Medical Device Cleanroom Environmental Monitoring Log Worksheet
Cleanroom monitoring records are among the first things an auditor asks to see for devices assembled or packaged in a controlled environment. This log captures counts and flags excursions as you type.
| Date | Location | ISO class | Particles >= 0.5 um per m3 | Class limit per m3 | Percent of limit | Excursion (1 = yes) | Temp (C) | RH (%) | Technician | |
|---|---|---|---|---|---|---|---|---|---|---|
51.7% | 0 | |||||||||
68.5% | 0 | |||||||||
54% | 0 | |||||||||
111.1% | 1 | |||||||||
59.7% | 0 |
Limits shown are the ISO 14644-1 maximum concentrations for 0.5 um particles in the 'at rest' or 'operational' state as defined by your own specification: ISO 5 = 3,520, ISO 6 = 35,200, ISO 7 = 352,000, ISO 8 = 3,520,000 per cubic metre. Use your own alert and action levels in addition.
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Optional review of routing monitoring data into quality notifications.
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How to use the log
Add a row for each monitoring event. Select the ISO class for the location, enter the measured count of particles at 0.5 micrometres and larger per cubic metre, and enter the limit from your specification. The percent of limit and excursion flag are calculated. Record temperature and humidity at the same time because they are often part of the same environmental specification. Export to Excel for trending.
Limits and what they mean
ISO 14644-1 sets maximum concentrations per class, and the 0.5 um limits are 3,520 for ISO 5, 35,200 for ISO 6, 352,000 for ISO 7 and 3,520,000 for ISO 8. Many companies also set alert levels, for example 70% of the limit, and action levels at the limit itself. A count above the action level should open an investigation and a documented product impact assessment.
- Alert level triggers a look
- Action level triggers investigation
- Trend by location, not just pass or fail
- Record the room state: at rest or operational
Common mistakes
Averaging counts across locations hides a bad spot, so keep results by location. Another frequent finding is monitoring only at convenient times, not during peak activity such as shift change. Tie the monitoring plan to risk, include recovery tests after maintenance, and keep a process for excursion investigation, as in the example row for the packaging room.
Frequently Asked Questions
Which standard defines cleanroom classes?
ISO 14644-1 defines classes by airborne particle concentration. It is often paired with ISO 14644-2 for monitoring plans and ISO 14698 for biocontamination, depending on your product.
Do all medical device cleanrooms need ISO 7?
No. The class depends on the product, risk and process. Many assembly rooms use ISO 7 or ISO 8, while sterile fill or exposed implantable steps may need more stringent control.
What do I do with an excursion?
Document it, investigate the cause, assess affected product and batches, take corrective action and record closure. Escalate to CAPA if it repeats.
Does this cover viable monitoring?
No. This tracks non-viable particles. Add separate logs for settle plates, contact plates and air sampling if your plan requires viable monitoring.
If you want excursions to create quality events in your ERP or QMS automatically, Netray can help. Ask for a short review.
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