Eliminate silicone in both barrel and plunger to protect sensitive biologics in glass pre-filled syringes (PFS)
Today’s complex biologics, such as monoclonal antibodies and conjugate vaccines, can be vulnerable to silicone-induced protein aggregation and particle formation. In addition, over time, silicone migration can impact consistency of delivery, as it may change break loose and glide force (BLGF) and injection time. As a result, many biopharmaceutical manufacturers are actively seeking ways to address these silicone-related issues.
Now, GORE™ ImproJect™ Plungers Offer A New Solution
New GORE™ ImproJect™ Plungers for pre-filled syringes protect complex and sensitive biologics from silicone-induced protein aggregation and particulation. They do so by completely eliminating the need for silicone in both the plunger and the glass barrel.
- The plungers are silicone-free: Silicone is not a raw material and is not used in the manufacture of the plungers.
- The plungers, designed for use in bare-glass (non-siliconized) barrels, provide excellent container closure integrity (CCI) and maintain consistent injection performance over time.
Exceptionally Low Particles
GORE™ ImproJect™ Plungers effectively protect many of the more complex biologics that are silicone-sensitive. Testing demonstrates that GORE™ ImproJect™ Plungers provide:
- Orders of magnitude reduction in sub-visible particles, compared to siliconized syringes.
- Excellent biocompatibility: 21 CFR Part 4 and ISO 10993-1.
- No significant extractable compounds, due to our plunger’s proprietary PTFE-based fluoropolymer barrier.
The only plunger that enables low particulates and consistent delivery over time in bare glass (non-siliconized) barrels.
Due to its proprietary plunger design and fluoropolymer barrier, the GORE™ ImproJect ™ Plunger ensures:
- Excellent CCI, to protect against drug loss, leakage and microbial ingress.
- Consistent delivery including auto-injector applications – even after accelerated aging conditions.
- No significant extractable compounds.
A New Option for Drug Delivery
GORE™ ImproJect™ Plungers provide the only option for a silicone-free PFS (plunger with glass barrel), which protects sensitive biologics from potential interactions with silicone. To explore this new option in drug delivery, connect with your local Gore representative, or contact us.
Compliance & Quality
GORE™ ImproJect™ Plungers are manufactured in accordance with appropriate material and regulatory requirements, including USP <381>, EP 3.2.9 ad JP7.03, and in adherence to relevant Good Manufacturing Processes (cGMP) as defined in the Gore PharmBIO quality system, which is certified to ISO 13485, and ISO 15378.
To read our most current compliance statements, please contact us.
For additional product information, please review our Data Sheet. To request a technical consultation, product samples, or a Validation Guide, please contact us.
Gore plans to commercially launch the GORE™ ImproJectTM Plunger for Pre-Filled Syringes at the 2018 PDA’s Universe of Pre-Filled Syringe and Injection Device meeting in Orlando, FL on October 8th.
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