CLIMET Classic CI-x5x Series Portable Air Particle Counter For Cleanrooms
Pharmaceutical grade, a 4-channel instrument in manufacture over nearly two decades. The CI-x5x series offers traditional features, with unparalleled reputation for ruggedness and dependability.
Climet has developed virtually every meaningful feature for portable particle counters, many of which today are considered industry standard. This includes but is not limited to high flow rates of 50 LPM, 75 LPM, and 100 LPM. The CI-x5x Series is fully compliant with ISO 21501-4; PIC/S; FDA CGMP; EU GMP, Annex 1; ISO 14644-1/2:2015; 21 CFR Part 11, and others.
Detailed Description:
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. The CI-x5x comes with an RS-232 serial interface, wired Ethernet or 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.
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, thus eliminating the risk of short circuit or premature catastrophic damage to the sensor. A lightweight instrument, it is the industries 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 turn into unnecessary capital appropriation requests or expensive repair bills.
The CI-x5x Series is fully compatible with VHP with no reduction in our standard warranty.
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 own experience confirms that not all HEPA filters are created equal, and that among the more expensive and higher quality filters an average of 10% still fail a leak integrity test. For this reason, Climet is the only manufacture 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 level of assurance to end-users that their particle counters are not adding to the particle burden of their cleanroom.
A long-earned reputation in the industry for manufacturing the most accurate particle counters, studies confirm the CI-x5x Series have unparalleled repeatability (in metrological terms: stability or precision) of measurement. Over 50 years of manufacturing experience and use of the highest quality materials provides users unparalleled performance.
High quality materials, an expert level of engineering acumen, and a mature DFM (Design For Manufacturability) virtually eliminate short-term and long-term calibration drift. This also enhances product life cycle, offering users a decade or more of reliable use. This is but one factor that greatly 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.
Customers in regulated industries are generally required to re-calibrate their particle counter annually. Depending on the process or risk assessment, more frequent interval calibration may be required. When a particle counter is out-of-tolerance (OOT) during the interval calibration, a deviation report and investigation is required in regulated industries. Among pharmaceutical and biotechnology producers a simple failure investigation (assuming no batch rejection) costs between $8,000 to $12,000 on average. This cost is difficult to calculate as it's almost all labour and usually involves multiple departments. It is a hidden Cost of Poor Quality (CoPQ) associated with the instrument, which few end users track. As the cost of one simple 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 confirms that on average when a Climet particle counter is equal to or less than 7 years old, the instrument passes its interval calibration 99.6% of the time. In a separate internal study of 2,000+ Climet particle counters, it was confirm an in-tolerance rate of 98.3%, with approximately 25% of the particle counters included in this study being 10 or more years old. These statistics are absolutely unparalleled in the industry, and Climet uniquely provides value well beyond the simple use of the instrumentation.
The CI-x5x Series is compliant with 21 CFR Part 11, ISO 14644-1/2, ISO 21501-4, and others.