The experts at Extrusion Consulting have the experience and expertise needed to create your medical extrusion process validation plan or assist you in documenting your process validation. Medical products require process validation beyond the capability of routine inspection and product testing. Medical products, to a greater extent than most extruded products, require quality assurance to be certain that every component is within specification every time.
As a starting point, a Failure Modes and Effects Analysis (FMEA) is conducted by analyzing each process step to identify all potential failure modes and their effects. Following FMEA, IQ/OQ/PQ can start. Installation qualification (IQ) requires that all of the manufacturing equipment is installed correctly and all process control measurements are taken with calibrated equipment. Operation qualification (OQ) is the step requires that all of the installed equipment works properly and achieves the capability to manufacture the required product (tubing). This is achieved through detailed and documented engineering studies to establish processing minimums and maximums for every critical variable, often referred to as Process Characterization. Process qualification (PQ) builds on previous information with the objective of understanding the repeatability of the manufacturing process while also allowing for resin lot variation and it is typical to express the results as process control statistics. With all of this information in hand, then you are ready to start manufacturing products in the medical industry. Our extrusion engineers have decades of experience assisting manufacturers just like you. Our team offers a fully documented and traceable packet for validations and processes. Please refer to our original content blog to understand our depth of knowledge. Then give us a call.
As a starting point, a Failure Modes and Effects Analysis (FMEA) is conducted by analyzing each process step to identify all potential failure modes and their effects. Following FMEA, IQ/OQ/PQ can start. Installation qualification (IQ) requires that all of the manufacturing equipment is installed correctly and all process control measurements are taken with calibrated equipment. Operation qualification (OQ) is the step requires that all of the installed equipment works properly and achieves the capability to manufacture the required product (tubing). This is achieved through detailed and documented engineering studies to establish processing minimums and maximums for every critical variable, often referred to as Process Characterization. Process qualification (PQ) builds on previous information with the objective of understanding the repeatability of the manufacturing process while also allowing for resin lot variation and it is typical to express the results as process control statistics. With all of this information in hand, then you are ready to start manufacturing products in the medical industry. Our extrusion engineers have decades of experience assisting manufacturers just like you. Our team offers a fully documented and traceable packet for validations and processes. Please refer to our original content blog to understand our depth of knowledge. Then give us a call.
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