The publication of USP <73> marks a landmark shift in pharmaceutical microbiology, elevating ATP bioluminescence from alternative method to recognised compendial standard – cutting sterility testing timelines by at least 50 percent and opening new possibilities for faster, more reliable drug product release.
This In-Depth Focus explores how BPCs, RMMs and AI-enabled analytics are being evaluated as a tool to enhance aseptic manufacturing, bioburden testing and monitoring.
EPR Issue 2 includes articles on manufacturing, drug formulation, microbiology, downstream bioprocessing, and more.
Recombinant technologies are reshaping endotoxin testing, offering alternatives to horseshoe crab-derived reagents while maintaining pharmaceutical quality standards.
Download this application note to learn how the MAS-100 Libra® supports automated settle plate exposure while maintaining airflow integrity, first-air conditions and effective VHP decontamination in critical aseptic environments.
As pharmaceutical microbiology evolves, manufacturers are balancing contamination control, regulatory expectations and the need for faster, more actionable data. This In-Depth Focus explores emerging approaches across microbiological testing, monitoring and rapid methods.
At CPHI 2026, Testo will showcase digital solutions for monitoring, compliance, and supply chain transparency in the pharmaceutical industry.
Join Waters Corporation on the 23rd September for their webinar on the latest developments in nitrosamines testing, evolving regulatory expectations, analytical challenges, and advanced LC-MS/MS strategies for sensitive detection and risk assessment.
Pharmaceutical quality control laboratories face growing pressure to strengthen data integrity as regulators scrutinise incomplete records, manual data entry, and disconnected systems.
As biotherapeutic manufacturing accelerates, rapid PCR-based methods are enabling manufacturers to detect mycoplasma contamination sooner. However, realising their full potential requires robust validation, risk-based implementation and integration with a wider contamination-control strategy.
The publication of USP <73> marks a landmark shift in pharmaceutical microbiology, elevating ATP bioluminescence from alternative method to recognised compendial standard – cutting sterility testing timelines by at least 50 percent and opening new possibilities for faster, more reliable drug product release.
EPR’s 2026 nitrosamines report covers the key developments in manufacturing, quality, regulation, analytical development and beyond.
Tim Sandle explores the main factors that influence particle accumulation in pharmaceutical cleanrooms, advising how best to control risks and minimise operator contamination.
Pharmaceutical manufacturing takes centre stage on Day three of The Future of Bio/Pharmaceutical Analysis Virtual Summit 2026 as speakers examine how digital technologies, artificial intelligence and advanced production methods are reshaping what is possible in the field.
Selecting the right qPCR workflow strategy: task-based vs. full automation
Faced with increasing regulatory pressure and operational complexity, pharmaceutical manufacturers are rethinking the microbiology workflow. Intelligent automation is enabling a shift toward more consistent, scalable, and data-driven contamination control.
Automation, precision, and sustainability – Shimadzu’s MultiNA II MCE-301 redefines microchip electrophoresis, delivering faster, greener, and more reliable DNA and RNA analysis for QA/QC and research laboratories alike.
Microbial monitoring is an essential step for complying with GMP regulations in aseptic pharmaceutical manufacturing. For air monitoring, active air samplers must efficiently collect viable particles and be validated according to EN 17141 or ISO 14698 requirements. Efficiency can be determined by flow rate accuracy and sampling time, which together ...