Excellent cosmetic and dimensional quality for precise integration into pen systems
Nipro's pen cartridges are manufactured to meet the highest standards of the pharmaceutical industry. Our precise forming process and advanced inspection systems ensure that each cartridge adheres to stringent dimensional tolerances, providing excellent mechanical durability and minimizing the risk of breakage during use. The precise dimensional tolerances of our cartridges guarantee seamless integration and functionality with pen systems, ensuring safe and reliable administration every time.
Our state-of-the-art inspection systems also maintain strict cosmetic standards, delivering cartridges with pristine surfaces that meet the expectations of both pharmaceutical customers and end-users.
We use premium glass tubing that complies with pharmacopeia standards in the United States, Europe, and Japan (USP, EP, and JP). Our production takes place in controlled ISO class 8 environments, monitored by quality systems that comply with ISO 15378, ISO 9001, ISO 14001, and OHSAS 18001 standards.
Specifications
The Right Quality for Your Pen Cartridges
Depending on your drug product and service requirements, you can choose from two different Quality Levels. Each Quality offers specific benefits and lists a comprehensive scope of product and service attributes, providing the perfect base to fine-tune the quality precisely to your needs.
EHANCE | High-quality
[Preset, standardized product specifications, Exceptional strict AQLs, Advanced service level, Comprehensive support, Extended data package]
For complex drug products demanding the utmost quality and service level, particularly for biologics or other highly sensitive drug products.
Designed for Precise Integration into Pen Systems1
-
Extremely accurate dimensional tolerances enables precise integration and functionality with pen systems
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Very accurate inner dimensional tolerances support accurate filling accuracy
- Safe operation of injection mechanisms due to strong mechanical durability
Excellent Cosmetic Quality1
- High cosmetic quality for reduced risk of rejects due to glass defects2
- Pristine appearance ensures higher acceptance by end-user
Extended Data Package for Fast Acceptance of Goods
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Fast acceptance of delivered goods is facilitated
[CoA3 | CoS4 | additional certificate upon request] -
Regulatory data confirms compliance with standards
[physical & chemical properties | compliant to pharmacopeia | level of sub-visible particles | risk analysis] -
Drug Master File related data
[for FDA, Health Canada, and NMPA | easy procedure to receive LoA5]
ENGAGE | Custom-quality
Fully customize your product and service specifications to meet your unique, non-standard quality and design requirements. Customization is fully supported by an experienced and cross-functional team.
Footnotes
- 100%, in-line camera inspection for a broad range of dimensional and cosmetic parameters
- Stones, knots, inclusions, scratches, particles, ...
- Certificate of Analysis
- Certificate of Sterility
- Letter of Access/Authority
Range
| Volume [mL] | Outer diameter [mm] | Printing |
|---|---|---|
| 1.8 | 8.15 | Ceramic |
| 3.0 | 11.6 |
Need help?
Get in touch
For information regarding Nipro products, services, and resource material:
| Give us a call +32 15 263 500 |
E-mail us [email protected] |
| Submit a detailed inquiry: Contact per expertise |
View our manufacturing locations: Our global network |