Highly Purified Water (HPW) is water of the highest quality for use in the pharmaceutical and biopharmaceutical industries. Its quality is defined by the European Pharmacopoeia (PhEur, 8th Edition 2014):
Highly Purified Water is intended for use in the preparation of products where water of high biological quality is needed, except where Water for Injections (WFI) is required. Highly Purified Water meets the same quality standards as WFI but the production methods are considered less reliable than distillation, and thus it is considered unacceptable for use as WFI.
For the production of Water for Injection, the current edition of the European Pharmacopoeia (PhEur, 8th Edition 2014) states that distillation “… currently remains the only official method for WFI.” Contrary to the European Pharmacopoeia, both the United States and Japanese Pharmacopoeias allow a cold membrane-based process for the generation of WFI, i.e. single or double-pass reverse osmosis, deionization and ultrafiltration.
In the past years, an increasing number of Bosch customers in Europe have decided to use HPW for their pharmaceutical or biopharmaceutical production. The high purity of HPW corresponds to that of WFI, especially regarding bacterial endotoxins and conductivity. This makes it a cost saving alternative media for cleaning as well as for other processes where the use of WFI is not required. Furthermore, HPW can be used for several cold processes instead of cooling down WFI.
Technically, the extension of a conventional purified water generation system to produce HPW is fairly simple: by adding an additional ultrafiltration (UF) module after the last step of PW generation, HPW quality will be achieved. Depending on the size and output of the system, one or more UF cartridges will be installed.
Bosch uses UF modules from the leading supplier in the market, which ensures reliable function and long lifetime of the membranes. These UF modules can be individually tested for integrity and sanitized chemically or with hot water, depending on the design of the generation system. Worldwide service is provided by the local support of our supplier, combined with the global availability of Bosch After-sales Services.
Klaus H. Schreiber
phone: +49 351 28278-833