Package Inspection White Papers & Case Studies

1. Effects Of X-Ray Inspection On Pharmaceutical Products 3/7/2023

   Some manufacturers still have reservations about adopting X-ray inspection as a safe method of product inspection. Explore the potential effects of X-ray inspection on pharmaceutical products and more.

2. 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.

3. 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.

4. Considerations In Formulation Development Of Injectable Solutions 2/8/2022

   Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.

5. How To Select Critical Control Points For X-Ray Systems 5/13/2011

   Manufacturers typically install an X-ray inspection system at the end of the production line, although it can be installed at any point. This white paper addresses questions about CCPs for x-ray inspection.

6. How To Properly Test Your Industrial Metal Detector 2/7/2019

   In this paper, we explain the differences between validation, verification and routine performance monitoring and give an overview of recommended test methods for different metal detection systems.

7. Rapid Nondestructive Moisture Determination Of Freeze-Dried Product 12/28/2018

   Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.

8. Extractables And Leachables: Risk Management And Analytical Solutions 10/11/2023

   Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

9. Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines

   Although metal detection has been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants for decades in the pharmaceutical industry, it has not been widespread.

10. High-Speed Pharmaceutical Glass Vial Inspection With In-Sight Vision Systems

    Few industrial sectors have such stringent quality requirements as the pharmaceutical industry. To meet these exacting specifications, companies are increasingly utilizing intelligent vision systems.