GORE® IMPROJECT® Plungers Offer a New Solution

Today’s complex biologics, such as monoclonal antibodies and conjugate vaccines, can be vulnerable to silicone-induced protein aggregation, particle formation and drug product precipitation. 

In ophthalmic applications, complications from silicone oil include increased risk of particle counts which can lead to floaters, inflammation, and interocular pressure with repeated injections. 

In addition, over time, silicone migration can impact consistency of delivery, as it may change break loose/ glide force (BLGF) and injection time to silicone sensitivity.

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Data Sheet: GORE Improject Plungers
Features & Benefits
Applications

Eliminate silicone in both barrel and plunger* of glass and plastic pre-filled syringes (PFS) to protect sensitive biologics and to reduce silicone-related complications from intravitreal injections

New GORE® IMPROJECT® Plungers for pre-filled syringes protect complex and sensitive biologics from silicone-induced protein aggregation and particulation, and reduce the risk of silicone-induced complications in ophthalmic injections. They do so by completely eliminating the need for silicone* in both the syringe plunger and the glass barrel.


  • The syringe plunger material is completely silicone-free†: Silicone is not a raw material and is not added during the manufacture of the plungers.
  • Designed for use in bare-glass and plastic (non-siliconized) barrels, these syringe plungers provide excellent container closure integrity (CCI) and maintain consistent drug delivery time in two-year and accelerated aging tests.
     

GORE® IMPROJECT® APPLICATIONS

GORE® IMPROJECT® Plungers provide the only option for a silicone-free† PFS (plunger with glass or plastic barrel), which protects sensitive biologics from potential interactions with silicone, and reduces risk of silicone-induced complications in ophthalmic applications.

Biologics
Ideal for protein-based drugs, monoclonal antibodies, and vaccines, as these plungers help prevent silicone-induced protein aggregation and particulation that could compromise drug efficacy and safety.

Sensitive Formulations
Suitable for formulations sensitive to chemical interactions, ensuring drug stability by eliminating potential silicone contamination.

Precision Drug Delivery
Beneficial for applications demanding consistent dosing, such as pre-filled syringes for chronic disease management.

Long-Term Drug Storage
Used in scenarios requiring extended shelf life, as the plungers maintain drug delivery and container closure integrity over time.

Ophthalmic
Suitable for ophthalmic intravitreal injections by reducing the silicone oil from the plunger and barrel, which reduces the risk for silicone oil and silicone oil-induced particulates to contaminate the drug product. Silicone oil has been associated with floaters, inflammation, and intraocular pressure with repeated injections.

Manufactures can now completely eliminate silicone from both plunger and barrel* in their PFS

Gore Pre filled Syringe

Technical Specifications

Our pre-filled glass syringes are designed to address critical challenges in drug delivery, offering unmatched performance and reliability for silicone-sensitive biologics and ophthalmic injections. With a focus on reducing particulates, ensuring container closure integrity, and maintaining consistent injection performance, these plungers provide superior protection against contamination and drug degradation. Their compatibility with regulatory standards and advanced manufacturing practices ensures high quality and compliance, while innovative features like low extractables and a proprietary fluoropolymer barrier safeguard drug purity. By solving industry pain points, GORE IMPROJECT Plungers set a new standard for drug delivery.

Product BenefitsProduct Testing
Exceptionally Low Particles

Sub-visible Particulate

  • Testing has demonstrated plungers are associated with orders of magnitude fewer sub-visible particles compared to siliconized syringe systems.
  • Plungers are tested against the limits of USP <788> Particulate Matter in Injections or USP <789> Particulate Matter in Ophthalmic Solutions.
Functional Performance

Container Closure Integrity (CCI)

  • Test results on PFS containing the plunger have demonstrated CCI following the guidance of USP <1207>

Reliable Performance

  • Test results on PFS containing the plunger have demonstrated consistent injection times, including auto-injector applications, with no stalls or failures, even under accelerated aging conditions.

Extractables and Leachables

  • An extractables study performed by an outside contract lab showed plungers with PTFE-based fluoropolymer barrier demonstrated a low extractables profile.
High Compliance & Quality Standards

Standards Compliance

  • Manufactured to meet USP <381>, EP 3.2.9, and JP 7.03 standards.

cGMP Adherence

  • Produced under strict Good Manufacturing Practices (cGMP) as defined by the Gore PharmBIO quality system.

Certified Quality Systems

  • Certified to ISO 13485 and ISO 15378 for reliable quality and performance.

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NOT INTENDED FOR USE in food contact applications or with radiation sterilization

* Not including needles or tip caps
† Silicone oil not intentionally added to raw materials or process for manufacturing plunger.
 

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