INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Ensure compliance with 21 CFR Part 11 and ensure 100% with a cutting-edge technology that inspects up to 400 vials per minute, ranging from 2ml to 100ml.

  • Thermo Scientific APEX 300 Compact, Flexible Metal Detector is the most flexible member of the APEX product family.

  • 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.

  • Discover a MicroCurrent conductivity test method, HVLDmc, that is completely non-destructive to the container and product. Learn in greater detail about this static test and how defects are detected.

  • The Thermo Scientific™ Global VersaWeigh™ and Global Versa GP checkweighers are designed to improve accuracy and reliability, decreasing maintenance, product giveaway and total cost of ownership. Our global manufacturing and service teams enable a high level of solutions and service support wherever you do business.