Cleanroom Assembly, Welding and Packaging Services
Norman Noble provides final cleaning, assembly, welding and packaging capabilities in our ISO Class 8 Cleanroom. This capability completes the production chain for our customers’ products, and allows Norman Noble to be a single source to Medical Device OEM’s that require complete contract manufacturing services for packaged medical devices and implants. Our 1000 sq. ft. cleanroom is a modern facility with temperature, humidity, & contamination controls that can be partitioned into micro environments for particulate control as strict as the customer deems necessary. ISO 14644 mandates that contract manufactures keep airborne particulate levels below 3.5 million per cubic meter in order to earn Class 8 certification.
Per internal SOPs, our technicians incorporate the use of cleanliness controls when performing the following operations in our Clean room:
- Assembly of machined medical devices & implants
- Assembly of other bioburden-sensitive purchased components
- Packaging of medical devices and implants
- Double barrier sterile packaging
- Label printing services
- Welding of sub-components and medical implants
Assembly & Packaging
We also utilize a temperature-controlled secure area which provides a room for post-sterile barrier packaging, label printing, and controlled storage. Laminar flow hoods are also utilized throughout our facilities to support clean assembly and packaging for many projects.