Clean Room Manufacturing & Converting
The Tape Lab operates an ISO 8 (Class 100K) Clean Room, so we have the ability to manufacture and package for the medical and health care industries as well as other industries where small particles can adversely affect the manufacturing process or the end product. Some industries we utilize our ISO 8 Clean room for are: aerospace, electronics, pharmaceuticals (non-drug related), health care, wearable devices, and stick to skin applications.
The Tape Lab has several ISO Class 8 “portable” clean rooms that contain state-of-the-art converting equipment as well as slitting equipment. All our Clean rooms are certified and operate in a temperature and humidity controlled environment.
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.
Clean Room Manufacturing & Converting Applications
The Tape Lab operates several rotary presses in our ISO 8 Cleanroom. This allows The Tape Lab to produce parts in a clean and low particulate manner to give our customers the highest standards of manufacturing when needed.
The Tape Lab can move one of our portable clean rooms over our rewind slitter to control the particulate count when we need to slit material for certain jobs and ensure the material is free of dust and debris while slitting it to size. This gives our customers peace of mind that all the components that we manufacture for them in our ISO 8 cleanroom have the highest standards to meet their requirements.
Packaging and Assembly
At The Tape Lab we have dedicated ISO 8 clean room packaging and assembly areas to add value to our customers parts. We are able to bag, kit and do light assembly in our ISO 8 cleanroom. This allows The Tape Lab to offer end to end fulfillment of our customers needs and contain all the parts in one clean environment.
Some of our methods of clean room manufacturing & converting include:
- Rotary Die Cutting
- Rewind Slitting
- Packaging and Assembly
- Inspection services (CMM)