Clinicians know the importance of sterility. But they may not know what manufacturers do to ensure medical devices can be effectively sterilized. After all, devices must be clean before entering the sterilization process. In this blog I’ll provide a glimpse into the environment where medical devices are made.
Before Mar-Med devices are sterilized, we manufacture them in a cleanroom. A cleanroom is a controlled environment that filters pollutants like dust, airborne microbes, and aerosol particles. Positive air pressure in the cleanroom keeps only filtered air inside. But simply having a cleanroom doesn’t guarantee that it’s functioning or that other inputs are clean.
We take a number of steps to maintain strict control of the manufacturing environment and sterilization of our devices, including the following:
Quarterly biological monitoring by Summit Labs:
Every quarter Tom Krueger (pictured below) from Summit Labs in Grand Rapids comes in to do environmental testing. He tests for bacteria in the air inside and outside the cleanroom with a microbial air sampler. He also tests a variety of surfaces in the cleanroom, including our employees hands to verify that our hand washing procedure is carefully followed. You might be surprised how gross your own hand can be if you don’t wash carefully!
Indicated in the picture are the following:
- – Tom Krueger testing the air outside the clean room
- – Positive pressure inside the cleanroom seen by the bowing of the soft walls
- – Mar-Med employees wearing cleanroom gowns, hair caps, and gloves
- – Isopropyl alcohol spray bottles and wipes
- – Air filters in the ceiling
Isopropyl alcohol everywhere:
Non-porous work surfaces and furnishings are frequently wiped down, and the devices themselves are bathed in isopropyl alcohol to kill any pyrogens before sterilization. There’s nothing quite like that fresh and clean smell of isopropyl alcohol!
Quarterly verification of air particulate:
Cleanrooms are rated based on the amount of particulate in the air (see more here). We maintain a class 8 cleanroom, verified quarterly and certified yearly by accredited vendors testing with calibrated laser equipment. I don’t use the word laser often, but when I do it’s serious stuff.