Process Validation

Better Processes for Better Products

At Flexan, we understand that the performance and capability of your product relies heavily upon the engineering work and manufacturing process that we employ. We rigorously validate all of our equipment and processes, ensuring consistent manufacturing over the product lifecycle. We perform numerous qualification exercises in order to deliver to you the best product possible, including:

Qualifications and Protocols

Installation Qualification (IQ)

IQ is performed to confirm the correct equipment installation prior to manufacturing start up.

Operational Qualification (OQ)

OQ is performed to confirm that the equipment and processes have been tested at the limits at the process.

Performance Qualification (PQ)

Understanding the vital importance of process stability, we perform multiple performance qualifications (manufacturing runs), ensuring process capability at the nominal settings over repeated production cycles.

Custom Protocols

We can collaborate with you developing custom protocols depending upon your design and manufacturing process. This includes software validation, enhanced statistical techniques and analyses, and other unique requirements for your product.