Nexcel® Pharma Material Testing & Validation
Proven performance in processing and drug stability
Sealed Air's expertise in materials development can be shown through testing and validation work.
It is known that certain materials are able to absorb the active ingredients of
drugs to a greater or lesser extent. One study undertaken in China by three
independent laboratories looked at the efficacy of M312 against PVC and glass containers
over a range of 45 drugs.
- Without exception, Nexcel® M312 maintained the drug concentration better than the other two materials
- The loss of concentration depended on the drug and the alternative packaging material but ranged, over a 48 hour period, from 3% at the low end up to a loss of concentration of 30% at the high end
M312 even exceeded glass, generally considered the most inert packaging material,
in its ability not to absorb active ingredients and so weaken drug efficacy.
Change in concentration of drugs tested with various primary packaging materials
|Absorption level||Number of drugs|
|Reduction of drug concentration after 48h||M312||PVC bag||Glass|
|N: None (<5%)||32||15||28|
|L: Low (>5%, <10%)||8||6||8|
|M: Medium (>10%, <20%)||4||5||5|
|H: High (>20%, <40%)||1||7||4|
|VH: Very High (>40%)||0||12||0|