Container Closure Integrity Testing of Prefilled Syringes In the pharmaceutical industry, maintaining the sterility and safety of drug products is paramount. Container closure integrity testing of prefilled syringes plays a critical role in verifying that a syringe’s sealing system effectively protects against contamination. As injectable drug products grow in popularity, ensuring container closure integrity (CCI) has become a regulatory expectation and a fundamental part of product development and quality control. At Cell Instruments Co., Ltd., we understand the importance of accurate, reliable CCI testing. Our advanced equipment and customized solutions support pharmaceutical companies in meeting stringent quality standards. Understanding Container Closure Integrity Testing of Prefilled Syringes Container closure integrity testing […]

Introduction to Container Closure Integrity Testing Dye Ingress USP Container closure integrity testing dye ingress USP is a vital method used to evaluate whether sterile packaging systems can maintain a microbial barrier. This test is particularly critical in the pharmaceutical and medical device industries, where packaging failure can compromise product sterility and patient safety. USP 1207 The dye ingress method is one of the deterministic and probabilistic techniques recommended in USP 1207, which provides a comprehensive framework for evaluating container closure systems. In this test, a package is submerged in a dye solution (commonly methylene blue), and vacuum or pressure is applied to force dye into any breaches in the […]

Leak Burst Tester for Package IntegrityBurst Pressure Leak Testing Introduction to Leak Burst Tester Ensuring the integrity of sealed packages is critical in industries such as food, pharmaceuticals, and medical devices. A leak burst tester is an essential tool for evaluating package strength and seal reliability. It performs burst pressure leak tests in compliance with ASTM F2054 and ASTM F1140, ensuring packages can withstand pressure variations during manufacturing, storage, and transportation. Understanding Burst Pressure Leak Testing Burst pressure leak testing is a widely used method to assess package durability. This test involves applying internal pressurization to a package until failure occurs. The two primary standards guiding this testing are: ASTM […]