Scope
Which zone, product contact and cleaning conditions are being assessed?
Pre-selection is not site validation.
Environmental class
Classification of airborne particle cleanliness.
Sterility
Scope of the validated process and packaging.
Product performance
Findings obtained with a specific sample, method and conditions.
Evidence dossier structure
- Method
- Which question is being addressed, using which method.
- Sample
- Identity of the product and configuration under review.
- Condition
- The environment and parameters of the test.
- Revision
- Document version and applicable scope.
No report is currently approved for publication.
Technical dossier consultation
Read a result with its sample.
When method, sample or test conditions change, the scope of results is reassessed.
Review the evidence dossier structureLet's start with your process conditions.
Assess environment, surface, chemistry and use cycle together.