INSIGHTS ON PHARMACEUTICAL INSPECTION
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Inspecting On The Edge — Understanding Punch Tip Wear
Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?
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Why Is It Important To Have Properly Trained Visual Inspectors?
Properly trained visual inspectors are crucial for identifying defects in parenteral drugs, safeguarding patient safety and product quality.
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5 Common Bowie-Dick Test Failures And How To Prevent Them
Bowie-Dick test failures indicate serious sterilization issues. Learn the five most common causes and proven strategies to prevent downtime, compliance risks, and compromised product integrity.
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6 Things To Consider During Visual Inspection Operations
Even with automation, manual visual inspection remains vital in sterile drug manufacturing. Discover six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.
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Guide To Product Inspection Systems In The Pharmaceutical Industry8/29/2024
Explore the critical role of inspection systems, specifically metal detectors, X-ray systems, and checkweighers, in pharmaceutical manufacturing.
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Determining The Limit Of Detection In CCIT12/18/2025
Accurately determining the smallest detectable defect in pharmaceutical packaging is essential for sterility. Learn how test sensitivity, positive controls, and regulatory standards shape CCI strategies.
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The Significance Of Preventive Maintenance For Product Inspection Systems10/9/2024
Watch to gain insight into the crucial role of maintenance in ensuring the ongoing optimal performance, reliability, and longevity of your inspection systems.
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Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation9/17/2025
Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.
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Helium Leak Detection On Glass Cartridge Containers1/5/2026
Helium leak detection offers unmatched sensitivity for verifying glass cartridge seal integrity. Learn how this advanced method outperforms traditional tests and provides confidence in packaging.
PHARMACEUTICAL INSPECTION SOLUTIONS
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Used Nikka Densok pinhole inspector, model HDB-204V-AS+DL, currently with 2ml change parts, with controls and control computer, with reject, serial# 490, built 2005.
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The XR75 Pharma X-ray is optimized for the quality control of pharmaceutical, nutraceutical, and cosmetic products in thin opaque packaging materials that cannot be inspected manually or with visual systems. The leakage prevention curtains are designed to leave a 10 mm-clearance that ensures safety and reduces false rejects caused by product jams or changed orientation during conveyance. The system checks for different product integrity issues simultaneously: products trapped in seals, missing, chipped, or broken tablets in blisters, and the presence of foreign contaminants. The high-resolution X-ray images ensure reliable inspection of the small items at belt speed up to 90 m/min.
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Bottles come in a wide array of sizes and configurations, reflective of their diverse use in the health sciences industry. Typically, they exhibit a screw top closure threaded onto the bottle mouth, though sealing properties ranges from elastomeric liners, to o-rings, to induction seals and reliance on plastic-to-plastic contact and compression. One specific trend is the increase in need to test sterile bulk containers or sterile API containers. As the industry continues to move toward outsourcing or even insourcing through a network of suppliers or sites, transport of sterile drug product or API is becoming increasingly common. These types of containers are traditionally challenging to test, but can be qualified prior to use or as a proof of concept using helium leak detection.
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The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.
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METTLER TOLEDO Safeline pharmaceutical metal detector systems are designed to offer maximum flexibility in process areas. A compact footprint enables systems to be inserted into areas where space is restricted. Robust, low profile, fully rotating castors provide ease of mobility, enabling the system to be used in multiple locations. Flexibility is further enhanced by the ability of the metal detection head to be adjusted easily (without the need for tools) in all three axes to suit any configuration.