Enotnost vsebine Evropska farmakopeja in ISO 9187

Content uniformity European pharmacopoeia is a fundamental aspect of pharmaceutical quality control, ensuring that each dosage form contains the intended amount of active ingredient within defined limits. For injectable drugs in ampoules, uniformity is crucial not only for efficacy but also for patient safety. By adhering to pharmacopoeial standards and following ISO 9187, manufacturers can […]

Laboratorijska oprema za testiranje ampul: Celovit vodnik za skladnost s standardom ISO 9187

Introduction In the pharmaceutical industry, ensuring the integrity and usability of ampoules is essential for patient safety and production efficiency. Reliable lab equipment for ampoule testing plays a vital role in assessing quality parameters such as breaking force, hydrolytic resistance, and annealing quality. One of the most authoritative standards in this domain is ISO 9187, […]

Kako opraviti preskuse penetrabilnosti za elastomerna zapirala v skladu s standardoma ISO 8871-5 in USP 381

How to Perform Penetrability Tests for Elastomeric Closures According to ISO 8871-5 and USP 381 The penetrability test for elastomeric closure plays a vital role in pharmaceutical packaging validation. Elastomeric closures—such as rubber stoppers used in ampoules and vials—must allow for easy needle penetration while maintaining sealing integrity. In this article, we explore how to […]