Methodological standard · §5
CEI-MS-06 — system suitability and acceptance criteria
The performance the system must demonstrate, and the criteria a result must meet to be reportable.
§5System suitability and acceptance criteria
§5.1System suitability
Table 1. System suitability criteria. A determination is reportable only where every criterion is met at the time of analysis.
| Parameter | Criterion | What it establishes |
|---|---|---|
| Growth promotion, both media | Visible growth within the stated period for all challenge organisms | Medium fertility |
| Method suitability in the presence of product | Growth comparable to the control | Absence of product inhibition |
| Negative control | No growth | Aseptic technique |
| Environmental monitoring | Within Grade A and B limits | Facility control |
§5.2Acceptance criteria
- No growth in either medium after 14 days is reported as complying with the test for sterility.
- A result is not reportable where method suitability was not established.
- A single growth event requires investigation and, where a laboratory cause cannot be established, the batch does not comply.
§5.3Limitations
Compound Evidence Institute · CEI-MS-06/5 · https://compoundevidence.com/methods/sterility-usp71/acceptance-criteria/ · retrieved 30 July 2026