Labthink Knowledge

In the highly regulated worlds of pharmaceutical and food packaging, the material " barrier property " is only half the story. While we often focus on what stays out (Oxygen and Moisture), it is equally critical to monitor what moves in—specifically, the migration of chemicals from the packaging material into the product. To ensure safety, the industry relies on a hierarchy of tests: Residue on Evaporation (ROE), Overall Migration (OM), and Extractables & Leachables (E&L). (AI generated image) 1. Defining the Terms While these terms can be confusing, they are essentially different "lenses" used to view the same physical phenomenon: the transfer of mass. Gravimetric Testing: This is the fundamental physical method. It involves using a high-precision microbalance to measure the weight of solids left behind after a solvent has been evaporated. Residue on Evaporation / Non-Vol...

To accelerate time-to-market for life-saving therapies, manufacturers must move toward data-driven Container Closure System (CCS) qualification. By leveraging high-precision, nondestructive testing, teams can ensure regulatory compliance and patient safety throughout the product lifecycle. The Challenge: Biologic Sensitivity Biologics (vaccines, monoclonal antibodies) are highly sensitive. Infinitesimal ingress of oxygen or microbes can trigger protein aggregation or loss of sterility. A CCS must be qualified with extreme rigor to maintain a robust barrier under all storage conditions. Container Closure Integrity (CCI): Verifying that interfaces (vial/stopper or syringe/plunger) prevent the passage of microorganisms and gases. Barrier Performance: Quantifying how materials limit water vapor and oxygen transmission—vital for lyophilized or liquid-stable drugs. Mechanical Performance: Ensuring components like crimp seals and plunger rods withst...

Sterile Barrier System (SBS) is the minimum package that prevents the ingress of microorganisms and allows aseptic presentation of the product at the point of use. To maintain the highest levels of safety, manufacturers are increasingly turning to advanced instrumentation like the Labthink C660B and C660M to validate and monitor their packaging performance. This article explores how a dual-testing approach, combining qualitative leak detection with quantitative seal strength analysis, provides the rigorous data required for ISO 11607 compliance. The Integrity Challenge: Why Leak and Seal Strength Tests Matter ？ A Sterile Barrier System must remain intact from the point of sterilization until it is opened by a healthcare professional. However, flexible medical packaging faces numerous risks during its lifecycle, including pressure changes during air transport, mechanical shocks during shipping, and compression in storage. Re...

The Labthink C370H is an automated, ASTM E96 –compliant gravimetric tester that delivers precise permeability measurements for films, containers, packaging materials, and more. Labthink International, Inc. Feb 2, 2026 Looking for a game-changer in water vapor permeability testing ? Meet the  Labthink C370H Water Vapor Transmission Rate Test System . This powerhouse is built on the gravimetric method , fully compliant with ASTM E96 standards, making it perfect for the pharmaceutical, food, and new energy sectors . What makes it so special? First, its 360-degree air circulating technology ensures a perfectly stable test environment. High-precision sensors monitor temperature and humidity in real-time, while the pneumatic chamber seal protects the sensitive balance from any interference. It’s incredibly versatile, too! You can test films, containers, fabrics, and more, using either the desiccant or water method . This system is all about efficiency and accuracy. With up to nine indepe...