Non-viable and viable particle monitoring for cleanroom classification, routine environmental monitoring and EU GMP Annex 1 compliance. TSI instruments supplied and supported by Saksham.
Hand-held particle counter for ISO 14644 cleanroom certification, routine GMP monitoring, and EU Annex 1 compliance. Six user-selectable channels with…
Continuous 24/7 cleanroom monitoring for EU GMP Annex 1 Grade A–D environments. Integrates with FMS/SCADA via Ethernet, RS-485, or 4–20 mA. VHP-resistant…
The only real-time viable particle counter accepted by regulators to replace active and passive air sampling in EU GMP Grade A zones. Simultaneously counts…
Remote active air sampler for continuous microbiological monitoring in critical cleanroom environments. Integrates with FMS for automated sampling schedules…
| Need | Instrument | Why |
|---|---|---|
| Cleanroom classification and periodic monitoring | TSI AeroTrak+ A100 portable (replaces 9310) | ISO 14644-1:2015 classification reports, ISO 21501-4 calibrated, 1 CFM or 50 LPM |
| Continuous Grade A/B monitoring | TSI AeroTrak+ 7510 / 7510-VHP remote | 24/7 monitoring linked to FMS/SCADA; VHP-resistant version for isolators |
| Real-time viable monitoring | TSI BioTrak 9510-BD | Counts total and viable particles together using biofluorescence, with a gelatin filter for identification |
| Microbial air sampling | TSI Remote Active Air Sampler | Automated active air sampling integrated with FMS |
Annex 1 (2022) requires continuous particle monitoring in Grade A for the full duration of critical processing, and encourages rapid and alternative microbiological methods. India's revised Schedule M brings Indian manufacturers in line with these expectations. TSI's FMS software adds 21 CFR Part 11 compliant data handling. See our guide choosing particle counters for Annex 1.
Saksham supports ISO 21501-4 calibration coordination, loaner arrangements, installation of remote sensors, FMS configuration and validation documentation for TSI systems across India.
The TSI AeroTrak+ A100 Series portable particle counter replaces the 9310. It has six selectable channels, 1 CFM or 50 LPM flow, and onboard ISO 14644 and Annex 1 reporting.
Non-viable counters measure all airborne particles by size. Viable monitoring identifies living microorganisms, traditionally with settle plates and air samplers. The TSI BioTrak does it in real time using biofluorescence.
At least annually to ISO 21501-4, or more often if your SOPs require it.
50 LPM (about 1.77 CFM) collects the 1 m³ samples needed in Grade A/ISO 5 classification faster. 1 CFM is the industry standard for routine monitoring.
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