Cleanroom Assessment
Determine if the microbial bio-burden (bacteria and fungi) in a facility is acceptable or unacceptable, based on established ISO Class limits and FDA Action levels established by “USP 797 Pharmaceutical Compounding – Sterile Preparations” guidelines. Comply with 797 guidelines for corrective actions by identifying isolated bacteria and fungi.
| FUNGAL CLEANROOM ASSESSMENT USP 797 | Turnaround |
Fungal Air Culture Count Only | 5-7 days |
Fungal Air Culture ID Follow-up for Cleanroom Count | 5-10 days |
Fungal Fingertip Surface Count | 4 days |
Fungal Contact/Rodac Surface Count | 4 days |
BACTERIAL CLEANROOM ASSESSMENT USP 797 | |
Bacterial Air Culture Count Only | 4 days |
Bacterial Air Culture ID Follow-up for Cleanroom Count | 5-7 days |
Bacterial Fingertip Surface Count | 4 days |
Bacterial Contact/Rodac Surface Count | 4 days |