Understanding Cleanroom
A cleanroom is a controlled environment specifically designed to maintain the cleanest levels of airborne particles, such as dust, microbes, and aerosol particles. These environments are essential in industries where even microscopic contaminants can compromise product quality or safety, including pharmaceuticals, biotechnology, semiconductor manufacturing, and aerospace.
Cleanrooms utilize High-Efficiency Particulate Air (HEPA) or Ultra-Low Penetration Air (ULPA) filters to remove contaminants from the air. They also control environmental parameters like temperature, humidity, and pressure to reduce the risk of contamination further. Personnel entering cleanrooms must follow strict protocols, including wearing specialized garments, to minimize the introduction of particulates.
Cleanroom Classifications and Standards
The numbers of particles classify cleanrooms in a given volume of air. The FED STD 209E counts the number of particles per cubic foot. The ISO 14644-1 counts the number of particles per cubic meter.
US FED STD 209E Cleanroom Standards | Cleanroom Classifications
| Class | >0.1 um | >0.2 um | >0.3 um | >0.5 um | >5 um | ISO equivalent |
|---|---|---|---|---|---|---|
| 1 | 35 | 7 | 3 | 1 | ISO3 | |
| 10 | 350 | 75 | 30 | 10 | ISO4 | |
| 100 | 100 | ISO5 | ||||
| 1000 | 1000 | 7 | ISO6 | |||
| 10,000 | 10,000 | 70 | ISO7 | |||
| 100,000 | 100,000 | 700 | ISO8 |
ISO 14644-1 Cleanroom Classification Standards
| Class | >0.1 um | >0.2 um | >0.3 um | >0.5 um | >1 um | >5 um | FED STD 209E equivalent |
|---|---|---|---|---|---|---|---|
| ISO 1 | 10 | 2 | |||||
| ISO 2 | 100 | 24 | 10 | 4 | |||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | Class 1 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | Class 10 | |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | 352,000 | 83,200 | 2,930 | Class 10,000 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | Class 100,000 | |||
| ISO 9 | 35,200,000 | 8,320,000 | 293,000 | Room Air |
These standards directly affect what level of consumables you need. For example, a Class 5 cleanroom used in semiconductor manufacturing demands wipes with ultra-low particle generation, while a Class 8 room for general assembly may tolerate more flexible options.
Why Cleanroom Consumables Matter
However, maintaining these standards isn’t solely reliant on infrastructure and procedures; it also depends heavily on the appropriate use of specialized consumables. That’s why cleanroom consumables play an essential role in controlling contamination.
Cleanroom consumables are single-use or limited-use items specifically designed to minimize contamination within controlled environments. They include products such as gloves, gowns, masks, wipes, and cleaning agents.
Key Categories of Cleanroom Consumables
| Category | Example Products | Main Functions |
|---|---|---|
| Wiping Materials | Cleanroom wipes (polyester, microfiber), cleanroom paper | Surface cleaning, equipment wiping, spill control |
| Protective Apparel | Gloves, gowns, face masks, shoe covers, coveralls | Protect products from human contamination |
| ESD Supplies | ESD gloves, wrist straps, and mats | Protect sensitive electronics from static discharge |
| Adhesive Products | Sticky mats, adhesive rollers | Trap dust and particles at entry points or on surfaces |
| Cleaning Tools | Cleanroom swabs, mops, and alcohol dispensers | Precision cleaning and solvent application |
| Packaging | Cleanroom bags, double-layer vacuum packaging | Safe transfer of sterile components |
1. Cleanroom Wipes
Cleanroom wipes are designed to remove particles, oils, and residues while minimizing the risk of shedding or chemical interference.
Types of Cleanroom Wipes:
- Polyester: Durable and low in particle generation. Ideal for ISO Class 5-7.
- Microfiber: Excellent for absorbing oils and particles. Used in optics and LCD manufacturing.
- Nonwoven: Economical and good for general cleaning in ISO Class 7-8.
- ESD Wiper: Dissipate static electricity
Edge Sealing Methods:
- Hot Knife: Heat-seals the edge during cutting, soft and clean.
- Laser: High-precision sealing with excellent edge integrity.
- Ultrasonic: Creates a soft, sealed edge with minimal heat distortion.
Lint-Free Explained:
“Lint-free” means the wipe is engineered not to release loose fibers during use, which is critical in micro-contamination-sensitive applications like semiconductor fabs or HDD assembly.
Size and Weight Reference Table:
| Size (inch) | Weight (gsm) | Typical Use Case |
| 4″x4″ | 110 | Precision cleaning in compact devices |
| 6″x6″ | 120-150 | General wiping in ISO 5-6 cleanrooms |
| 9″x9″ | 130-160 | Large surface cleaning in LCD, optics, and semiconductors |
| 12″x12″ | 160-180 | High-absorbency tasks or equipment prep |
Larger sizes cover more surface per wipe and are suited for broad-area cleaning. Smaller sizes offer better control for precision cleaning tasks.
Higher grammage means better absorbency and durability, but also higher cost. Lower grammage offers better flexibility and economy for less demanding applications.
Most cleanroom operations use a combination of sizes and weights across different workstations to optimize efficiency and cost.
2. Sticky Mats & Adhesive Rollers
These products trap dust and particles from shoe soles and equipment wheels before entering critical areas.
Sticky mats：
Also known as tacky mats or cleanroom mats, they are multi-layered adhesive surface mats placed at the entrances of cleanrooms or controlled environments. Each layer can be peeled off after use to reveal a fresh, clean surface.
Cleanroom Entry Points: Remove dust, dirt, and particulates from shoes and cart wheels before entry.
- Multi-layer PE or PP film
- 30 or 60 layers per mat, numbered for easy tracking
- Adhesive levels: low, medium, high
- Custom Sizes Available in various sizes (e.g., 18″x36″, 24″x36″, 26″x45″) and colors (blue, white, gray)
Adhesive Rollers:
Also called sticky rollers or cleanroom dust rollers, they are handheld or machine-mounted cleaning tools that use a tacky surface to collect dust and particulates from flat surfaces, walls, floors, or garments.
- Handheld or mop-style
- Replaceable adhesive sheets
- Used on floors, walls, ceilings, or work surfaces
3. Cleanroom Swab
A cleanroom swab is a precision cleaning tool specifically engineered for use in controlled environments such as ISO Class 3–8 cleanrooms. These swabs are designed to be lint-free, non-shedding, and chemically resistant, making them ideal for critical cleaning tasks, applying or removing materials, and sampling processes.
- Precision Cleaning: Removes contaminants from hard-to-reach or delicate areas like circuit boards, sensors, and connectors
- Solvent Application: Used to apply cleaning agents (e.g., IPA) in a controlled and uniform way
Types of Cleanroom Swabs by Tip Shape:
| Tip Shape | Use Case |
|---|---|
| Round Tip | For general surface cleaning |
| Pointed Tip | Ideal for crevices, corners, and micro-areas |
| Flat Paddle Tip | Useful for flat surface wiping and sampling |
| Mini/Micro Tip | Designed for cleaning in narrow or tight spaces (e.g., print heads, fiber optic ports) |
4. Cleanroom Paper
Cleanroom paper is specially formulated to generate minimal particles and resist shedding while maintaining writability and heat resistance. Used in document handling, instruction manuals, batch records, and note-taking inside clean zones.
Features:
- Synthetic fiber or cellulose-polyester blend
- Surface-treated to reduce ion and particle release
- Available in various colors for zone differentiation
5. Cleanroom Gloves
Cleanroom gloves protect both the operator and the product from contamination.
Common Types:
- Nitrile: Highly chemical-resistant, latex-free, ideal for semiconductor and pharmaceutical use
- Latex: High flexibility and tactile feel, but may cause allergies
- PVC (Vinyl): Cost-effective for low-risk environments
Other Terms Explained:
- Powder-free: No inner powder, reducing particle contamination
- Latex-free: Prevents allergic reactions
Sterile vs. Clean Gloves:
- Sterile Gloves: Gamma-irradiated, used in aseptic environments
- Clean Gloves: Clean-manufactured but not sterile, suitable for ISO 5-7 cleanrooms
Testing and Certification for Cleanroom Consumables
To ensure compliance and performance, high-end cleanroom consumables should undergo rigorous testing:
Key Tests:
- NVR (Non-Volatile Residue): Residue left after evaporation
- Particle Count (LPC/APC): Number and size of particles
- Ion Content: Sodium, potassium, chloride, etc.
- Bioburden: Microbial load on sterile products
Certifications:
- ISO 9001 / ISO 13485 / ISO 14644
- CE / SGS / RoHS
- FDA-compliance (for gloves, papers)
Packaging and Handling Considerations
Packaging is critical to prevent secondary contamination. Cleanroom consumables are usually packaged in:
- Double-layer vacuum bags
- Class 100 packaging zones
- ESD-safe materials (for electronic industries)
Always follow FIFO (First In, First Out) and store in a clean, dry place.
Cleanroom Consumables Buying Guide
| Factor | Details | Examples / Notes |
|---|---|---|
| Cleanroom Classification | Match consumables to your cleanroom class (ISO 3–8 or FED STD 209E Class 1–100,000) | ISO 5 → Laser-sealed polyester wipes, nitrile gloves |
| Material Properties | Choose based on performance requirements | Wipes: Polyester (lint-free), Microfiber (soft)
Gloves: Nitrile (chemical-resistant), Latex (flexible), PVC Paper: Synthetic fiber blends, low particle generation |
| Cleanliness Standards | Assess product cleanliness based on lab-tested metrics | Particle count, NVR (Non-Volatile Residue), Ion content, Bioburden |
| ESD & Sterile Requirements | Required for electronics or sterile environments | Use ESD-safe gloves for electronics. Use gamma-irradiated sterile swabs for pharma |
| Packaging & Traceability | Protect product cleanliness and ensure batch traceability | Double-bagged or vacuum-packed packaging |
How to Choose a Qualified Supplier:
- In-house testing capabilities
- Cleanroom-certified production facilities
- Stable supply chain & customization options
OEM/ODM Customization:
- Private labeling
- Custom sizes and materials
Common Pitfalls:
- Overlooking ion contamination in cleanroom paper
- Using non-sealed edge wipes in sensitive areas
- Mixing industrial and cleanroom-grade gloves
Cleanroom Consumables FAQs
- How do I store cleanroom wipes?
- What’s the difference between Class 100 and Class 1000 gloves?
- Can I reuse cleanroom gloves or mats?
Case Studies & Applications
- Semiconductor: 9″x9″ laser-sealed wipes with low LPC for wafer cleaning
- Biopharma: Gamma-sterilized nitrile gloves with low-endotoxin paper
- LCD/Optics: High-absorbency microfiber wipes and medium-stick mats
