NextGen CI-x70 Series Portable Air Particle Counters

The Smallest and Lightest Industrial & Pharmaceutical Grade Portable Counter Available

  • NextGen Portable Air Particle Counter For Cleanrooms.
  • Serious Instruments for Serious Users.
  • Smallest and lightest Industrial and Pharmaceutical Grade Air Particle Counter with stainless steel enclosure.
  • A 6-channel instrument with a built-in printer, pdf reports, and up to 6 hours of continuous operation (depending on model). The most advanced technology and features ensure the highest level of accuracy and repeatability of measurement.
  • Drop and vibration tested for industrial use.
  • With Wi-Fi and options of RH/Temp capabilities.

Brief description:

Aerosol Pharmaceutical grade, a 6-channel instrument with a built-in printer, pdf reports, and up to 6 hours of continuous operation (depending on model). The most advanced technology and features ensure the highest level of accuracy and repeatability of measurement.

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-x70 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:

Smallest and lightest Industrial and Pharmaceutical Grade Particle Counter with stainless steel enclosure, and 6-channels with a built-in printer, pdf reports, and the most advanced technology ensuring the highest level of accuracy and repeatability of measurement.

Drop and vibration tested for industrial use.

Now with Wi-Fi and RH/Temp capabilities.

The CI-x70 NextGen 6-Channel Portable Particle Counter offers numerous enhancements including new patent pending or patented technology.

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

  • User Authenticator (LDAP Active Directory Login). See below for further description.
  • Flow Rates: 1 CFM, 50 LPM, 75 LPM, and 100 LPM.
  • Channels: 6-channels: 0.3 µm to 10 µm, some models up to 25 µm.
  • Ports: Wi-Fi, Ethernet, USB, and Serial I/O connectivity Wi-Fi and USB can be factory disabled or disabled by ADMIN settings.
  • Enhanced Cyber Security features and comes with a Hardened Security Guide. Optional SSL and SFTP encryption.
  • Sample Abort Reporting: A robust optional reporting feature that provides partial sample counts when a sample is terminated for any reason.
  • Sample Validation: Original or true copy is guaranteed as each sample record can be computer validated to ensure metadata is valid and has not been manipulated per 21 CFR Part 11, §11.10(a). Requires DataPro 2.5e, Climet USB Translator Utility, and Lonza MODA, among others. Contact us for details.
  • Relative Humidity and Temperature Probe Optional.
  • Multi-Gas Calibration: Single instrument capable of sampling compressed Clean Dry Air (CDA)/Nitrogen, and with a special calibration: Argon and CO2 (user switchable).
  • Industrial Grade: 1m drop and vibration tested, then passed calibration. Independently certified to ISTA procedure 3a.
  • Portable Document Format (PDF) reports for ISO 14644:2015, GMP, FS 209e, Average Data, Alarm Data, User Audit Log, Program Settings, Stored Data, and Raw Data with Sample Data Filtering (dates, etc.)
  • Display: A color LCD cell phone-type capacitive touch screen (pinch to zoom, swipe to scroll). Designed to work with triple-gloved hands.
  • Alarms: User-defined Alert and Action Levels (Counts); Laser Status; Flow, and Low Battery. Climet's proprietary Light Rings user-configurable (enable/disable, 5-colors, patters, etc.). An Audible Tone (100 dB) is user-configurable to support multi-pitch beep on count and alarms.
  • Battery: A single lithium-ion for up to 6 hours of continuous operation (depending on model), or 12 hours assuming a 50/50 duty cycle.
  • New patented ultra-quiet / ultra-clean blower technology.
  • Network Time Server synchronization ensures contemporaneous sample data (ALCOA) .
  • Sample Data Storage: Up to a 10 million samples.
  • Programs: 1,000 and factory expandable.
  • Location IDs: 1,000 and factory expandable.
  • User IDs: 1,001 and factory expandable.
  • HEPA filtered exhaust factory certified to ISO Class 3.
  • Thermal printer: Fully integrated internal.
  • Fully integrated internal battery charger (external battery charger is optional).
  • Simplified Unit-to-Unit Cloning.
  • Same sensor optics as the CI-x5x model providing unparalleled accuracy and repeatability of measurement.
  • Only the highest quality materials used ensure long product life and up to 99.6% passing an interval calibration.
  • Security: Five (5) levels of user security with user authentication.
  • VHP Compatible with no reduction in warranty.
  • Weight: Stainless Steel enclosure at only 9.4 lbs. with battery installed.
  • Dimensions 8.38" x 7.4" x 9.48" (That's only 587.9 cubic inches).
  • Telnet and serial LIMS commands backwards compatible with the CI-x5x Family.

An energy efficient design, the CI-x70 will run longer on a single battery than the competition's dual-battery configuration. 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 money over the life of the instrument on consumables, including batteries.

The CI-x70 Series is truly the next generation of particle counter, with on-board intelligence unsurpassed on the market today, it provides Climet a platform for future enhancements, and scalability to satisfy custom technical requirements.

The CI-x70 Series are pharmaceutical industrial grade 6-channel portable particle counters that comes in your choice of 1 CFM, 50 LPM, 75 LPM or 100 LPM flow rates.

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.

An expert in manufacturing industrial instrumentation, every new Climet instrument design/prototype 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.

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

  • The failure to properly manage login credentials [21 CFR Part 11 §11.200(a)(1), and §11.300(a)].
  • The failure to assign appropriate Access Levels [21 CFR Part 11 §11.10(d)].
  • The failure to periodically check, recall, or revise said login credentials [21 CFR Part 11 § 11.300(b)].
  • The failure to de-authorize 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. Using the optional User Authenticator feature, System Administrators establish access levels for each user. Users then login into their particle counters using their network username and password via the network's Active Directory.

The benefit to you, is a significant reduction or elimination of User & Data Integrity risks, and elimination of unnecessary audit findings and investigations by using already existing network permissions and security protocols.

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. 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, Climet particle counters 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 counters at least 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 costs between $8,000 to $12,000 on average assuming no scrap or batch rejection. 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 frequently 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-x70 Series is compliant 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 3rd party laboratory. Instruments were placed in an isolation chamber, and while operated, were exposed to 1,000 cycles of VHP. The only damage reported was a faded calibration sticker. Climet recommends routinely VHP'ing our instruments on a monthly basis, and at least every six months.

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