ABSTRACT
The present section discusses issues involved in the process laboratory, drawing samples for chromatographic analysis from a reactor or any other component of a production process. These issues can be categorized as
• Safety • Durability • Sampling site and frequency • Sample preparation, especially the removal of particulates • Speed of analysis
Sterility, an important issue in biopharmaceutical manufacturing, is not covered in this section. Briefly, in sampling from a biopharmaceutical process, the sample port should not compromise the physical integrity of the process step. In other words, the port should be designed so that flow is unidirectional out of the process stream, with no possibility of flow back into the process. Also, the port should not constitute a stagnant pool in the flow path. Stagnant pools do not give representative samples, are potential locations for the growth of adventitious organisms, and are difficult to clean between batches. There are similar concerns in process scale manufacturing of biopharmaceuticals. In particular, the fittings must be designed to preserve the physical integrity of the system. This requirement places restrictions on the flow cell used in detectors.
