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2026 Pharma Guide - Efficient Container Closure System Qualification for Biologics

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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...
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How to Improve SBS Integrity with Labthink C660 and C690 Leak Testers

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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...
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Water Vapor Transmission Rate Test System

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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...
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Comprehensive Quality Control for Stretch Wrap Film Performance

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Stretch wrap film has become an indispensable packaging solution globally, used to tightly secure goods for efficient transportation and reliable storage. Its versatility stems from its unique properties: lightweight yet strong, highly elastic, self-adhesive, and capable of conforming to any shape without damaging the contents. Produced through advanced cast film extrusion processes, these films boast excellent tensile performance, tear and puncture resistance, high transparency, superior self-adhesiveness, and impressive retraction rates, ensuring packages remain compact and secure. From chemical raw materials and food products to electromechanical goods and textiles, stretch wrap film provides crucial protection, with specialized types like PE (eco-friendly) and PVC (specific uses) catering to diverse needs. The Imperative of Quality Control Given its critical role in safeguarding products throughout the supply chain, the consistent quality of stretch wrap film is paramount. Manufa...
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Case Study: Oxygen Barrier Properties of Recycled PET Bottles

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Recycling plastic bottles is vital for environmental protection, but it can affect their oxygen barrier properties, making them less suitable for oxygen-sensitive products. Our case study on PET bottles with varying amounts of recycled material found that increasing the recycled content from 25% to 50% only slightly reduced their oxygen barrier. This suggests that using more recycled material does not significantly compromise the bottles' performance. The Problem The growing trend of recycling waste plastic bottles requires an understanding of how reclaimed materials affect a product's performance. For PET bottles, a crucial metric is their ability to act as an oxygen barrier. High oxygen permeability can compromise the quality of packaged goods, limiting the use of recycled materials in food and beverage containers. This study aims to quantify that effect by testing bottles with varying percentages of recycled content. The Test Two types of PET bottle samples were tested...
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Why Non-Volatile Residue Detection in Purified Water is Critical for Regulated Industries

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Significance of Non-Volatile Residue Detection in Purified Water Purified water is a crucial raw material in industries like pharmaceuticals, biotechnology, and electronics manufacturing. Non-volatile residues are non-evaporating substances (like inorganic salts, organic matter, microbial byproducts) that remain after evaporation at a specific temperature (e.g., 105℃). Detecting Non-Volatile Evaporation residues is important for Regulatory Compliance: Meeting limits set by pharmacopoeias (e.g., For " Purified Water in Containers", the Ph. Eur. European Pharmacopoeia has a requirement for "Residue on Evaporation" of ≤0.001%). Process Stability and Risk Control: Accumulation of residues can alter water conductivity and pH, affect process consistency, clog equipment, corrode metal parts, or interfere with reactions. Drug Production Safety: Heavy metals (e.g., lead, mercury) or endotoxins in residues can contaminate drugs, causing allergic reactions or toxicity in...
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Non-Destructive Leak Detector C690H Delivers High-Accuracy, High-Throughput CCI Testing for Pharma Packaging

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Labthink C690H Non-Destructive Leak Detector uses a vacuum-based testing method (and also a positive pressure method) to find tiny leaks in different kinds of containers. It's built according to international standards like ASTM F2338 and is particularly useful for checking various packaging in industries like food, pharmaceuticals, daily chemicals, and electronics, such as vials, ampoule, cartridge bottles, infusion bottles and prefilled syringes. How it works It works by placing the sample in a sealed chamber, creating a vacuum, and then using sensors and a fluid dynamics model to calculate the leak rate and the size of the leak based on how fast the pressure drops. It can operate in two modes: Vacuum mode: It creates a negative pressure (vacuum) around the sample and measures how quickly the pressure inside the sample drops. This works well for most packaging types because the vacuum helps to "pull" out any leaks, making them easier to detect. ...
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