Regulators Debate Methods for Producing Water for Injection - Pharmaceutical Technology

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Regulators Debate Methods for Producing Water for Injection
Might European officials reverse their position on acceptable production methods?

Pharmaceutical Technology
Volume 35, Issue 9, pp. 48-52

The prospects for harmonization

Harmonization of requirements would give pharmaceutical manufacturers a choice of technologies for producing WFI. Two-pass reverse osmosis could help firms reduce the capital costs, operating costs, and maintenance costs of their WFI system, which "would be of considerable benefit for world market needs," says Michael Foster, water group lead at OBK, a provider of water-purification systems. Harmonization also would lower costs for drugmakers in emerging countries because one type of water would suffice for purified-water and WFI applications, he adds.

Events indicate that harmonization of EP, USP, and JP requirements for WFI is possible. During recent meetings of the Parenteral Drug Association, European regulators showed openness to discussing the topic of producing WFI through reverse osmosis, says Maik Jornitz, senior vice-president of marketing bioprocess at Sartorius-Stedim North America.

On Mar. 24, 2011, the European Directorate for the Quality of Medicines and HealthCare (EDQM) held a water workshop with experts from JP, USP, the pharmaceutical industry, and equipment manufacturers. By the end of the meeting, the experts saw sufficient reason to recommend that the European Pharmacopoeia Commission initiate discussions regarding the potential use of membrane systems for producing WFI, says Georg Roessling, senior vice-president of Parenteral Drug Association Europe. Regulators stipulated that the discussions should consider a potential revision of current specifications for WFI and the introduction of methods to deal with the contaminants likely to be present in reverse-osmosis systems to ensure the safety of the resulting WFI.

European regulators are looking for robust, long-term data that show that the quality of WFI produced by reverse osmosis is comparable to that produced by distillation, says Jornitz. They want to be sure that reverse osmosis can produce WFI reliably, and sharing experience of reverse-osmosis WFI systems with them would be advantageous, he adds.

In June 2011, EP decided that advances in membrane systems since the late 1990s warranted a review of its previous policy. "However, the data collected in the past months still need to be reviewed to answer questions about new multimodule reverse-osmosis systems and associated improvements (e.g., hot water and chemical sanitization) designed to overcome concerns linked to the microbiological quality of the water," says Susanne Keitel, director of EDQM. It is likely that EP ultimately will receive a request for revision of the monograph on WFI, she added.

*Theodore Meltzer, who served as a respected member of Pharmaceutical Technology's Editorial Advisory Board for more than 20 years, passed away in August 2011. He is dearly missed by his colleagues in industry and on this magazine.


1. USP 34–NF 29 (US Pharmacopeial Convention, Rockville, MD, 2011), p. 4596.

2. EurPh, General Text 01/2009:0169 (EDQM, Strasbourg, France, 2010), p. 3219.

3. EMA, "Reflection Paper on Water for Injection Prepared by Reverse Osmosis," Doc. Ref. EMEA/CHMP/CVMP/QWP/28271/2008, Mar. 5, 2008 (London).

4. T. Meltzer et al., PDA J. Pharm. Sci. Technol. 63 (1), 1–7 (2009).

5. FDA, Guide to Inspections of High Purity Water Systems (Rockville, MD, July 1993).


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