WHICH WATER IS CLASSIFIED IN PHARMACOPOEIAS
Only few types of water have USP designation and are subjects of official monographs in the current US Pharmacopeia. However, the same document says that “Although there are no absolute microbial standards for water (other than water intended to be sterile), the cGMP regulations require that appropriate specifications be established and monitored. (…) i.e. water used to formulate a product should contain no organism capable of growing in the product. (…)”. This is the reason for which in Bram-Cor every water treatment system is really customized and oriented to a specific pharmaceutical plant, line and product.
ISPE document (ISPE BASELINE© GUIDE, Water and steam Systems) explains what water can be used in the development, in manufacturing and in the preparation of drugs. These waters are divided into two categories:
1. COMPENDIAL WATER
2. NON-COMPENDIAL WATER
1. COMPENDIAL WATER
Compendial waters meet the USP, EP (European Pharmacopoeia) and JP (Japan Pharmacopoeia) requirements but, in according with FDA, the ISPE document notes that: “(…) the specifications outlined in the monographs (USP, EP end JP) are the minimum requirements for compendial water. Additional specifications may be added or combined based on process requirements”.
Compendial waters in ISPE examples are:
– PW (Purified Water), as defined by USP, EP, JP, ChP and IP monographs.
Purified Water is classified for pharmaceutical use as an excipient in the production of non-parenteral preparations and in specific pharmaceutical preparations/tests and assays, for which water is indicated, unless otherwise specified (see related USP, EP and JP pharmacopeia for reference). Drinking water is the minimal source of feed water to produce PW, through deionization, distillation, ion exchange, reverse osmosis, filtration or other appropriate procedures. PW is also a starting material in the WFI and pure steam preparations.
Sterile Purified Water, as defined by USP, is PW packaged and rendered sterile; it is used in applications requiring Purified Water, where access to a validated Purified Water System is not serviceable (small q.ty needed, for example).
– WFI (Water For Injection), as defined by USP, EP, JP, ChP and IP monographs.
Water For Injection is classified for pharmaceutical purposes as an excipient in the production of parenteral preparations and in other pharmaceutical preparations where the endotoxin content must be verified (see related USP, EP and JP pharmacopeia for reference). Deionized water (that may be pre-treated for subsequent distillation or appropriate process) is the minimal source of feed water to produce WFI.In addition to the PW specifications, WFI adds the test for Bacterial endotoxins and complies with all requirements (except for Labeling) for the packaged water know as “Sterile Purified Water” (see USP monograph).
Sterile Water for Injection, as defined by USP, is WFI packaged and rendered sterile; it is used in applications requiring Water for Injection, where access to a validated WFI System is not serviceable (small q.ty needed, for example).
Bacteriostatic Water for Injection, as defined by USP, is WFI with addition of one or more antimicrobial preservatives; it is used as a diluent in the preparation of parenteral solutions (especially for multi-dose products that allow repeated withdrawals).
– HPW (Highly Purified Water), as defined by EP monograph.
Highly Purified Water is classified (see EP monograph) as an excipient in the production of pharmaceutical products where bacterial endotoxins need to be controlled, unless WFI specified, i.e. for example WFI.
– WFH (Water For Hemodialysis), as defined by USP monograph.
Water For Hemodialysis is primarily classified in pharmaceutical purposes for hemodialysis applications (see related USP monograph), i.e. for example in the diluition of concentrate solutions. It’s made from EPA (US Environmental Protection Agency) drinking water which has been further purified to reduce chemical and microbiological components. Note that WFH is not intended for injection.
Note that Purified Water or Water For Injection that are packaged must be sterilized to preserve their microbiological properties; so we have other packaged monographed waters, as Sterile purified water, Sterile water for injection, Bacteriostatic water for injection, and so on (see related USP monographs).
2. NON-COMPENDIAL WATER
Non-compendial waters meet, at least, the requirements of potable water. Note that non-compendial waters are not necessarily of lesser quality than compendial waters, but non-compendial water systems may or may not be validated and, generally, non-compendial waters are intended of the appropriate quality required by the single application. For example: Potable Water, Softened water, Ultra Filtration water, Reverse Osmosis Water, EDI (Deionization process) water, Distilled water.
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