Pharma

Automation for Pharma with Focus on Quality and Validation

At Kjærgaard A/S, we have solid experience delivering pharma-related automation solutions using robotic technology both for production environments and packaging processes in classified areas (typically ISO Class C and D). Our solutions are based on proven processes and documentation that can be directly integrated into your validation efforts.

Documented Automation Processes According to GAMP5

We follow the GAMP5 framework for automated systems. This means our solutions are built on a structured and traceable lifecycle, where we:

• – conduct risk assessments early in the project
• – develop FAT and SAT with clear and relevant test coverage
• – deliver documentation that can be directly reused in your validation process

We offer FAT and SAT as standard and can also support IQ/OQ if required by your quality system.

Focus on Operational Reliability in Classified Environments

Our systems are used in classified zones, typically in connection with secondary packaging and handling. We are experienced with GMP-related cleaning requirements, hygienic design and maintenance-friendly solutions although we generally do not operate in aseptic zones such as ISO 5/Class A.

Scalable and Flexible Solutions

We deliver systems tailored to both small-scale and high-volume production environments. This allows us to support everything from niche production setups to larger GMP-compliant facilities, where documentation and validation-readiness are essential.

Want to know more?

Get in touch for a dialogue about how we can deliver an automation solution that fits your GMP setup with documentation that simplifies and strengthens your validation process.