Description
Climet CI-99 – Fixed Microbial Air Sampler for Isolators and Biological Safety Cabinets
The Climet CI-99 is a robust, high-performance microbial air sampler specifically designed for fixed installation in controlled environments such as isolators, RABS (Restricted Access Barrier Systems) and Biological Safety Cabinets (BSCs). With its 100% stainless steel enclosure and proven reliability, it provides a dependable solution for long-term use in critical environments.
Climet has been a leader in cleanroom monitoring instrumentation since 1962 and holds numerous international patents in particle counting and microbial sampling technology. The CI-99 is designed according to these high standards and provides users with a robust, validated solution that meets or exceeds the requirements of ISO 14698, enhanced by selected criteria from ISO 21501-4.
Full Compliance with Regulatory Standards
The CI-99 is designed to meet the requirements of ISO 14698-1, PIC/S, FDA cGMP, EU GMP Annex 1 and 21 CFR Part 11. The instrument supports both standard 90 mm Petri dishes and RODAC plates and operates at a constant flow rate of 100 LPM, making it ideal for continuous monitoring in aseptic environments.
Designed for Long-Term Operation – Without Compromise
The CI-99 incorporates the same robust engineering principles used in Climet particle counters, including shock and vibration testing in accordance with ISTA Procedure 3A. This level of mechanical quality assurance is uncommon within the industry and helps ensure reliable operation over many years, minimising unplanned downtime and costly repairs.
The instrument is fully compatible with VHP decontamination, allowing it to be safely used in environments requiring regular sterilisation without compromising performance or warranty conditions.
Outstanding Measurement Accuracy and Repeatability
Climet has conducted extensive validation studies to verify both the physical and biological collection efficiency of the CI-99. These studies demonstrate excellent accuracy and, importantly, a very high degree of measurement repeatability, confirming the instrument’s long-term stability.
This performance exceeds the minimum requirements specified in ISO 14698 and reflects Climet’s focus on quality throughout the design and manufacturing process. With high-quality components, precise manufacturing and a mature DFM (Design for Manufacturability) approach, the CI-99 is engineered to provide reliable performance year after year.
Exceptional Calibration History
Since Climet began manufacturing microbial air samplers in 2004, no unit in the CI-9x series has reportedly been found outside calibration limits during routine interval calibration. This represents a significant advantage for users operating in regulated environments, where an out-of-tolerance calibration result can trigger a deviation report and extensive internal investigation.
Such investigations can require substantial resources across multiple departments and result in significant costs even when no batch is lost. The exceptional calibration stability of the CI-9x series therefore contributes to a very low Total Cost of Ownership (TCO) throughout the instrument’s service life.
Meets and Exceeds ISO 14698
The Climet CI-99 is fully compliant with ISO 14698-1 and is designed to meet all applicable requirements and recommendations of the standard. It is also engineered in line with complementary requirements from ISO 21501-4, making it an excellent choice for organisations requiring a high level of regulatory assurance.
Flexibility and Customisation
In addition to the standard configuration, the CI-99 can be customised to meet specific technical requirements or integrated into existing monitoring and process systems.
Certification and Compliance
The CI-99 is CE marked and complies with applicable EU health, safety and environmental protection requirements. It is designed for long-term use in GMP-regulated environments and is particularly suitable as part of a continuous environmental monitoring programme.
Please contact CIAB for more information, technical documentation or advice on selecting the most suitable solution for your application.
