Medical Device Production


It is amazing that modern science has advanced to an era in which we can make replacement hips, joints, insulin pumps, and other medical devices. These devices require precision and must be made under strict conditions. Before these items are used to help someone in a hospital, they are manufactured in a clean room.

What is a clean room? These rooms vary greatly, depending on what they are being used for, but generally speaking it is a controlled environment. These rooms are ranked according to an international standard called ISO 14644 which limits the amount of particulates that can be in a sample of the air within the room. Most medical devices are built in ISO 7 or ISO 8 (Class 10,000 – Class 100,000) rooms.

The reason these rooms are used for medical devices is to ensure contaminate free products. Inside a these rooms you’ll find HEPA filters, air showers, HVAC systems, and humidity controls. Generally speaking, the biggest enemy of these controlled environments is the workers. Depending on which ISO class the room is, operators may need to take extra precautions through wearing specialized protective clothing. These garments may include gloves, shoe coverings, hats, face coverings, and coveralls. The goal of this clothing is to contain particles shed by the operator and not compromise any of the work conducted in the controlled environment.

Since the clean room is a clean environment, special equipment is often required for the processes conducted within the room. This ranges from specialized cleaning supplies, like non linting wipers and mops to specialized paper and pens. All these extra precautions are taken to keep the clean room clean. Standard office supplies and cleaning products could potentially contaminate the room and or the processes that occur within the room.

Medical devices are often packaged within clean rooms too. Sometimes clean rooms elect to create separate areas with a higher level of cleanliness. These sections of the room are often referred to as micro environments. These areas sometimes incorporate a laminar flow bench. These benches included a HEPA filter that filters air down in flat layers know as laminar flow. Micro environments are a great, cost efficient way for more sensitive process requiring a higher level of cleanliness to occur in your controlled environments.

In closing, controlled environments are a necessity for producing medical devices. Clean rooms make sure these products arrive contaminate free and are quality made.