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USP 23-29 PURIFIED WATER CLOSED-LOOP |
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PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURING WATER SYSTEM SELECTION GUIDE |
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PHARMACEUTICAL USP WATER SYSTEMS, APPLICATIONS IN PHARMACEUTICAL MANUFACTURING, MEDICAL DEVICE MANUFACTURING, MEDICAL DEVICE RINSING |
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USP WATER |
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USP 22 OR EARLIER WATER FOR INJECTION CLOSED-LOOP |
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USP 22 OR EARLIER PURIFIED WATER |
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USP 22 OR EARLIER PURIFIED WATER CLOSED LOOP |
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USP 23-29 PURIFIED WATER |
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USP 23-29 WATER FOR INJECTION CLOSED-LOOP |
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USP 23-29 WATER FOR INJECTION |
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USP 22 OR EARLIER WATER FOR INJECTION |
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1 According to U.S. FDA, USP purified water and USP WFI are components or “ingredient materials” as they are termed by the USP, intended to be used in the production of drug products. Neither FDA nor USP considers them as drug products. These two water categories are popularly used within pharmaceutical and medical device manufacturing establishments. |
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Blue Spring has the most diversified |
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APPLICATION |
SYSTEM TO USE |
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Pharmaceutical manufacturing. Water quality according to USP 22 Water-for-Injection standards1 or similar international standards. Single point of use; such as, a compounding tank or a WFI storage tank. |
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Pharmaceutical manufacturing. Water quality according to USP 23-29 Purified Water standards1 or similar international standards. Single point of use; such as, a compounding tank or a storage tank. |
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Pharmaceutical manufacturing. Water quality according to USP 22 Purified Water standards1 or similar international standards. Multiple points of use; such as, compounding, steam sterilization, bottle washing machines, laboratory. |
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Pharmaceutical manufacturing. Water quality according to USP 23-29 Purified Water standards1 or similar international standards. Multiple points of use; such as, compounding, steam sterilization, bottle washing machines, laboratory. |
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Pharmaceutical manufacturing. Water quality according to USP 22 Water-for-Injection standards1 or similar international standards. Single point of use; such as, a compounding tank or a storage tank. |
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Pharmaceutical manufacturing. Water quality according to USP 23-29 Water-for-Injection standards1 or similar international standards. Single point of use; such as, a compounding tank or a storage tank. |
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Pharmaceutical manufacturing. Water quality according to USP 22 Water-for-Injection standards1 or similar international standards. Multiple points of use; such as, compounding, steam sterilization, bottle washing machines, laboratory. |
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Pharmaceutical manufacturing. Water quality according to USP 23-29 Water-for-Injection standards1 or similar international standards. Multiple points of use; such as, compounding, steam sterilization, bottle washing machines, laboratory. |
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Medical device manufacturing, rinsing, testing. Non-critical devices. Non-pyrogenicity required. Medium chemical and ionic purity required. |
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Medical device manufacturing, rinsing, testing. Non-critical devices. Non-pyrogenicity not required. High chemical and ionic purity required. Water per USP Purified Water standards1. |
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Medical device manufacturing, rinsing, testing. Non-critical devices. Non-pyrogenicity required. Medium chemical and ionic purity required. Multiple production lines, or multiple points of use. |
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Medical device manufacturing, rinsing, testing. Critical devices. Non-pyrogenicity required. High ionic purity and low TOC required. Water per USP Water-for-Injection standards1. |
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Medical device manufacturing, rinsing, testing. Critical devices. Non-pyrogenicity required. High ionic purity and low TOC required. Water per USP Water-for-Injection standards1. Multiple production lines, or multiple points of use. |
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Medical device re-processing. Final rinse water, such as used with typical washing machine. Water per USP Purified Water standards1. Single point of use. |
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Application not listed above |
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