Tiếng Việt
Lasair Pro 310
Handheld 0.3-0.5 µm · 2.83 LPM
Standard handheld for Grade A/B/C/D audits, HVAC validation and ISO 5-8 classification. Fast-charging lithium battery, touchscreen, supports 5,000 locations.
PHARMACEUTICAL GMP & BIOLOGICS
Particle & Microbial Contamination Monitoring Solutions for GMP Pharmaceuticals
Sterility assurance, compliance with EU GMP Annex 1, USP 788/797 and 21 CFR Part 11 — from Particle Measuring Systems, officially distributed in Vietnam by Techmaster.
“Solution hub for particle and microbial monitoring in pharmaceutical cleanrooms GMP Vietnam — Lasair Pro, IsoAir Pro, Airnet II, BioCapt, MiniCapt, APSS, FacilityPro.”
GMP Compliance Standards
Sensitivity & limits per EU GMP Annex 1 and USP
0.5 µm
Air · Particles ≥0.5 µm
5 µm
Air · Particles ≥5.0 µm
10 µm
Liquid · USP 788 ≥10
25 µm
Liquid · USP 788 ≥25
<1 CFU
Microbial · Grade A
Product Portfolio
5 monitoring solution families for GMP cleanrooms
From GMP cleanroom certification to 24/7 Grade A monitoring, microbial sampling and USP 788 injectable testing — Techmaster recommends the optimal configuration for each line.
1
Lasair® Pro Family — GMP-certified handhelds
Lightweight rechargeable handhelds — built for HVAC validation, ISO 14644 spot-checks, EU GMP Annex 1 routine inspection and Grade A/B/C/D audits.
Lasair Pro 350
Handheld · 50 LPM
50 LPM handheld — twice as fast as the 310 version. Ideal for auditing multiple GMP cleanrooms in a single shift, saving 50% of classification time.
Lasair Pro 5100
Handheld · 100 LPM
100 LPM flow — classify an entire GMP plant in one shift. Built for large-scale aseptic pharma, meeting EU GMP Annex 1:2022 sampling times.
2
Lasair® III Family — Premium trolley counters
Fixed or portable trolley, sensitivity from 0.1 µm — for the most stringent Grade A/B cleanrooms and high-level biologics (BSL-3/4).
Lasair III 110
0.1 µm sensitivity · Grade A
The highest-sensitivity particle counter — the standard configuration for aseptic fill/finish Grade A, isolators and RABS. Detects submicron particles that 0.3 µm counters miss.
Lasair III 310B
0.3 µm · 6 channels · ISO 5-7
6 measurement channels (0.3, 0.5, 1.0, 5.0, 10 µm) — most popular at EU GMP-compliant pharma plants in Vietnam. Balances sensitivity and cost for 90% of applications.
Lasair III 350L
50 LPM flow · Large audits
50 LPM sampling flow (vs the standard 28.3 LPM) — cuts sampling time by 40% for plants with large cleanroom volumes or 20+ location ISO 14644-1 testing.
3
IsoAir® Pro Family — Fixed 24/7 Grade A/B
Integrates with FacilityPro FMS with continuous data streaming — instant excursion detection, 21 CFR Part 11 audit trail and automated EU GMP Annex 1 reporting.
IsoAir Pro-E
Ethernet TCP/IP connectivity
Fixed counter with Ethernet connectivity for areas with existing cabling. Integrates with FMS via TCP/IP, OPC UA, BACnet — the standard for new GMP plant builds.
IsoAir Pro-Plus
Wireless · Flexible deployment
Wireless version for GMP cleanrooms — no cabling required, flexible deployment, AES-encrypted 2.4 GHz. Saves 70% of cabling cost for existing plants.
IsoAir Pro
Economical entry version
Entry-level option for pharmaceutical cleanroom projects on tighter budgets. Still delivers PMS reliability, audit trail and Annex 1 compliance at optimized cost.
4
Airnet® II Family — Networked sensors
Lowest cost per measurement channel — facility-wide monitoring, deploying tens to hundreds of sensors across a single GMP plant.
Airnet II 4-channel
4 size channels · Network
4-size-channel particle sensor with centralized network connectivity and the lowest cost per channel — ideal for dense facility-wide deployments in GMP plants.
Airnet II 2-channel (IIS)
2 channels 0.5 µm + 5.0 µm
Economical 2-channel version — sufficient for GMP pharma requiring only 0.5 µm and 5.0 µm per EU GMP Annex 1. About 30% lower cost than the 4-channel.
5
Liquid & Microbial — USP 788 injectables + Microbial
Particle measurement in injectable solutions (USP 788/789) and active air microbial sampling per EU GMP Annex 1.
APSS-2000 / SLS-2000
Injectables · USP 788/789
Particle counters and samplers for injectable solutions per USP 788/789. Fully automates batch testing, with FDA / EMA audit-ready data.
BioCapt® / MiniCapt® Mobile
Active air sampler · CFU
Active air microbial samplers for Annex 1 viable monitoring. BioCapt Single-Use prevents cross-contamination; MiniCapt Mobile is battery-powered for mobile audits.
MiniCapt® Pro
Remote microbial sampler
Fixed 24/7 microbial samplers for Grade A/B, integrated with FacilityPro FMS. Meets EU GMP Annex 1:2022 continuous viable monitoring requirements.
Selection guide by Grade
How to choose a particle counter by GMP Grade & ISO 14644
Each GMP Grade has its own particle limits and monitoring requirements — choosing the right counter up front meets EU GMP Annex 1:2022 and USP 797.
GRADE A
Aseptic Fill/Finish · Isolator
ISO 5 in operation. Requires continuous ≥0.5 µm monitoring and microbial <1 CFU/m³. The most critical area in an aseptic plant.
GRADE B
Background to Grade A · RABS
ISO 5 at rest, ISO 7 in operation. The area surrounding Grade A. Requires 24/7 monitoring + viable microbial.
GRADE C-D
Preparation · Packaging
ISO 7-8. Compounding, support, packaging. Lower requirements — prioritizes economy, high sensor density and periodic audits.
Pharma software & FMS
FacilityPro Pharma — 21 CFR Part 11 compliance
FacilityPro is an FMS software purpose-built for GMP pharmaceuticals — full audit trail, electronic signatures and automated reporting for EU GMP Annex 1 and USP.
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Full 21 CFR Part 11 audit trailRecords every operation, electronic signature, immutable log — ready for FDA / EMA audits.
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EU GMP Annex 1:2022 readyAutomated classification, recovery, viable + non-viable monitoring reports per Annex 1 templates.
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Multi-sensor integrationMonitor 1,000+ sampling points in real time, alarm management, escalation rules, mobile alerts.
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Global regulatory complianceEU GMP Annex 1, USP 788, USP 797, ISO 14644, ISO 21501-4, FDA 21 CFR Part 11.
Optimal configuration consulting for your GMP plant
Techmaster Vietnam engineers provide free configuration consulting, on-site demos, and turnkey FMS proposals for your GMP pharmaceutical, biologics and injectables cleanroom project.
