing high quality technical and maintenance support, including assisting users in establishing specifications, regular maintenance and customized service solutions. Maintenance services are in place to ensure peace of mind. 
Can CLRW meet all the requirements of a clinical laboratory?
Clinical laboratory reagents Pure water CLRW is pure enough to meet the requirements of most routine clinical laboratories. However, CLSI also stipulates that specific pollutants should be excluded according to specific needs, so pure water (ultra-pure water) with different parameters is required. For example, special reagent water (SRW) for metal analysis, PCR, DNA/RNA analysis, cell culture, immunoassay, etc.; instrument recommended by the instrument manufacturer - biochemical analyzer, etc. - IFW (influent water) Instrument feed water).
Lefeng can provide a complete set of clinical laboratory water solutions based on the specific needs of users. Lefeng has a full range of formulated packing purification columns - low TOC type, low magnesium type, low boron type, ICP type, etc., which can accurately provide pure water for users. Lefeng also offers different end filters to prepare ultrapure water without pyrogen (endotoxin), nuclease and bacteria for biochemical analysis and molecular biology.
Keywords: CLSI, CLRW, clinical, pure water, biochemical analyzer, ISO15189, Chinese Pharmacopoeia, Shanghai Lefeng, RephiLe, Genie water purifier, Super-Genie water purifier
About Shanghai Lefeng Biotechnology Co., Ltd.
Shanghai Lefeng Bio is specialized in the research, development, design and manufacture of high-end water purification and laboratory separation and purification products, and is committed to providing cutting-edge, high value-added innovative products for life sciences and biotechnology. The Lefeng product line includes laboratory pure water systems, Millipore pure water compatible consumables and laboratory separation and purification filtration products. Established ten years ago, Lefeng has established its own brand RephiLe (Ruifeng), with more than 30 patents and multiple software copyrights. Products are sold to nearly 90 countries and regions around the world. For more information on RephiLe products, please visit: Le Feng official website 
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