ISO 14644-1 and GMP Annex 1 set the standards. Medicair HEPA H14 supplementary units, Light Progress bio-decontamination cycles, and particle/CO₂ monitoring give you the documented control trail a GMP inspector expects.
MHRA / FDA inspectors increasingly focus on documented recovery testing, bio-decontamination cycles, and the environmental monitoring trend — not just the once-a-year certification. Specifically:
Sized for a typical 40 m² Class 7 lab adjacent to a Class 5 hood.
HEPA H14 supplementary filtration (1,500 m³/h) as a recovery aid post-intervention. The widest-throughput tower in the range, with concealed UV-C.
Mobile 5-lamp 360° UV-C tower for terminal bio-decontamination between campaigns or after spill events — University-tested to FDA standards, with motion-sensor cut-off.
Continuous CO₂, PM2.5, chemical VOCs, temperature and humidity on a touch LED display, with real-time alerts — a continuous trend record between scheduled certifications.
Includes 2× MedicAir Pro Max (HEPA H14). The shared UV-PENTALIGHT bio-decon tower and 3× air-quality monitors are quoted alongside, in your currency. 12-month consumables included.
Configure for my site →Pre-populated templates aligned with the 2023 Annex 1 revision and ISO 14644 series.
GMP non-conformances cost £50k+ in batch loss + remediation per event. The kit becomes a one-event payback.
Run my numbers →Bring a MedicAir Pro Max (HEPA H14) + an air-quality monitor in for a 30-day deployment alongside your existing EMS. We'll show you the recovery-time and air-quality uplift on your real campaigns.