Description
Climet CI-97
CI-97 – Next-Generation Microbial Air Sampler for Aseptic Environments
The Climet CI-97 is an advanced microbial air sampler designed for use in GMP-classified cleanrooms and aseptic environments. It combines high measurement precision with intelligent functionality and robust construction and is fully compatible with current regulatory requirements including 21 CFR Part 11, ISO 14698, ISO 21501-4 and BS EN 17141.
The instrument is manufactured entirely from stainless steel, weighs only 3.2 kg and is designed to withstand both shock and vibration. Each unit undergoes rigorous testing according to ISTA 3A and is supplied with a HEPA-filtered exhaust certified to ISO Class 3, minimising the risk of contamination in cleanroom environments.
Automatic Flow Control and High Precision
The CI-97 features an internal hot-wire anemometer that automatically adjusts the airflow to maintain operation within calibration limits. Together with Climet’s illuminated status ring and audible alarm, this helps reduce the risk of calibration deviations and subsequent investigations.
Data Integrity According to ALCOA and FDA Requirements
The CI-97 supports network login via Active Directory (LDAP) with five user access levels. The instrument can store up to 50,000 sample records together with extensive metadata, including user ID, location, sample volume, flow rate, programme settings, calibration date and alarm status.
PDF reports including user logs, GMP data and audit trails can be generated directly.
Key Features
Colour touchscreen designed for operation while wearing double gloves
Illuminated status ring indicating sampling status and alarms
Internal HEPA-filtered exhaust certified to ISO Class 3
Automatic flow adjustment to maintain calibration accuracy
Storage for up to 300 programmes, 300 users and 1,000 locations
Metadata export via USB, Ethernet or RS-232
Segmented or continuous sampling
USB port can be disabled by an administrator or at the factory at no additional cost
High Biological Efficiency – Validated According to Current Standards
The CI-97 meets or exceeds validation requirements for physical and biological collection efficiency according to BS EN 17141. Its experimentally determined d50 is below 1.0 µm, making the instrument particularly suitable for aseptic environmental monitoring.
Proven Long-Term Stability
Since 2005, Climet reports that it has not received a report of a microbial air sampler being outside calibration tolerance during annual verification. This long-term stability contributes to a low total cost of ownership by reducing the risk of costly investigations and operational interruptions.
VHP Compatibility Without Affecting the Warranty
The CI-97 is designed to withstand regular VHP decontamination without affecting the product warranty. VHP decontamination can also be used within the instrument’s internal airflow path according to Climet’s recommendations.
Compliance and Certification
The CI-97 is designed to meet applicable requirements including ISO 14698, ISO 21501-4, BS EN 17141 and FDA 21 CFR Part 11. It is CE marked in accordance with applicable EU health, safety and environmental protection requirements.
Customised Solutions
Custom configurations are also available to meet specific technical requirements and application needs.
Please contact CIAB for more information, advice or assistance in selecting the right microbial air monitoring solution for your application.
