White Paper: Skid-Mounted Liquid Chromatography Systems

IPEC provided three (3) skid-mounted liquid chromatography systems to Cook Pharmica, located in Bloomington, Indiana. The systems consisted of piping, valves, pumps, filters, bubble traps and instrumentation and are suitable for operation under cGMP guidelines. The systems are capable of in place cleaning and sanitization.

The liquid chromatography skids included Delta V control systems with software to perform the following functions:

• Delivery of product, designated buffers and cleaning/sanitization chemicals to packed chromatography columns with instrumentation appropriate for process control and monitoring.
• On-line mixing of buffers for dilution and gradient formation. Control and monitoring of on line buffer mixing included flow, pH conductivity and pressure.
• Monitoring of column effluent for use in control of product destination and column equilibration. Automated delivery of the column effluent to fraction collection vessels or to waste.

The systems were designed to enable the automated pumping and instrumentation skid with analytical instrumentation to detect product. The skids are capable of receiving 2-27ºC buffer and product solutions from storage containers, delivering these solutions to the chromatography columns and routing the column effluent through the chromatography skids into product storage bags. Buffers and product at 2-27ºC are supplied to the skid from owner supplied piping, hoses and vessels or bags. Connection of solutions to the skids are made using flex hoses with sanitary tri-clamp fittings. The selection of the solution delivered is controlled using a multi-port inlet diaphragm valve on the skid.