Package Process Validation

What is the goal of a package process validation?

The main reasons for carrying out a package process validation are:

Quality assurance: Validation of the process ensures that packaging is produced that meets all specified requirements. To this end, we support you with functional qualification (OQ) and performance qualification (PQ).
Error prevention: Process 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 reject costs.
Continuous improvement: By monitoring and evaluating the process as part of the validation, weak points can be identified and improvement measures can be taken. This helps to improve the process and increase efficiency and productivity.
Compliance with regulatory requirements: The validation of the manufacturing process is part of the validations in accordance with DIN EN ISO 11607-1 and serves to demonstrate compliance with the requirements of the essential safety and performance requirements of Regulation (EU) 2017/745.

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 is crucial for ensuring the integrity of a sterile barrier.

What happens during a package process validation?

The manufacturer must submit a documented process validation program that demonstrates the effectiveness and reproducibility of all packaging processes. This includes forming, sealing and the assembly of prefabricated sterile barrier systems and packaging systems.

We support you in carrying out the functional assessment (OQ) and the performance assessment (PQ):

Creation of validation plans
Determination of suitable test systems
Final documentation
Revalidations

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In which areas are package process validations used?

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

At PAConsult, we validate the manufacturing processes of sterile barrier systems particularly for medical products. Package 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

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