INSIGHTS ON PHARMACEUTICAL INSPECTION

  • Cryogenic Storage Of IV Bags For Cell And Gene Therapies
    12/18/2025

    Cryogenic storage can compromise packaging integrity for cell and gene therapies. Learn how vacuum decay technology detects micro leaks and ensures product safety under extreme conditions.

  • Physical Contamination Detection
    3/23/2026

    Learn how physical contaminants enter production lines and how detection systems like metal detection and X-ray inspection help prevent defects and recalls to strengthen quality control.

  • 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.

  • Advanced Aseptic Filling Assembly Helium Integrity Testing
    10/15/2025

    Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.

  • Understanding Injectable Drug Container Closure Systems
    6/20/2024

    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.

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Pharmaceutical companies face cost, complexity, and speed pressures. Inspection solutions support quality and compliance with fill detection, weighing, foreign body detection, and label verification.

  • The Thermo Scientific™ Sentinel™ Multiscan Metal Detector utilizes an innovative new technology to overcome the limitation of fixed single or dual frequency metal detectors that can miss metal contaminants hidden in product signals.

  • A helium based test method for verifying the integrity of a blister card holding drug product has been proven to be the most effective approach due to the extreme sensitivity offered. The test method relies on detecting helium sealed in the package system as it escapes through micro-channels in the package. A test sequence begins by placing the package in the test fixture and a vacuum is quickly drawn. The resulting pressure differential causes helium to escape through potential holes or cracks in the package.

  • The HDC-4 offers 100% inspection for BFS large bottle production and non-destructive leak testing.

  • As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.