Inside the CleanroomSeptember 6, 2013
In today’s medical manufacturing world you see a lot of innovation and advancement in device design, but there’s one thing that is truly imperative and often overlooked in the process of making these designs a reality: Cleanrooms. The goal of cleanrooms is to keep environmental pollutants to an absolute minimum. This is very important when it comes to manufacturing medical devices because many components will have either direct contact with tissue or blood or could be implanted into the human body long term. Either one of these scenarios require stringent environmental controls within the manufacturing process to insure products do not contribute to patient infection or sickness. Dust, airborne microbes, particles, and other particulate matter can be very harmful to medical device components despite their microscopic size.
Cleanrooms are classified according to the number and size of particles permitted per volume of air. MRPC has four rooms certified at ISO Class 8 and one room certified at the ISO Class 7 standard. Careful precautions are taken to ensure purity in the cleanroom area, including air showers, gowning areas, special furniture, and protective clothing. The air inside a cleanroom is constantly circulated through a High Efficiency Particulate Air (HEPA) or Ultra Low Penetration Air (ULPA) filter. Designated protective clothing must be worn in the environment to prevent contamination and to trap contaminants that are naturally generated by skin and the body.
MRPC has cleanrooms that monitor particulate counts on a daily basis. Molding, inspection, assembly, testing, and packaging is all done in these rooms to eliminate any chance of outside contamination.