CI-x70 NextGen 6-Channel Portable Particle Counter
The Climet CI-x70 NextGen is the world’s smallest and lightest pharmaceutical-grade portable particle counter, engineered for cleanroom monitoring in pharmaceutical, biotechnology, and industrial environments. Built on patented new technology and fully compatible with ISO 14644-1/2, 21 CFR Part 11, and GMP requirements, the CI-x70 sets the industry standard for accuracy, data integrity, and total cost of ownership.
Key Features of the CI-x70 Portable Particle Counter
- 6-Channel Particle Counting:3 µm to 10 µm (select models up to 25 µm)
- Flow Rates: 1 CFM, 50 LPM, 75 LPM, or 100 LPM
- Connectivity: Linux platform with Wi-Fi, Ethernet, USB, and RS-232 Serial I/O
- Display: Colour LCD capacitive touchscreen (pinch to zoom, swipe to scroll) — designed for double-gloved operation
- Battery: Single lithium-ion battery for up to 6 hours of continuous operation — outlasting competitor dual-battery configurations
- Enclosure: Seamless stainless steel — easy to clean, sanitise, and VHP-decontaminate
- Drop and Vibration Tested: 1m drop tested (14× up to 94 g’s) and 1-hour vibration tested — instrument passed calibration post-testing
- Weight:4 lbs. with battery (8.38” × 7.4” × 9.48”)
- Optional: Relative Humidity and Temperature probe
- Optional: Multi-Gas Calibration — single instrument capable of sampling Air, Argon, Helium, and CO2
Data Integrity and 21 CFR Part 11 Compliance
The CI-x70 portable particle counter is purpose-built for regulated environments. It directly addresses the four most common data integrity audit findings cited by the FDA and global regulators:
- Failure to manage login credentials [21 CFR Part 11 §11.200(a)(1) and §11.300(a)]
- Failure to assign appropriate access levels [21 CFR Part 11 §11.10(d)]
- Failure to periodically review or revise login credentials [21 CFR Part 11 §11.300(b)]
- Failure to deauthorise compromised or terminated user credentials [21 CFR Part 11 §11.300(c)]
Climet pioneered the User Authenticator™ in November 2017 — the first portable particle counter to allow users to log in using existing network credentials via Active Directory. This feature is fully integrated into the CI-x70 at no additional charge, significantly reducing User and Data Integrity risks without adding administrative overhead.
Additional data integrity features include:
- User Integrity Audit Trail
- 5-level user security with individual authentication
- Network Time Server synchronisation for contemporaneous sample data (ALCOA-compliant)
- PDF reports for ISO 14644:2015, GMP Annex 1, and Federal Standard 209e with sample data filtering
- Massive onboard storage: up to 10 million samples (approximately 190 years at 100 LPM continuous monitoring)
- 300 programs, 1,000 location IDs, and 300 user IDs — all factory expandable
VHP Compatibility — Fully Tested, Warranty Preserved
Every CI-x70 portable particle counter is 100% VHP (Vaporised Hydrogen Peroxide) compatible, with Climet’s standard 2-year warranty fully preserved. Climet is the only particle counter manufacturer to conduct third-party VHP validation testing: instruments were placed in an isolation chamber and exposed to 1,000 cycles of VHP while operating. The only damage reported was a faded calibration sticker. Climet recommends VHP decontamination monthly and at least every six months.
HEPA-Filtered Exhaust Certified to ISO Class 3
Every particle counter deployed in a GMP cleanroom must have a HEPA-filtered exhaust to avoid regulatory observations related to rogue particle emissions. Climet is the only portable particle counter manufacturer that emission-tests every new unit and certifies exhaust to ISO Class 3, providing documented assurance that your instrument is not contributing to the particle burden of your cleanroom.
Unmatched Accuracy and Calibration Stability
Climet portable particle counters have a 50-year reputation for measurement accuracy and repeatability. High-quality materials and expert-level DFM (Design for Manufacturability) virtually eliminate short-term and long-term calibration drift, extending product life to a decade or more.
The CI-x70 uses the same sensor optics as the CI-x5x series — delivering unparalleled accuracy and repeatability across the entire product range.
Interval Calibration Out-of-Tolerance (OOT) Performance:
- Internal studies confirm that CI-x70 instruments seven years old or younger pass interval calibration 99.6% of the time
- A separate study of 2,000+ Climet particle counters — approximately 25% aged ten years or more — confirmed an in-tolerance rate of 98.3%
These statistics are unmatched in the industry. In regulated environments, a single OOT investigation costs between $8,000 and $12,000 on average (excluding scrap and batch rejection), meaning Cost of Poor Quality (CoPQ) is frequently the #1 hidden cost driver associated with particle counter ownership. Climet’s calibration stability directly reduces this risk.
Lowest Total Cost of Ownership in the Industry
The CI-x70’s single lithium-ion battery configuration delivers longer continuous runtime than competitor instruments requiring dual batteries. Climet tests battery life under continuous use conditions (laser and blower at 100% duty cycle with a zero-count filter installed) — not “nominal” or “typical” use figures. The result: lower consumable costs over the instrument’s lifetime and reduced downtime in critical cleanroom operations.
Customisable Alerts and User Experience
- Light Ring: Configurable status indicator and alarm (5 colours, multiple patterns, on/off)
- Audible Tone: User-configurable multi-pitch beep on count and alarm
- Simplified unit-to-unit cloning for rapid fleet deployment
- Fully integrated thermal printer
- Fully integrated battery charger
Compliance Summary
The CI-x70 Series portable particle counter complies with:
- 21 CFR Part 11 (Electronic Records and Electronic Signatures)
- ISO 14644-1 and ISO 14644-2 (Cleanroom Classification and Monitoring)
- ISO 21501-4 (Calibration of Single-Particle Light Interaction Methods)
- GMP Annex 1 (Manufacture of Sterile Medicinal Products)
About the CI-x70 Platform
The CI-x70 Series is Climet’s next-generation portable particle counter platform. Its onboard intelligence provides a scalable architecture for future enhancements and custom technical configurations, ensuring long-term value for pharmaceutical, biotechnology, semiconductor, and industrial cleanroom operations.
Ready to reduce audit risk, lower your total cost of ownership, and bring industry-leading cleanroom monitoring to your facility? Contact the team at Opira to discuss your requirements or request a Data Integrity web conference.