ABSTRACT
This chapter focuses upon the sampling methods used most frequently for biotechnology cleaning validation studies. Sampling methodologies vary tremendously depending on the nature of the equipment, the cleaning process, the product, and related soils. Many sampling techniques can be used to obtain cleaning validation data. As a sampling technique, surface sampling is an effective means of directly evaluating the cleanliness of a production surface. Sampling sites may include both accessible areas and hard to reach areas. Several important factors can affect sampling programs including operator training, sample stability and sample containers. Many sampling techniques can be used to obtain cleaning validation data. Sampling techniques should be evaluated before use to determine what information can be gained by using each particular method. Rinse water is probably the most commonly sampled element of a cleaning circuit due to the fact that rinse water is relatively easy to sample and is conducive to many analytical test methods.
