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Needle Penetration Test for Vial Stopper Quality Assurance ISO 8871-5

Needle Penetration Test for Vial Stopper Quality Assurance I. What is Needle Penetration Testing? Definition and Purpose Needle penetration testing is a crucial method used to assess the puncture resistance of vial stoppers and the puncture ability of needles. This test ensures that the materials used in medical and pharmaceutical packaging maintain their integrity when penetrated by needles, thereby guaranteeing safety and effectiveness. Standards and Guidelines This test is governed by stringent standards such as ISO 8871-5 and USP 381. These standards outline the procedures and criteria for testing to ensure consistency and reliability. ISO 8871-5 specifically details the requirements for elastomeric parts used in parenterals and for devices for …

Needle Penetration Test for Vial Stopper Quality Assurance ISO 8871-5 続きを読む "

How To Use Penetration Force Tester To Meet ISO 8871-5

新製品 | 試験機器、記事を読む、試験方法、テスト標準

I. What is a Penetration Force Tester? A penetration force tester is a specialized instrument designed to measure the force required for a needle to penetrate a stopper, such as those used in pharmaceutical packaging. Significance of Needle Penetration Tests Needle penetration tests are essential for verifying the quality and performance of stoppers used in medical vials and syringes. These tests ensure that the stoppers can be reliably punctured by needles without compromising the sterility or safety of the contents. This is particularly important for maintaining the quality of injectable medications and vaccines. II. Introduction Cell Instruments is a leading manufacturer of materials testing instruments, specializing in packaging material testing, …

How To Use Penetration Force Tester To Meet ISO 8871-5 続きを読む "

最高の ISO 8771-5 針貫入試験装置

新製品 | 試験機器、記事を読む、試験方法

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、…

最高の ISO 8771-5 針貫入試験装置続きを読む "

Needle Penetrability Tester for Vial Stopper | ISO 8871-5

新製品 | 試験機器、記事を読む、試験方法、テスト標準

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 "

Penetrability Tester for Vial Stopper | ISO 8871-5

新製品 | 試験機器、記事を読む、試験方法、テスト標準

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 …

Penetrability Tester for Vial Stopper | ISO 8871-5 続きを読む "

What is Penetrability Testing? | ISO 8871-5

記事を読む、新製品 | 試験機器、試験方法

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 …

What is Penetrability Testing? | ISO 8871-5 続きを読む "

3 Reasons to Test Needle Puncture Resistance

新製品 | 試験機器、記事を読む、試験方法

Testing needle puncture resistance is crucial for ensuring the safety and durability of materials, especially those used in protective gear like gloves or garments and medicines that require a needle to puncture the rubber stopper of the vial. What is needle puncture resistance? It’s refers to a material’s ability to withstand penetration or puncture from sharp objects, such as needles or pins. It serves as a crucial parameter in assessing the robustness and protective capabilities of various materials, including but not limited to packaging films, medical gloves ,rubber stopper of vials top, and protective clothing. Needle Puncture Testing for Vial Rubber Stoppers Here are three reasons why you need needle …

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Pre-vacuum Blood Collection Tube Suction Volume Tester RDVT-01

新製品 | 試験機器

RDVT-01 blood collection tube suction volume tester is suitable for the suction volume test of disposable human venous blood sample collection containers. It is a test specially applied to the suction volume test of vacuum blood collection tubes, which can accurately measure whether the suction volume of vacuum blood collection tubes meets the standard requirements at different altitudes. RDVT-01 Drawing Volume Tester Standard Test YY 0314-2021 Disposable human venous blood sample collection container Test Principle Pierce the test blood collection tube into the puncture site of the test system to keep the pressure consistent with the pressure inside the vacuum tank; then make different pressure values inside according to the …

Pre-vacuum Blood Collection Tube Suction Volume Tester RDVT-01 続きを読む "

Penetrability Testing for Butyl Rubber Stopper

新製品 | 試験機器、試験方法

Penetrability Testing for Butyl Rubber Stopper Butyl Rubber Stoppers Butyl rubber stoppers stand out for their exceptional sealing performance and robust drug resistance, making them the primary choice for glass bottles in direct contact with pharmaceuticals. As the pharmaceutical industry embraces these stoppers, assessing their penetrating performance becomes crucial, focusing on key parameters such as penetrating force and penetrating residue. Rubber Stoppers Quality Control–Penetrability Testing Penetrability testing for butyl rubber stoppers is a critical quality control measure in the pharmaceutical industry. As these stoppers play a vital role in sealing glass bottles that directly contain pharmaceuticals, ensuring their penetrability is of paramount importance. Penetrability Testing with Cell Instruments’ Tensile Tester …

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Stretch Wrap Film Testing for Transport Packaging

新製品 | 試験機器、パッケージングニュース、試験方法、テスト標準

Stretch Wrap Film Testing for Transport Packaging Stretch wrap film, also known as stretch film, is a new type of industrial packaging film products. It is characterized by light, soft and thin, good tensile properties, elongation properties and self-adhesive properties. Its application in transportation packaging is a packaging method that improves packaging efficiency and saves costs. In order to ensure the production quality of packaging stretch wrap film, manufacturers need to produce according to certain standards. This article introduces some testing methods about stretch wrap. 1.Stretch Wrap Film Thickness Test Carry out in accordance with the provisions of GB/T 6672. Cut the entire stretch wrap film sample of 100mm along …

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