Considerations and Limitations of USP | |
|---|---|
Aseptic Techniques | Strict aseptic handling is required during sampling and testing to avoid false contamination. |
Time Efficiency | Sterility testing is time-sensitive, and the duration of incubation must be carefully controlled to yield accurate results. |
Result Interpretation | False positives or negatives may occur due to reagent composition; results must be carefully validated. |
Testing Suitability | Highly viscous or antimicrobial buffers may require pre-validation for sterility testing. |
Equipment Maintenance | Testing equipment and filtration systems must themselves be sterile to ensure reliable results. |