The new Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform combines ground-breaking technology and ease-of-use to automate endotoxin assay setup without altering reaction biochemistry or compliance. It reduces usage of Limulus Amoebocyte Lysate (LAL) reagent by up to 90 percent and increases the speed and ease with which the assay can be started. With Eclipse, compliant 21-sample assays can be set up in as little as nine minutes with minimal analyst training, leading to substantial efficiency gains and reduction of human errors.
Register for this on-demand session to get answers to the following questions: how does the Eclipse technology work? Why is so little LAL required? How do analytical results on the Eclipse compare to other platforms? What about validation and data integrity?
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.
What you’ll discover:
Key trends shaping the pharmaceutical formulation sector
Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
Why and how the Sievers Eclipse platform was developed
How precision crafted microfluidic technology greatly simplifies assay setup without robotics and with drastically reduced use of LAL
How the Eclipse platform aligns with USP <85>, EP 2.6.14, and JP 4.01
How analytical results compare across different platforms
How data integrity needs are met
What validation tools are available to customers and how it can be validated in a QC lab.
KEYNOTE SPEAKERS
Daniel Kellner-Steinmetz, EMEA Application Lead UPW/CV, SUEZ
Daniel Kellner-Steinmetz is the EMEA Applications Specialist for SUEZ, focusing on Life Science UPW and Cleaning Validation applications. He has eight years of experience in the Quality, Manufacturing, and Training areas of the pharmaceutical industry. Most recently he served as the Global Product Quality Lead for several commercial products at Shire (formerly Baxter) in Vienna. Daniel holds a Bachelor of Science in Biomedical Engineering.
Dave Wadsworth, Global Product Manager, Bio-Detection, SUEZ
Dave Wadsworth is the Global Product Manager, Bio-Detection at SUEZ – Water Technologies & Solutions, focusing on next-generation endotoxin detection. Dave has a Bachelor of Science degree in Biology from Wheaton College Massachusetts and has over 14 years of experience in the endotoxin industry. His first introduction to endotoxin detection was as a seasonal employee responsible for collecting and processing amebocytes for a LAL manufacturer, and he’s been enthusiastic about bacterial endotoxins testing ever since!
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Daniel Kellner-Steinmetz is the EMEA Applications Specialist for SUEZ, focusing on Life Science UPW and Cleaning Validation applications. He has eight years of experience in the Quality, Manufacturing, and Training areas of the pharmaceutical industry. Most recently he served as the Global Product Quality Lead for several commercial products at Shire (formerly Baxter) in Vienna. Daniel holds a Bachelor of Science in Biomedical Engineering.
Dave Wadsworth, Global Product Manager, Bio-Detection, SUEZ
