Clean Room Assembly Services
Custom Wire’s ISO 14644.1 Class 7 and Class 8 Clean rooms provide unique and comprehensive manufacturing, assembly and packaging capabilities. Our clean room product assembly delivers quality ultra-fine wire parts and sub-assemblies, including custom guidewires, continuous coils and additional medical and dental surgical components as well as other cleanroom-specific components for diverse industries.
By adding Class 7 and Class 8 Cleanroom services to our custom wire fabrication expertise, CWT is committed to becoming your full-service, value-added process engineering and manufacturing partner for all your cleanroom fine-wire component needs. We serve a variety of medical device OEMs, designers and researchers who are looking for high-quality clean room assembly services performed in the United States. Our assembly facility coupled with our coiling, grinding, and forming services enables us to provide competitive pricing and lead times for fully assembled medical device components.
- Medical Component Assembly
- Medical Component Packaging
- Ultrasonic Clean Room Washing
- ISO 9001:2008 Certification – View or Print
Clean room manufacturing and assembly has increasingly moved toward turnkey manufacturing. This trend has resulted in preferences of OEMs to choose manufacturers who can perform multiple services under one roof – including welding, forming, and assembly. The ability to provide full packaging and sterilization services is a valuable asset due to the increased demand for disposable medical products.
Current Trends: Medical device assembly manufacturers are eager to automate their processes that attach plastic medical tubing to valves, catheters, connectors, and other devices. Key reasons include increased levels of quality control, increased demand for higher volumes of tubing assemblies, and increasingly stringent quality requisites for production tracking.
Following Custom Wire Technologies’ Standard Operating Procedures, the clean room technicians adhere to strict cleanliness controls while performing the following services:
- Clean Room Assembly – Assembly of medical devices and other bioburden-sensitive machined parts
- Electronic Assembly – Assembly in a clean room environment
- Medical Device Packaging – Requires a certified clean room
- Clean Room Welding – Multi-axis, fiber beam delivery with pulse shaping capabilities
- Additional Clean Room Services – Assembly with other components, pad printing, inspection, sorting, kitting and packaging
From ultrafine wire precision coiling and forming to custom wire welding and assembly, we have incorporated multiple medical device component manufacturing capabilities all under one roof to save you time and money.
Custom Wire Technologies is registered for ISO 9001:2008 certification through Performance Review Institute. Scope of registration recognizes their demonstrated Quality Management System (QMS) for the fabrication of custom wire forms and assemblies, primarily for medical application.