Lasair II 350L

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, 21CFR 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 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 diluter
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
50 L/min. flow rate samples 1.0 m
3
in twenty minutes
Compact and convenient: Only 15.5 lb. (7.0 kg) with battery
Built-in thermal printer
Stores 3,000 samples
21CFR 11-compatible data storage and electronic transfer
Password-protected sampling recipes
Integrates up to six external analog sensors
Optional validation manual meets all pharmaceutical
validation requirements
Certification of cleanrooms to ISO or EC GMP standards
Commissioning aseptic filling lines
Monitoring vial sterilization, filling, freeze-drying, and capping
Troubleshooting aseptic processing rooms and process flow
Without measurement, there is no control.
APPLICATIONS
Airborne Particle Counter
Meet GMP sampling requirements faster
BENEFITS
LASAIR II 350L, 550L
LASAIR

II 350L, 550L
FEATURES
With the recent EC GMP Annex 1 changes, pharmaceutical
manufacturing facilities must take much larger air samples; where
before one cubic foot was adequate, now one cubic meter is
required per clean zone.
The LASAIR II 350L and 550L feature 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 is extremely portable and reliable, with the
features most useful to pharmaceutical users: data security, pass-
word-protected sampling recipes, as well as speedy, paperless,
21CFR 11-compliant data download and electronic storage.
Registration applies to the Boulder, Colorado facility
LASAIR
is a registered trademark of Particle Measuring Systems, Inc.

KYDEX
is a registered trademark of Kleerdex Company.

Microsoft
is a registered trademark of Microsoft Corporation.

U. S. patents: 6, 167,107. Foreign patents pending.
Particle Measuring Systems, Inc. reserves the right to change specifications without notice.
LASAIR II 350L 550L
Channel thresholds:
Flow rate:
Laser source:
Calibration:
Maximum concentration
@ 5% coincidence loss:
Counting efficiency:
Zero count level:
Data storage:
Data download:
Communication modes:
Controlling software:
Remote operation:
Environmental sensors:
Display:
Languages:
Printer:
Reports:
Key software features:
External surface:
Cleaning materials:
Sample inlet tubing:
Sample output filtering:
Power:
Battery:
Dimensions (h, w, d):
Weight:
Operating environment:
0.3, 0.5, 1.0, 5.0, 10.0, 25.0 m 0.5, 1.0, 2.0, 5.0, 10.0, 25.0 m
50 L/min. (1.77 ft.
3
/min.) with 5% accuracy
Laser diode
Materials traceable to US National Institute for Standards and Technology (NIST)
> 350,000/ft.
3

> 250,000/ft.
3

50% 10% for most sensitive threshold (exceeds JIS standards)
Meets JIS standard
3,000 data sets (includes particle and environmental data, plus location, time, etc.); data cannot be altered
Paperless download to Pharmaceutical Net; complies with 21CFR Part 11
Ethernet or RS-232, optional 4-20 mA output board, optional wireless Ethernet, optional USB download
Pharmaceutical Net, Facility Net, Microsoft
Internet Explorer Rev. 5.0+

Real-time control by Pharmaceutical Net; use web browser to operate unit, save/load recipes
Temp/RH probe; up to 4 external environmental sensors can be integrated via 4-20 mA inputs
1/4 VGA color LCD screen
English, French, German, Italian, Japanese (Kanji), Korean, Mandarin (Classical or Simplified), Spanish
Built-in thermal printer
EC GMP and ISO certification reports validated to meet published standards, sample printouts, averages of multiple
runs, print on alarm, sampling configuration
Pharm mode, recipes, scheduled sampling, historical data filtering, sorting and review, password protection
ESD-minimizing KYDEX chassis, polyester display screen, and zinc-plated steel bottom
Bleach, formaldehyde, ethyl/isopropyl alcohol, peroxide/quaternary ammonium solutions
Tubing ID: 1/2 in. Maximum tubing length: 10 ft. (3 m)
Internally filtered to HEPA standards (>99.97% at 0.3 m)
85-264 V, 50-60 Hz
NiMH; expected operation 3-4 hrs.; External recharge: 2-3 hrs.; Internal recharge (@ 24C): 80% by 4 hrs., 100% by 5-10 hrs.
11.5 x 10.7 x 9.0 in (29 x 27 x 23 cm)
Without battery: 12 lb. (5.4 kg), with optional battery: 15.5 lb. (7.0 kg)
Temperature: 15-35C, Humidity: 10-85% non-condensing
Accessories
AUTHORIZED REPRESENTATIVE
2006 Particle Measuring Systems, Inc. All rights reserved. 0.75K0406V1.1
Included: Printer paper, Operations Manual, sample probe, probe adapters, sample tubing, zero count filter, power cord, spare fuse.
Optional: Battery, external battery charger, external filter, HHIPA, temperature and relative humidity probe, air velocity probe, differential pressure probe, 4-20 mA
data output board, USB data download, USB keyboard, TouchRAM recipe storage, validation manual, sample EOP and SOP documents
Particle Measuring Systems Europe
Tel: +44 1684 581000
Particle Measuring Systems Japan
Tel: +81 3-5298-8175
Particle Measuring Systems Singapore
Tel: +65 68460-500
Particle Measuring Systems Headquarters
5475 Airport Blvd., Boulder, CO 80301
1-303-443-7100 1-800-238-1801 Fax: 1-303-546-7331
Instrument Service & Support: 1-800-557-6363
Customer Response Center: 1-877-475-3317
23 redland drive
mitcham vic 3132
suite 206, 10 norwest central
century circuit, baulkham hills nsw 2153
T 1300 73 2233
F 1300 73 2244
T 02 8831 8366
F 02 8831 8399
[email protected] www. kenelec.com.au

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Lasair II 350L

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Increase Productivity

Save fifteen minutes of sampling time per clean zone

is a registered trademark of Particle Measuring Systems, Inc.

is a registered trademark of Kleerdex Company.

is a registered trademark of Microsoft Corporation.

Internet Explorer Rev. 5.0+

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