Lean Lab - Testing Quality Attributes of Water for Pharmaceutical Production

The quality of water for pharmaceutical production (purified water, water for injection, and ultrapure water) is quantified and regulated through four parameters – total organic carbon (TOC), conductivity, endotoxin, and bioburden. Historically, the testing of water for pharmaceutical production has been labor intensive and costly, requiring quality analysts to isolate samples from a water loop to evaluate the purity in the lab. These tests can take up to days to see results; therefore, pharmaceutical manufacturers either conditionally release water at risk of potential out-of-specification (OOS) results or delay production until results are reported. More recently, technologies have been developed to better support and streamline the release of water for production and improve the adoption of process analytical technologies (PAT) for greater efficiencies. Real-time release testing (RTRT) for TOC and conductivity, microfluidic technology for bacterial endotoxins testing (BET), and rapid microbiological methods (RMMs) for bioburden are all ways in which quality control laboratories can lean out processes and reduce human interference associated with water quality testing. Through the adoption of lean laboratory practices/PAT, pharmaceutical companies and their employees will benefit from improving process efficiencies, optimizing product release to market, ameliorating analysts’ workload, and maximizing sustainability all while maintaining data integrity and compliance.

 

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