Opira recommends the range of Climet Particle Counters
The CI-3100 TRIDENT Series primarily differs from the CI-3100 OPT, in that it provides:
• High reliability: Push to FTP with auto sample data recovery, and sample data memory buffer for up to 10,080 samples (up to 1 week)
• Industry First, automatic sync to a network time server to avoid regulatory citations
• Industry First PoE+ operation with a built-in vacuum pump for easy installation
• Light Ring with full 360 view of sample status
• Optional Climet dedicated light tower
• Relative Humidity and Temperature probe is optional
• Climet patented laser diode diagnostic to mitigate failure investigations
• Push button ON/OFF in addition to remote controlled for added convenience
In yet another industry first, the Trident Series is the first particle counter with a built-in vacuum pump that operates with Power-over-Ethernet (POE+). This technology injects power and ground onto standard network cabling, thus eliminating the need for wall power. POE+ is a much sought after technology given safety protocols of some of the larger pharmaceutical and biotechnology producers. Alternative configurations also include Wi-Fi with wall power, or standard Ethernet TCP/IP with wall power.
The Trident Family offers LIMS-friendly sample data file push to network.
The standard programmable delay allows users enough time to press the button and step back six feet allowing the instrument to sample “in-operation.”
Sample data is provided end-users with a choice of either Ethernet Modbus, or CSV file upload; and the Trident model connects to existing network infrastructure.
The sample data output is 21 CFR Part 11 compliant, and can be easily uploaded into standard environmental monitoring systems including LIMS software. Wi-Fi synchronization and Checksum insures data integrity.
Climet particle counters have a well known reputation in the industry for providing the lowest out-of-tolerance (OOT) rates on interval calibrations. In fact, an order of magnitude less than our major competitors. Our new patented diagnostic routines provide a much higher level of failure detection against contaminated laser optics and laser failure, which further reduces the probability of having to conduct a failure investigation.
The Trident particle counter is a 2-channel particle counter used in continuous monitoring applications in a variety of industries – generally Grade A or B (ISO 5) clean zones. Standard particle sizes are 0.5 µm and 5.0 µm, but custom sizes are also available (Call for details). The CI-3100 has a self-contained power supply and vacuum pump that eliminates the need for an external vacuum source and plumbing, which can be extremely expensive in new installations. Designed for fixed continuous monitoring deployment, the CI-3100 offers a standard flow rate of 1 CFM. Other flow rates may also be available – please call for details.
Fully VHP Compatible & Rugged
The CI-3100 Trident is fully VHP compatible ensuring easy cleaning and sanitation. Unlike other manufacturers, Climet does not reduce or void our warranty when the instrument is exposed to VHP. Climet recommends VHP decontamination be conducted routinely with the instrument turned ON. This will eliminate expensive 483’s resulting from a failure to disinfect the interior of the particle counter. Testing was conducted by an independent laboratory, in an isolation chamber, with the particle counter turned-on, and exposed to 1,000 VHP decontamination cycles. The particle counter passed calibration, the internal sensor exhibited no damage, and there was no functional damage to the instrument. The only unfavorable effects reported by the laboratory was purely asthetic, and was fading of the exterior calibration sticker.
An expert in manufacturing industrial instrumentation, every new instrument design is drop and vibration tested, then must pass a calibration. This ensures end-users can expect up to a decade (and beyond) of reliable operation. This level of ruggedized testing is unique, and ensures accidents don’t turn into capital appropriation requests or an expensive repair bill.
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 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.
Accuracy and Stability of Measurement
A long-earned reputation in the industry for manufacturing the most accurate particle counters, studies confirm that Climet particle counters offer 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.
Interval Calibration Out-of-Tolerance Rates
Customers in regulated industries are generally required to re-calibrate their particle counter annually. Depending on the process or risk assessment, the CI-3100 may be calibrated at shorter intervals. 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 labor and usually involves multiple departments. It is a hidden Cost of Poor Quality (CoPQ) associated with the instrument, which few medicinal drug manufacturers 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 as well as customer 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 in manufacture ten years or less, it was confirmed that 99.5% passed their calibration. These statistics are absolutely unparalleled in the industry, and Climet uniquely provides value well beyond the simple use of the instrumentation.