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The United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The scope of USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systemsⁱ introduces a paradigm shift away from testing elastomeric components individually by the supplier, as was done historically under USP <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systemsⁱⁱ, to a holistic evaluation of these components when assembled into drug product packaging and delivery systems. In addition, the testing is performed on the final packaging/delivery system as produced by the drug manufacturer, using product-filled systems or systems filled with a suitable proxy, where applicable. As such, the elastomeric component supplier cannot perform USP <382> testing without knowledge of the specific drug product/proxy or the complete packaging system that the drug manufacturer plans to use. Therefore, the responsibility for USP <382> testing shifts from the elastomeric component supplier to the drug manufacturer.

As pharmaceutical formulations become more complex, the need for precision and reliability in auto-injector technology has never been greater. Traditional plungers, once considered adequate for simpler drug formulations, are now facing limitations when it comes to delivering modern complex molecules. In this article, we will explore why traditional plungers may not be suitable for these advanced medications and outline key considerations for selecting plungers tailored to the needs of auto-injectors delivering complex molecules.

West partnered with SK Pharmteco to evaluate the impact of vial material of construction on the stability of adeno-associated virus (AAV) serotypes under varying stress and storage conditions associated with cell and gene therapy applications. AAV8 and AAV9 were chosen as representative serotypes, with respective titers in a common buffer formulation (10mM Tris-HCl, 3.5mM NaCl, 8.5% Trehalose, 0.06% PS80, pH 7.2). This was evaluated across three 2mL vial types : Daikyo Crystal Zenith® (CZ), and two commercially available borosilicate glass containers. All containers were sealed with West 13mm Serum NovaPure® 1358 4023/50G bromobutyl stoppers and filled with 0.35mL fill volume.

Post-market surveillance reporting and lifecycle management of drug products are vital to the safety of patients, as these activities allow for long-term monitoring of drug effects. When a device is co-packaged with a drug, the device manufacturer must also follow thorough post-marketing activities and maintain a systematic lifecycle management process to ensure the device is safe and effective as both a stand-alone device and co-packaged product throughout the life of the device.

The use of medical devices in combination products has increased greatly in the past 15 years and is expected to continue to increase for the foreseeable future. This has been bolstered by an industry push to fill a demand for patients to have access to at-home therapies with the use of self-dosing and on-body wearable solutions. Companies that decide to use devices like these to deliver their drugs have plenty to consider with regards to extractables, leachables, and the overall chemical safety of their product. A strong understanding of the risks that leachables may pose during the use of a combination product first requires thoughtful and informed design of extractables studies as part of chemical characterization of both the device and container closure system, with the appropriate application of industry guidance. 

Components for vial containment systems are offered in an array of options; for stoppers they are elastomer type, configuration, size, and surface treatment (coating or laminate). Stopper selection is based on: (a) compatibility with the vial selected and (b) system ability to protect the drug product through shelf life.