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When combined with the industry trends of increased regulatory scrutiny and higher focus on patient safety, risk management, and compliance, the market is seeing an increased need for high-quality drug delivery systems such as prefillable syringes.
Prefillable syringes have become an increasingly important option in the packaging and delivery of injectable drug products due to two major factors:
The prefillable syringe serves two major purposes.
Benefits of prefillable syringes include:
Typical Prefillable Syringe System
A prefillable syringe system is composed of the liquid drug, the syringe barrel, the elastomeric plunger, the tip cap or needle shield, the plunger rod, and depending on the application, the backstop or finger flange. The typical fill volume is 0.5mL to 5mL. Traditionally, a prefillable syringe barrel has been made from glass tubing. Syringe manufacturers typically form and process the glass. Pharmaceutical companies purchase syringes and the complementary elastomeric components (e.g., plungers, tip caps, needle shields) that complete the primary package. Prefillable syringe designs can include double chamber syringes, syringes with fixed needles, insert needle syringes, and luer lock syringes.
Polymer vs Glass Prefillable Syringe Systems
There are two major types of prefillable syringe systems:
The benefits of glass systems include:
There are, however, drawbacks:
Polymer-based syringe systems are gaining acceptance because of their benefits compared to glass systems. For example, the Japanese market has transitioned many of its syringe applications to polymer because of superior performance.
The most widely used prefillable polymer syringe systems are manufactured from cyclic olefin polymer (COP) and cyclic olefin co-polymer (COC) resin. It is imperative to understand the unique characteristics of the polymer syringe system because the package choice is critical in ensuring the long-term success of a drug product.
The benefits of polymer-based systems over glass systems include:
However there are still drawbacks, including:
Whether a glass or polymer system is right depends upon specific needs.
Prefillable Syringe Plunger Selection and Additional Components
In addition to deciding between a glass or polymer barrel there is the matter of selecting a plunger. The main requirements for prefillable syringe plungers include compatibility with glass or polymer syringe barrels, compatibility with the drug product, compatibility with gamma-irradiation or steam sterilization, and good break loose and gliding forces.
Decisions when selecting a plunger include the elastomer formulation (typically bromobutyl or chlorobutyl), the barrier film and/or coating (FluroTec® barrier film, silicone oil, or B2 coating), and the processing of the plunger (bulk, washed, or sterile). If a needle shield or tip cap is required, West has several options including rigid needle shields, soft needle shields, and tip cap designs.
Analytical Testing for Prefillable Syringes
As part of our commitment to Simplify the Journey™ for customers, West offers expert consultation and container closure integrity testing in alignment with USP Chapter <1207> Sterile Product Packaging – Integrity Evaluation. This testing is essential to help customers demonstrate prefillable syringe performance, in particular:
In addition to CCI testing, West's lab capabilities include:
The West team can assist in putting together a holistic testing plan for a prefillable syringe system.To learn more about prefillable syringe systems, click here.
FluroTec and NovaGuard are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec and B2-Coating technologies are licensed from Daikyo Seiko, Ltd.
Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)<sup>1</sup>.
We are delighted to share that West has been honored at the Korea Bioprocessing Excellence Awards (KBEA) for the second year in a row. This year, we were recognized as the grand winner of the Best Bioprocessing Supplier Award: Fill-Finish.
<p><em>Lloyd Waxman, Harold Murray and Vinod Vilivalam</em></p><div id="g_93cd4f5a_be87_417c_be5f_5391eae75b241"><div><div><em></em> </div><div><strong>ABSTRACT</strong></div><div><strong> </strong></div><div><strong>Purpose: </strong>The shipment and storage of biopharmaceuticals in prefilled syringes (PFS) places new demands on PFS performance. Studies compared package integrity of glass and plastic PFS: piston movement was evaluated under reduced pressures to simulate transport by air in non-pressurized holds, and container closure integrity was tested on PFS that had been frozen or frozen and thawed, since some biopharmaceuticals are stored and transported in the frozen state. Piston release and travel forces were also measured in plastic PFS since in order to be competitive with siliconized glass PFS, the functional characteristics of plastic PFS must meet or exceed the criteria established for glass PFS.</div></div></div>
Marisa Leuzzi, Senior Specialist, Global Communications, from our Exton Headquarters, is one of the growing number of coronavirus survivors. Her experiences with her illness is not uncommon – but what she did after her recovery to keep her family whole is remarkable.
Gene and cell therapies require cryo storage – approximately -80<sup>o</sup>C for genes, and approximately -180<sup>o</sup>C (i.e., vapor of liquid nitrogen) for cells. This requirement places a very high demand on the packaging to provide both good container closure integrity (CCI) and preservation of drug product viability.
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