FDA Recognizes ISO Standard 11040-4 for Glass Syringes

“FDA has recognized International Organization for Standardization (ISO) Standard 11040-4 for glass syringes that are intended to deliver drugs or biological products.  FDA has become aware of adverse events and product quality events related to connectivity problems when certain glass syringes are used with connecting devices, including connecting devices that conform to the FDA-recognized ISO 594-2 standard. “Connecting devices” include needles, luer connectors, adapters, and transfer units. Accordingly, FDA has determined that, for glass syringes, demonstrating conformity with the ISO 11040-4 standard alone does not ensure that the glass syringe can be properly connected to connecting devices. Therefore, this guidance identifies additional, technical information that should be submitted by sponsors who seek to rely on conformity to ISO 11040-4 for a glass syringe product.”

As you know a drug or biological product filled into a glass syringe is a combination product.  Sponsors can rely on the device master file for device information.  However, the Sponsor needs to work with the supplier of the syringe to ensure that the recommendations contained in this guideline have been addressed.

Read the documentation here.