パーティクルカウンタに関するバリデーション

摘要

Particle counters as environmental measuring instruments are widely used in electronics industry or pharmaceutical industry. Those are also widely used for the management of cleanliness of liquid such as DI water and air cleanliness of clean rooms. Generally, there are two kinds of particle counters. The airborne particle counter is used for measuring particles in air. The liquid-borne particle counter is used for measuring particles in liquids. As standards of the evaluating methods for classification of air cleanliness in clean rooms, there are ISO 14644-1 and JIS B 9920. These standards serve as guidance of validation for the medicinal products in manufacturing environment. In this article, I will explain about the validation of particle counters evaluating methods of cleanliness in the manufacturing environment of medicinal products.