Validation & Qualification

Much of the development work for Millipore’s membrane validation/qualification process happens in a manufacturing environment because a lot of the R&D work is not predictive. Our validation and qualification program is clearly defined:

1. First, we generate several lots of membrane to the required specifications
2. Each cast lot is thoroughtly analyzed to determine consistency within each lot and reproducibility between lots. (A single cast lot can total several thousand feet of membrane,)
3. Resulting datais statistically analyzed to determine the appropriate sampling plan on finished product and ensure the predictability of membrane performance in a variety of applications.

• Visual tests – to detect defects by eye that cannot be detected by camera
• Physical tests – to evaluate thickness, flow rate, bubble point, tensile strength, elongation, and other tests specific to the membrane involved
• Application tests – to determine performance in specific applications that the membrane will be used