Qosina, a global supplier of OEM single-use components for the medical and pharmaceutical industries, recently announced it had completed the construction of its new cleanroom. The 1700-square-foot cleanroom is ISO Class 8, meaning that the room needs less than 3,520,000 of ≥ 0.5-micron sized particles per cubic meter of air.

An ISO 14644-1 classified cleanroom is a room or contained environment where it is crucial to keep particle counts low. These particles are typically dust, airborne microbes, aerosol particles, and chemical vapors. There are several general requirements and environmental parameters that need to be considered when designing a cleanroom, including HEPA filtration, air changes per hour, air pressure, temperature and humidity, amount of personnel working in the space, static control, lighting, and noise levels. Through the design and construction phases of the cleanroom, the company developed novel shipping techniques for its medical and bioprocessing components. Within the room, there are 10 workstations designated for Qosina’s scale counting and repacking process.

For Qosina, the new cleanroom will support the expansion of its pick and pack process and allow for an increase in capacity, as well as reduced customer lead times.

“Our new cleanroom was built to accommodate the increased growth of our business, further showcasing our commitment to meet our customers’ most critical component requirements,” said Scott Herskovitz, president and CEO of Qosina. “This cleanroom further validates that Qosina is an important part of the supply chain for medical device and bioprocess system manufacturing. We want our customers to have the confidence and peace of mind that components manufactured in a cleanroom are always opened and repacked in a similar environment.”

When contacted, Qosina was unable to supply MD+DI with additional comment.