Process Troubleshooting and Investigations

BPS’s exclusive focus on the Biologics business means we can help you resolve the common and not-so-common issues associated with the following typical process steps:

Clean-In-Place

• Root out continued and intermittent CIP failures in various equipment and difficult to clean surfaces and locations
• Design reviews of existing equipment to determine design flaws such as dead legs, simultaneous multiple paths, excessive use of purified water and WFI and use of sub-optimal CIP cleaning agents.
• Develop and optimize washer patterns and loads.

Sterlization & Sanitization

• Root out intermittent causes of failures in autoclave and tunnel sterilization cycles.
• Design reviews of existing equipment to determine design flaws such as dead legs, simultaneous steam multiple paths, and excessive use clean steam.
• Determine root causes for contamination and non-conforming sterilization and sanitization procedures for fermentors, bioreactors, liquid filter housings, media and buffer tanks and associated piping.

Process Troubleshooting

• Fermentation and cell culture operations and performance.
• Cells and cell debris removal via depth filtration.
• Chromatography column maintenance, packing, sanitization, testing and storage.
• Chromatography column and skid operations.
• Chromatography Purification problems.
• Filtration and recovery problems.
• Media prep and buffer operations.
• Contamination and bioburden investigations and troubleshooting.
• Formulation or stability challenges

Automation, Instrumentation and Controls

• Root out causes of intermittent communication and integration errors.
• Determine reasons for frequent instrument/probe failures.
• Simplify valve sequencing to address dead legs/wetted routes.