Pharma-Wasser - Ein kritischer Rohstoff in der pharmazeutischen Verwendung Heinz Kudernatsch PAC Pharma-Anlagen-Consult GmbH, Nürnberg Water for Pharmaceutical Use as a Critical Raw Material for Pharmaceutical Purpose During the last ten years a special dynamic could be observed in the field of “Water for Pharmaceutical Purpose”. On the one hand this refers to the alterations of the requirements of the pharmacopoeias and the definitions of the guidelines, as well as to the alterations of the technologies of the production processes. The conductivity measurement as a sum examination for the chemical quality and the TOC-measurement as a total value for the oxidisable substances have been introduced by the United States Pharmacopoeia (USP) 23 (1996). FDA and Ph. Eur. have defined microbial limits.
The European Agency for the Evaluation of Medicinal Products (EMEA) published the CPMP/CVMP “Note for Guidance on Quality of Water for Pharmaceutical Use” in October 2001, which should be used starting with June 2002. In the meantime there has been published an alterated version, which is dealt with in this paper. By the “Note for Guidance on Quality of Water for Pharmaceutical Use” a new quality of water - Highly Purified Water (HPW) - has been introduced, which was already fixed in the European Pharmacopoeia. For the production of purified water a combination of reverse osmosis and electro-chemical desalting (RO/EDI) is used, to fulfill the high requirements in due to the conductivity of the pharmaceutical production. A remarkable part of the expenses for the purified water refers to the high expenditure of energy and the loss of rinsing water during the period of circulation, when no water is produced.
For the production of water for injec-tion (WFI) the thermo-compression process and the multi-stage pressure column process will be compared. When cold WFI is mainly used, the thermo-compression process is more profitable. However, for hot storage and hot distribution the multi-stage process is more favourable; not at last due to the low costs for maintenance and servicing. By a thorough planning of the storage and distribution system it has to be assured, that the produced water will be provided without any loss of quality and up to the quantities needed and temperatures requested at the point of use. Beneath that it is not depending on the question whether purified water, water for injection, or highly purified water are concerned. First in the planning the correct choice of material besides the decisions for sanitization or sterilization of the systems have to be done. Moreover the design of the plant, dead-legs, the sanitary design of connections and drainability are of remarkable importance. Key Words Note for Guidance on Quality of Water for Pharmaceutical Use · Purified Water · Highly Purified Water · Water for Injection |
