Autoclave & Equipment Bio-Decontamination, HDM
Between loads and campaigns, autoclaves, isolators and transfer hatches still need a reliable decontamination step, without shutting down a whole room to get it. BIO15PHARMA applies the HDM method to enclosed equipment and chambers, for targeted bio-decontamination on a fast cycle.
Who it is for
Sterile manufacturers and laboratories that need to decontaminate autoclaves, isolators, freeze-dryers and transfer items, separately from a full-room treatment.
What we cover
- Autoclaves and processing chambers, before and after campaigns
- Isolators, transfer hatches and pass-through boxes
- Fast turnaround between batches and campaign changes, to break cross-contamination
Proof
The same HDM evidence applies at equipment scale: reproducible cycles, a non-corrosive formula that protects high-value equipment, a tamper-evident ALCOA+ PDF report after each cycle, and fast re-access. Compliant with EU GMP Annex 1.
Standards
EU GMP Annex 1, ALCOA+ data integrity.
Contact us to discuss equipment 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, ISO 13485, ISO 9001, PMDA (Japonese Pharmaceuticals and Medical Devices Agency) |
|---|---|
| Product composition | HDM (HyperDryMist) treatment for enclosed equipment: autoclaves, isolators, freeze-dryers, transfer hatches and pass-through boxes, on a fast cycle, with a tamper-evident ALCOA+ PDF report per cycle. |
| Power Source | Eletric |
| Environment of use | Laboratory |
| Private label | No |