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.
Have you ever dropped your new phone and cracked the screen? It’s never a good feeling to lose something of value. Now imagine if that something was worth thousands to millions of dollars and had the potential to change lives. That’s what drug manufacturers stand to lose if a single-use bulk drug storage bag — holding biologic substances — is damaged. A new solution from Gore addresses this issue.
Single-use systems increasingly need to withstand the rigors of cold chain handling at -40°C to -80°C, particularly for packaging valuable bulk drug product for shipment. Read the article in Genetic Engineering to learn more about how Gore is helping to advance single-use technology in the pharmaceutical space.
Visit Booth 70 at BPI Europe in Vienna and Booth 3737 at Interphex in New York City to learn how Gore's innovative technologies help biopharmaceutical manufacturers achieve efficiency and operate reliably.
Trends in the biopharmaceuticals market prompted the development of a new high-performance pouch that addresses the mechanical and purity challenges of packaging bulk drug product at low temperatures. The GORE® STA-PURE™ Flexible Freeze Container maintains package integrity after freezing at -86° C (-123° F) and it's durable design minimizes product loss due to package failure.