COC/COP (With Luer Lock)
● Suitable For Various Sterilizations: EO, Gamma,Steam, E-Beam, X-Ray
Product Features
ultra-low temperature frozen drugs, ophthalmic injections, etc
FAQ (Frequently Asked Questions):
Q: What are COC/COP syringes?
A: They are prefillable syringes made from Cyclic Olefin Copolymer (COC) or Cyclic Olefin Polymer (COP), offering superior clarity, strength, and chemical resistance for high-value pharmaceutical applications.Q: What are the key physical properties?
A: They feature high physical strength, good antioxidant properties, and suitability for ultra-low temperature cryopreservation, maintaining integrity under extreme conditions.Q: Why is low protein adsorption important?
A: Low protein adsorption ensures sensitive biologics (like monoclonal antibodies) do not stick to syringe walls, maintaining full drug potency and accurate dosing.Q: What does "low dissolution and precipitation" mean?
A: It means minimal extractables and leachables from the material, ensuring drug purity and stability for sensitive formulations.Q: What sterilization methods are compatible?
A: Compatible with EO, Gamma, Steam (autoclave), E-Beam, and X-Ray sterilization methods, offering manufacturing flexibility.Q: What are the intended applications?
A: Designed for high-value biological preparations, medical aesthetics (sodium hyaluronate), ultra-low temperature frozen drugs, and ophthalmic injections.Q: What quality standards do these syringes meet?
A: Raw materials comply with USP Class VI and ISO10993 requirements for biocompatibility and safety.Q: Are these syringes suitable for ophthalmic use?
A: Yes, they are specifically indicated for ophthalmic injections due to high clarity, low particles, and excellent biocompatibility.Q: Can these syringes be used for cryopreservation?
A: Yes, they are designed for ultra-low temperature cryopreservation, maintaining structural integrity at very low temperatures.Q: What is the advantage over glass syringes?
A: COC/COP syringes offer superior break resistance, lower protein adsorption, no delamination risk, and consistent dimensional tolerances.Q: What is the endotoxin level?
A: Bacterial endotoxin meets requirements for injection water (<0.25 EU/ml), ensuring safety for parenteral administration.Q: Are these syringes compatible with automated filling lines?
A: Yes, designed for compatibility with standard prefillable syringe filling equipment.Q: How is quality ensured during manufacturing?
A: Manufactured under strict quality systems with 100% visual inspection for defects and foreign particles.Q: What sizes are available?
A: Various sizes available to meet different volume requirements. Contact us for specific size ranges.Q: What documentation is provided for regulatory submissions?
A: Comprehensive regulatory support files including biocompatibility testing and extractables/leachables data available.
