Providing Validation Every Step of the Way
ISO 14644 mandates that contract manufacturers keep airborne particulate levels below 3.5 million per cubic meter in order to earn ISO Class 7 certification. At Norman Noble we provide final cleaning, assembly, welding and packaging capabilities in our ISO Class 7 cleanroom certified to ISO 14644-1 and ISO 14844-3. This capability completes the production chain for our customers’ products and enables Norman Noble to be a single source supplier to medical device OEMs that require complete contract manufacturing services for packaged medical implants and nitinol devices. 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 OEM 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 devices and nitinol implants
- Double barrier sterile packaging of vascular implants and orthopedic implants
- Welding of sub-components and medical implants