Package Process Validation

What is the goal of a package process validation?

The main reasons for validating and verifying the manufacturing process of medical devices are:

Quality AssuranceBy validating the process, we ensure that packaging is produced that meets all specified requirements. To achieve this, we support you with operational qualification (OQ) and performance qualification (PQ).
Error PreventionProcess validation helps to identify and rectify errors or deviations in the process at an early stage before they lead to quality problems or even safety risks. This reduces rejects and scrap costs.
Continuous improvementBy monitoring and evaluating the process within the scope of validation, weak points can be identified and improvement measures can be taken. This contributes to improving the process and increasing efficiency and productivity.
Compliance with regulatory requirementsThe validation of the manufacturing process is part of the validations according to DIN EN ISO 11607-1 and also serves to demonstrate compliance with the requirements of the essential safety and performance requirements of Regulation (EU) 2017/45.

According to DIN EN ISO 11607-2, the manufacturing process of a sterile barrier system must be validated. The development and validation of packaging processes are crucial for ensuring the integrity of a sterile barrier.

What happens during a package process validation?

The manufacturer must provide a documented process validation program that demonstrates the effectiveness and reproducibility of all medical device packaging processes. This includes forming, sealing, and assembling pre-formed sterile barrier systems and packaging systems.

We support you in carrying out the Operational Qualification (OQ) and Performance Qualification (PQ):

Creation of Validation Plans
Definition of appropriate testing systems
Final documentation
Revalidations

In which areas are package process validations used?

Process validations are required in many industries where packaging must comply with certain legal and specific requirements.

At PAConsult, we specifically validate the manufacturing processes of sterile barrier systems for medical devices. Process validation is an important component in many industries to ensure that manufacturing processes consistently deliver high-quality products.

Standards: DIN EN ISO 11607-1, DIN EN ISO 11607-2