ISO Class 7 Cleanroom: Quality Above All Else

A MediSurge employee works to make medical devices while white text over them reads, "Our state-of-the-art facility, which features a Class 8 Cleanroom, allows us to bring products to life through innovative design control processes."

 

Partnering with a medical device company is a big decision, and it is important to work with a team who places quality above all else in order to ensure the success of your product. At MediSurge, we are committed to providing our customers with safe, high-quality, easy-to-use medical devices that will ultimately improve patient care and outcomes.

Our state-of-the-art facility, which features a Class 7 cleanroom, allows us to bring products to life through innovative design control processes. Here is a bit more information about cleanrooms, what they are used for, and how this controlled space benefits our customers:

What is a Cleanroom?

A cleanroom is a controlled environment. At MediSurge, our cleanroom is used for medical device assembly and packaging. Cleanrooms are designed to maintain an extremely low particulate count, which means lowering the presence of airborne organisms, dust, or vaporized particles.

Air that enters a cleanroom from the outside is filtered to remove dust, and the air inside is continuously recirculated by high-efficiency particulate air (HEPA) filters.

Cleanroom Classifications

Cleanrooms are classified by the cleanliness of the air inside, according to the quantity and size of particles per volume of air. The ISO classification system is the primary authority for cleanrooms in the United States and Canada, and they range from ISO 1, which is the “cleanest” possible, to ISO 9. Most medical devices require class 8, and MediSurge is proud to have an ISO Class 7 cleanroom on site at our facility.

Maintaining Quality

Our team carefully goes through all necessary steps to ensure we maintain Class 7 standards in our cleanroom. This includes following specific gowning techniques, using hand sanitizing stations, continually monitoring air and surface requirements, designating specific apparel requirements, and following line clearance procedures. We also have daily, and monthly cleaning procedures in place that help keep everything compliant.

Benefits for Customers

Cleanrooms are expensive to maintain, which makes our ability to offer this type of space to our customers very valuable. In addition to our cleanroom, customers have the ability to expand into our warehouse or build additional cleanrooms if needed, since our team has the expertise to do so. For those who have a great product but not enough experience with managing and maintaining a cleanroom themselves, we are a perfect fit.

By investing in our cleanroom space and the needed training to properly maintain it, we are putting our customers and their patients first. We are committed to producing products that are designed to be the best, every time, with no exceptions.

To learn more about our facility and cleanroom capabilities, please reach out to us today.

 

 

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