Pharmaceutical Package Inspection
FEATURED ARTICLES
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
WHITE PAPERS & CASE STUDIES
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The Importance Of Package Integrity To Shelf Life Of Products
Pharma Tech Industries, a contract manufacturer and packer of pharmaceuticals and medical devices relies on x-ray, metal detection systems, and checkweighers to achieve their high quality standards
PRODUCTS AND SERVICES
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X-ray inspection systems for packaged products offer maximum contamination detection sensitivity at high throughputs for a diverse range of food and pharmaceutical applications. Typical packaged applications include the inspection of foil and plastic containers, cartons/boxes, foil pouches, bags and sacks, trays, tubes, sachets, flow-wraps, PET bottles and blister packs.
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The Leak Testing Machine is used for off-line Non-Destructive Integrity Testing of Tubs (Trays) of pre-filled syringes. It performs the Leak Testing process on one Tub at a time by means of a Testing Section under Vacuum.
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Used Brevetti vial inspection unit, model A1, speeds up to 360 pcs/hour, currently set up for 53.5 mm diameter 100 mL vails, 8mm - 95 mm diameter x up to 240 mm high vial size range, with integrated robotic arm, (4) inspection units, with vial feed infeed and acceptable exit tables, dual reject stations, with HMI panel, serial# BM242, built 2016.
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With our Switch 350, you benefit from the advantages of two machine concepts: We have combined the modularity, handling options, and technologies of our well-proven standard platforms with the flexibility of our small batch inspection machine to run syringes and vials on one and the same machine – with nesting system for syringes and vials alike.
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Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV bags, pouches, or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines).
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A helium based test method for verifying the integrity of a blister card holding drug product has been proven to be the most effective approach due to the extreme sensitivity offered. The test method relies on detecting helium sealed in the package system as it escapes through micro-channels in the package. A test sequence begins by placing the package in the test fixture and a vacuum is quickly drawn. The resulting pressure differential causes helium to escape through potential holes or cracks in the package.
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Sealing problems with new packaging designs present a new area of concern for developers. Specialized packaging materials for the pharmaceutical industry, including blister packs continue with innovative approaches
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The OX-TRAN Model 702 is the latest innovation in oxygen transmission rate (OTR) testing, incorporating the finest in technology while setting a new standard for accuracy, throughput, and ease of use.