Injekčné striekačky, najmä predplnené, zohrávajú v zdravotníctve kľúčovú úlohu, pretože umožňujú bezpečné a sterilné podávanie liekov. Zabezpečenie ich integrity prostredníctvom testovania tesnosti je nielen opatrením na zabezpečenie kvality, ale aj regulačnou požiadavkou. Tento článok sa zameriava na testovanie tesnosti injekčných striekačiek, ktoré je v súlade s medzinárodnými normami a osvedčenými postupmi a slúži výrobcom a orgánom kontroly kvality ako návod na [...]

Úvod do metódy vniknutia farbiva Metóda vniknutia farbiva je všeobecne uznávanou technikou v oblasti testovania integrity uzáverov kontajnerov (CCIT). Zabezpečenie integrity uzáverov kontajnerov je rozhodujúce pre bezpečnosť výrobkov, najmä v odvetviach, ako sú farmaceutický priemysel, zdravotnícke pomôcky a balenie potravín. Táto metóda využíva farebné farbivo na zisťovanie netesností alebo [...]

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 […]