Clean Room Plastics
889 Global Solutions: Your Source for Clean Room Plastic Manufacturing
Clean Room Manufacturing Environment
Strictly in accordance with GMP standard, our partners of Chinese manufacturers have established 100,000 class clean rooms under ISO 14644-1 standard, equipped with advanced processing machinery and testing equipment, strict contamination control procedure is in place in the clean room environment to ensure the products quality.
- 16,000 square feet of class 100,000 clean room workshop for production
- 8,500 square feet of class 100,000 clean room space for laboratory purposes, with a quarter of the space used for class 100 clean room laboratory.
Our Quality System
- CE certified manufacturer
- ISO 13485 certified manufacturer
Our Production Capabilities
- Tube Extrusion: clear or frosted tubing, single- and multi-lumen tubes
- Injection: wide variety of injection connectors
- Blowing: cuff or balloon blowing
- Tip Forming: closed and open ends, bonded soft tips
- Holes/Eyelets: punch, drill, fire polished
- Tube Ending: flared or flanged ends
- Cuff Bonding: bondinig cuff onto tubes
- Tube Printing: pad printing on tubes
Types of Catheters/Tubes:
- Foley catheters
- Coude catheters
- 3-way catheters
- Suprapubic catheters
- Catheter insertion kits
Workshop and Assembly in Clean Room
- The air entering clean rooms from outside is filtered to exclude dust;
- The air inside is constantly re-circulated through high efficiency particulate air HEPA and/or ultra low particulate air ULPA filters to remove internally generated contaminants;
- Staff enter and leave through airlock and wear protective clothing;
- The materials used are medical class plastic materials.
What 889 can do for you
SOURCING WITH 889
Taking Title: 889 takes ownership of products, assuming responsibility for importing.
Communication: 889’s multilingual staff deals direct with manufacturer. A dedicated project manager will provide you with correspondence & ensure your products will be delivered on time and to your exact specifications.
Quality: 889’s staff in China handles facility credentials & pre-shipment inspections.
Samples: 889 offers pre-production samples for review and approval.
Shipment: 889 manages logistics from the manufacturer to your door, including customs, duties & delivery.
Timing: 889 products have a 12 week lead time.