Water management in the manufacturing process of Pharmaceutical products with TOC-5000A

Introduction

Water is a raw material in the manufacturing process of pharmaceutical products and is also used for cleaning. The water used in these operations is laid down in the GMP (Good Manufacturing Practices: Clauses 2.5 and 3.7 of article 5 of ordinance No. 4, Ministry of Health and Welfare). Appropriate water is selected and monitored in accordance with the applications in the ordinance and this is accompanied by tests and inspections that are required. An important monitoring item among water controls for pharmaceutical manufacturing water is organic impurities that may have a relationship to fluctuations in microorganisms and pyrogenes. Usually a potassium permanganate consumption test is used for organic matter tests, but in recent years the use of TOC (Total Organic Carbon) - with its superb accuracy, high sensitivity, speed and ease of use - is becoming popular. Shimadzu's worldwide bestseller TOC analyzer TOC-5000A is also widely used for applications such as water monitoring and residual matter evaluation of cleaning validation in pharmaceutical manufacturing. This Application News edition features reports on the ability of the Shimadzu TOC-5000A to accommodate the requirements of GMP. JP (Japanese Pharmacopoeia) and USP (United States Pharmacopoeia) as well as comparisons with competitor TOC analyzers and an actual example of continuous monitoring of water used in pharmaceutical manufacturing using the online TOC-5000A WM.

November 3, 2001 GMT