Consistent and repeatable batch operations are key to productivity in pharmaceutical and biotech processes. But obtaining repeatability, batch after batch, remains elusive in the industry according to a recent survey by Pharmaceutical Manufacturing. In many cases, this problem can be mitigated or eliminated by careful attention to measurement and control of fundamental process parameters such as temperature, pH, dissolved oxygen (DO), pressure and flow.
This white paper explores how typical pharmaceutical and biotech manufacturing batch operations depend on fundamental process parameters. It shows the importance of precision and repeatability, and describes how reliable, accurate instrumentation allows automation to support quality and productivity strategies such as the process analytical technology (PAT) initiative, continued process verification (CPV), and the ICH Q10 Pharmaceutical Quality System. It includes information on how to select and specify instrumentation and systems that can improve batch repeatability, quality and productivity.