Description
Why Choose Kohope for Your Prefilled Syringe Needs
Industry-Leading Manufacturing Excellence
Kohope has established itself as a trusted prefilled syringes manufacturer with over 15 years of experience in medical device production. Our state-of-the-art facilities are equipped with cutting-edge technology and operate under strict ISO 13485 and GMP compliance, ensuring every custom prefilled syringe meets the highest quality benchmarks.
Comprehensive Customization Options
We understand that each pharmaceutical application requires unique specifications. Our custom prefilled syringe solutions offer:
- Material Selection: Glass and polymer-based syringe barrels tailored to your drug formulation
- Volume Range: From 0.5ml to 10ml capacity options
- Needle Configuration: Various needle gauges, lengths, and safety features
- Plunger Design: Customized stopper materials compatible with your medication
- Sterilization Methods: ETO, gamma radiation, or autoclaving based on your requirements
End-to-End Service Solutions
Beyond manufacturing prefilled syringes, Kohope provides comprehensive support services:
- Regulatory consultation and documentation assistance
- Compatibility testing with your drug formulations
- Packaging design and validation
- Supply chain management and logistics
- Technical support throughout product lifecycle
Technical Parameters
Our prefilled syringes are engineered with precision to ensure optimal performance:
| Specification | Details |
|---|---|
| Material | Borosilicate glass (Type I) or COC/COP polymer |
| Capacity Range | 0.5ml – 10ml |
| Accuracy | ±5% of nominal volume |
| Sterility Assurance Level | 10⁻⁶ |
| Extractables & Leachables | Fully tested and documented |
| Silicone Oil | Low or no silicone options available |
Quality Assurance
As a certified prefilled syringes manufacturer, we implement rigorous quality control:
- 100% visual inspection using automated systems
- Batch testing for functionality and sterility
- Comprehensive documentation and traceability
- Stability testing protocols
- Regulatory compliance verification
Applications & Industries
Kohope’s custom prefilled syringes serve diverse medical applications:
- Vaccines: Flu, COVID-19, and other immunization programs
- Biologics: Monoclonal antibodies and protein therapeutics
- Emergency Medications: Epinephrine auto-injectors and antidotes
- Chronic Disease Management: Insulin, anticoagulants, and hormone therapies
- Aesthetic Medicine: Dermal fillers and cosmetic injectables
Manufacturing Process
Design & Development
Our engineering team works closely with clients to develop custom prefilled syringe solutions that match exact specifications. Using advanced CAD software and prototyping capabilities, we ensure optimal design before mass production.
Production Excellence
Kohope’s manufacturing process for prefilled syringes incorporates:
- Class 100 cleanroom environments
- Automated filling and assembly lines
- Real-time quality monitoring systems
- Validated sterilization processes
- Tamper-evident packaging solutions
Quality Documentation
Every batch of prefilled syringes includes complete documentation:
- Certificate of Analysis (CoA)
- Batch manufacturing records
- Sterility test results
- Dimensional inspection reports
- Material safety data sheets
Regulatory Compliance
As an established prefilled syringes manufacturer, Kohope maintains certifications including:
- ISO 13485:2016 Medical Device Quality Management
- FDA registration and compliance
- CE marking for European markets
- GMP certification
- Regular third-party audits and inspections
Custom Solutions Process
Step 1: Consultation
Share your requirements with our technical team to evaluate feasibility for your custom prefilled syringe project.
Step 2: Design & Sampling
Receive detailed specifications and prototype samples of prefilled syringes for evaluation and testing.
Step 3: Validation
Conduct compatibility studies and validation protocols with your drug formulation.
Step 4: Production
Begin mass manufacturing with consistent quality and reliable delivery schedules.
Step 5: Ongoing Support
Benefit from continuous technical assistance and supply chain optimization.
Sustainability Commitment
Kohope is committed to sustainable manufacturing practices for prefilled syringes:
- Energy-efficient production facilities
- Waste reduction and recycling programs
- Eco-friendly packaging materials
- Carbon footprint minimization initiatives
Contact Kohope Today
Partner with a reliable prefilled syringes manufacturer that delivers quality, compliance, and innovation. Whether you need standard prefilled syringes or custom prefilled syringe solutions, Kohope has the expertise and capacity to support your project from concept to commercialization.
Get in touch with our team to discuss your requirements and receive a customized quote.
Kohope – Your Trusted Partner in Prefilled Syringe Manufacturing Excellence
