White Room vs. Clean Room: Key Differences and How to Choose the Right Environment for Your Medical or Technical Product

Understanding Controlled Environments in Medical and Technical Converting

If you’re designing a medical device, sensor, or diagnostic patch, you’ve likely heard of clean rooms and white rooms. But what do those terms really mean? And which one is right for your converting needs?

In this guide, we break down the differences and show how Sur-Seal’s dual-environment setup supports quality, flexibility and compliance across healthcare and technical industries.

What is a Clean Room?

A clean room is a highly controlled environment where both airborne particle count and microbial presence are regulated. These rooms follow stringent standards such as:

• ISO 14644-1 classifications
• Strict gowning procedures
• HEPA filtration systems
• Positive air pressure to prevent contamination

Clean rooms are used for:

• Devices requiring sterility or near-sterile conditions
• Products in direct contact with open wounds or mucous membranes
• Critical components for diagnostics, biotech, or pharmaceuticals
• Customers requiring ISO 13485 or similar certifications

What is a White Room?

A white room, sometimes called a controlled environment, is focused on controlling dust and particulates, but without the rigorous microbial controls of a clean room. White rooms often feature:

• Filtered air
• Clean gowning procedures
• Particulate and static control
• Enhanced cleanliness vs. general manufacturing

White rooms are used for:

• Medical wearables, tapes, or sensor housings that don’t require sterility
• Electronics, optical films and sensitive foam components
• Multi-layer laminates or adhesives used on skin
• Products where cleanliness is critical, but sterility is not

Why Sur-Seal Offers Both

At Sur-Seal, we understand that every application is different, and your converting partner should adapt to your needs. That’s why we offer both white room and clean room environments at our facilities.

Backed by ISO 9001, ISO 13485 and AS9100 certifications, we give customers the flexibility to choose the right environment for their performance, regulatory and cost requirements, without compromising on quality or speed.

Choosing the right environment is key to product success. With Sur-Seal, you don’t have to choose between precision, compliance and flexibility — you get it all. Whether your product requires white room cleanliness or clean room stringency, our team is ready to meet your needs with certified converting expertise and responsive support.

Not sure which environment is right for your next project? Our team can help assess your needs and guide you through the optimal converting solution, whether it’s a white room, a clean room, or both.

→ Talk to a Sur-Seal Specialist