Cleanroom swabs are specially designed sampling tools used in controlled environments to detect and remove particulate, ionic, or molecular contaminants. Manufactured under ISO Class 5-8 cleanroom conditions, these swabs meet stringent requirements for industries such as semiconductor manufacturing, pharmaceuticals, and biotechnology where even microscopic contamination can compromise product integrity.
Material Composition
Handle: Polypropylene (PP) or polyethylene (PE) with anti-static properties
Head: Polyester (PES), foam, or non-woven materials with low particle shedding (<100 particles per swab)
Adhesive: Non-migrating, solvent-free bonding agents
Performance Standards
Compliance with ISO 14644-1 for airborne particulate cleanliness
Extraction efficiency >95% for 0.5μm particles (per ASTM F51)
Bioburden levels <1 CFU/swab (USP <71> tested)
Variants
Dry Swabs: For surface sampling
Pre-wetted Swabs: Available with isopropanol (IPA), deionized water, or proprietary cleaning solutions
Customizable: Length (6" to 12"), head shape (flat, pointed, or cylindrical)
Semiconductor Industry: Wafer cleaning validation and photomask inspection
Pharmaceuticals: Aseptic processing area monitoring (per FDA 21 CFR Part 211)
Medical Devices: Sterile packaging integrity testing
Research Laboratories: DNA/RNA sampling with RNase/DNase-free options
|
Parameter |
Critical Consideration |
|---|---|
|
Cleanliness Class |
Match to ISO classification of target area |
|
Chemical Compatibility |
Resistance to process solvents (e.g., acetone, HF) |
|
Sampling Method |
Wipe vs. roll technique for particle recovery |
Pre-Use Inspection: Verify packaging integrity and expiration date
Sampling Technique:
Apply 5-10N pressure during 25cm wipe trajectory
Use fresh swab per 1m² area to prevent cross-contamination
Post-Sampling: Seal immediately in clean sample bags
FDA: Class I medical device (510(k) exempt)
EU: CE-marked under MDD 93/42/EEC
EMEA: Compliant with Annex 1 (2022) for sterile manufacturing
Recyclable: PP handles and PES heads are compatible with industrial recycling streams
Low VOC: Meets EPA Method 24 requirements
