Date: July 28, 2022
Time: 9:00am (PDT), 12:00pm (EDT), 6:00pm (CEST)
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.
- In the context of TOC and conductivity, the audience will learn about how Real-Time Release Testing (RTRT) allows for the migration from laboratory-based TOC and conductivity testing to online TOC and conductivity testing. With this knowledge, they will understand how to successfully implement RTRT within their facilities and the efficiencies associated with implementation of RTRT.
- In the context of bacterial endotoxin testing (BET), the audience will be provided an overview of the technologies that currently exist, and the drawbacks associated with each. Microfluidic technology will be discussed with the intent of educating the audience on the advantages it has over the traditional methods (gel clot and 96-well plates) and how through implementing microfluidic technology, quality control lab testing can be leaned out with respect to LAL testing and sustainability.
- In the context of bioburden testing the audience will be provided with a background on Rapid Microbiological Methods, or RMMs, and their current advantages and limitations. The use of viability-based flow cytometry as an RMM will be discussed and why there are advantages to implementing this rapid micro method instead of waiting on the compendial method for bioburden enumeration (agar plates). By adopting a RMM for bioburden enumeration, pharmaceutical companies and their employees will benefit from improved process efficiencies.
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