Tiếng Việt
IsoAir Pro-E
Ethernet · Annex 1 ready
Fixed Ethernet TCP/IP counter for aseptic lines with existing cabling. Integrates with FacilityPro via TCP/IP, OPC UA, BACnet for isolators, RABS filling and sterility test isolators.
ISOLATOR & CONTROLLED SYSTEMS
Particle & Microbial Monitoring in Isolators, RABS & Filling Lines
Comprehensive contamination monitoring solutions for aseptic manufacturing — particle (non-viable) + microbial (viable) in isolators, RABS, closed/contained systems and filling lines. Particle Measuring Systems partners directly with leading isolator/RABS manufacturers — officially distributed in Vietnam by Techmaster.
“Solution hub for simultaneous particle + microbial monitoring in isolators, RABS and Grade A aseptic filling lines Vietnam — IsoAir Pro, BioCapt Single-Use, MiniCapt Pro, Manifold & FacilityPro FMS.”
Grade A Aseptic Sensitivity
Fully meets Annex 1 GMP & ISO 14644
1
cfu/m³ · Grade A
0.5 µm
Particle · Grade A
3520
/m³ max · ISO 5
100 L/min
Microbial Flow · BioCapt
24 /7
Continuous · FMS
Product Portfolio
5 product families for isolators, RABS & aseptic filling
Comprehensive particle (non-viable) + microbial (viable) for aseptic fill-finish, sterility test isolators, contained powder filling and cell & gene therapy — Techmaster recommends configurations per Annex 1 and USP <1116>.
1
IsoAir® Pro Family — Particle Counter trong Isolator
Fixed FacilityPro-connected particle counter — purpose-designed for installation inside isolators, RABS and closed filling lines. Continuous data streaming, instant alarms.
IsoAir Pro-Plus
Wireless 2.4 GHz · AES
Wireless version — saves 70% of cabling cost, flexible deployment in RABS and isolators with penetration restrictions. AES-encrypted, no need to drill the isolator wall for cabling.
IsoAir Pro
Economical version
Entry-level option for aseptic R&D, prototype isolator and small-scale sterile lab projects. Still delivers PMS reliability at an optimized investment cost.
2
BioCapt® & MiniCapt® — Microbial Sampling
Active air microbial sampling inside isolators, RABS and fill lines — compliant with Annex 1, USP <1116> and EU GMP. Single-use sterile cassette for aseptic, no autoclaving required.
BioCapt Single-Use
Sterile cassette · 100 L/min
Single-use sterile microbial impactor — eliminates cross-contamination risk from autoclaving, with convenient validation for Grade A isolators. Closely partnered with leading isolator manufacturers.
MiniCapt Pro
Remote · Active air
Fixed active air microbial sampling in fill rooms and Grade B RABS surrounds. FacilityPro-connected with continuous 21 CFR Part 11 audit trail.
MiniCapt Mobile
Handheld · Spot sampling
Portable microbial sampler for spot checks and routine EM sampling in Grade A/B/C/D. Lithium battery, PDF/XML report output integrated with DataAnalyst.
3
Handheld Particle Counter — Audits outside the isolator
Audit Grade B/C/D surrounds around the isolator, ISO 14644-1 classification, HVAC validation of aseptic plants.
Lasair Pro 310
Handheld 0.3 µm · 2.83 LPM
Standard handheld for Grade B/C/D surround audits, fill-room HVAC validation and ISO 14644-1 certification. Lithium battery, 5,000-location memory.
Lasair Pro 350
Handheld · 50 LPM
50 LPM handheld for fast audits of multiple fill rooms, isolator surrounds and contained powder facilities. Accelerates PQ qualification.
HandiLaz® Mini II
Compact · <1 kg
The lightest handheld at an economical price for fast audits of background rooms, qualification phases and sterile R&D labs. Audit-ready XML/PDF output.
4
Manifold & Compressed Gas — Multi-Point trong Isolator
Manifold for multi-point sampling from a single counter, plus a compressed-gas kit for testing aseptic-grade N2/Ar entering the isolator and fill needle.
Airnet II Manifold
16/32 channel · Sequential
16- or 32-channel sampling manifold from a single counter — cost-effective for isolators with many fill points. Automatic channel switching, no need for a dedicated counter at each location.
HPGP-101-C
High Pressure · N2/Ar/CDA
High-pressure compressed-gas particle counting entering the isolator/fill needle — clean aseptic-grade N2, Ar for wash baths, breathing-air CDA. Prevents contamination from supply gas reaching the product.
Chem 20™ / APSS
Liquid · WFI/Injectables
Particle counting in WFI (Water For Injection), purified water and injectable solution entering the isolator. Meets USP <788> for parenteral fill.
5
FacilityPro® FMS — Annex 1 integration software
FMS system monitoring particle + microbial simultaneously, integrated with isolator BMS/SCADA, 21 CFR Part 11 audit trail.
FacilityPro Software
FMS · 21 CFR Part 11
FMS software integrating particle + microbial + RH/T/DP in one dashboard. Electronic-signature audit trail, alarm escalation, automated PQ/OQ reporting for Annex 1.
DataAnalyst
Trend · SPC Charts
EM data analysis software — trends, SPC charts, alert/action limits, batch reporting for FDA, EMA and PMDA regulatory submissions.
Sterility Test Isolator Kit
Validation · Turnkey
Turnkey validation package for sterility test isolators — particle + microbial sampler + software + IQ/OQ/PQ documents. Deploy once to meet EU GMP Annex 1.
Guide by GMP Grade
How to choose a configuration by EU GMP Annex 1 Grade
Inside the isolator demands the most stringent Grade A — continuous particle + microbial. Surround/background steps down to Grade B/C/D. Choose the right configuration up front to pass PQ qualification and the first FDA/EMA inspection.
GRADE A · ISO 5
Inside the Isolator · Fill Needle
Aseptic fill needle, stopper bowl, sterility test isolator, cell & gene therapy work zone. <1 cfu/m³ microbial, <3,520/m³ particles at 0.5 µm continuously.
GRADE B · ISO 7
RABS Surround · Background
Rooms around RABS, isolator background, transport of uncapped product. <10 cfu/m³, <352,000/m³ particles at 0.5 µm.
GRADE C/D · ISO 7-8
Preparation · Material Airlock
Material preparation, gowning, material airlock, non-sterile compounding. <100 cfu/m³, periodic ISO 14644-1 classification.
EU GMP Annex 1 (2026) compliance
FacilityPro — particle + microbial, Annex 1 integration
Annex 1 (revised 2022/2023, enforced 2026) requires continuous particle + microbial monitoring in Grade A — no more periodic sampling. PMS partners with leading isolator/RABS manufacturers (Skan, IMA, Bosch, Optima) to integrate from the design stage.
- ✓
Continuous Process Verification (CPV)Particle + microbial 24/7 in Grade A, instant alarms on exceedance, electronic-signature audit trail per 21 CFR Part 11 and Annex 11.
- ✓
Contamination Control Strategy (CCS)Integrates EM, utility (WFI, N2, CDA), personnel monitoring and cleaning verification data — into a living CCS for the entire aseptic plant.
- ✓
Skan, IMA, Bosch, Optima partnershipPMS has pre-integrated IsoAir Pro & BioCapt into the isolators/RABS of major OEMs — fast installation, no custom engineering required.
- ✓
Quality Risk Management (ICH Q9)Risk-based EM plan, alert/action limits per ICH Q9, USP <1116> and EU GMP Annex 1 — audit-ready reporting for FDA, EMA and PMDA.
Configuration consulting for aseptic isolators & RABS
Techmaster Vietnam engineers provide free particle + microbial configuration consulting, on-site demos, IQ/OQ/PQ documents and turnkey FMS proposals for aseptic fill-finish, sterility test isolators, and cell & gene therapy — ready for Annex 1 (2026).
