Completing the clean room injection molding is only the start of the process of to develop contaminant-free components. With medical devices, particularly implants and other types of components that will be used inside the human body, multiple parts may be involved in the design. This means that the components have to be assembled into parts or devices and this has to be done without any chance of contamination.
Even if each of the components was manufactured in a clean room, there would still be the risk of contaminants entering the device during the assembly stage. For this reason, many of these devices require clean room assembly.
The process of clean room assembly includes putting the specific components together in the clean room under the specific environmental conditions offered. Once assembled the parts or the complete device can be moved out of the clean room for further assembly or as a device that is ready for use.
To be able to provide clean room assembly, technicians have to be specifically trained in the process. This includes the correct methods for entering a clean room to avoid bringing in contaminants and dust. It will also include the proper procedures in the clean room and how to operate equipment with the room based on the classification of the clean room.
Additionally, most clean room technicians have specific certifications. This can include various cleanroom certifications that may be more general or an industry specific certificate. There is also considerable on the job training with most companies utilizing a mentor or supervisory role between new employees to the clean room and experienced assemblers.
Assembly and Inspection
The assembly technicians will be specifically trained in the different required assembly methods for each particular project. These protocols or procedures will be followed exactly for each assembly and across and between complete production runs.
Additionally, some of the technicians will also provide quality assurance and inspections. These inspections will also be completed as to the prescribed protocol based on the part or device type. These inspections will verify conformation to the required standards for the part through a variety of different testing options. Often there is specific testing equipment used to verify the integrity of the assembly process.
Additionally, some of the clean room staff will also inspect the procedures used and all attributes of the room. This ensures that the clean room is meeting or exceeding standards and that all parts and devices are assembled to the standards required.