Climet Portable Particle Counters CI-x5x Series

The CI-x5x Series is a pharmaceutical grade 4-channel portable particle counters that comes in your choice of 1 CFM, 50 LPM, 75 LPM or 100 LPM flow rates. Each model comes standard with an RS-232 serial interface, further differentiated by other data communication interfaces (Ethernet TCP/IP, Wi-Fi, and USB). An internal thermal printer, no plastics, VHP compatibility, fully integrated battery charger, internal sample data memory storage, integrated mass flow meter with automatic flow control, and other advanced features make Climet unique in the market.

The seamless stainless steel enclosure simplifies cleaning and sanitation. A completely sealed front panel display prevents biocides, IPA, and other cleaning fluids from accidentally leaking into the interior of the particle counter, eliminating the risk of short circuits or premature catastrophic damage to the sensor. A lightweight instrument, it is the industry’s smallest and lightest full-featured particle counter, allowing easy transportability.

An expert in manufacturing industrial instrumentation, every new instrument design is drop and vibration-tested, ensuring end-users can expect up to a decade (and beyond) of reliable operation. This level of ruggedized testing is unique among other manufacturers and ensures accidents don’t become unnecessary capital appropriation requests or expensive repair bills.

The CI-x5x Series is fully compatible with VHP and has no reduction in our standard warranty.

Tested and Certified HEPA Filtered Exhaust (ISO Class 3)

Each particle counter deployed in the Life Science industry must have a HEPA Filtered Exhaust or otherwise risk regulatory action (i.e., an observation, finding, etc.) due to rouge particle emissions. Over the past 50 years, our experience confirms that not all HEPA filters are created equal. An average of 10% still fail a leak integrity test among the more expensive and higher-quality filters. For this reason, Climet is the only manufacturer of particle counters that conducts emissions tests on every new factory model and certifies emissions to ISO Class 3 or better. This provides an added assurance to end-users that their particle counters are not adding to the particle burden of their cleanroom.

Accuracy and Stability of Measurement

With a long-earned reputation in the industry for manufacturing the most accurate particle counters, studies confirm the CI-x5x Series has unparalleled repeatability (in metrological terms: stability or precision) of measurement. Over 50 years of manufacturing experience and the use of the highest-quality materials provide users with unparalleled performance.

High-quality materials, an expert engineering understanding, and a mature DFM (Design For Manufacturability) virtually eliminate short-term and long-term calibration drift. This also enhances the product life cycle, offering users a decade or more of reliable use. This factor significantly enhances Climet’s reputation for providing the lowest TCO (Total Cost of Ownership). End users in regulated industries and others of discerning taste for high precision instrumentation exclusively sole source Climet as their preferred solution provider.

Interval Calibration Out-of-Tolerance Rates

Customers in regulated industries are generally required to re-calibrate their particle counters annually. Depending on the process or risk assessment, more frequent interval calibration may be necessary. A deviation report and investigation are required in regulated industries when a particle counter is out-of-tolerance (OOT) during the interval calibration. A simple failure investigation (assuming no batch rejection) costs between $8,000 to $12,000 on average among pharmaceutical and biotechnology producers. This cost is difficult to calculate as it involves almost all labour and involves multiple departments. A hidden Cost of Poor Quality (CoPQ) is associated with the instrument, which few end users track. As the cost of a straightforward failure investigation well exceeds the initial purchase price of a particle counter, we can conclude that CoPQ is the #1 cost driver.

Internal studies and customer Total Cost of Ownership (TCO) feedback confirm that when a Climet particle counter is equal to or less than seven years old, the instrument passes its interval calibration 99.6% of the time. A separate internal study of 2,000+ Climet particle counters confirmed an in-tolerance rate of 98.3%, with approximately 25% of the particle counters included in this study being ten or more years old. These statistics are unparalleled in the industry, and Climet uniquely provides value beyond the simple use of the instrumentation.

Fully Compliant

The CI-x5x Series complies with 21 CFR Part 11, ISO 14644-1/2, ISO 21501-4, and others.