PHARMACEUTICAL INSPECTION SOLUTIONS

• Analytical And Testing Services

  As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.

• Pharmaceutical Vacuum Decay Leak Testing System

  Vacuum decay is a container integrity test method taking advantage of the fundamental physical properties. This test method which was proved over decades has been improved with the advancement of technology.

• Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements

  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.

• Helium Leak Testing Equipment For Parenterals

  Parenteral products, specifically vials, both glass and, increasingly, polymeric vials, represent one of the most common package systems historically tested by helium leak detection, largely due to their continued dominance as a package system for high-potency drugs requiring utmost protection. The primary sealing interface of a traditional vial system is between the elastomeric closure and land seal of a vial, physically compressed together by a crimped aluminum seal.

• Metal Detectors Designed To Thrive In Harsh Environments

  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.

• Reliable, Flexible, And Progressive Automatic Inspection Machines
• Expert Support For Container Closure Integrity
• Used Mettler Toledo Safeline Pharmaceutical Metal Detector
• Versa Flex and Versa Flex GP Checkweigher