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THE PHARMA REVIEW
FEBRUARY 06
Water for Pharmaceutical use
S S Biradar, S T
Bahagavati, R D Hunshyal
Introduction: The pharmaceutical and bio-pharmaceutical industries demand high purity water systems that are reliable and capable of consistently providing the required Water for Injection (WFI) and Purified Water (PW) to meet the established standards of purity. The United States Pharmacopeia (USP) defines several types of water including: Purified Water, Water for Injection, Sterile Purified Water, Sterile Water for Injection, Sterile Bacteriostatic Water for Injection, Sterile Water for Inhalation, and Sterile Water for Irrigation. The USP states qualifications for sterility and packaging methods that delineate between the various specific types of water. However, there are two basic types of water preparation, Water for Injection and Purified Water. The analytical standards for these two types of water are very similar, differing in the fact that Water for Injection has stricter bacterial count standards and must also pass the bacterial endotoxin test. Preparation methods are very similar to a point The USP designation means that the water is the subject of an official monograph in the current US PHARMACOPEIA with various specifications for each type. The latter 4 waters are "finished" products that are packaged and labeled as such and need not be of concern during an inspection outside of plants which actually produce these products. The above content is an abstract only. For the full Article please contact: |
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