Cleanroom Assembly, Welding and Packaging Services
At Norman Noble we provide final cleaning, assembly, welding and packaging capabilities in our ISO Class 8 cleanroom certified to ISO 14644-1 and 14844-3. ISO 14644 mandates that contract manufacturers keep airborne particulate levels below 3.5 million per cubic meter in order to earn ISO Class 8 certification. This capability completes the production chain for our customers’ products and enables Norman Noble to be a single source to medical implant and device OEM’s that require complete contract manufacturing services for packaged medical devices and implants. Our cleanrooms are modern facilities that include certified gowning rooms, along with temperature, humidity and contamination controls that can be partitioned into micro-environments for particulate control as strict as the customer deems necessary.
We also use a temperature-controlled secure area, which provides a room for post-sterile barrier packaging, label printing and controlled storage. Laminar flow hoods throughout our facilities support clean assembly and packaging for many projects.
Our technicians incorporate the use of cleanliness controls when performing the following operations in our cleanroom:
- Assembly of machined medical implants and devices
- Assembly of other bioburden-sensitive purchased components
- Packaging of medical implants and devices
- Double barrier sterile packaging
- Welding of sub-components and medical implants
Process validation for Cleanroom Assembly, Welding and Packaging Services begins at Norman Noble, Inc. (NNI) with a clear understanding of our customers' needs together with ISO standards, Current Good Manufacturing Practices (CGMPs) and the NNI Quality Policy.