2.25ml 27G 1/2
2.25 mL pre-filled borosilicate glass syringe with 27G × ½” needle—sterile, BPA-free, triple-sealed, and ideal for vaccines, biologics, and aesthetic fillers across global clinical and home-care settings.
Our 2.25 mL pre-filled syringe is a next-generation drug delivery solution engineered for safety, precision, and global compliance. It bridges a critical market gap between standard 1 mL and 3 mL formats, offering optimal dosing for medium-volume therapeutics while excelling in five core dimensions: material integrity, ergonomic performance, long-term stability, manufacturing excellence, and multi-scenario adaptability.
Material Safety & Global Regulatory Compliance:
Constructed from medical-grade high-borosilicate glass, it delivers exceptional chemical inertness—ensuring zero interaction with vaccines, biologics, hormones, antibiotics, and even lipid-soluble formulations. Fully compliant with ISO 11040, USP/NF, EP, and JP pharmacopeial standards, and certified under CE, FDA, and GMP, it enables seamless market access worldwide. Free from BPA, phthalates, and heavy metals, it meets stringent requirements for pediatric and high-sensitivity drugs. The ultra-smooth inner surface achieves protein adsorption <0.08%, minimizing drug loss and preserving potency. Validated for 121°C steam sterilization with a sterility assurance level (SAL) of 10⁻⁶, it satisfies the most rigorous aseptic packaging demands.
Precision Engineering & Clinical Usability:
The 2.25 mL capacity uniquely addresses mid-dose applications—such as certain vaccines, aesthetic dermal fillers, and antibiotic regimens—eliminating under-dosing or wasteful overfilling. A 27G × ½” (12.7 mm) ultra-fine needle ensures low-pain injection (≤3/10 on pain scale), ideal for children and sensitive patients. Optimized for subcutaneous and intramuscular routes, it offers high procedural tolerance. The pre-filled, ready-to-use design reduces clinical prep time by over 60%. With ≥92% light transmittance, the barrel allows clear visual inspection for particulates or discoloration. Needle sharpness meets top-tier industry standards with puncture force <8 N, while plunger glide force is uniformly controlled at ≤12 N to prevent dosing errors. Uniform wall thickness (tolerance ≤0.08 mm) ensures comfortable grip and precise single-handed control.
Sealing Integrity & Storage Robustness:
A triple-seal system—medical-grade butyl rubber plunger + aluminum crimp + PP tip cap—provides comprehensive protection against leakage, microbial ingress, oxidation, and evaporation, supporting a shelf life of 24–36 months. The glass barrier achieves an ultra-low oxygen transmission rate of <0.008 cc/(pkg·day·atm). Dose accuracy is maintained within ±1.5%. Stable across –25°C to +65°C, it withstands extreme shipping conditions with a breakage rate <0.1%. The medical-grade PP needle cap ensures sterility and prevents needlestick injuries during handling.
Quality Assurance & Traceability:
Needle-barrel bond strength exceeds 60 N, eliminating detachment risk. Manufactured in a Class 10,000 (ISO 7) cleanroom with microbial load ≤5 CFU/unit—surpassing industry norms. Every batch undergoes 12 rigorous QC tests, including leak integrity, sharpness, clarity, and seal validation, achieving 100% pass rate. Needles are precision-polished and passivated to minimize tissue trauma. Butyl rubber plungers are extractable-free and odorless, ensuring broad drug compatibility. Full digital traceability enables real-time access to batch number, production date, and full QC reports.
Market Differentiation & Versatility:
Perfect for vaccination programs, insulin therapy, aesthetic medicine, hospital treatments, and lab research. The 2.25 mL volume fills a strategic niche, offering clear differentiation from competitors. Compact (≤9 cm length) and lightweight (≤12 g/unit), it reduces logistics costs. Customizable printing (brand, drug name, expiry, batch) enhances recognition and premium positioning. As a closed-system pre-filled device, it minimizes contamination risk—making it indispensable for public health initiatives and high-value biologic delivery.
| Category | Specification / Feature |
|---|---|
| Barrel Material | Medical-grade high-borosilicate glass |
| Fill Volume | 2.25 mL |
| Compliance & Certifications | ISO 11040, USP <1>, EP, JP; CE Marked, FDA-registered, GMP-compliant |
| Chemical Compatibility | Compatible with acidic, alkaline, aqueous, and lipid-soluble drugs |
| Harmful Substances | BPA-free, phthalate-free, heavy metal-free |
| Protein Adsorption Rate | < 0.08% |
| Sterilization Method | Steam sterilization at 121°C |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Needle Gauge / Length | 27G × ½ inch (12.7 mm) |
| Pain Level (Subjective) | ≤3 / 10 (on standardized scale) |
| Injection Routes | Subcutaneous (SC), Intramuscular (IM) |
| Delivery Format | Pre-filled, ready-to-use |
| Time Savings vs. Vial+Syrg | >60% reduction in preparation time |
| Barrel Light Transmittance | ≥92% |
| Needle Puncture Force | <8 N |
| Plunger Glide Force | ≤12 N (uniform) |
| Glass Wall Thickness Tolerance | ≤0.08 mm |
| Sealing System | Triple seal: butyl rubber plunger + aluminum crimp + medical-grade PP tip cap |
| Shelf Life | 24–36 months |
| Oxygen Transmission Rate (OTR) | <0.008 cc/(pkg·day·atm) |
| Dose Accuracy | ±1.5% |
| Storage Temperature Range | –25°C to +65°C |
| Breakage Rate (Logistics) | <0.1% |
| Needle-Barrel Bond Strength | ≥60 N |
| Cleanroom Class | ISO Class 7 (10,000) |
| Microbial Limit | ≤5 CFU per unit |
| Plunger Material | Medical-grade bromobutyl rubber (low extractables, odorless) |
| Needle Finish | Precision-polished & passivated; low tissue trauma |
| Quality Control Tests | 12-point inspection: leak test, sharpness, clarity, seal integrity, sterility, etc. |
| Traceability | Full digital traceability (batch, production date, QC report) |
| Applications | Vaccines, insulin, aesthetic fillers, antibiotics, biologics, lab reagents |
| Use Environments | Hospitals, clinics, vaccination centers, aesthetic studios, home care, laboratories |
| Dimensions | Total length ≤9 cm |
| Weight | ≤12 g per unit |
| Customization | Laser/inkjet printable: logo, drug name, expiry, batch, barcode |
| Environmental Profile | Recyclable glass; sustainable primary packaging |