Cleanroom Converting

A cleanroom (or clean room) is a highly controlled environment designed to maintain minimal levels of airborne particles, contaminants, and pollutants. These specialized spaces are essential in industries where even the smallest particles can compromise product integrity. Cleanrooms play a critical role in many fields including:

By utilizing strict environmental controls, clean rooms help ensure that manufacturing and assembly processes occur with maximum cleanliness, reducing defects and improving product quality and safety.

Turnkey Medical Solutions

How Do Cleanrooms Work?

In a cleanroom, factors such as air quality, temperature, humidity, and pressure are strictly controlled. Processes are carried out under specific guidelines to limit the presence of airborne particles. Each room uses advanced systems like flow hoods and High-Efficiency Particulate Air (HEPA) filters to trap contaminants, ensuring a sterile environment for manufacturing.

At Marian, we adhere to ISO and FDA procedures for gowning in clean rooms to prevent contamination from working personnel.

Types of Cleanroom ISO Classifications

Cleanrooms are classified according to ISO standards, with each level representing a degree of air cleanliness. The classifications range from ISO 9 (the least stringent) to ISO 1 (the cleanest). Marian operates cleanrooms classified as ISO 8, ISO 7, and ISO 6, each with specific particle count requirements:

ISO 8 Clean Room:

Allows <3,520,000 particles larger than 0.5 microns per cubic meter (100,000 particles/cubic foot).

ISO 7 Clean Room:

Allows <352,000 particles larger than 0.5 microns per cubic meter (10,000 particles/cubic foot).

ISO 6 Clean Room:

Allows <35,200 particles larger than 0.5 microns per cubic meter (1,000 particles/cubic foot).

To ensure compliance with these ISO standards, we continuously monitor particle levels using airborne particle counters.

Cleanrooms: Precision and Quality

At Marian, we specialize in cleanroom manufacturing to convert high-quality, precision components for various applications. The cleanroom manufacturing process begins with:

Material Management: We maintain partnerships with top suppliers like Solventum and Avery Dennison, ensuring that only premium materials are used.
Controlled Manufacturing: Once inspected, materials enter our cleanrooms for a variety of processes including:
- Die cutting
- Precision slitting
- Assembly
- Packaging

These processes are crucial for producing items like:

Wearable medical devices with skin-contact adhesives
Scar therapy products
Wound care dressings
Components for electronics, including medical electronics devices
Digital displays

Cleanroom entrance with pressure control at Marian Chicago

Our cleanroom capabilities extend to kitting, allowing us to handle everything from individual retail packs to bulk packaging, all within a controlled environment.

Class 10,000 Cleanroom at Marian Shenzhen

Marian’s Global Cleanrooms

Marian’s commitment to cleanliness and quality extends across our global network. Our Monticello, IN facility primarily manufactures medical and skin-contact applications and is ISO 13485 certified and FDA registered, ensuring that we meet the most stringent requirements for medical devices that will adhere to the human body.

Many other Marian locations are also equipped with cleanrooms, including:

View the quality certifications for all of our locations here.

Why Use a Marian Cleanroom?

When cleanliness, precision, and quality are crucial, Marian is a trusted partner for customers requiring cleanroom manufacturing solutions. Our advanced facilities and expertise in converting operations allow us to deliver high-quality, reliable components for industries with strict cleanliness standards.

Interested in learning more? Contact us today to discuss how our clean room capabilities can meet your manufacturing needs.