How to Choose a Reliable Supplier for Glass Syringes and Injection Pens
Verified Certifications & Global Compliance A trustworthy supplier must meet international medical device standards:
ISO 13485, ISO 9001
Product-specific ISO standards (11040 for syringes, 11608 for pens)
Biocompatibility (ISO 10993)
Regulatory readiness for CE, US FDA, and other markets
At Sunrise: All our facilities are ISO 13485 certified, production complies with ISO 11040/11608, and we have experience supporting CE and FDA submissions for global clients.
Medical-Grade Materials Materials must be drug-compatible, traceable, and safe for patient contact:
Type I borosilicate glass with anti-delamination treatment
SUS316L stainless steel for critical metal parts
Medical-grade PP, COC/COP polymers, and bromobutyl/chlorobutyl stoppers
At Sunrise: We source exclusively from audited medical-grade suppliers, maintain full batch traceability, and conduct extractables & leachables testing for each design.
Advanced Manufacturing Capability Precision and consistency are key:
Automated assembly in ISO 7/8 cleanrooms
In-line vision inspection for 100% defect detection
Validated processes with Cpk ≥ 1.33 for critical dimensions
At Sunrise: Our cleanroom lines combine automation with rigorous process control, ensuring stability from pilot batches to high-volume runs.
At Sunrise: We keep product retain samples for up to 5 years and provide defect rate data transparency to all long-term partners.
Customization & Co-Development For branded pharmaceutical products, design flexibility matters:
Custom colors, finishes, scale markings, and ergonomic designs
DFM/DFA support for cost efficiency
Usability engineering and risk management
At Sunrise: We offer full customization — from outer appearance to scale engraving — and collaborate closely with clients through every stage from concept to mass production.
Global Supply & Support A good supplier can deliver consistently worldwide:
Experience in Europe, Middle East, Korea, USA, and more
Multi-language support and regulatory documentation
Flexible shipping and aftersales service
At Sunrise: We ship to over 20 countries and provide end-to-end support, ensuring your projects meet local market requirements.
A Yes, we are not only the factory but also we have our own design team to make the perfect and professional design with your own particular logo, concepts and special requirements.
