Systems and methods for detecting syringe seal defects

#The present disclosure relates generally to methods for inspecting syringes, and more specifically, to systems and methods for detecting seal defects in syringes.

#Syringes used for delivery of medicaments are principally constructed of a barrel and a stopper. The stopper is slidably fitted within the syringe barrel and may have a plunger rod affixed to it for actuation of the syringe and delivery of medicament. The stopper is generally constructed of an elastomer, with silicone oil applied. The silicone oil is applied to reduce sliding friction between the stopper and barrel and to improve the seal between them. The oil, allows for ease of sliding when administering a dose which ensures the full dose can be administered. This is particularly critical in the case of pens and so-called auto injecting syringes. The oil is also critical to prevent jamming of the device which can lead to trauma at the site of injection.

#Though silicone oil has traditionally been utilized in syringes, such use can be problematic. In pharmaceutical applications, the use of silicone oil is particularly concerning. For example, the silicone oil may undesirably degrade medicine contained in the syringe and may cause aggregation of certain proteins in the medicines.

#The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.

#FIG. 1 is a schematic view of a syringe according to some embodiments;

#FIG. 2 shows a portion of a stopper of the syringe of FIG. 1, according to some embodiments;

#Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. It is to be appreciated that the terms “stopper” and “syringe stopper” may be used interchangeably herein.

#FIG. 1 is a schematic view of an exemplary syringe 10. As shown, the syringe 10 includes a syringe barrel 12, a stopper 14 that forms a complementary fit with the syringe barrel 12, a plunger rod 16, a tip cap or needle shield 18, and, in the case of a pre-filled embodiment, a liquid 20, such as a medicament, for dispensing from the syringe 10. Although the syringe 10 is shown as a “wet” system (i.e., a fluid is contained in the syringe barrel 12 for dispensing), various embodiments will be described in association with “dry” systems (i.e., one in which a fluid has not yet been introduced, into the syringe barrel 12 for dispensing).

#As shown, the syringe barrel 12 and the stopper 14 are first and second complementary syringe components that are slidably engaged with one another, the stopper 14 is intended to form a slidable seal within the syringe barrel 12. Although the syringe barrel 12 and the stopper 14 are slidably engaged in a linear relationship, it should be understood that other sliding relationships (e.g., rotational sliding between a valve body and a valve plug) are considered to be within the scope of the invention.