Environmental monitoring for medical device manufacturers
For cleanrooms in which medical devices are manufactured, assembled or packaged: sampling, reading, trends and deviations in one application.
Proving cleanroom quality.
Where medical devices are made in a cleanroom, its condition must be monitored and documented regularly – without gaps and ready to show in any audit.
Monitored cleanrooms
Air and surfaces are sampled regularly and the results assessed against warning and action limits.
Spotting trends
Rising counts at a sampling point should stand out before a limit is exceeded.
Traceable deviations
Root cause analysis, risk assessment and actions belong, documented, with the deviation.
Many sample types
Airborne microbes, particles, contact and settle plates, fingertips, water monitoring and endotoxins – depending on product and cleanroom class, different measurements come together.
Staff and equipment in view
Operator validations and equipment calibrations have deadlines. When something is about to expire, it has to be noticed in time – not during the audit.
Evidence on demand
In audits, results, trends and actions have to be available quickly – organised, complete and traceable instead of spread across binders and spreadsheets.
How SteriTrend supports your site.
Sample plans in a daily view, barcodes from label to reading, an incubation timer that logs the actual incubation time, and the release process with digital signature.
Trends per sampling point and floor plans that show problem areas in production at a glance. Plus charts and reports with metrics such as the contamination rate – easy to print and at hand for regulatory audits.
An automatic event for every limit exceedance – with root cause analysis, actions with due dates and a deviation report.
Operator validations for aseptic processes with reminders of expiring deadlines, positive controls, and calibration dates for your equipment with automatic reminders.
Scan samples directly in the cleanroom and the lab, record CFU results when reading and upload photos – in the browser on your phone or tablet, nothing to install.
Frequently asked.
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Which sample types does SteriTrend support?
Is SteriTrend itself validated?
Can we map our existing SOPs?
What happens when a result exceeds a limit?
Which formats can reports be exported in?
Can we keep using our existing printers and scanners?
Book a demo now
In a roughly 60-minute demo we show you SteriTrend based on the workflows of your site.