What are Clean Rooms?
Clean rooms are controlled environments designed to maintain low levels of airborne particles and contaminants. They are used in a wide range of industries where cleanliness is paramount, including medical, electronics, biotechnology, display, aerospace, and more.
Within clean rooms, processes like manufacturing and assembly are carried out under strict guidelines to prevent contamination. The controlled environment reduces the risk of defects and helps improve the safety and quality of products.
Types of Clean Rooms
Clean rooms are categorized based on their level of cleanliness. They are classified according to ISO standards, with ISO 1 being the cleanest and ISO 9 the least stringent. Marian offers manufacturing in ISO 8, ISO 7, and ISO 6 rated clean rooms.
ISO 8 classification requires less than 3,520,000 particles larger than 0.5 micron per cubic meter (100,000 particles/ft.3), while ISO 6 requires less than 35,200 particles larger than 0.5 micron per cubic meter (1,000 particles/ft.3). We monitor particle levels and ensure our compliance by using airborne particle counters.
Our clean rooms are constructed with flow hoods and HEPA filters systems. Additionally, we have ISO and FDA procedures in place for clean room gowning.
How Can Marian Use Clean Room Manufacturing for my Applications?
Manufacturing die-cut parts in clean rooms begins with proper delivery and management of the materials that will be used. Marian works with and maintains strong relationships with many of the top suppliers of thin, flexible materials like Solventum, Avery Dennison, and more, who supply only the highest quality materials.
Once materials are received and inspected, production can begin. Marian's clean rooms are used for precision slitting, die cutting, assembly, and packaging. Within our clean rooms we produce products that include wearable medical devices with skin contact adhesives, scar therapy products, wound care dressings, surgical dressings and surgical aids, and many other products and components of medical devices and other applications with strict cleanliness standards. Our ability to package products in the clean rooms include individual retail packs all the way up to bulk packages.
Almost every Marian location utilizes some level of clean rooms for manufacturing. These locations include:
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- Indianapolis, IN (headquarters)
- Monticello, IN (medical converting facility)
- Chicago, IL
- Fort Worth, TX
- Milwaukee, WI
- Singapore
- Suzhou, China
- Shenzhen, China
- Indianapolis, IN (headquarters)
Our Monticello facility is also certified to ISO 13485 and is FDA Registered. These state-of-the-art facilities are fully equipped to meet the diverse needs of our customers.
In a world where cleanliness and care are paramount, clean room manufacturing and clean rooms have emerged as vital tools in the medical industry and beyond. With our expertise and commitment to quality, Marian offers solutions for businesses whose products must meet high standards of cleanliness. Contact us today to see how we can help with your controlled custom solution.
