Clean Room Manufacturing & Converting

The Tape Lab operates our cleanroom(s) in a controlled environment that has a low level of particulates such as Chemical vapors, aerosol particulates, dust, or airborne microbes. To reduce these particulate contaminants from staying in the air the temperature, humidity and pressure are controlled in a given contained space. All of the air delivered to our cleanroom passes through a HVAC system, followed by a High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. The temperature and humidity are controlled and the environment is monitored on a regular basis to ensure there is positive pressure and a low, acceptable particle count.

Our Clean rooms are classified using standards that account for permissible particle limits and sterility requirements. Many people understand the cleanliness of your clean room with terms from the Standard Federal Standard 209E and the Internationals Standards Organization (ISO) TC209, which classified a cleanroom according to the quantity and size of particles permitted per volume of air. Numbers like “class 100” or “class 1000” refer to FED-STD-209 and denote the number of particles of size 0.5 µm or larger permitted per cubic foot of air in the defined space. ISO classifies clean rooms according to airborne particulate cleanliness per cubic meter, ranging from class 1 to class 9. The highest standard of cleanroom is a class 1 while a typical room air corresponds to an ISO Class 9. The Tape Lab operates an ISO Class 8 cleanroom. We manufacture parts that are commonly used for Class I to Class 3 medical devices. These devices have low or moderate risk to the patient or user.