For medical devices that are implanted into the body, manufacturing and assembly of the parts and the devices have to be completed under very specific conditions. These conditions are found in a specialized production facility known as a clean room. All aspects of clean room molding have to follow specific protocols to eliminate the introduction of any possible contaminants into the space.
A clean room is a sealed room that is designed to eliminate dust, moisture and airborne particles or contaminants that are present in other types of production facilities. The clean room also requires specific protocols for what type of equipment can be used in the room, and even how the employees working in the room are dressed to prevent cross-contamination or the introduction of contaminants into the production environment.
Clean Room Considerations
The choice of clean room molding starts by understanding the level of class of clean room process required. For medical devices produced by injection molding, a Class 7 clean room is the most commonly required production facility. The manufacturer should offer an ISO compliant facility, and it should FDA registered and have the ISO 13485 certification for the production of the medical devices.
A class 7 clean room has to meet specific maximum levels of particulate matter in the air. This is measured per cubic meter, and there are maximum particulates that are 0.5, 1, and 5 microns in size allowed when the air is tested.
Machines used for clean room molding have to be specially designed to maintain the sterile space. This includes the use of electric equipment and avoids the use of hydraulic equipment, reducing the risk of introduction of any contaminants.
In most cases, particularly for medical devices, the clean room is also used for assembly of the parts and well as any other manufacturing services required.
