
- Description
- Specifications
- Made from 100% USP Class VI virgin resin
- ZeroDraft syringe barrel walls
- Enhanced biocompatibility for medical use
- Certified safe for industrial use and manufactured in silicone-free facilities in the USA
- Ease of process validation for regulatory approvals
- Market-leading traceability for documentation requirements
- Ability to sterilize to ensure a bacteria-freeproduct
- Components do not contain colorants, making them easier for engineers to document for regulatory approvals
Nordson EFD’s Optimum Class VI dispensing components are manufactured from United States Pharmacopeia (USP) Class VI resin. This helps medical manufacturers improve process validation and traceability to more easily meet regulatory requirements. Sterilization is possible to eliminate bacteria. These dispensing components feature the same highly-engineered design as standard Optimum components. Class VI syringe barrels feature ZeroDraft walls with consistent internal diameters that maintain an airtight seal with pistons. The complete Optimum Class VI system includes syringe barrels, pistons, end caps, and tip caps. Note: These components are not manufactured in a clean room environment.
Overview
Using 100% virgin USP Class VI resins to mold these fluid dispensing components helps Nordson EFD provide assurance of the quality and safety of the components for use in medical device manufacturing. Class VI syringe barrels feature ZeroDraft walls with consistent internal diameters that maintain an airtight seal with pistons. This design delivers accurate and repeatable fluid deposits used in coating, bonding, and other medical assembly processes. These biocompatible components also can be sterilized to guarantee a bacteria-free product. Ethylene oxide (ETO), autoclave, and gamma sterilization methods were tested. Those results can be found in the product literature, though Nordson EFD states that all customers must to do their own testing to validate their processes. Note: These components are not manufactured in a clean room environment.
The complete Optimum Class VI system includes syringe barrels, pistons, end caps, and tip caps, available in 3cc, 5cc, 10cc, 30cc, and 55cc capacities.