ARTICLE

From Probabilistic to Deterministic: A Modern Approach to Seal Integrity Verification

In the healthcare packaging industry—covering devices such as sterile implants, parenterals, surgical tools, catheters, and Class I–III medical devices—ensuring package integrity is critical. Proper packaging format, materials, sterilization method and inspection approach play key roles in protecting the patient and maintaining sterility until point of use. Inspection-method classifications Inspection methods Read more

By nordtest, ago

Container Closure Integrity Testing (CCIT) under GMP Annex 1: Guidelines and Best Practices

Ensuring container closure integrity (CCI) is a fundamental requirement for sterile pharmaceutical products to prevent contamination and maintain product stability. The revised EU Good Manufacturing Practice (GMP) Annex 1, which provides detailed guidance on the manufacture of sterile medical products, emphasizes the necessity of container closure integrity testing (CCIT) throughout Read more

By nordtest, ago

Vacuum Decay

Introduction and physical principle Vacuum Decay is the most widely used deterministic method for testing the Container Closure Integrity. This method has been in use for several decades, and it is offered in advanced versions both for online and bench-top applications. The Vacuum Decay finds applications in the most different Read more

By nordtest, ago

HVLD High Voltage Leak Test

Among the different techniques for Deterministic Leak Test procedures, one of the most interesting and effective is the HVLD High Voltage Leak Test. This method is known and applied for many years, at least from the early 70ies of last century, but originally it has been developed for application in Read more

By nordtest, ago