Airborne Particle Counters: LASAIR II 350L and 550L
To meet the requirements of GMP Annex 1, pharmaceutical manufacturing facilities must take a one cubic meter air sample per clean zone.
The LASAIR II 350L and 550L Particle Counter features a 50 liters/minute sampling rate, sampling one cubic meter in only 20 minutes and saving 15 minutes per zone over 1.0 CFM instruments. The software guides the user through the certification process, verifies adequate sample numbers and volumes, collects the data, then prints a full final report.
The LASAIR II Particle Counter is extremely portable and reliable, with the features most useful to pharmaceutical users: data security, password-protected sampling recipes, as well as speedy, paperless, 21CFR11-compliant data download and electronic storage. Our Lasair II airborne particle counters have unsurpassed laser life expectancy, with less than 3% of the units failing after 4 years, for a projected laser life of over 13 years! Download the graph at the bottom for data.
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- Increase Productivity
- Save fifteen minutes of sampling time per clean zone
- Software-guided EC GMP and ISO sampling, with comprehensive PASS/FAIL final report
- Final reports validated to meet ISO and EC GMP standards
- Quick, paperless, 21 CFR Part 11-compliant data download to Pharmaceutical Net, periodically or in real-time
- Removable battery with optional external charger allows continuous mobile use
- Ease of instrument validation using comprehensive manual
- Reduce Defects
- Detect breakdowns in isolator protection
- Troubleshoot potential airborne particle sources
- Test installed filters for leaks
- Monitor the sub-visible environment in cleanrooms
- Cost Effective
- Use in up to ISO Class 8 rooms (FS209 Class 1-100,000) or in Class 9 with diluteror in Class 9 with diluter casing for easy wipe-down sanitation
- Rugged, chemical-resistant, ESD-minimizing Kydex® casing for easy wipe down sanitation
- Comprehensive validation manual simplifies meeting FDA and EC GMP requirements
- Sample EOP and SOP documents ease implementation
- Certification of cleanrooms to ISO or GMP standards
- Commissioning aseptic filling lines
- Monitoring vial sterilization, filling, freeze-drying, and capping
- Troubleshooting aseptic processing rooms and process flow
See our complete pharmaceutical product offerings
- An Analysis of Acceptable Losses in Tubing to Particle Counters
- Basic Guide to Particle Counters and Particle Monitoring
- Long Lasting Lasers for Particle Counters
- Selecting Particle Counters for ISO 14644 Certification of Cleanrooms
- Wireless Particle Monitoring of Cleanrooms
- Is it possible possible for the Lasair II (550) to monitor/measure particulates in a low pressure nitrogen line (50 psi)? If so what accessories would be required to accomplish this?
- What is the frequency for performing a zero count on the LASAIR II 550L? How do you perform the zero count? What is the acceptance criterion for the zero count?
Contact us if you need more information or have questions.
Learn more about our microcontamination monitoring services.
This airborne particle counter is CE certified.
LASAIR® is a registered trademark of Particle Measuring Systems, Inc.
U.S. patents and applications apply - US 6167107; Japan 3559782; Germany 60005581.3; foreign patents pending.
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