Package Inspection White Papers & Case Studies

  1. Gene Therapy: Maintaining Sterility At Low Temperature Storage

    A gene therapy for pediatric Spinal Muscular Atrophy required a leak and break-resistant container which maintains sterility over product shelf life, through freeze and defrost cycles.

  2. What Is Enterprise Serialization? 1/9/2013

    For those who haven’t checked their watch lately we’d like to remind you there are only two years until California’s serialization mandates take effect. By John DiPalo, Chief Operations Officer

  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. Major Pharmaceutical CMO Installs Product Inspection Equipment To Achieve High Quality Standards 1/20/2012
    Pharma Tech Industries (PTI), a contract manufacturer and packer of pharmaceuticals, medical devices and personal care products, is focused on exceeding customers’ expectations.
  5. Integrity Testing Of Inhaler Products 1/5/2026

    Ensuring inhaler integrity is vital for patient safety and regulatory compliance. Discover how Vacuum decay testing provides a sensitive, non-destructive method to detect leaks and maintain sterility.

  6. How Real-Time Checkweigher Monitoring Boosts Profitability 7/14/2017

    With ingredient costs rising, it’s critical to minimize product give away. This paper discusses advanced checkweighing technology and how it ensures over/under-filled containers don't reach the marketplace.

  7. Headspace Moisture Analysis For Determination Of Residual Moisture Content In Lyophilized Pharmaceutical Products 8/24/2021

    Here, we describe how rapid non-destructive headspace moisture determination enables the generation of insightful data for product life cycle activities.

  8. A Faster 'Time-To-Market' With Automated Proofreading Solutions

    In the past, numerous departments at P&G were part of the verification process. For example, artwork traveled from Marketing, Production, Legal, Regulatory, Consumer Relations, Print Production, Product Development & Creative Services.

  9. Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing 5/22/2023

    Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

  10. Less Unnecessary Rejects Thanks To Automated Inspection 2/24/2022

    Pharmaceutical manufacturer CDM Lavoisier fully automates its inspection process for injectable glass ampoules allowing it to remove manual inspection steps.