Assembly and Clean Room Services
Integer specializes in assembling medical devices in a clean room in compliance with medical standard ISO:13485.
All of the assemblies come with complete documentation of the process and with a DHR – Device History Record.
About the Integer Clean Room
The clean room and the laminar hoods leading to it are ISO 7 (Class 10,000) compliant. The clean room is controlled and monitored:
- Air pressure control, temperature and humidity control at a 24/7 monitoring level
- Continuous computerized control and fault indication
- Microbial control of, molds, fungi, and bacteria (Bio-Burden) on a weekly basis or according to customer requirements
The work process
The cleaning process performed at Integer is suited to the raw material, the component structure, the geometry and so forth.
Options for cleaning processes:
Cleaning in IPA and electrical components
Water jet and soap cleaning
Drying under laminar hoods – when the cleaning process is complete, the parts are inserted into the clean room via laminar hoods to be dried in a clean environment.
The assembly process – which is performed in the clean room, consists of a broad range of applications including special bonding with biocompatible adhesives, welding of various materials, precision laser welding (micro-laser), mechanical assembly, electronic assembly, and electromechanical assembly.
Packing – Integer has packing machines for blisters and pouches, which enable flexibility and customization to customer requirements. Includes packing in CO2, vacuum packing and packing in large-size blisters.
- Contact us for more information