Clean Room Manufacturing & Packaging
MBK Tape Solutions offers ISO Class 8 Clean Room Manufacturing and Packaging for the medical and health care industry, as well as other industries where small particles can adversely affect the manufacturing process, such as in aerospace, electronics, pharmaceuticals, food contact, optics and military applications. To meet our customer’s requirements, we have four ISO Class 8 independent works cells that contain state-of-the-art converting equipment, plus three portable clean rooms that can be used when and where needed. Our certified cleanroom and controlled environment rooms are equipped to fabricate FDA compliant adhesives, films, foams and other specialty materials.
Typically, a cleanroom is a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. To reduce particulate contamination, temperature, humidity and pressure are controlled in a given contained space. All of the air delivered to the 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 is controlled and the environment is monitored on a regular basis for positive pressure and particle count.
Clean rooms are classified under a number of different standards that account for permissible particle limits and sterility requirements. In the past, The Standard Federal Standard 209E and the Internationals Standards Organization (ISO) TC209, 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.
More recently, ISO classifies clean rooms according to airborne particulate cleanliness per cubic meter, ranging from class 1 to class 9. The “cleanest” cleanroom is a class 1 while an ordinary room air corresponds to an ISO Class 9 room. Our ISO Class 8 cleanrooms are commonly used for Class I and II medical devices, which are devices that have low or moderate risk to the patient or user.
Cleanroom Clothing Requirements
At MBK, personnel selected to work in the cleanroom undergo training in contamination control. In order to prevent substances from being released off the body and contaminating the environment, our workers enter and exit the cleanroom through a gowning room, dressing in anti-static lab coats, hair nets, face masks and shoe covers. Gloves are worn, depending on the product specifications. To keep the room in sterile conditions, the room and equipment is cleaned and disinfected continuously.
MBK Cleanroom Manufacturing Process
With over 45 years of adhesive tape knowledge and experience with a wide range of applications, we’re able to work with each customer from concept to full scale manufacturing. We begin by collaborating with you on the initial product design and then utilize our prototyping process to turn around samples in a short period of time. Once the prototype is approved, we can proceed with tooling and scaling up production. We continuously handle with care to assure quality performance and functionality in all our component parts and finished products.