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