After a component is pulled out of inventory or provided by a supplier, the required documentation is gathered and the inspector creates a material examination log (MEL). Each component is checked for surface finish, ovality, wall thickness, and compliance to ASME Bioprocessing Equipment (BPE) standards. The inspection process can vary, depending on the individual documentation requirements. For example, valves require added material test reports, elastomer test reports, welding documents, and COCs for compliancy, along with wall thickness and surface finish verifications.
CSI's process requires that 20% of every production lot is inspected and cleared. If every piece passes inspection, then the lot is approved and the MEL is closed out. To give an idea of the scope of this process, 271 MELs have been created so far for this project alone. Each MEL includes hundreds of components; for example, the inspection of 100 three-inch elbows can be included on one MEL.