最高の ISO 8771-5 針貫入試験装置 針貫入試験装置は、貫入性試験装置とも呼ばれ、包装、食品、医療、医薬品などのさまざまな業界で重要な役割を果たしています。この装置は、製薬業界でバイアルストッパーの品質と安全性を確保するために役立ちます。Cell Instruments は精密試験技術の最前線に立ち、ISO 8871-5 で概説されている基準を満たすだけでなく、それを超える装置を提供しています。ISO 8871-5 では、貫入性をエラストマー クロージャーを突き刺すために必要な力と定義しています。この規格では、試験方法を詳しく説明しています。多くの医薬品用エラストマー クロージャーは、注射針とペアになっています。穿刺に必要な力を評価することは、…
Vial Stopper Needle Penetrability Tester I. Introduction of needle penetrability tester In the realm of pharmaceutical quality control, ensuring the integrity of vial stoppers is paramount. A crucial aspect of this evaluation is assessing the needle penetrability of elastomeric closures, a process facilitated by specialized equipment known as Needle Penetrability Testers. This instrument plays a crucial role in guaranteeing the safety and efficacy of pharmaceutical products by meticulously examining the force required to penetrate rubber closures. II. Understanding Needle Penetrability in Pharmaceutical Quality Control Needle penetrability refers to the force necessary to pierce an elastomeric closure, a key parameter in evaluating the suitability of vial stoppers for pharmaceutical …
Needle Penetrability Tester for Vial Stopper | ISO 8871-5 続きを読む "
The NPT-01 penetrability tester is used to test the force required to pierce vial stoppers and complies with ISO 8771-5. I. Introduction of Penetrability Tester In the realm of pharmaceutical packaging, ensuring the integrity of rubber stoppers is paramount. The seal provided by these stoppers can mean the difference between preserving the efficacy of life-saving medications or risking contamination and degradation. Penetrability testing emerges as a critical procedure in guaranteeing the reliability of these stoppers, thereby safeguarding the quality of pharmaceutical products. 1. Overview of penetrability testing and its necessity Penetrability testing is a method employed to evaluate the puncture resistance of materials, such as rubber stoppers used in pharmaceutical …
What is Penetrability Testing? ISO 8871-5 is a standard within the ISO 8871 series, which focuses on penetrability testing for the elastomeric components of injectables and pharmaceutical devices. Introduction of ISO 8871-5 and Penetrability Testing In the realm of pharmaceuticals, the integrity and performance of elastomeric closures are paramount. Many elastomeric closures for pharmaceutical use are used in conjunction with injection needles. The force necessary to penetrate or pierce a rubber closure is an important parameter in evaluating the suitability of the closure for its intended use. ISO 8871-5 shines a spotlight on these requirements, particularly through the penetrability testing. The Definition of Penetrability At the heart of ISO 8871-5’s …
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