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In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
An all in-one system purpose-built for rapid deployment, ease of use and scalability in markets where time-to-results is critical.
How the Vaya handheld Raman spectrometer differentiates and identifies PS 20 and PS 80 with spatially offset Raman spectroscopy (SORS) technology.
The detection and identification of bacteria is essential for biopharmaceutical production, the assessment of new antimicrobials and assessing contamination control measures. Developing methods for complex environments is challenging due to interference from the various molecules present. Here, pharmaceutical microbiologist and contamination control expert Dr Tim Sandle explains how Raman spectroscopy…
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
Raman mapping is a powerful tool that can be used to reveal details about the size and spatial arrangement of components throughout a tablet matrix. Here, Andrew Ewing, Don Clark and Fiona Clarke from the Materials Characterisation Team at Pfizer present a 3D imaging approach using Raman mapping to investigate…
EPR highlights the development of a model to predict dissolution of sustained release formulations based on Raman process analytical technology (PAT) sensor data that could enable real-time release testing.
Study combining Raman spectroscopy with PLS-DA multivariate analysis achieves fast and non-invasive detection of contaminated drug products within vials.
Research reveals how combining sample sectioning with Raman imaging enables the three-dimensional (3D) imaging of an oral solid dosage form matrix.