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HM-CL2
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Product Introduction
When an auditor asks "who sampled this room, when, and with what settings," a paper logbook answers slowly and only if the entries were made correctly. The HM-CL2 from HM Instruments is built for facilities that have decided to replace that paper trail with electronic traceability, without buying a separate data system. The audit trail module is queryable, traceable and controllable, compliant with FDA 21CFR PART11: every sampling run, every configuration change and every user login is logged automatically, and the log is searchable on the instrument itself.
The measurement core is the same six-channel light-scattering engine used across the HM-CL series. A single pass at 2.83 L/min (0.1 cfm) simultaneously counts 0.3, 0.5, 1.0, 3.0, 5.0 and 10.0 µm particles. Confidence-level evaluation follows GB/T 6167-2007 and JJF-1190-2008, results are computed at 95% UCL, and the instrument assigns the cleanliness class automatically against national standard, ISO 14644, FS 209E or GMP criteria — in both dynamic and static states. Counts convert between per m³ and per ft³, so the same report serves an ISO-classified room and a customer specification written in FS 209E terms.
What separates the HM-CL2 from the entry-level HM-CL1 is what happens after the count. The AC/DC lithium battery (74 Wh, 16.8 V/5 Ah) supports over six hours of continuous sampling away from wall power, so the instrument can be carried to a room without a convenient bench outlet. The built-in thermal printer lets an operator print selected particle size channels before leaving the room — so the report signed at the next shift change reflects actual measured counts, not a transcription. For facilities needing higher flow for large-volume rooms, the HM-CL2 configuration with 28.3 L/min sampling can be compared with the HM-CL3 model.
Applications
- Pharmaceutical manufacturing — Grade A/B/C/D cleanroom classification and routine monitoring where audit trail is expected by inspectors, including at-rest and in-operation qualification.
- Semiconductor and precision machining — trend logging in ISO Class 3–7 bays where sub-micron counts correlate with yield loss and the data record must survive an internal audit.
- Food hygiene processing — clean-area evidence for HACCP files in dairy, plastic-sealed meat, seasoning and fine-processing lines, with on-site printed reports for batch release documentation.
- Filter manufacturers — upstream and downstream counting to verify filter quality and filtration efficiency during production runs and after filter replacement.
- Optical, aerospace and bioengineering cleanrooms — precision test chambers where rework cost per contaminated part is high and the sampling record must be traceable to an operator.
- Research and contract testing laboratories — method development and customer-facing cleanroom certification reports where the printed result and the stored log must agree.
Key Features & Advantages
- FDA 21CFR PART11-compliant audit trail: queryable, traceable and controllable — every sampling run, configuration change and user login is logged automatically.
- AC/DC dual-use power with built-in rechargeable lithium battery (74 Wh, 16.8 V/5 Ah) supporting more than 6 hours of continuous sampling away from wall power.
- Built-in new-generation high-speed thermal printer — operator selects which particle size channels to print and receives the report before leaving the room.
- Six particle size channels measured simultaneously in one sampling pass: 0.3, 0.5, 1.0, 3.0, 5.0 and 10.0 µm.
- Automatic cleanliness class judgment against national standard, ISO 14644, FS 209E and GMP criteria in both dynamic and static states.
- 95% upper confidence limit (UCL) calculation applied by the instrument, matching the statistical basis expected in classification reports.
- Integrated temperature, humidity and ambient barometric pressure sensors recorded in the same data row as the particle counts.
- Light-scattering sensor design that suppresses stray light inside the optical cavity for a higher signal-to-noise ratio at the 0.3 µm threshold.
- Imported semiconductor laser diode rated beyond 30,000 hours supports long-term duty without frequent light-source service.
- Android 7.1 platform with a 7-inch colour touchscreen for direct on-machine configuration, data review and audit log search.
- Sampling modes: single, repeated (up to 99 times, user-defined) and continuous; period adjustable from 1 second to 30,000 seconds.
- WiFi data upload to the supervision platform for multi-room dashboards and long- and short-term cleanliness trend analysis.
- Internal storage for 1 to 100,000 records — searchable and exportable on the touchscreen, so raw data is available even during a network outage at audit time.
Technical Specifications
| Item | Specification |
|---|---|
| Sampling method | Single, repeated (≤99 times, custom), continuous |
| Sampling volume | 2.83 L/min (0.1 cfm) |
| Six particle size channels | 0.3, 0.5, 1.0, 3.0, 5.0, 10.0 (µm) |
| Maximum sampling concentration | 35,000 particles/L (particle size ≥ 0.5 µm) |
| Self purification time | ≤ 10 min |
| Particle size distribution error | 0.5 µm 5 µm ≤ ±30% |
| Particle concentration indication error | 0.5 µm ≤ ±30% |
| Measurement repeatability relative deviation | < 10% |
| Cleanliness standards | National standard, ISO 14644, FS 209E, GMP |
| Operating environment | 15–35 °C, 10–85% RH |
| Sampling period | 1 second – 30,000 seconds (user-set) |
| Sampling delay | ≤ 60 s |
| Measurement interval | ≤ 60 s |
| Power supply | AC/DC dual use, built-in lithium battery 74 Wh (16.8 V/5 Ah) |
| Audit trail | Queryable, traceable, controllable, FDA 21CFR PART11 compliant |
| Thermal printer | Built-in, selectable particle size channels |
| Light source | Imported semiconductor laser diode (life over 30,000 hours) |
| Screen display mode | 7-inch colour touchscreen |
| Operating system | Android 7.1 |
| Data communication | WiFi, standard USB |
| Data memory capacity | 1–100,000 records, searchable and exportable |
| Alarm function | Particle count alarm via user-set parameters |
| Outline dimensions | 185 × 220 × 200 mm (D × W × H) |
| Bare weight | 3.25 kg |
| Packing size | 460 × 265 × 420 mm |
| Packing weight | 8.6 kg |
| Reference standards | GB/T 6167-2007, JJF-1190-2008, ISO 14644, FS 209E, GMP (dynamic/static) |
FAQ
Q1: What does the FDA 21CFR PART11 audit trail module actually record?
It logs three categories of event: user authentication (login, logout, failed access attempts), configuration changes (sampling period, alarm thresholds, class standard selection), and sampling actions (start, stop, channel counts, results). Each entry is timestamped and tied to the logged-in user. The log is queryable on the 7-inch touchscreen — an auditor can search by date, user or event type without exporting first. Records are also exportable via USB or WiFi for archiving in the quality system.
Q2: How does the thermal printer change the cleanroom workflow?
Without an onboard printer, the operator leaves the room with counts stored in memory, then prints or transcribes them at a desk terminal. That gap is where transcription errors enter. The HM-CL2 prints selected particle size channels on the spot — before leaving the room — so the report reflects the counts actually measured. The paper can be signed at the next shift change and filed with the batch record, while the electronic record remains the searchable source of truth.
Q3: Can the HM-CL2 operate on battery during a planned power shutdown?
Yes. The built-in rechargeable lithium battery (74 Wh, 16.8 V/5 Ah) supports continuous sampling for more than 6 hours on a single charge, with a design working time of 8 hours. For facilities with scheduled maintenance shutdowns or power interruptions, the instrument maintains sampling coverage without interruption. The audit trail records that the measurement was taken on battery power — so the context of the reading is preserved.
Q4: How does the HM-CL2 compare with the HM-CL3 for high-flow applications?
Both models include the audit trail module, AC/DC battery and thermal printer. The difference is the sampling volume: the HM-CL2 samples at 2.83 L/min (0.1 cfm), which suits rooms up to ISO Class 6 depending on volume and location count. The HM-CL3 samples at 28.3 L/min (1 cfm), collecting ten times the air per minute, preferred for large cleanrooms or ISO 14644-1 plans specifying a minimum volume per location. For mixed room sizes, deploying an HM-CL2 per room and reserving an HM-CL3 for large-volume certification is common.
Q5: Does the HM-CL2 support both ISO 14644 and GMP class judgment?
Yes. The instrument judges purification level automatically against four selectable frameworks: the Chinese national standard, ISO 14644, FS 209E, and GMP in both dynamic and static states. Confidence-level evaluation follows GB/T 6167-2007 with calibration traceable to JJF-1190-2008, counts reported at 95% upper confidence limit. Results convert between particles per m³ and per ft³, so the same instrument serves an ISO-classified facility and a customer specification that still quotes Class 100 in FS 209E terms. The selected standard is recorded in the audit trail, making each judgment traceable.
Expert Review
Article address:https://www.cleanlinesstesting.com/pro1/fda-compliant-cleanroom-particle-counter.html
