INSIGHTS ON PHARMACEUTICAL INSPECTION

  • Root Cause Investigation Into A Possible Container Closure Integrity Failure
    Root Cause Investigation Into A Possible Container Closure Integrity Failure

    In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.

  • New Guidelines For Container Closure Integrity Testing
    New Guidelines For Container Closure Integrity Testing

    Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.

  • Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage
    Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage

    A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.

  • Understanding Sensitivity Principles For Industrial Metal Detectors
    Understanding Sensitivity Principles For Industrial Metal Detectors

    This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in contaminants detected.

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PHARMACEUTICAL INSPECTION SOLUTIONS

  • Non-Destructive, Non-Subjective Package Testing: VeriPac System

    VeriPac systems can be easily integrated into the packaging process to improve quality, reduce waste, and provide operators with a clear understanding of package quality. VeriPac test systems are non-destructive, non-subjective and require no sample preparation. Test fixtures are designed to inspect flexible, rigid and semi-rigid packaging. VeriPac inspection systems use cutting edge innovation to provide repeatable, more sensitive, and more robust detection of defects.

  • Pharmaceutical Contract Packaging: Quality And Technologies
    Pharmaceutical Contract Packaging: Quality And Technologies

    Our cutting-edge technology and impeccable standards ensure that our customers receive products that meet their exact needs.

  • Container Closure Integrity Testing

    Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.

  • Non-Destructive Leak Detection And Package Integrity Testing: Veripac 310
    Non-Destructive Leak Detection And Package Integrity Testing: Veripac 310

    The VeriPac 310 is a non-destructive, non-invasive inspection system for leak detection and package integrity testing.

  • Seal Integrity Tester for Pouches and Flexible Packaging: Seal-Scan 520
    Seal Integrity Tester for Pouches and Flexible Packaging: Seal-Scan 520

    Seal-Scan® characterizes seals that appear visually acceptable yet possess defects that affect product quality and shelf-life. Seal-Scan systems utilize non-contact airborne ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging. Testing is non-destructive, non-invasive and requires no sample preparation.

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