New advanced OSD facility turnkey complying with EU GMP & US FDA regulations located in Oman

PHILEX Pharmaceuticals, located in the Salalah Free Zone of the Sultanate of Oman, specializes in the manufacture and packaging of high-quality pharmaceutical and biopharmaceutical products across a diverse range of therapeutic areas. Their cutting-edge facility boasts HPL-class cleanrooms, equipped with the latest systems, tools, and facilities necessary for the production and packaging of both sterile and OSD drugs.

AUSTAR delivered a turnkey solution for PHILEX's state-of-the-art plant, tailoring it specifically to the environment required for the production of OSD products and more. Spanning a built-up area of over 12,000m2, the cleanroom facility is compliant with both EU GMP and FDA standards. There are plans for expansion in the near future to accommodate the manufacturing of sterile drugs.

Throughout the project, AUSTAR took the helm in management, coordination, and leadership, overseeing everything from design reviews to project execution. Their extensive service scope encompassed procurement, installation, qualification, commissioning, HVAC, dehumidification systems, electromechanical setups, low voltage (LV) equipment/instruments, SCADA, BMS/EMS, information systems, BU systems and equipment, and dispensing booths. Their involvement also extended to design review and re-engineering tasks.

The project brought together a global team, including design reviewers, construction professionals, and supply chain vendors from Europe, the Middle East, China, and partnering nations such as the UK, Germany, Sweden, Belgium, Spain, Saudi Arabia, Jordan, and Oman. United in purpose, the team was committed to the project's success.

Given Salalah's humidity levels, which can surge beyond 90% for three consecutive months each year, the team faced a challenge in maintaining humidity below 35% for OSD manufacturing. Tackling this, they implemented a dynamic humidity control and dehumidification system integrated with the AUSTAR BMS. This allows for systematic management of the AHU, VAV, Chillers, and dehumidifiers, with GMP data monitored via the EMS system.

Despite the obstacles posed by the COVID-19 pandemic and global supply chain disruptions, the facility was impressively built at breakneck speed. Initiated in 2021, it became fully operational by 2022. In recognition of their unwavering dedication and professionalism, AUSTAR was honored with an appreciation letter from PHILEX Pharmaceuticals.