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System suitability testing pharmacopoeia is a cornerstone of pharmaceutical quality assurance. When dealing with injectable drugs packaged in glass ampoules, international standards such as ISO 9187 establish strict criteria for hydrolytic resistance, annealing quality, and breaking force. By following these procedures, manufacturers not only meet regulatory expectations but also safeguard patient safety and product reliability. Importance of System Suitability Testing Pharmacopoeia The purpose of system suitability testing pharmacopoeia is to verify that analytical methods and packaging components perform consistently as intended. For glass ampoules, this means proving that the container can preserve sterility, withstand sterilization, and break cleanly at a designed point. Failure in ampoule performance can lead to serious […]

Package Compression Test The package compression test is a vital method used across packaging, pharmaceutical, and medical industries to evaluate the structural integrity of packaging materials. This test simulates real-world pressure conditions that packaging may encounter during transportation, stacking, or handling. It ensures that packaging does not rupture, deform, or fail under load—helping protect contents like medicines, food, or medical fluids. At Cell Instruments, we understand that packaging performance isn’t just about appearance—it’s about strength, compliance, and safety. Our PCT-01 Package Compression Tester is purpose-built for high-precision, standard-compliant compression testing across diverse applications. Test Standards and Industry Applications TAPPI T804 and Other  Standards The TAPPI T804 standard is widely adopted

Introduction to Sodium Chloride Ampoules Sodium chloride ampoule is a widely used packaging format in the pharmaceutical industry, commonly serving injectable solutions for clinical and hospital use. These ampoules must meet strict safety and quality standards to ensure sterile conditions and break integrity. One of the essential performance indicators is the breaking force, which determines the ease and safety of ampoule opening during medical procedures.This article outlines the standardized testing process for sodium chloride ampoules based on ISO 9187-1:2010, focusing on the practical use of a break force tester machine to ensure conformity, product safety, and operational efficiency. The information is particularly useful for quality control professionals, manufacturers, and validation

Maximizing Package Integrity with Packaging Compression Strength Tester In today’s fast-paced logistics and pharmaceutical supply chains, packaging compression strength tester solutions are indispensable for safeguarding product quality and consumer safety. At Cell Instruments, we understand the significance of maintaining packaging integrity under real-world stress. This article provides a professional yet accessible overview of compression testing, guided by ISO 12048, and introduces effective testing methods that enhance packaging reliability—especially when using high-performance equipment like the PCT-01 Package Compression Tester. Understanding the Role of Packaging Compression Strength Tester A packaging compression strength tester is a precision instrument designed to measure how much compressive force a packaging unit can endure before it deforms

Plastic Infusion Bottle Compression Test In the pharmaceutical and medical packaging industry, ensuring that packaging materials withstand external forces is crucial. The plastic infusion bottle compression test is an essential method to evaluate the strength and durability of plastic bottles used for infusion therapies. This article explores the significance of this test, highlighting related concepts like plastic film packaging compression performance, packaging integrity testing, and composite film bag finished product packaging compression test. We also introduce advanced testing solutions such as the Cell Instruments PCT-01 package compression tester to help quality professionals achieve reliable results. Why the Plastic Infusion Bottle Compression Test Matters Plastic infusion bottles must maintain their structural integrity

Break Loose and Glide Force Testing: A Key Indicator of Syringe Performance In the pharmaceutical and medical device industries, break loose and glide force testing is a critical procedure used to evaluate the usability and quality of syringes. These tests determine how much force is required to start (break loose) and continue (glide) the movement of the plunger within the syringe barrel. The results directly impact product compliance, injection comfort, and patient safety. This testing method is especially vital for manufacturers developing prefilled syringes, sterile subassemblies, and auto-injector components. An overly tight or loose plunger can lead to dosing errors, plunger detachment, or inconsistent medication flow—all of which pose safety

Download Catalog In the quality assurance of medical syringes, glide force testing plays a pivotal role in assessing the smoothness and reliability of piston movement. It directly impacts user safety, comfort, and product compliance with critical international standards. This article explores the essentials of glide force testing, including related parameters like break loose force, and how standards such as ISO 11040-4, ISO 7886-1, and ISO 8537 guide the testing process. We will also introduce the Cell Instruments MST-01 Syringe Functionality Tester, a reliable solution for laboratories and manufacturers performing syringe functionality testing. MST-01 Glide Force Tester by Cell Instruments To ensure precise syringe functionality testing, we recommend the Cell Instruments

Injectability TestSyringe Functionality Testing The injectability test is a crucial evaluation method used in the development and quality control of syringes and injection systems. It directly impacts patient comfort, drug delivery effectiveness, and regulatory compliance. By examining how easily and consistently a formulation can be delivered through a syringe, the test ensures the usability and performance of injectable products under real-world conditions. For medical device developers, pharmaceutical manufacturers, and packaging engineers, understanding injectability testing is key to delivering safe and efficient drug delivery systems. Syringe Functionality Testing – ISO Syringe Standards To maintain safety and global regulatory compliance, several ISO standards define the framework for injectability and syringe functionality testing.