Single-use Prefiled Flush Syringe
◆ CE certification, manufactured according to ISO 13485 standards.
FAQ (Frequently Asked Questions):
Q: What is the intended use of these prefilled syringes?
A: These products are specifically designed for the injection of pre-filled vaccines, anti-cancer drugs, anti-tumor drugs, and other pharmaceutical preparations.Q: What sizes are available?
A: Available sizes include 3ml, 5ml, 10ml, and 20ml to accommodate various medication volumes and dosing requirements.Q: What type of connector does the syringe have?
A: The syringe features a luer lock tip with a protective cap, ensuring secure attachment to needles and IV access devices while preventing leakage and accidental disconnection.Q: What are the key safety features?
A: The syringe is aseptic, non-toxic, non-pyrogenic, and designed for single-use only. The safe design ensures easy operation while maintaining sterility and patient safety.Q: What materials are used in manufacturing?
A: The syringe is made of medical-grade Polypropylene (PP) for the barrel and mandrel, BIIR rubber for the stopper, and medical silicone oil for lubrication. All materials are biocompatible and drug-compatible.Q: Does the syringe meet international standards?
A: Yes, it meets ISO7886-1 standards for sterile hypodermic syringes, holds CE certification, and is manufactured according to ISO13485 quality management systems.Q: Is the product sterile?
A: Yes, the syringe is sterile, non-toxic, and non-pyrogenic, ensuring patient safety for direct drug administration.Q: What is the shelf life?
A: The shelf life is 5 years from the date of sterilization, provided the packaging remains intact and stored under recommended conditions.Q: What are the product components?
A: The syringe consists of protective caps, barrel (jacket), rubber stopper, and mandrel (plunger rod).Q: Is this syringe suitable for viscous drugs?
A: The luer lock design and medical-grade materials make it suitable for a wide range of drugs, including some viscous formulations. For specific drug compatibility, please consult our technical team.Q: Can this syringe be used with automatic injection systems?
A: These are manual prefilled syringes. For use with auto-injectors or other devices, please verify compatibility with your specific system.Q: What quality certifications apply?
A: The product is CE certified and manufactured in full compliance with ISO13485 quality systems, ensuring consistent quality and traceability.Q: Is the rubber stopper compatible with sensitive biologics?
A: The BIIR (Bromobutyl) rubber stopper is specifically chosen for its excellent compatibility with a wide range of drugs, including sensitive biologics and vaccines, with low extractables and leachables.Q: How should these syringes be stored?
A: Store in a cool, dry place away from direct sunlight and extreme temperatures. Follow specific storage recommendations for the pre-filled medication.Q: Are the syringes latex-free?
A: Yes, all components are latex-free, making them safe for patients and healthcare workers with latex allergies.Q: What is the advantage of the luer lock tip?
A: The luer lock tip provides a secure, twist-lock connection that prevents needles from accidentally detaching during injection, which is especially important for high-pressure or critical applications.Q: Can custom labeling or packaging be arranged?
A: Yes, we offer customization options for labeling, packaging, and other requirements based on customer specifications.Q: Are these syringes suitable for clinical trials?
A: Yes, their sterile, single-use design and compatibility with various drugs make them suitable for clinical trial applications. Custom volumes and configurations can be discussed.Q: What is the BIIR rubber material?
A: BIIR (Bromobutyl rubber) is a halogenated butyl rubber with excellent impermeability, chemical resistance, and low extractable profiles, making it ideal for pharmaceutical stoppers.Q: Is medical silicone oil safe for injection?
A: Yes, the medical-grade silicone oil used is biocompatible and meets pharmacopoeial standards for safety in medical devices that contact drugs and patient tissue.
