Graham Reynolds

Vice President & General Manager, Biologics

August 28, 2013

FDA Issues Draft Guidance on Glass Syringe Connectivity

The U.S. Food and Drug Administration recently issued a draft guidance, “Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations to Supplement International Organization for Standardization (ISO) Standard 11040-4 (Draft).” The document relates to issues encountered with glass Luer lock syringes when connecting to Luer fittings, including needles, needle-free Luer connectors, adapters and transfer units.

Issues such as breakage, detached needles, jammed IV lines, or syringe tip cracking and breaking have prompted the FDA to issue new recommendations and potential solutions to avoid delays in the administration of a medication.  In extreme situations, including medical emergencies, such delays may potentially result in harm to the patients.  Because of this, FDA has recognized that compliance to ISO 11040-4 alone does not ensure that glass syringes can be connected effectively, and requires supplemental tests to help ensure patient safety.

The FDA also recommends:

-the use of a bonded or staked needle with appropriate sharps protection for intramuscular or subcutaneous injections
-glass syringes designed with specific internal dimensions to ensure connectivity
-new designs for dedicated dual connections between the syringe and connecting devices

West offers a variety of packaging and delivery solutions that can help to ensure effective delivery, including the Daikyo Crystal Zenith® syringe systems, passive and active safety systems for staked and Luer lock syringes, needle-free administration systems, and collaborative development  solutions for combination products.

Partnering with West early in the drug development process will help to ensure that challenges of packaging, delivery and administration can be overcome through the use of innovative design, high-quality materials and/or novel polymers that meet or exceed the FDA recommendations for connectivity.  Contact West today to discuss your delivery requirements.