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Syringe Leakage Testing ISO 11040-4 Annex G2 In the field of pharmaceutical and medical device manufacturing, syringe leakage testing is a critical quality assurance process. It ensures that prefilled syringes maintain sterility and do not leak during transport, storage, or use. To meet stringent regulatory expectations, manufacturers must follow international standards such as ISO 11040-4, especially Annex G2, which outlines the liquid leakage testing method for syringe closure systems. What is Syringe Leakage Testing? Syringe leakage testing evaluates whether a syringe’s closure system—either a needle shield or tip cap—can withstand internal pressure without allowing fluid to escape. According to ISO 11040-4 Annex G2, the standard test pressure is 110 kPa, […]

Needle Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and regulatory compliance of syringe systems. Proper implementation of this test ensures that needles do not detach under normal or stress-use conditions, which is crucial for both clinical use and patient safety. Importance of Needle Pull-Out Force Needle pull-out force refers to the maximum axial force required to detach the needle from a syringe. Poor bonding

Needle Penetration Testing ISO 11040-4 Annex F The syringes needle penetration test is a crucial procedure in the medical device industry, ensuring the sharpness and effectiveness of needles used in medical applications. This test evaluates the needle penetration force required to pierce a test foil, reflecting the ease with which a needle can penetrate human skin or other materials. To guarantee patient safety and product reliability, international standards like ISO 11040-4 outline precise testing methodologies for syringe needles. These standards help manufacturers maintain quality control and regulatory compliance. Needle Penetration Test Equipment Required According to ISO 11040-4, the following apparatus is essential for conducting a needle penetration test: Universal tensile

Bloom Strength of Soft Gelatin Capsules Understand Bloom Strength of Soft Gelatin Capsule Soft gelatin capsules are widely used in the pharmaceutical and nutraceutical industries to encapsulate liquid or semi-solid ingredients. The bloom strength of soft gelatin capsules plays a critical role in determining the gel’s mechanical properties, influencing its durability, elasticity, and dissolution behavior. Ensuring optimal bloom strength is essential for maintaining capsule integrity during storage, transportation, and consumption. The Role of Bloom Strength for Gelatin Capsule What Is Bloom Strength? Bloom strength refers to the firmness or gel strength of gelatin, measured in grams using a bloom tester. It quantifies the force required to depress a standard-sized plunger

Syringe Glide Force Testing ISO 11040-4 Annex E In the medical and pharmaceutical industries, ensuring the performance and quality of syringes is paramount. One critical method for assessing syringe functionality is through the ISO 11040-4 syringe glide force testing. This standard helps manufacturers ensure that syringes, whether lubricated or non-lubricated, perform consistently and reliably when used for drug delivery. What is ISO 11040-4 Syringe Glide Force Testing? ISO 11040-4 outlines the procedure for measuring the glide force of a syringe, which is the force required to move the plunger within the barrel. This test is vital for assessing the quality and consistency of syringes, especially when they are used in

Break Loose and Glide Force Testing Method​ The Break Loose and Glide Force Testing Machine is an advanced testing device designed for the mechanical verification of syringes, particularly focusing on testing the forces required to operate the plunger. These tests, known as syringe break loose and syringe glide force testing, are critical in ensuring that syringes perform consistently and safely when used for medical injections. Break Loose and Glide Force Testing What is Syringe Break Loose Force Testing? The syringe break loose force refers to the initial force required to move the syringe plunger from its resting position. This force must be neither too high, which could make the syringe

Gelatin capsules are widely used in the pharmaceutical and nutraceutical industries for encapsulating various drugs, supplements, and other substances. Here are some common types and variations: 1. Hard Gelatin Capsules (HGC): These widely used capsules undergo stringent hardness tests to ensure they maintain structural integrity. They are composed of gelatin, water, and a plasticizer like glycerin or sorbitol. Available in various sizes, typically ranging from 000 (largest) to 5 (smallest), they are subjected to rupture tests to verify their resistance to breaking under pressure. They can also be colored and printed for branding and identification purposes. 2. Soft Gelatin Capsules (SGC): Soft gelatin capsules, subjected to both hardness and rupture