The Theory Behind Automatic Inspection Technologies for Subvisible-to-Visible Particle Detection and Container Closure Integrity

The Theory Behind Automatic Inspection Technologies for Subvisible-to-Visible Particle Detection and Container Closure Integrity

04/19/2018, 10:30 AM - 11:15 AM

Technical Conference Stage 1, Booth 1076, Exhibit Hall


Increased quality compliance is a challenge best addressed with well-developed concepts and valuable industry experience. This presentation will take a deep dive into inspection technologies deployed within the pharmaceutical industry, their strengths and the potential pitfalls. In the pharma industry, the traditional manual inspection process is being slowly replaced by automated inspection, which increases accuracy and offers repeatability and reproducibility of the test method. The automatic inspections of subvisible-to-visible particles and container closure Integrity have become a crucial part of any pharmaceutical manufacturing process. This process is the means of rejecting nonconformities and assuring good quality products. The introduction of new technological methods and updated inspection equipment has helped to overcome the problems associated with traditional approaches. In order for us to make the correct decision while selecting, integrating, and qualifying the right technology, we need to fully understand the theory behind each detection method. This presentation covers a theoretical approach to the principles behind the inspection solutions including Particle Detection using Static Diode, X-Ray inspection, and the Container Closure Integrity inspection methods such as High Voltage Leak Detection and Laser Head Space Analysis. Depending on the inspection methodology applied, some drug substances could be susceptible to this inspection process and this could cause degradation to the products under possible stress conditions. Therefore, there are pros and cons on each of these methods depending on your product properties, line space, line throughput, or budget. One method may be more suitable for your process than the other. This session will provide an in-depth understanding of the available technologies for pharmaceutical package inspection, how they each differ in both strengths and challenges that may be faced. Participants will leave with a stronger sense for which inspection technology may provide them a solution they are seeking.


  • Edwin Martinez


    Sr Engineering Manager

    Baxter Healthcare

Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. Understand the theory behind different technologies, for a better understanding of the limitations and any possible impact to the product. 2. Have a clear understanding of the requirement of each method 3. Understand the best validation strategy to be implemented.


  1. Track
    Optimizing Facilities through Innovation & Technologies

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