ISO 21501-4: Light Scattering Airborne Particle Counter for Clean Spaces
ISO 21501-4 covers instrument calibration procedures to ensure air particle counter sampling measurement inaccuracies are reduced. A Counting Efficiency Test is also included as a final confirmation of air particle counting performance.
All GMP cleanroom operators/users must ensure the air particle counters used to classify and monitor their cleanrooms are compliant with ISO 21501-4 requirements.
ISO 21501-4 Parameters | Target Limit |
Size calibration | ±10% |
Counting efficiency at first channel | 50% ± 20% |
Counting efficiency at particle size 1.5-2.0 times first channel | 100% ± 10% |
Instrument resolution (at manufacturer specified size) | ≤ 15% |
Zero count test | ≤ 1 count in 5 mins |
Max particle number concentration (specified by manufacturer) | ≤ 10% |
Sampling flow rate (volumetric) | ± 5% |
Sampling time | ± 1% |
Calibration interval | ≤ 1 year |
Helping researchers and labs maintain compliance with standards
-
Industry Standards
- USP<643>
- 21 CFR Part 11 - Data Integrity
- Maintaining Data Integrity: Understanding FDA ALCOA Guidance
- European Pharmacopoeia EP 2.2.44
- EU GMP Annex 1
- EU GMP Annex 11
- ICH Q2
- ISO 21501
- ISO Regulations
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IVD-Regulation (IVDR)
- IVDR compliant instruments*
- IVDR compliant software*
- IVDR compliant reagents
- E-book
- Future proofing your flow cytometry panel under IVDR
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- Impact of the new EU IVD-Regulation on the daily life of the clinical Flow cytometry laboratory webinar
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- IVD-R Annex I Global Safety and Performances Requirements (GSPR). A New Set of Requirements for Clinical Laboratories Performing Laboratory Developed Tests
- IVD-R: Key Considerations to Validate a Flow Cytometry Assay According to ISO 15189 Requirements
- Regulatory Entities: Separation with Cooperation
- USP 1046
- USP 1047
- USP <788>, <787> and EP2.9.19
- USP <790>
- ISO 11171 Standard
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ISO 14644: Airborne Particulate Cleanliness in Cleanrooms and Clean Zones
- Particle Counters Designed to Support ISO 14644-1 and ISO 21501-4 Requirements
- 2015 Published Standards for ISO 14644
- ISO 14644-1 Classification of Air Cleanliness by Particle Concentration
- ISO 21501-4: Light Scattering Airborne Particle Counter for Clean Spaces
- Particle Counting: Terms and Formulas
- USP <787>