INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • See how integrated advanced inspection technologies can support an effective and compliant drug production process.

  • Improve efficiency and profitability with a checkweigher designed for better accuracy and faster speeds. The Thermo Scientific™ Global Versa GP Checkweigher is a versatile, general purpose checkweigher that scans at line speeds up to 350 packages per minute without ever sacrificing accuracy, and now it features more than 10 engineering and functionality improvements to reduce maintenance and cost of ownership. The Versa GP Checkweigher comes with a compact cantilever construction for height adjustment and is ideal for packages up to 3 kilograms (6.6 pounds).

  • The VeriPac 465 performs leak detection based on the basic principles of physics and does not require the use of trace gasses or sample preparation to perform the test. The VeriPac 465 core technology is based on the ASTM vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments.

  • Used 200 mm Cassel flow thru metal detector, type Shark 2A GF0200. 200 mm diameter aperture, with stainless steel reject system, and digital readout, serial# D180288.03G, built 2018.

  • 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.