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Pharmaceutical Manufacturing and Packing Sourcer

Bursting the Bubble

Bubble-free filling can enhance the dosing accuracy and efficiency of a syringe; Shawn D Kinney, Andrea Wagner and Christian Phillips at HCM explain

Prefilled syringes have gone a long way towards improving dosing accuracy and decreasing waste relative to vials. With their ease of use and reduced overfill requirements, prefilled syringes significantly decrease the risk of dosing errors and provide the potential for an increase of up to 23 per cent in product dose yield compared with a vial (1).

Two recent studies suggest that the dosing advantages of a prefilled syringe can be enhanced even further by decreasing the size of the gas bubble inside. A gas bubble is not intrinsic to a syringe but is a byproduct of the filling process. These studies show that reducing or eliminating the bubble inside a prefilled syringe offers added assurance that the exact deliverable dose will be expelled regardless of needle orientation.

FILLING AND STOPPERING PREFILLED SYRINGES

Until recently, there were two methods for filling and stoppering syringes: online filling and online stopper (piston) placement, and online filling followed by offline vacuum stoppering. Then, a third method was introduced by filling equipment manufacturers that allows for online vacuum filling and online vacuum stoppering. This was initially designed to enhance the filling of viscous products and reduce handling of the filled syringe prior to vacuum stoppering. More recently still, a fourth method for filling prefilled syringes was developed which uses vacuum filling and online vacuum stoppering along with proprietary technology to entirely eliminate the bubble inside a syringe. Reducing or eliminating the bubble in a prefilled syringe can have a significant impact on dosing accuracy, quantity and ease.


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Dr Shawn D Kinney, PhD, is the Founder and President of Hyaluron Contract Manufacturing (HCM), located in Burlington, MA. Prior to starting HCM in 1999, Shawn was employed by Anika Therapeutics, Wyeth-Ayerst and Millipore, where he gained over 20 years of experience in the development of sterile formulation and filling processes including viscous and difficult-to-fill products. Shawn holds a Bachelor of Science and a PhD in Chemistry from the University of Massachusetts, as well as a Masters in Medicinal Chemistry from Northeastern University.

Dr Andrea Wagner, PhD, is the Vice President of Business Development at Hyaluron Contract Manufacturing (HCM), a position she has held for six years. Prior to joining HCM, Andrea was employed by the New Jersey Institute of Technology and Niton Corporation, in the capacities of Senior Scientist and Business Development Manager, respectively. Andrea holds a PhD in Toxicology and a Masters in Analytical Chemistry.

Christian W Phillips is the Senior Manager of Process Engineering at HCM. Christian has 14 years of experience in R&D, process development, tech transfer and manufacturing environments suited for the introduction of novel biotherapeutics and generics, including fill/finish applications. Prior to HCM, Christian was employed by TransKaryotic Therapies (now Shire HGS). He holds a BS in Biology from St Michaels College and is the co-inventor of HCM’s Bubble-free FillingTM technology.

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Dr Shawn D Kinney
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Dr Andrea Wagner
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Christian W Phillips
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