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 |
