Does Supplement OEM/ODM Manufacturing Need a Cleanroom? What Class 100,000 Means

A Class 100,000 cleanroom is a critical clean environment for supplement OEM/ODM production, controlling airborne particles of 0.5 microns or larger to no more than 100,000 per cubic foot — meeting GMP standards and ensuring product safety, especially for tablets, capsules, probiotics and collagen drinks.

In supplement production and OEM/ODM, the cleanroom is one of the most important facilities for guaranteeing product quality and safety. Here's what "Class 100,000" means in practice.

What Is a Class 100,000 Cleanroom?

A Class 100,000 cleanroom operates under the US Federal Standard FS209E (also known as ISO Class 8). The core definition: per cubic foot of air, particles 0.5 microns or larger may not exceed 100,000.

• 0.5-micron particles — extremely small (about 50× smaller than a typical bacterium)
• 100,000 maximum — far cleaner than ordinary indoor air, which often contains particles in the millions per cubic foot

Why Class 100,000 Cleanrooms Matter

In supplement production, cleanrooms protect products from contamination during manufacturing — especially in three key areas:

1. Product Safety

Supplements often contain sensitive ingredients such as probiotics, collagen and NMN. Cleanrooms prevent contamination from dust, bacteria, mould and other microorganisms, safeguarding consumers.

2. International Compliance

Supplement production typically must meet GMP (Good Manufacturing Practice) standards, and cleanrooms are a core requirement. Class 100,000 is the minimum cleanliness level for many international markets and suits most supplement formats.

3. Product Quality and Consistency

A cleanroom environment stabilises production conditions and reduces batch-to-batch variation — especially during the packaging and sealing of capsules, tablets and liquid products — ensuring consistent end-product quality.

How Is Class 100,000 Achieved?

Achieving and maintaining Class 100,000 cleanliness requires the following facility and management controls:

1. HEPA Air Filtration

HEPA filters remove 99.97% of particles at 0.3 microns or larger, ensuring clean air supply.

2. Airflow Design

Laminar or controlled-flow airflow continuously exhausts contaminants, preventing buildup.

3. Sealed Construction

Walls, floors, doors and windows are fully sealed to prevent external contamination.

4. Personnel and Material Controls

• Strict gowning and behavioural rules — cleanroom suits, shoe covers and access protocols
• Materials pass through air showers before entering to remove surface dust

Which Supplements Need a Class 100,000 Cleanroom?

Class 100,000 is the standard choice for many supplement categories, especially:

• Tablets and capsules — protecting active ingredients from contamination
• Probiotic products — preventing microbial contamination of active strains
• Collagen drinks — ensuring sterile conditions during production and filling
• Powders and granules — preventing dust adhesion to powder particles

Summary

A Class 100,000 cleanroom represents a highly controlled production environment that ensures supplement quality, safety and international competitiveness. For brands targeting global markets, investing in compliant production facilities is essential. For more advice on cleanroom design or supplement production, contact ACC Biotech — your supplement production specialists.