Cleanroom & ZAC Bio-Decontamination, HDM (Annex 1)
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Annex 1 has raised the bar for sterile and aseptic manufacturing, and cleanroom decontamination has to keep pace. The HDM (HyperDryMist) method delivers a validated 6-log kill with a fraction of the hydrogen peroxide a conventional VHP cycle needs, so 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.
Contact us to plan your cleanroom decontamination.
| Medical International certifications | ANVISA (Agência Nacional de Vigilância Sanitária), CDSCO (Indian Central Drugs Standard Control Organization), CE Mark, CFDA China Food and Drug Administration), DHA (Dubai Health Authority), FDA (Food and Drug Administration), Health Canada, HSA (Singapour Health Sciences Authority), ISO 13485, ISO 9001, MDSAP (Medical Device Single Audit Program), SFDA (Saudi Food and Drug Authority) |
|---|---|
| Product composition | HDM (HyperDryMist) treatment with 7.5% hydrogen peroxide: validated 6-log cycle, levels adjustable from 4-log to 6-log by zone, re-access after four hours, and a tamper-evident ALCOA+ PDF report per treatment. |
| Power Source | Eletric |
| Environment of use | Hospital, Clinic, Laboratory |
| Private label | No |