The classification of the particle cleanliness of a clean room is carried out with a particle counter. The requirements relating to the device and the reference method are described in appendix A of standard NF EN ISO 14644-1. This standard is the international reference standard that classifies clean rooms according to the number of particles present in the air. It defines the maximum number of particles allowed by size and by class of particles.
The particle counter used must comply with ISO 21501-4 and have a valid calibration certificate guaranteeing its follow-up on periodic metrological verification.
CLIMET particle counters comply with ISO 14644, FDA CGMP and EU GMP Annex 1 standards. Compliant with 21 CFR Part 11 regulation, they guarantee data integrity. CLIMET particle counters can be used through an EMS (Environmental Monitoring System) or other data acquisition and backup system.
Standards and guidelines governing the use and verification of particle counters
- ISO 14644-1: Clean rooms and related controlled environments. Part 1: Classification of the particulate cleanliness of the air.
- ISO 14644-2: Clean rooms and related controlled environments. Part 2: Monitoring the maintenance of cleanroom performance for particulate air cleanliness.
- ISO 14644-3: Clean rooms and related controlled environments. Part 3: Test methods.
- GMP: Good Manufacturing Practices for the pharmaceutical industry; EU GMP Annex 1.
Another standard governs the periodic verification of particle counters:
- ISO 21501-4: Determination of particle size distribution. Methods of light interaction of single particles. Part 4: Scattered light airborne particle counter for clean spaces. Standard revised by ISO 21501-4: 2018.
Our equipment: for what use?
The standards and references, depending on the type of industry, require the performance of specific measurements depending on the applications:
- Particle counts in your clean rooms, laminar flows and critical areas,
- Daily environmental monitoring,
- Periodic monitoring of the specific quality of your environment to anticipate any deviations,
- Real-time monitoring of aseptic filling,
- Validation of clean rooms,
- Counts in the gases used in your manufacturing process.
These operations are essential for the protection of operators, products being manufactured and the environment.
The ISO dust classes of the pharmaceutical and related industries require particularly demanding particle monitoring. This monitoring is defined in the GMPs (Good Manufacturing Practices).
Our equipment and particulate measurement solutions allow you to continuously monitor air quality. Thus, you prove the compliance of the environmental conditions of your production areas during the manufacture of your products.
Our equipment: which model, for which type of control?
The range of CLIMET particle counters allows the use of a specific model depending on the class of particle cleanliness and its use:
- Periodic qualification according to ISO 14644-1 (prefer meters with high flow rates in order to reduce measurement time).
- Periodic monitoring and surveillance (adapt the model according to the duration and periodicity of the measurements).
Our equipment for particle counting
Portable particle counters
- The CI-x70 series incorporates the smallest and lightest portable particle counter in the CLIMET range. It has many advanced features. It is guaranteed for industrial use, in particular pharmaceutical.
- The CI-x5x series is renowned for its robustness and reliability. It is suitable for the pharmaceutical and biotechnology industries.
CLIMET particle counters comply with current standards.
Our guarantees for your equipment
Single supplier. We provide you with the equipment necessary for the qualification of clean rooms and related accessories and consumables.
Advice and support for the use of your equipment. We build phone support into your contract. You pay no extra cost if you need us.
Metrological verification of the material. We maintain your equipment in operational condition thanks to the regular intervention of our metrology center. We are the sole manager of the equipment fleet.
Rental capacities. We rent you all the necessary equipment if you face a specific need.