Three-piece syringe
3-piece disposable syringe with medical-grade PP barrel, HDPE plunger, and stainless steel needle—BPA-free, CE/FDA-certified, highly precise, and ideal for antibiotics, vaccines, biologics, and global clinical or home use.
Our 3-piece disposable syringe is engineered for maximum safety, precision, and versatility in modern healthcare and pharmaceutical applications. Constructed from a tri-material system—medical-grade polypropylene (PP) barrel, high-density polyethylene (HDPE) plunger, and precision stainless steel needle—it delivers exceptional chemical inertness, ensuring no interaction with sensitive drug formulations such as antibiotics, vaccines, hormones, and biologics. Free from BPA, phthalates, and heavy metals, with ultra-low extractables, it meets the stringent demands of pediatric and high-sensitivity therapies.
The syringe complies with ISO 11040, USP Class VI, and holds CE and FDA certifications, enabling seamless entry into regulated markets worldwide. Its excellent biocompatibility (cytotoxicity ≤ Grade 1) and resistance to acids, bases, and organic solvents ensure broad drug compatibility. It withstands both gamma irradiation and 121°C steam sterilization, achieving a sterility assurance level (SAL) of 10⁻⁶—fully compliant with injectable packaging standards.
Designed as a true 3-component system, each part is independently molded and precisely assembled to guarantee structural integrity. The HDPE plunger fits the PP barrel with ≤0.01 mm clearance, ensuring leak-proof sealing and zero backflow during injection. With a plunger glide force of ≤10 N, operation is smooth and consistent, enhancing dosing accuracy. The needle-barrel bond exceeds 40 N in tensile strength, eliminating wobble during puncture and minimizing tissue trauma.
Available in 0.5 mL to 10 mL volumes, with 0.1 mL (small) or 0.5 mL (large) graduations, it supports diverse therapeutic needs. Needle options range from 23G to 31G (lengths: ½” to 1.5″) for subcutaneous, intramuscular, or IV delivery—with ultra-fine gauges reducing patient pain and larger gauges handling viscous drugs. The ≥91% transparency allows clear visual inspection of drug clarity.
Packaged in individual sterile blisters with protective needle caps, the syringe offers dual protection against contamination and needlestick injuries. Its polymer construction is 4× more impact-resistant than glass, weighs only ⅓ as much, and remains stable from –15°C to 45°C, with a 24-month shelf life—ideal for tropical climates, field clinics, and emergency logistics.
Widely used in hospitals, labs, pharmacies, home care, and CMO production, its modular design supports both manual and automated filling lines. Fully customizable with multi-language labeling, brand logos, and dosage markings, it offers superior cost-efficiency versus glass alternatives—making it a smart choice for large-scale procurement and global health initiatives.
| Category | Specification / Feature |
|---|---|
| Barrel Material | Medical-grade Polypropylene (PP) |
| Plunger Material | Medical-grade High-Density Polyethylene (HDPE) |
| Needle Material | Stainless steel (AISI 304 or equivalent) |
| Available Volumes | 0.5 mL, 1 mL, 2 mL, 5 mL, 10 mL |
| Graduation Accuracy | 0.1 mL (for ≤2 mL); 0.5 mL (for ≥5 mL); volume tolerance ±1% |
| Needle Gauge Options | 23G, 25G, 27G, 29G, 30G, 31G |
| Needle Length Options | ½” (12.7 mm), 5/8″, 1″, 1.5″ (38.1 mm) |
| Transparency | ≥91% light transmittance |
| Plunger Glide Force | ≤10 N (uniform) |
| Barrel-Plunger Clearance | ≤0.01 mm |
| Needle-Barrel Connection Strength | ≥40 N |
| Biocompatibility | ISO 10993 compliant; cytotoxicity ≤ Grade 1; passes sensitization & irritation tests |
| Harmful Substances | BPA-free, phthalate-free, heavy metal-free |
| Sterilization Methods | Gamma irradiation, Steam sterilization (121°C) |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Impact Resistance | >4× that of glass syringes |
| Weight | ~⅓ the weight of equivalent glass syringe |
| Barrel Surface | Non-slip textured grip for secure one-handed operation |
| Needle Sharpness | Industry Grade A standard; low penetration resistance |
| Packaging | Individual sterile blister pack + rigid needle cap |
| Storage Temperature Range | –15°C to +45°C |
| Shelf Life | 24 months |
| Breakage Rate (Logistics) | <0.1% |
| Environmental Resistance | Moisture-resistant, UV-stable; no special storage required |
| Regulatory Certifications | ISO 11040, USP Class VI, CE Marked, FDA-registered |
| Assembly Type | 3-piece (barrel, plunger, needle) – modular and compatible with manual/automated filling |
| Use Scenarios | Hospitals, clinics, laboratories, CMOs, home care, vaccination programs |
| Customization | Brand logo, multi-language instructions, dose markings, batch/expiry |
| Key Advantage | Cost-effective, shatterproof, precise, globally compliant, and adaptable to diverse drugs |