Cleanroom & ZAC Bio-Decontamination, HDM (Annex 1)

With the HDM method, you decontaminate faster, at lower cost, with a traceable record every time.

Who it is for : Sterile and aseptic manufacturers in pharma, biotech and medical device that need validated cleanroom and ZAC bio-decontamination under EU GMP Annex 1.

Why HDM : *A validated 6-log reduction with 7.5% hydrogen peroxide, three times lower in concentration than VHP *Non-toxic to operators and non-corrosive to equipment *Up to ten times lower cost than equivalent VHP cycles, with quick in-house training and no specialised external staff *Up to six times less downtime, with re-access to the area after four hours *Data integrity by design: a tamper-evident PDF report after each treatment, following ALCOA+ principles *Reproducible after 1,000 cycles, with levels adjustable from 4-log to 6-log by zone sensitivity

Standards : EU GMP Annex 1, ALCOA+ data integrity.