Purity by Design. Compliance in Practice

 

In pharmaceutical and biotech manufacturing, there is no margin for error. The integrity of your product and the safety of patients depend on the quality and reliability of your equipment. Edal Projects is a trusted partner with a deep understanding of the regulatory landscape and the technical challenges of sterile manufacturing. We engineer solutions that are not just built to perform, but built to comply.

Our Expertise in Pharmaceutical Solutions:

  • GMP-Centric Design: Every aspect of our design process is guided by Good Manufacturing Practices (GMP). We focus on sanitary construction using high-grade materials like 316L stainless steel, ensuring smooth, crevice-free surfaces that prevent contamination and facilitate effective cleaning (CIP/SIP).

  • Cleanroom Automation: We develop robust automation and robotic solutions designed specifically for operation within controlled environments. Our systems minimize human intervention, reducing the risk of contamination while increasing process consistency and throughput.

  • Custom Process Equipment: From bioreactors and mixing vessels to aseptic filling and closing machinery, we build equipment tailored to your unique process. We work with you to engineer a solution that optimizes your workflow and ensures product integrity.

  • Validation and Documentation Support: We understand that equipment is only part of the solution. We provide comprehensive documentation packages (e.g., FRS, DDS, FAT/SAT protocols) to support your validation processes (IQ/OQ), ensuring a smoother and faster path to regulatory approval and production readiness.

Delivering Confidence for Critical Applications:

  • Active Pharmaceutical Ingredient (API) production

  • Sterile liquid and powder filling

  • Medical device assembly

  • Cell culture and fermentation processes

Partner with Edal for engineering that meets the highest standards of purity and precision. Contact our pharmaceutical sector specialists today.