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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

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 "

Best ISO 8771-5 Needle Penetration Test Equipment

Best ISO 8771-5 Needle Penetration Test Equipment Needle penetration test equipment, also known as penetrability testers, plays a crucial role in various industries such as packaging, food, medical, and pharmaceuticals. This instrument is instrumental in the pharmaceutical industry for ensuring the quality and safety of vial stoppers. Cell Instruments stands at the forefront of precision testing technology, offering equipment that not only meets but exceeds the standards outlined in ISO 8871-5. ISO 8871-5 defines penetrability as the force necessary to puncture an elastomeric closure. The standard details the testing methodology: Many pharmaceutical elastomeric closures are paired with injection needles. Evaluating the force required for puncture is vital to assess the …

Best ISO 8771-5 Needle Penetration Test Equipment 続きを読む "

Needle Penetrability Tester for Vial Stopper | ISO 8871-5

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

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

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 "

needle puncture testing instrument

3 Reasons to Test Needle Puncture Resistance

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

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 …

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Penetrability Testing for Butyl Rubber Stopper

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

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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