Ensuring the purity and safety of pharmaceutical products is paramount, as even trace amounts of particulate matter can pose significant health risks. Gateway Analytical’s Particulate Analysis highlights our comprehensive approach to detecting, analyzing, and preventing foreign particulates in pharmaceutical products.
The Importance of Particulate Analysis
Particulate Analysis is not merely a regulatory requirement; it’s a vital commitment to patient safety. Foreign particulates, from undissolved ingredients to contamination during manufacturing can cause adverse reactions, compromise drug efficacy and erode patient safety. Gateway Analytical’s advanced Particulate Analysis services ensure your products not only comply with regulations but also meet the highest standards of purity and safety.
Gateway Analytical’s Comprehensive Approach
At Gateway Analytical, we utilize a robust methodology for Particulate Analysis. Our state-of-the-art laboratories are equipped with the latest microscopic and spectroscopic technologies, enabling precise detection and characterization of particulate matter.
- Subvisible/Visible Particle Quantification: Using advanced imaging and analysis software, we quantify particulate loads in pharmaceutical products, ensuring they meet regulatory standards.
- Root Cause Analysis: Beyond detection and quantification, we conduct root cause analysis to identify the source of particulates, implement corrective measures, and prevent recurrence, ensuring continuous product improvement.
Adherence to Regulatory Standards
Our Particulate Analysis services are designed to exceed the stringent requirements of regulatory bodies such as the US FDA and the European Medicines Agency (EMA). Adhering to standards like USP <787>, <788>, and <789> for particulate matter in injections, we ensure your products are compliant and safe for patient use.
Collaborative Expertise
Our expert team brings extensive experience in Particulate Analysis, providing not only testing services but also valuable insights and recommendations to enhance product purity and safety. We collaborate closely with clients to understand their unique challenges and tailor our approach to their specific needs.
Conclusion: Partner with Gateway Analytical for Ensuring Purity and Safety
Particulate Analysis is a critical component of pharmaceutical quality assurance. Gateway Analytical stands as your dedicated partner, ensuring the purity and safety of your products through our detailed approach to detecting and analyzing foreign particulate matter. Prevent potential health risks and uphold the highest quality standards with our services.
Discover how our Particulate Analysis services can enhance your quality assurance processes. Contact Gateway Analytical to ensure your pharmaceutical products are synonymous with purity, safety, and excellence.
Explore how Gateway Analytical can support your journey to market. With over a decade of expertise in parenteral testing, we cover a broad range of services from process and formulation development, product-package validation, clinical & commercial manufacturing, to visual inspection, quality control, and release testing. Reach out to our experts at (724) 443-1900 or info@gatewayanalytical.com, or feel free to visit our contact page to connect with us!
