Climet Microbial Sampler CI-97

The CI-97 is a high-efficiency microbial air sampler suitable for cleanrooms and aseptic environments. It fully complies with 21 CFR Part 11 and has many advanced data integrity features. These include username and password login, 50,000 onboard sample memory buffer, User Audit Trail (pdf), audit reporting, sample abort reporting, User Authenticator™ (Active Directory Login), and more. The CI-97 is drop and vibration tested, certified to ISTA Procedure 3a, and passed its calibration (see video).

Pharmaceutical and industrial grade, the enclosure is 100% stainless steel that weighs only 7 lbs.

The CI-97 has an internal HEPA-filtered exhaust and incorporates an internal hot-wire anemometer that automatically adjusts the flow rate, ensuring it is always within calibration. Combined with Climet’s unique light ring, an audible alarm, and sample termination, this eliminates the risk of deviation reports and investigations caused by interval calibration out-of-tolerance conditions.

A capacitive touch screen allows users to run GMP metadata reports and view PDF audit reports. It provides pinch-to-zoom and scroll capabilities. The screen usually operates when used with a double-gloved hand.

Proprietary Light Ring

Personnel are the most significant cause of biological contamination in a cleanroom (USP <1116>). During routine environmental monitoring, deviations have been caused by cleanroom personnel walking too closely to a microbial air sampler while engaged. Where Climet units have been deployed, pharmaceutical manufacturers report fewer deviations as the light ring indicates a sample is in progress.  Climet’s unique light ring also turns red, providing a ground-level indication of a flow alarm. In the words of one user, “It’s not just pretty, it’s also smart!”

Physical Collection & Biological Efficiency

Click here to download an Application Note regarding regulatory changes between ISO 14698-1:2003(E) and BS EN 17141:2020. The application note also describes the comprehensive testing and validation of physical and biological collection efficiency, demonstrating that the CI-9x Series are high-efficiency and high-precision instruments.

Theoretical d50 = 1.08 µm (Per BS EN 17141)
Experimental d50 < 1 µm
Testing confirms the CI-9x families are high-efficiency and precision air samplers.

USB Ports

The front USB 2.0 Type A (data) port downloads sample data onto a flash drive. Pharmaceutical users will want to disable this port electronically through the Admin settings. Alternatively, Climet (or our international distributors) can physically disable this port during manufacture or through a service request, typically during an interval calibration.

The rear USB 2.0 Type B (comms) port is used exclusively for Remote Network Driver Interface Specification (RNDIS), a proprietary Microsoft communications protocol that provides a virtual Ethernet link to most versions of Windows, Linux, and FreeBSD operating systems. Sample data cannot be downloaded onto an external flash drive with the rear USB communications port. This is a valuable communications feature when wired Ethernet connectivity cannot practicably be deployed.

Cleaning and Sterilization

The CI-97’s enclosure is stainless steel and compatible with standard cleaning and sterilization procedures.  If wiped down with a diluted bleach solution, we recommend a second wipe-down with sterilized water, as bleach will cause stainless steel to rust.  Climet also recommends users VHP the CI-97 at least quarterly while the instrument is engaged.  This will allow VHP to enter the flow path and HEPA filter, disinfecting the instrument’s interior and helping mitigate cross-contamination. The CI-97 is 100% compatible with VHP without reducing our standard 2-year warranty.

An expert in manufacturing industrial instrumentation, every new Climet 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 in the industry and ensures accidents don’t turn into capital appropriation requests or expensive repair bills.

Tested and Certified HEPA Filtered Exhaust (ISO Class 3)

Each CI-97 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 experience confirms that not all HEPA filters are created equal and that an average of 10% still fail a leak integrity test among the more expensive and higher-quality filters.  For this reason, Climet is the only manufacturer that conducts emissions tests on every new factory model and certifies emissions to ISO Class 3. This assures users that their microbial air samplers are not adding to the particle burden of their cleanroom.

Interval Calibration Out-of-Tolerance Rates

Customers in regulated industries must 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.  A simple failure investigation costs between $8,000 to $12,000 among pharmaceutical and biotechnology producers on average, assuming no scrap or batch rejection.  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 users track. As the cost of a straightforward failure investigation well exceeds the initial purchase price of a microbial air sampler, we can conclude that CoPQ is frequently the #1 cost driver.

Internal and external studies confirm that since 2005, Climet started manufacturing microbial air samplers; we have yet to hear of even one report of a Climet microbial air sampler failing an interval calibration. These statistics are unparalleled in the industry, and Climet uniquely provides value beyond the simple use of the instrumentation.