Körber offers comprehensive support for the smooth integration of your new machine into your production facility. 

Our services begin with the professional setup of the machine according to the specific requirements of your facility and the technical specifications. We take care of the professional connection to the on-site media supply, such as power and compressed air, to ensure immediate operational readiness. Subsequently, our specialists conduct initial test runs to check the basic functionality of the machine.

A key component of our support is assistance with Installation Qualification (IQ) and Operational Qualification (OQ) to document the correct installation and function of the machine according to regulatory standards.

Furthermore, we place great importance on empowering your team: We offer customized training to optimally prepare your personnel for the operation and maintenance of the new machine. This ensures that your employees acquire the necessary knowledge and skills to operate the machine efficiently and safely.

Körber offers comprehensive support for the qualification and validation of your machines to ensure compliance with regulatory requirements (e.g., GMP). Our CQV support (Commissioning, Qualification, Validation) is modular and can be flexibly adapted to your needs. The spectrum ranges from providing test protocols that you can use independently to taking over the full qualification and validation activities by our specialists. We are happy to advise you on which scope of support is most suitable for your project.

The required quantity of test material for qualifying your machine depends on various factors, including the qualification phases, product specifications, and test objectives. For pharmaceutical manufacturers, we provide the following recommendations: 

• Installation Qualification & Operational Qualification (IQ/OQ): For this, dummy material (e.g., empty blisters, placebo) is usually sufficient. The goal is technical functional testing. Plan for approximately 1 to 2 product batches (depending on line speed and test depth).
• Performance Qualification (PQ): For PQ, real material is necessary to demonstrate process capability and product quality under real conditions. Three complete batches are recommended (standard for FDA and EMA). Consider start-up losses, format changes, stops, etc., and plan for a minimum of 10-20% buffer.
• Format Change Qualification & Product Change Qualification: The test quantity depends on the complexity of the change. A consultation with your Quality Assurance and Validation department is important here. Körber also offers qualification services that help you plan the material requirements precisely and avoid unnecessary losses.

As part of machine installation and commissioning, Körber supports you in obtaining relevant certifications required for the operation of your system. This may vary depending on the machine type and regional requirements. Please contact us to discuss the specific certification requirements for your project.