Nipro Custom Manufacturing Division
The Custom Manufacturing division at Nipro Medical provides solutions to fulfill the needs of our customers. Our state-of-the-art manufacturing plants are uniquely qualified and equipped to provide custom designs or completely build to the most demanding drawing specifications. We manage the product development cycle, from design to testing, to ensure the highest level of quality and safety.
Customers rely on our strength in manufacturing the finest quality standard and custom medical products in the industry. All custom manufactured products enjoy the same level of innovation and technology applied to all of our Nipro branded products. Our Custom Manufacturing facilities are located in Japan, Thailand and China.
We are uniquely qualified and equipped to provide custom design solutions or completely build to your most demanding drawing specifications. Count on us for our strength in manufacturing the finest quality standard and custom needles in the industry.
- Cannula Forming – grinding, polishing & tube extrusion
- Plastic molding and extrusion; Injection, blow & insert
- Design, fabrication, and validation of tooling and fixtures
- Automated assembly; Ultrasonic welding solvent, adhesive, & UV cure bonding
- Packaging – form, fill & seal; heat seal poly bag & pouch
- Sterilization, shelf life, and packaging validation
- In-House Sterilization; ETO, Gamma, Steam & E-Beam
- Certified class 100,000 & class 10,000 (ISO Class 7 & 8) clean rooms
- Complete design engineering, R & D, Prototyping, Testing, Verification, Quality Assurance
- Regulatory Affairs – support all phases of U.S. FDA and international product approvals
- Registered with U.S. Food & Drug Administration
- ISO 13485; ISO 9001; CE Certified; QMS (Japan); cGMP (US FDA QSR)
- Factory ocean container shipments depart daily to the United States
For more information on our Custom Manufacturing division, please fill out the Contact Us form.