Pharmaceutical Grade with Built-in Label Printer
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-90A is fully compliant with ISO 14698, PIC/S; FDA CGMP; EU GMP, Annex 1; 21 CFR Part 11, and others.
The CI-90A has a stainless steeel enclosure with an built-in thermal label printer. It is an active air microbial sampler used in either sequential or continuous monitoring applications in aseptic areas.
The CI-90A is able to accomodate 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-9xA Series of microbial samplers 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 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.
Accuracy and Stability of Measurement
A long-earned reputation in the industry for manufacturing high efficiency microbial samplers, our CI-9xA 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-9xA 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-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. 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.
Custom Engineered Solutions
If you have a specific technical requirement, please contact us. We specialize in customizing our product to fit your needs.
Need something not shown below, please contact us!
CI-90A 1 CFM Microbial Sampler
with HEPA Filtered Exhaust
9500904-1Z: Aluminum Sample Head, 90mm dish
9500908-1Z: Aluminum Sample Head, RODAC & 90mm dish
9500905-1Z: Stainless Steel Sample Head, 90mm dish
9500909-1Z: Stainless Steel Sample Head, RODAC & 90mm dish
CI-90A 25 LPM Microbial Air Sampler
with HEPA Filtered Exhaust
9500904-2Z: Aluminum Sample Head, 90mm dish
9500908-2Z: Aluminum Sample Head, RODAC & 90mm dish
9500905-2Z: Stainless Steel Sample Head, 90mm dish
9500909-2Z: Stainless Steel Sample Head, RODAC & 90mm dish
CI-90A 100 LPM Microbial Air Sampler
with HEPA Filtered Exhaust
9500900-0Z: Aluminum Sample Head, 90mm dish
9500908-0Z: Aluminum Sample Head, RODAC & 90mm dish
9500901-0Z: Stainless Steel Sample Head, 90mm dish
9500909-0Z: Stainless Steel Sample Head, RODAC & 90mm dish
(Z: Power Cord Type) 1=US; 2=UK; or 3=Euro
Some non-standard models may be subject to extended lead time. Please, call for further details.
Exceeding standards and expectations. Climet uniquely manufactures our instrumentation, not to simply meet ISO 14698 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: 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 microbial sampler 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.
Included with the purchase of every new unit is EVERYTHING you need to get started:
- Internal Thermal Label Printer
- Internal Batter Charger
- AC/DC Power Adapter with standard phono power connector
- User Replaceable Battery
- Choice of Aluminum or Stainless steel sample head
- Stainless Steel locking collar
- Two Rolls of Standard Adhesive Labels
- Validation Document
- IDLoader Software
- Manual with IQ/OQ Documents
- Rolls of Thermal Cleanroom Labels
- Rolls of Thermal Standard Labels
- External Battery Charger
- Hard Shell Shipping Case (small or large)
- Spare User Replaceable Battery
- Spare Sample Heads (Aluminum or Stainless Steel)
- High Pressure Diffuser for Compressed Gas Sampling
- Adapter head and remote sample head
- Adapter head for the High Pressure Diffuser
- Silicon Braided Tubing for remote sampling
- Bev-A Line tubing for Compressed Gas Sampling