Climet Portable Particle Counters CI-x70 NextGen Series

The CI-x70 NextGen 6-Channel Portable Particle Counter offers numerous enhancements, including new pending or patented technology. Like our other particle counters, the CI-x70 family is 100% compatible with VHP (our standard 2-year warranty is not reduced).

It’s the smallest and lightest industrial and pharmaceutical-grade particle counter, with many new user-inspired innovations, including:

An energy-efficient design, the CI-x70 will run longer on a single battery than the competition’s dual-battery configuration. When comparing battery efficiencies, don’t be fooled by comparisons of “nominal” or “typical” use. Climet conducts battery testing with “continuous” use (laser and blower engaged with 100% duty cycle and with a zero-count filter installed). The single battery configuration means Climet customers will spend substantially less on consumables, including batteries, over the instrument’s life.

The CI-x70 Series is the next generation of particle counters. With unsurpassed onboard intelligence, it provides Climet with a platform for future enhancements and scalability to satisfy custom technical requirements.

General information

The CI-x70 Series are pharmaceutical industrial-grade 6-channel portable particle counters with flow rates of 1 CFM, 50 LPM, 75 LPM, or 100 LPM. Each model has an RS-232 serial interface, Ethernet TCP/IP, and USB.

A seamless stainless steel enclosure simplifies cleaning and sanitation. A wholly sealed front panel display prevents biocides, IPA, and other cleaning fluids from accidentally leaking into the particle counter’s interior, eliminating the risk of short circuits or premature catastrophic damage to the sensor.

An expert in manufacturing industrial instrumentation, every new Climet 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 in the industry and ensures accidents don’t turn into capital appropriation requests or expensive repair bills.

Setting the Standard for Data Integrity –

The most common data and user integrity audit findings cited by regulators are:

(1) the failure to properly manage login credentials [21 CFR Part 11 §11.200(a)(1), and §11.300(a)];

(2) the failure to assign appropriate Access Levels [21 CFR Part 11 §11.10(d)];

(3) the failure to periodically check, recall, or revise said login credentials [21 CFR Part 11 § 11.300(b)]; and

(4) the failure to deauthorize compromised login credentials, i.e., including lost, stolen, and terminated employees [21 CFR Part 11 §11.300(c)].

In November 2017, Climet was the first to pioneer our User Authenticator™ software, which allowed users to log into their portable particle counters using computer network credentials.

This feature is fully integrated into our CI-x70 Family and available at no additional charge. Optionally, System Administrators establish access levels for each user. Users log into their particle counters using their network username and password via the Active Directory.

The benefit to you is significantly reducing or eliminating User & Data Integrity risks and eliminating unnecessary audit findings and investigations by using already existing network permissions and security protocols. Please see the video on this page and contact us for further information. We would also be happy to conduct a Data Integrity web conference to help ensure you’re implementing industry best practices.

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. 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

Climet particle counters have a long-earned reputation in the industry for manufacturing the most accurate particle counters. They have 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 level of 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 must re-calibrate their particle counters at least annually. Depending on the process or risk assessment, more frequent interval calibration may be required. 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 costs between $8,000 to $12,000 among pharmaceutical and biotechnology producers on average, assuming no scrap or batch rejection. 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 frequently the #1 cost driver.

Internal studies and customer Total Cost of Ownership (TCO) feedback confirm that, on average, 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. In a separate internal study of 2,000+ Climet particle counters, an in-tolerance rate of 98.3% was confirmed, 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-x70 Series complies with 21 CFR Part 11, ISO 14644-1/2, and ISO 21501-4.

All Climet particle counters and microbial air samplers are fully VHP compatible and the only instruments tested by a third-party laboratory. The instruments were placed in an isolation chamber and exposed to 1,000 cycles of VHP while operated. The only damage reported was a faded calibration sticker. Climet recommends routinely VHP’ing our instruments monthly and at least every six months.