Insights On Pharmaceutical Inspection

1. Key Considerations For In-Line Checkweighing Of Packaged Products In Pharma 4/17/2020

   Checkweighers used in pharmaceutical packaging need to achieve high levels of dynamic weighing accuracy. In addition to weighing accuracy, it is essential that any checkweigher, and its operating software, are suited for the unique regulatory environment under which pharmaceutical plants operate. Learn what system design and support considerations can help manufacturers select the correct system for use in a wider quality control regime.

2. Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines 12/27/2018

   Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.

3. Contract Pharmacal Corporation Installs X-Ray Inspection And Checkweighers For Brand Protection And Quality 5/12/2020

   CPC develops, manufacturers and packages premium pharmaceuticals, over-the-counter drugs and dietary supplements. Since five of their lines package product in a foil-laminated film, which disrupts traditional metal detector, they need to implement x-ray systems for those lines.

4. Lyo Chamber Moisture Mapping 12/27/2018

   Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.

5. In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers 12/27/2018

   Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.

6. Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing 12/26/2018

   This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

7. E-Scan 655 High Voltage Leak Detection Technology Overview 4/24/2019

   PTI Sales Engineer, Rob Zecchin, at the recent Interphex event in New York City, demonstrated PTI’s E-Scan 655 MicroCurrent HVLD technology for Container Closure Integrity Testing.

8. Effects Of X-Ray Inspection On Pharmaceutical Products 12/12/2019

   Some manufacturers still have reservations about adopting x-ray inspection as a safe method of product inspection. This white paper examines the potential effects of x-ray inspection on pharma products.

9. Container Closure Integrity Of Sterile Vials During Deep Cold Storage 12/26/2018

   Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.

10. Test Method Development, Experimental Design And Positive Controls For Package Integrity 4/9/2020

    Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of  positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.