Las jeringas, especialmente las precargadas, desempeñan un papel fundamental en la atención médica, ya que permiten la administración segura y estéril de medicamentos. Garantizar su integridad mediante pruebas de fugas no solo es una medida de control de calidad, sino también un requisito regulatorio. Este artículo se centra en las pruebas de fugas de jeringas, de acuerdo con las normas internacionales y las mejores prácticas, para orientar a los fabricantes y a los responsables del control de calidad […]

Introducción al método de penetración de colorante. El método de penetración de colorante es una técnica ampliamente reconocida en el campo de las pruebas de integridad de cierres de contenedores (CCIT). Garantizar la integridad de los cierres de los contenedores es fundamental para la seguridad de los productos, especialmente en industrias como la farmacéutica, la de dispositivos médicos y la de envasado de alimentos. Este método utiliza un colorante para detectar fugas o […]

Gross Leak Test Meaning and ASTM F2096 Bubble Test Understanding the gross leak test meaning is essential for quality assurance in packaging, especially in the food, pharmaceutical, and medical device sectors. This test is designed to detect large leaks in flexible packaging systems that could compromise product sterility, shelf life, or performance. Companies like Cell […]

Ensuring the integrity of syringes is essential for patient safety and product quality in the medical and pharmaceutical industries. One of the most critical procedures for quality control is the syringe leak test method, which determines whether a syringe can prevent liquid leakage under specific conditions. This test is particularly crucial for both manually operated […]

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) […]

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 […]

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 […]