Package Inspection White Papers & Case Studies

  1. Nitrogen Purging Process Development For Oxygen Sensitive Formulations In Pre-Filled Syringes 6/22/2021

    A new biological product, in pre-filled glass syringes, had demonstrated oxygen sensitivity in stability studies. Therefore, the headspace was purged with nitrogen during filling, and the client wanted to validate the batch production process and assess the nitrogen purge efficiency. In this study we demonstrate by performing a 100% inspection on the engineering batches using non-destructive headspace oxygen analysis you could gather the data needed before a commercial launch.

  2. An Introduction To High Voltage Leak Detection (HVLD) Technology 4/8/2021

    A majority of methods used to detect pinholes, cracks, and defective seals in containers are destructive. Learn about High Voltage Leak Detection (HVLD) and why it is free from these shortcomings.

  3. Test Method Development For A Container Closure Integrity Test Using Headspace Gas Ingress 3/11/2021

    To ensure patient safety, good container closure integrity (CCI) is of great importance for all sterile injectable products. Recent regulatory guidance has made clear that there is no ‘gold standard’ for CCI testing. As a CCI test method, headspace analysis is based on detecting changes in the headspace gas composition that result from gas ingress through a leak. Non-destructive headspace analysis, using laser-based spectroscopy, can be used to directly quantify the gas concentration inside a sealed parenteral package. It can be applied to a range of product configurations, and formulations, and has historically been used for detecting leak defects in modified headspace product.

  4. Oxygen Sensitive Product: Comparing Oxygen Testing Methods 3/7/2021

    The accurate determination of oxygen concentration as a critical quality parameter for oxygen-sensitive products is important across the product life cycle activities. Traditional methods for determining headspace oxygen levels in parenteral containers, such as electrochemical methods or gas chromatography, are slow and destructive. This article describes several case studies comparing non-destructive laser-based oxygen headspace analysis with electrochemical oxygen analysis and gas chromatography.

  5. Ensuring CCI For Products Requiring Deep Cold Storage By Correlating Seal Quality To CCI 3/3/2021

    This case study describes how packaging development and process study data of a pharmaceutical vial product requiring deep cold storage can be combined in a holistic approach.

  6. A Holistic Strategy To Ensure Container Closure Integrity Of Sterile Injectable Vial Product 1/25/2021

    Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity testing (CCIT). However, assuring good CCI of sterile injectable product goes beyond CCI testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This article describes a framework enabling such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.

  7. Dual-Lane Checkweigher Provides High-Throughput Tube Line Automation Inspection 6/15/2020

    Teligent produces a range of generic prescription topical and injectable pharmaceuticals. To automate inspection on their high-throughput tube line, they turned to a checkweigher with a two-lane configuration.

  8. Inline Weighing Technology Offers Additional Quality Check Features 6/10/2020

    Alongside weight monitoring, the checkweigher used at Protina Pharmazeutische GmbH offers other important functions that support the company's system of strict quality management.

  9. Utilizing A Checkweigher To Identify Inaccurately Filled Products 6/9/2020

    Sanofi-Aventis uses checkweighers to check vital insulin: in the Injectables Division, where liquid drugs such as different types of insulin or drugs for emergency medicine are produced, the packaged medical compounds are subjected to final checks using a dynamic checkweigher.

  10. The Importance Of Package Integrity To Shelf Life Of Products 6/9/2020

    Pharma Tech Industries, a contract manufacturer and packer of pharmaceuticals and medical devices relies on x-ray, metal detection systems, and checkweighers to achieve their high quality standards