INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

  • The X37 Series offers the most technically advanced x-ray inspection system on the market for tall, rigid containers. The X37 Series provides the customer with the tools to achieve compliance with industry standards such as HACCP.

  • 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.

  • Vision Robot Unit: driving pharma innovation

    The Vision Robot Unit (VRU) is a new generation inspection machine with world-class performance to position the pharma industry for future growth.

  • The Thermo Scientific™ Sentinel™ 3000 Combination System HD metal detectors are designed to thrive in harsh environments where typical metal detectors fail, eliminating expensive downtime, service costs and repair bills. The unique design offers the lowest total cost of ownership possible and can improve operational efficiency in many applications where standard metal detectors are in use today.