Standard Media and Incubation Conditions Used for Routine Microbial Enumeration in the Pharmaceutical Industry
| Microbiological Culture Media | Target Microorganisms | Referenced Methods | Incubation Conditions |
|---|---|---|---|
| Soybean-casein digest agar | Total aerobic microbial count | USP <61> Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests and USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments | 30–35 °C for 3 to 5 days |
| Sabouraud dextrose agar | Total combined yeast and mold count | As above | 20–25 °C for 5 to 7 days |
| R2A agar | Waterborne bacterial count | USP <1231>Water for Pharmaceutical Purposes and AWWA/APHA Standard Methods | 30–35 °C for 48 to 72 hr |