Plungers

Development of vaccines for COVID-19 and its variants continues to present challenges such as accelerated timelines. Since there is not the usual time available for selection, evaluation, and qualification of the package and delivery systems, risks must be mitigated at every phase. For vaccines packaged in prefilled syringes, use of an elastomer plunger laminated with FluroTec^® film can help.

In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.

Most physicians agree - of all the services that can be performed for patients, eliminating the pain and fear of injections is at the top of the list. How can pain be minimized? One approach is to maximize syringe performance - whether the syringe is employed by a clinician, in an autoinjector, or in a wearable device. A critical element of syringe performance is the break-loose force. This is the force needed to overcome the plunger inertia in a filled syringe to initiate plunger movement and introduction of drug product. A lower, more consistent, break-loose force can provide for increased patient comfort.

Particles in parenteral drug products have been a major source of product recalls in recent years (>100 from 2010-16). They are especially problematic for biologic drug products, where they can induce formation of protein particulates that may have immunogenic effects.

Modern biopharmaceutical drug molecules are often complex protein structures that need to maintain the molecular structure in order to convey full potency. With biologics, any alteration of the 3-D structure could lead to loss of activity or even to immunogenic reactions in the patient. Proteins can be disrupted by interactions with the container closure or with leachables. West FluroTec® lamination was chosen for NovaPure® plungers to reduce the interaction between the drug product and elastomer material. This includes less adsorption to the plunger surface as well as reduction of the leachables profile of the plunger, helping to maintain the stability of complex molecules.