Validation and documentation

What is process validation?

Process validation is a method used to ensure the results of a series of production steps that together constitute a manufacturing process. It is based on verifiable documents and data which show how product and process specifications are met.

Process validation is often required by regulatory authorities in the medical technology field. The most common processes that need validation are high-volume injection moulding and welding operations, such as those involved in sterile packagings.

Applicable in different industries

In addition to meeting statutory requirements, process validation is an excellent tool for safeguarding high-production manufacturing processes for extended periods. Because it’s a successful method for achieving acceptable costs in high-volume processes, it’s also used outside the medical technology field. There are different conventions in different industries concerning how to work with process validation. For example, the Production Part Approval Process (PPAP) method has long been used in the automotive industry.

IQ, OQ and PQ

At AMB, we use established process validation methods to safeguard our manufacturing. The basic structure for medical devices is divided into the steps IQ, OQ and PQ to verify production start, process limits, and continuous production for the steps involved in the production process. Our validation activities are documented, made available to our customers and often form part of the product’s technical file for CE marking.

For some of our customers, we use the PPAP model instead.

Equipment used for testing parts is calibrated by means of methods that are themselves subject to verification. We use documented statistical methods to determine sample sizes.