The CI-90A has a stainless steel enclosure with a built-in thermal label printer. It is an active air microbial sampler in sequential or continuous monitoring applications in aseptic areas.
The CI-90A can accommodate industry-standard 90 mm Petri dishes or RODAC plates and is available in 25 LPM, 1 CFM, or 100 LPM flow rates. The lower flow rates of 25 LPM or 1 CFM are recommended for continuous monitoring applications. Testing has confirmed that up to 3 hours (possibly longer) of continuous sampling with a custom agar fill of 40mL in a 90 mm petri dish is possible. Independent validation is recommended.
The Climet CI-9xA Series of microbial samplers is designed and built with the same ruggedness users have to come to expect in Climet particle counters. It is the only pharmaceutical-grade microbial air sampler that meets and exceeds all requirements AND recommendations of ISO 14698 and is augmented by some requirements in ISO 21501-4.
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 capital appropriation requests or expensive repair bills.
The CI-9xA series of portable microbial samplers is VHP compatible.
Accuracy and Stability of Measurement
Our CI-9xA series has a long-earned reputation in the industry for manufacturing high-efficiency microbial samplers. They have been tested to confirm excellent physical and biological efficiencies. Additionally, repeatability of measurement studies have been conducted, which statistically confirm a “near perfect linear relationship.” This Repeatability Study is unique in the industry and is yet another way Climet exceeds the testing required by ISO 14698.
High-quality materials, an expert level of engineering acumen, and a mature DFM (Design For Manufacturability) enhance the product’s life cycle, offering users a decade or more of reliable operation. In manufacture since 2004 (over 13 years), there has not been one report of a CI-9xA microbial air sampler being out-of-tolerance during its interval calibration.
These are but a few factors that significantly enhance Climet’s reputation for providing the lowest TCO (Total Cost of Ownership). End users in regulated industries and others with a 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 microbial sampler annually. Depending on the process or risk assessment, the CI-9xA series of microbial air samplers may be calibrated at six-month intervals or even more frequently. When a microbial sampler is out-of-tolerance (OOT) during the interval calibration, a deviation report and investigation is required in regulated industries. A simple failure investigation (assuming no batch rejection) costs between $8,000 to $12,000 on average among pharmaceutical and biotechnology producers. 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 microbial sampler, we can conclude that CoPQ is the #1 cost driver.
Standards Compliant
Climet’s CI-9x Series is fully compliant with ISO 14698-1 and is one of the few, if not the only, microbial air samplers that meet or exceed every requirement and recommendation of the standard.