Pharma Grade for Fixed Locations
A perfect solution for isolators, RABS, and biological safety cabinets. In manufacture for over a decade, the CI-9xA Series of microbial samplers is the only model manufactured to meet or exceed all ISO 14698 standards and recommendations. Eliminate or mitigate deviation reports and investigations due to interval calibration out-of-tolerance conditions. In business for over 55 years, Climet has dozens of multi-jurisdictional patents in the field of particle counting. The CI-99 is fully compliant with ISO 14698; PIC/S; FDA CGMP; EU GMP, Annex 1; 21 CFR Part 11, and others.
General information
The CI-99 has a stainless steel enclosure. It is an active air microbial sampler deployed in a fixed location, and generally used for monitoring isolators, RABS, and Biological Safety Cabinets (BSCs). The CI-99 is able to accommodate either industry standard 90 mm petri dishes, or RODAC plates; and is available in either 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-99 microbial sampler is designed and built with the same ruggedness users have to come 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, as well as augmented by 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-99 microbial sampler is VHP compatible.
Accuracy and Stability of Measurement
A long-earned reputation in the industry for manufacturing high efficiency microbial samplers, our CI-99 series 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 testing required by ISO 14698. High quality materials, an expert level of engineering acumen, and a mature DFM (Design For Manufacturability) enhances product life cycle, offering users a decade or more of reliable operation. In manufacture since 2004 (over a 13 years), there has not been one report of a CI-9x microbial air sampler being out-of-tolerance during its interval calibration. These are but a few factors 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 microbial sampler annually. Depending on the process or risk assessment, the CI-99 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. 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 end users track. As the cost of one simple 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 only microbial air samplers that meet or exceed every requirement and recommendation of the standard.
Custom Engineered Solutions
If you have a specific technical requirement, please contact us. We specialize in customizing our product to fit your needs.
Part Configurations
Need something not shown below, please contact us!
CI-99 100 LPM Microbial Air Sampler
95009900x : CI-99 with Bottom Port Assembly
95009901x : CI-99 with Side Port Assembly
(x: Power Cord Type) 1=US; 2=UK; or 3=Euro
Need to also order your choice of Sample Head
01210100: Aluminum Sample Head, 90 mm
01210103: Stainless Steel Sample Head, 90 mm
Technical Brief
Exceeding standards and expectations.Climet uniquely manufactures our instrumentation, not to simply meet ISO 21501-4 standards, but to exceed the standard in order to meet user expectations for: (1) accuracy and stability of measurement; (2) mitigation of deviation reports and investigations; (3) ease of use; and (4) overall product quality. These factors uniquely provide our loyal customers the lowest TCO (Total Cost of Ownership).
Buy From An Innovator, Not An Imitator: Climet, literally, invented the portable particle counter (1993), as well as higher flow rates of 50 LPM, 75 LPM, and 100 LPM (2005-2008). With a long history of successfully implementing disruptive technologies, our customers can rest assured they own the highest quality instrumentation available on the market. Every Climet particle counter is manufactured with the highest degree of engineering acumen, and incorporates one or more patented or patent pending technologies.
Uncompromising Quality is in our Corporate DNA. Our success is not based on quirky marketing gimmicks, but rather rock-solid instrumentation that adds personal value, and that's time-proven and built to last a decade or more.
Accessories
Included with the purchase of every new unit is EVERYTHING you need to get started:
- Power Cord
- Choice of Aluminum or Stainless steel sample head
- Stainless Steel locking collar
- Validation Document
- Manual with IQ/OQ Documents
Optional Accessories
- Spare Sample Heads (Aluminum or Stainless Steel)
- Silicon Braided Tubing for remote sampling
- CI-320 External Control Box
- High Pressure Diffuser
Optional Software
-DataPro 3
