Cleanliness and contamination have taken on completely new meanings in 2020. However, these ideas have always been important in the manufacturing realm – and not necessarily to prevent the spread of viruses.
When making products with sensitive components or to strict industry regulations, finding a reliable and certified cleanroom manufacturing partner is critical to your success.
What is a cleanroom?
A cleanroom is a dedicated space where elements are precisely controlled to prevent surface contamination – either from the environment or the workers entering the room.
One of the main objectives of a cleanroom is to remove and limit potentially hazardous airborne particles, including dust, microbes, aerosols, and chemical vapors. To accomplish this goal, a cleanroom typically uses a ventilation system featuring High-Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters. Furthermore, workers in a cleanroom will have specific protocols and may wear gowns, gloves, booties, hairnets, or other protective attire.
Why is a cleanroom important for manufacturing?
Maintaining a cleanroom is an important aspect of manufacturing in a wide range of industries, including medical devices, pharmaceuticals, biotechnology, and other products that are designed with circuits or flexible hybrid electronics.
Many of these industries have stringent cleanroom requirements. But even for those that don’t, it can be a quality control issue. A cleanroom can ensure that small particles do not contaminate the surface of sensitive components, which could impact defect rates. Regardless of regulatory requirements, cleaner products result in higher quality product and less scrap. With modular design options, cleanrooms can be sized and adapted to the customer’s exact needs.
Cleanrooms are certified by standards such as ISO 14644-1:2015, which includes nine classes based on the maximum concentration and size of particles in the air. Another standard, To put things in perspective, typical air in an urban setting contains 35,000,000 particles (0.5 microns and larger) for each cubic meter. An ISO 14644 Class 7 cleanroom can only contain 352,000 particles of the same size range per cubic meter. In general, the lower the ISO class number, the cleaner the room – in terms of fewer and smaller particles. Medical devices are typically manufactured in ISO 7 and ISO 8 environments.
Tapecon’s Cleanroom Capabilities
At Tapecon, we strive for the highest level of quality and contamination prevention for our clients. We’ve invested in a new ISO 14644 Class 7 cleanroom for some custom converting processes. This cleanroom allows us to prevent contamination for sensitive products, including converted medical components such as foam or pressure-sensitive adhesive constructions.
We also take a clean approach to our printing services. While not formally certified, our environment is calibrated annually, and internal testing demonstrates low particle levels consistent with ISO certification standards. This environment can improve quality and consistency – for example, reducing fallout of screen-printed overlays with multiple colors and user interfaces with printed windows.
Get Started with Contract Manufacturing
At Tapecon, we have over 100 years of experience helping customers solve their complex product challenges. Learn more about our contract manufacturing services.