In-Process and Release Testing Strategies Based on Technology Employed
| Technology | Basis of the Test | Time to Result | Detection Option |
|---|---|---|---|
| Gram Stain | Differential straining of bacterial cells | Around 30 minutes | Final product testing (3)a |
| USP <71> Sterility Tests | Growth in soybean-casein digest and fluid thioglycollate medium | At least 14 days incubation | Final product testing (3) |
| Respiration | CO2 production in proprietary aerobic and anaerobic broth | 48–72 hours | In-process monitoring; timed pre-release testing; final product testing (1, 2, or 3) |
| RT-PCR method | PCR amplification | 2–3 hours | Rapid release testing of final product (4) |
| Flow cytometry | Vital staining | 1–2 hours | Rapid release testing of final product (4) |
| Solid phase cytometry | Vital staining | 2–3 hours | Rapid release testing of final product (4) |
| ATP bioluminescence | ATP production in soybean casein digest and fluid thioglycollate medium | 48–72 hours | In-process monitoring; timed pre-release testing; final product testing (1, 2, or 3) |
↵a Number represents microbial contamination detection option.