Newsletter | April 7, 2021

04.07.21 -- Technologies For Package And Seal Integrity Testing

 
CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors
 
Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package life cycle stage, an approach where combination products will highlight the pitfalls.
Automation Of Class III Medical Device Packaging
 

When assuring the quality of all packaged products, testing container closure integrity (CCI) is critical, especially as it relates to Class III medical devices. If there is a breach of the seal, it affects the sterility of the device and may present a significant quality concern at a critical moment of use.  

Moisture And Oxygen Risk In The Medical Device Industry
 

The majority of medical device packaging is porous in nature. Some medical devices require a different layer of defense protecting against oxygen or moisture ingress. Any time a foil barrier comes into play with a high-risk application, detection of microleaks is absolutely critical to assuring the shelf-life of the products.

Medical Device Tyvek Seal Quality And Peel Strength
 

Class III medical devices must maintain product sterility for the duration of the product’s shelf-life and must be easy to open. Tyvek seal strength is critical for a product to survive transportation, shipping, and storage. Peelability of the pouch is equally as critical, providing those in a surgical environment the ability to deliver a device effectively into the sterile field while maintaining sterility. 

Helium Leak Detection Technology Solves Cold Supply Chain Challenges Of Today’s High-Risk Pharmaceuticals
 

The COVID-19 pandemic has highlighted many of the challenges facing the pharmaceutical industry, among them the importance of distribution logistics. Vaccines and other large-molecule products require unique storage conditions, especially during the cold chain. Helium detection technology can improve the quality of drug delivery system and container design.

Container Closure Integrity Testing: Sensitivity, Automation, And Efficiency
 

This article explores the need for sensitive, reliable, and automated container closure integrity (CCI) testing technologies, and how existing deterministic solutions can help achieve optimum quality assurance goals in CCI for pharmaceutical manufacturers.

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Solutions
Seal Quality Inspection And Analysis: Seal-Scan

Seal-Scan is an Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively offline.  It is a deterministic, quantitative, high resolution method that inspects pouch seals for defects and seal integrity for consistency.  Testing is non-destructive, non-invasive, and requires no sample preparation. 

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Seal-Sensor Non-Contact Seal Inspection Solution

Seal-Sensor utilizes ultrasound technology that provides non-contact seal inspection solutions for offline laboratory use and high speed 100% online applications. It is a very rapid, reliable method that provides an instant reading of seal presence and quality.

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