Environment guide
Understand the environment first.
Assess environment, surface, chemistry and use cycle together.
Define your needsEnvironmental 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.
Three different questions. Three different bodies of evidence.
Pre-selection is not site validation.
Environment guide
ISO Class 7 / 8 environment
Assess environment, surface, chemistry and use cycle together.
Hospital clean area
Assess environment, surface, chemistry and use cycle together.
Laboratory
Assess environment, surface, chemistry and use cycle together.
Controlled manufacturing
Assess environment, surface, chemistry and use cycle together.
Let's start with your process conditions.
Assess environment, surface, chemistry and use cycle together.