Particulate contamination is a critical quality and patient safety risk for injectable drug products.
In this case study, our expert shares how a targeted analytical investigation successfully identified and eliminated foreign particulate matter (FPM) in a lyophilised injectable product, helping to de-risk the manufacturing process and ensure product safety.
Download the case study to learn how you can:
- Identify the root cause of FPM using advanced microscopy and spectroscopy techniques
- Understand regulatory expectations for particulates in parenteral products and why route of administration matters
- Evaluate and screen alternative filter cartridges to minimise extractables and particulate release
- De-risk your manufacturing process and confirm ongoing control of subvisible particles
Discover how a data-driven analytical approach enabled safer production and supported confident decision-making for injectable drug products.
Download the full case study now
Recorded Webinars
- NEW: Regulatory Driven E and L Studies for Key Drug Delivery Formats
- Design of Robust and Sensitive Extractables and Leachables Studies
- Extractables and Leachables Studies on Process Materials and Container Closure Systems
- Biocompatibility - The Importance of Extractables & Leachables Testing
Whitepapers
- NEW: Risk-Based E&L Strategies for Bioprocessing Single-Use Systems
- From Extractables to Leachables: Problem Solving for Complicated Formulations and Container Closure Systems
- Evaluation of Extraction Conditions for Volatile Extractables
- Extractables and Leachables Strategies for Pharmaceutical Production Tubing
- Importance of a High Performing GC-MS Screening for Testing Stability Samples for Volatile and Semi-Volatile Leachable Impurities
- Impact of the GC-MS Injection Solvent and the Analyte Concentration on Relative Responses for common Extractables
- Extractables and Leachables Strategies for Transdermal Patch Products
- Trace Analytical Methods and Techniques for Testing Extractables and Leachables