LABORATORIES PHARMACEUTICALS USP WFI

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Abstract

The non-regulated laboratory environment has long been an overlooked aspect of the water purification community in regards to applying water purification standards. When we speak of water standards in regards to the scientific community, it is commonplace that the main focus is on those water purification standards that have been set forth for the bio-pharmaceutical market. Mainly, the water standards described by the United States Pharmacopeia (USP) that are in line with the water quality deemed appropriate by the U.S. Food and Drug Administration (FDA) for the production of parenteral drugs. This is all understandable because of the importance that these water standards hold in helping to provide safe drugs to those people in need of them. There also exists another large contingent of purified water users in the scientific community though and these include the non-regulated laboratory water users. Common examples include most academic laboratories, small research laboratories that exist as part of a larger organization, and small startup laboratories among many others. What these types of laboratories all have in common is that they do not fall under the regulatory umbrella. They are not regulated by such organizations as the FDA, and they do not have to adhere to such standards as those set forth by the USP. In fact, they do not have to adhere to any standard should they choose. These laboratories represent a large percentage of the actual purified water users within the scientific community, and it is for a logical reason that these users of purified water are not required to adhere to any specific standard, and that is because these users are not producing materials for human use. The question then becomes why should non-regulated laboratories adhere to any standard in regards to the purified water they apply to their research methods.

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