In the pharmaceutical industry, there is no room for error. We engineer and install highly specialized systems, including classified cleanroom environments, process piping for purified water (WFI), and validated HVAC systems that are essential for GMP compliance and product integrity.
Addressing the core challenges you face every day.
All systems must be designed, installed, and documented to meet stringent Good Manufacturing Practices (GMP) regulations.
Maintaining sterile environments through controlled airflow, pressure differentials, and filtration is absolutely critical.
Systems delivering utilities like WFI or clean steam must perform with flawless precision and repeatability.
Solutions Tailored for Pharma
Design and installation of validated HVAC systems for classified manufacturing areas (Grade A/B/C/D).
Engineering of Purified Water (PW) and Water for Injection (WFI) generation, storage, and distribution loops.
Installation of piping systems for clean steam, compressed air, nitrogen, and other process gases.
Providing full support for Installation Qualification (IQ) and Operational Qualification (OQ).
A pharmaceutical client needed to build a new FDA-compliant facility for sterile injectables, requiring ISO 5 (Class A) cleanrooms and a fully validated WFI loop.
We provide comprehensive validation support, including IQ, OQ, and PQ documentation, to ensure a smooth regulatory approval process.
Our team has extensive experience designing and building ISO-classified cleanrooms for sterile and non-sterile production.
We are experts in orbital welding and installation of high-purity stainless steel piping systems for WFI and clean steam.
"Their deep understanding of pharmaceutical validation was a game-changer for our project. They delivered a world-class facility, on time and ready for regulatory approval."
Dr. Evelyn Reed
Head of Quality, BioGenex Pharma
We provide a comprehensive documentation package, including material traceability certificates, weld logs, calibration certificates, and executed IQ/OQ protocols, ready for your regulatory submission.
Yes, we specialize in retrofitting and upgrading existing pharmaceutical facilities while minimizing downtime and maintaining compliance in operational areas.