September / October 2020

Technical

A temperature sensor in a medical autoclave is typically calibrated once a year. If the sensor proves to be inaccurate, all batches produced since the last calibration must be evaluated. Endress+Hauser has developed a self-calibrating sensor that automatically verifies its accuracy during each sterilization batch. This article describes a case study at the Merck Healthcare KGaA sterile...

Technical

Computational fluid dynamics (CFD) can reduce or eliminate the need to perform bioreactor scale-up studies because full-scale manufacturing bioreactors can be simulated to predict performance. This article discusses the use of computational fluid dynamics for that purpose, to predict the performance of a manufacturing-scale bioreactor under various operating conditions.

Technical

Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and regulatory hurdles in the life cycle of a process analytical technology application—including model...

Special Reports

Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and increase patients’ access to medicine, designed new tools or techniques that reduced the cost of drug...

Special Reports

The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital format offers greater flexibility for attendees.