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Glass Syringes: Testing and Performance Requirements for Connectivity with Needles and Other Devices (DRAFT)

This guidance addresses connectivity issues between glass syringes and connecting devices (needles, needleless luer connectors, adapters, and transfer units). It applies to: - Needleless glass syringes prefilled with drug/biological products - Empty glass syringes co-packaged with drug/biological products and/or connecting devices - Empty glass syringes for use with marketed drugs/biological products

This is a draft guidance. Not for implementation.

  1. Evaluate design options:
    • Consider bonded/staked needles with sharps protection
    • Design internal dimensions ensuring connectivity
    • Develop dedicated dual connections if needed
  2. Prepare testing documentation:
    • Dimensional conformance data
    • Design verification and validation data
    • Functional performance testing results
    • Biocompatibility data
    • Sterilization validation
    • Human factors testing results
  3. For prefilled/co-packaged syringes:
    • Conduct additional performance testing with actual drug/biologic
    • Evaluate product-specific requirements
    • Address drug-device compatibility
  4. Consider early interactions with FDA through joint meetings with relevant centers
  5. Ensure proper documentation of all testing with objectives, methods, acceptance criteria, and results

Key Considerations

Non-clinical testing

  • Seal Integrity Testing for liquid leakage, air ingress, and dye ingress
  • Mechanical testing: glide force, break force, separation force, unscrewing torque
  • Assembly testing: ease of assembly, resistance to overriding
  • Performance testing: stress cracking, graduation markings validation, dead space
  • Coring needle test
  • Connectivity testing with other necessary devices
  • Injection force testing
  • Tip cap removal force testing
  • Piston seal blowback testing

Human Factors

  • Human factors testing and risk analysis of use errors
  • Hazard analysis identifying use-related risks including medication errors
  • Design validation of user interface

Biocompatibility

  • Conformance to ISO 10993 with physicochemical, analytical, and biological testing

Safety

  • Performance testing of anti-needlestick mechanisms
  • System integrity demonstration throughout product shelf-life
  • Sterilization validation

Other considerations

  • ISO 11040-4: Prefilled Syringes - Part 4: Glass barrels for injectables
  • ISO 594-2: Conical fittings with 6% (Luer) taper - Lock fittings
  • ISO 10993: Biological Evaluation of Medical Devices
  • ISO 11135: Sterilization of Health Care Products - Ethylene Oxide
  • ISO 11137: Sterilization of Health Care Products - Radiation

Original guidance

  • Glass Syringes: Testing and Performance Requirements for Connectivity with Needles and Other Devices
  • HTML / PDF
  • Issue date: 2013-03-31
  • Last changed date: 2024-08-09
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Combination Products, Drugs, Biologics
  • ReguVirta summary file ID: f4222c48384c0b295ef8352212952f54
This post is licensed under CC BY 4.0 by the author.