Testing Systems for Injection and Drug Delivery Devices

  • Testing Systems for Injection and Drug Delivery Devices 1
  • Testing Systems for Injection and Drug Delivery Devices 2
Product Description

Depending on the force range, device, and test complexity, the solution can be based on the compact zwickiLine, the versatile AllroundLine, or a semi- or fully automated testing system. Application-specific fixtures, sensors, measurement technology, and testXpert testing software enable testing tailored to specific device and regulatory requirements. 

ZwickRoell supports implementation in regulated environments, from URS and FAT through DQ, IQ, and OQ, with support for subsequent PQ. Software options for electronic documentation and data integrity help laboratories meet FDA 21 CFR Part 11 requirements.

From individual components to complete drug delivery devices, ZwickRoell delivers an integrated solution combining testing technology, software, qualification, and automation.

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ZwickRoell Pte Ltd

  • Country/Region:
    Singapore
  • Founded:
    1854
  • On CPHI since:
    2021
  • Employees:
    1000 - 4999
Company types
Engineering
View company profile
Categories
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Specifications
  • Details
    Development, manufacturing, verification, validation, and quality control of injection and drug delivery devices. Suitable for prefilled and single-use syringes, cartridges, pen injectors, autoinjectors, on-body drug delivery systems (OBDS), needles, needle safety devices, and Luer/Luer lock connections. Supports testing throughout the product lifecycle, including applications for a wide range of drug viscosities, dosage strengths, and delivery concepts. 

    Modular testing solutions for determining mechanical and functional characteristics such as breakaway and glide forces, cap-removal force, activation force and travel, injection time, dose accuracy, injection depth, torque, and safety functions. Supports reproducible, standards-compliant testing in accordance with ISO 11040, ISO 11608, ISO 7886-1, and ISO 80369.

  • Selling Points
    ZwickRoell supports you in complying with these requirements with testXpert III testing software and the traceability option. All test-relevant actions and changes are automatically logged in an audit trail, stored in a tamper-evident manner, and can be retrieved in a readable format when required. Electronic signatures provide clear accountability and enable efficient, paperless documentation. The scope and depth of logging can be flexibly tailored to your internal QA requirements.

    In addition, ZwickRoell supports you with qualification services (DQ / IQ / OQ) for the validation of your testing systems. This creates the technical and organizational foundation for conducting compliant, efficient, and audit-proof testing of injection systems – in accordance with FDA 21 CFR Part 11 and the expectations of a regulated environment.

  • Model
    Universal Testing Systems
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ZwickRoell Pte Ltd

  • Country/Region:
    Singapore
  • Founded:
    1854
  • On CPHI since:
    2021
  • Employees:
    1000 - 4999
Company types
Engineering
View company profile

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