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ISO 14644-1:2015 Revisions Summary

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Sensitivity range: 0.3 - 25.0 µm 

The Lasair III Particle Counter sets the standard for portable aerosol particle counters and meets the requirements of ISO 14644-1:2015 and  ISO 21501-4

Lasair® III Aerosol Particle Counter

The Lasair® III Aerosol Particle Counter is designed for cleanroom work with your unique needs in mind. It sets the standard for portable aerosol particle counters in highly regulated environments, so you can make sure your environment is clean. It can be used for both remote and mobile routine cleanroom monitoring. We know the requirements and we’ve done the calculations for you; cleanroom certification results are available through a local printout, downloadable via USB in a secure format, or through the use of external software packages, such as DataAnalyst, FacilityNet or FacilityNet Pharma Software. Power is provided to the unit through the use of the on-board, hot-swappable batteries. Power can also be provided through the use of an external AC power source, which can simultaneously power the unit and charge the on-board batteries. The Lasair III Particle Counter accepts inputs from a wide range of environmental sensors through the four built-in 4-20 mA inputs. Wireless network communications are made easy with an externally mounted wireless adapter, simplifying communications with network systems. The unit can be remotely managed via the built-in Web browser function or through ethernet to FacilityNet Pharma, FacilityNet, or FacilityPro and DataAnalyst Software.

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Lasair® III 5100 Aerosol Particle Counter

Features

  • 100 LPM, 50 LPM, or 1 CFM flow rates available
  • 100 LPM flow samples 1 m3 in 10 minutes
  • ISO 21501-4 compliant with a built-in pulse height analyzer (PHA). Available with ISO 17025 calibration certificate. (Optional)
  • Large, 8.4 inch IR touchscreen can be used when wearing gloves for simplified use
  • Calculates and creates reports for ISO 14644-1:1999, ISO 14644-1:2015, EC GMP Annex 1, China GMP, and FS 209E
  • Access via a Web browser
  • Compatible with common cleanroom cleaning chemicals
  • Choose from 12 languages for display and printout
  • ISO 14644-1:2015 Compliant

Benefits

  • Comprehensive validation manual makes it easy to meet pharmaceutical regulatory requirements
  • Operates in cleanrooms via a web browser: Set up, sample, display, print, download data
  • Removable batteries with optional external charger for continuous mobile use
  • Pre-configured sampling recipes to reduce operator errors
  • Long-term data archiving with DataAnalyst software
  • Local printout for immediate hardcopy results
  • USB electronic printouts for long term storage
  • WiFi communication for easier data transfer and instrument control (optional)
  • CSV file download for easy data integration
  • Interactive software steps the user through the ISO 14644-1, EC GMP Annex 1, China GMP and FS 209E room certification process
  • Up to 32 customizable alarm comments for easier cleanroom problem identification
  • Modbus TCP/IP communication protocol for a wider integration with third party monitoring systems
  • Large IR touchscreen for simplified use
  • Quiet pump improves work environment
  • 21 CFR Part 11 compliant download

Applications

  • Cleanroom monitoring
  • Facility certification for ISO 14644-1:1999 & 2015, EC GMP, China GMP, FS 209E
  • Trend analysis
  • Statistical process control
  • Troubleshooting particle excursions
  • Manifold compatible
  • Portable or dedicated use

Supporting Materials

Each Lasair III particle counter is capable of tracking 1.0 μm particles without any additional upgrade or modification. Make sure you have the instrument configured with all 6 channels active using the system configuration menu. Alternatively, in order to have the new ISO standard statistical mode, including the new limits and sample point table, you will need the firmware upgrade available from our Service Labs. EU GMP Annex 1 provides specific particle concentration limits for specific cleanroom classes (Grade A, B, C and D). The Lasair III Aerosol Particle Counter, when used with GMP statistical mode, will refer to the GMP maximum concentration table. Refer to “Instructions for Programming Recipes and Assigning Locations” for instructions on how to program a recipe and assign it to a location using the Lasair® III Aerosol Particle Counter. Part numbers 1000000975 (cleanroom paper) and 1000009974 (thermal paper) can be used for the Lasair® III Aerosol Particle Counter. The Lasair II 550L cannot be upgraded to the new ISO certification requirements. This product has been obsolete since 2009 and it is recommended to upgrade to the fully compliant Lasair III. We can provide a quotation if you are interested in a new unit. The Lasair II is not compliant with either ISO 21501-4 nor with the new ISO 14644-1:2015. The ISO 21501-4 requires additional tests and hardware features not included in the Lasair II instrument family. This is because it was developed 10 years before the introduction of this standard. Unfortunately, this gap cannot be covered with just a firmware upgrade. Moreover, the Lasair II is an obsolete instrument and actually out of its service date, so the Lasair II will not receive any further upgrade and support. Please contact us today to learn how you can get a compliant instrument.

Available Accessories

Printer Paper

Printer Paper

Printer Paper is for use with standard printers, as well as for cleanroom-appropriate devices.

Spare Lithium Battery

Spare Lithium Battery

The Spare Lithium Battery is to keep on hand for replacement power as needed. Also available as a four-pack.

Facility Net Software

Facility Net Software

Facility Net Software provides a solution for comprehensive environmental monitoring, including a real-time and historical data display. Compatible with Particle Measuring Systems particle counters and molecular contamination monitors, as well as various third-party products.

Hand-Held Isokenetic Sampling Probe

Hand-Held Isokenetic Sampling Probe

The Hand-Held Isokenetic Sampling Probe works in conjunction with a 1CFM LASAIR III Particle Counter isokinetic in 90FPM airflow.

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