INSIGHTS ON PHARMACEUTICAL INSPECTION

• Managing Risk In The Most Complex Combination Device Format

  Autoinjectors add mechanical forces and interactions that change how container closure integrity must be evaluated. Learn why device complexity creates new risks and how testing strategies must adapt.

• A Comprehensive Guide To Sampling Protocols And Robust CCI Testing

  Effective CCI testing hinges on strategic sampling and statistical rigor. Learn why 30 samples matter, how positive controls validate defect detection, and why risk assessment ensures long-term reliability.

• Understanding Injectable Drug Container Closure Systems

  Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

• Ensuring Integrity: Testing Viscous Biologics In Pre-Filled Syringes

  Viscous biologics in pre-filled syringes demand precise integrity testing. Discover how advanced HVLD technology detects micro-defects and ensures sterility, meeting stringent USP <1207> standards.

• Microbial Challenge In-Use Studies

  6/13/2024

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• Protecting Your Drug Product

  5/13/2026

  With patient lives depending on every dose, even minor vulnerabilities in containment or delivery systems can have serious consequences for product integrity and patient outcomes.

• Why Is It Important To Have Properly Trained Visual Inspectors?

  8/4/2025

  Properly trained visual inspectors are crucial for identifying defects in parenteral drugs, safeguarding patient safety and product quality.

• Start Packaging Development Early

  5/12/2026

  To avoid costly delays later in the product lifecycle, it is essential to plan for key variables early and select container closure systems with confidence from the outset.

• Establishing A Container Closure System

  5/13/2026

  As a trusted partner to both established and emerging drug developers, we support the safe, effective containment and delivery of life-saving and life-enhancing medicines.