Classification, recovery times and airflow visualisation through to routine monitoring: risk-based to ISO 14644, EU GMP Annex 1 and ICH Q9, documented to stand up in audits. From Visp in Valais, on site across Switzerland.
Cleanrooms and the HVAC behind them govern particles, microbes and pressure cascades, and with them product quality. Our field:
Every service ends in an audit-ready document, not a recommendation. What you get:
Particle measurement at rest and in operation, a justified sampling grid, class limits properly derived.
Outcome: a classification report that stands up in audits.
Recovery-time tests after interventions and smoke studies that make protection concepts visible, documented for Annex 1.
Outcome: robust evidence for authority and customer audits.
Air change, filter integrity (e.g. HEPA leak test), pressure cascades and alarming, tested risk-based across the four stages.
Outcome: executed protocols and reports that carry the release.
Particle and microbial monitoring with justified locations and alert/action limits, tied into the contamination control strategy.
Outcome: a monitoring concept that surfaces trends instead of hoarding data.
Frequency and scope derived from risk, based on monitoring trends, change control and periodic review.
Outcome: a requalification plan that puts effort where it creates assurance.
Qualification during rebuilds and filter changes in running operations, scheduled so production and compliance keep going.
Outcome: a classified state that survives the rebuild.
Assess zones, pressure cascades and GMP impact; set test depth by risk.
Sampling points, acceptance criteria and responsibilities, aligned with your QA.
Classification, recovery times, smoke studies and HVAC tests; deviations assessed and closed.
Qualification report with assessment of all deviations as the basis for release.
Monitoring, change control and risk-based requalification hold the state.
Our engineers work in GMP cleanroom operations, not just at the instrument. Sampling points match real interventions and workflows.
We understand the HVAC behind the cleanroom. Findings lead to actions on the system, not just red numbers in a report.
Test depth is a risk decision. We measure what protects product and patient, and document the rationale for what we leave out.
Every requirement is traceable through to its test evidence. That is the standard we hold ourselves to.
Annex 1 requires requalification at least every 6 months for grades A/B and at least every 12 months for C/D; in between, risk decides: monitoring trends, changes and interventions can justify tighter cycles.
Classification demonstrates the class per ISO 14644-1 at defined points in time and grid. Monitoring watches the state continuously at risk-based locations with alert and action limits. They belong together but do not replace each other.
Both, depending on the claim: ISO 14644 defines at rest and in operation, and Annex 1 expects both views for grades A to D. What matters is that in operation reflects real interventions.
Yes, that is the core of our approach: cleanroom and HVAC are qualified together, from air change and filter integrity to pressure cascades and alarming.
With a 30-minute, no-obligation first call. Then zone concept and criticality are assessed, from which scope and a robust plan follow. Reply within one working day, straight from engineering.
In the initial conversation we place your starting point: 30 minutes, no strings attached. Reply within one working day, straight from engineering.
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