Newsletter | April 7, 2021

04.07.21 -- Technologies To Ensure Container Closure Integrity

 
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.

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.
Risk Mitigation Of Parenteral Packaging With Container Closure Integrity
 

Parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a threat of bacterial ingress. To manage this risk, the industry has continued to pursue leak detection methods that are more sensitive and reliable for vials, ampoules, cartridges and syringes.

Dye Ingress For CCIT: A Poor Bet In A High Stakes Game
 

The dye ingress test method continues to be a widely used test method for container closure integrity (CCI) within the pharmaceutical industry. Even with recent research attempting to support its use, this paper explains why the dye ingress test method is not a suitable approach.

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Solutions
Helium Leak Testing Equipment For Parenterals

Parenteral products, specifically Vials, both glass and, increasingly, polymeric vials, represent one of the most common package systems historically tested by helium leak detection, largely due to their continued dominance as a package system for high-potency drugs requiring utmost protection. The primary sealing interface of a traditional vial system is between the elastomeric closure and land seal of a vial, physically compressed together by a crimped aluminum seal.

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PTI Packaging and Inspection Systems
Sub-Micron Leak Detection For CCIT On Parenterals And Rigid Containers: VeriPac 465

The VeriPac 465 performs leak detection based on the basic principles of physics and does not require the use of trace gasses or sample preparation to perform the test. Its core technology is based on the ASTM vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing.

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PTI Packaging and Inspection Systems