11 - Equipment

Abstract

Chromatography equipment requires careful consideration of the needs for flexibility, documentation, reliability, hygiene, automation and validation. After functional, chemical and pressure specifications are established, components or systems can be selected that meet laboratory, pilot plant and production requirements. Local and national standards, such as those for electrical and explosion-proof requirements, should also be evaluated to ensure compliance. For production systems and even some pilot scale systems, the user should work with the supplier company to ensure that all design criteria are clearly defined. The user may even wish to inspect large engineered systems at the assembly site. Functional tests (factory acceptance test, FAT) that the supplier may perform include loop tests for conductivity, flow meters, pH, pressure, leakage, UV, valve and air sensors. Other tests include those for alarm and watch functions, gradient performance, pressure/flow, pump and leakage. Calibration should be performed at the time of delivery and the critical function tests will be performed to commission the system, i.e. ensure it is in working order. Training of operators and service engineers on the proper use and maintenance usually take place at the time of the commissioning. This chapter describes guidelines for selecting pilot and production systems and components, and discusses the advantages and disadvantages of several types of automation approaches. A decision support tool for assessing the use of disposable equipment versus stainless steel has been developed.