New Advanced OSD Facility Turnkey Complying with EU GMP, US FDA Regulations Located in Oman

PHILEX Pharmaceuticals is a generic manufacturing company, established in the Sultanate of Oman and located in the Salalah Free Zone, manufacturing and packing high-quality pharmaceuticals and biopharmaceutical products, covering a wide range of therapeutic areas. PHILEX′s state-of-the-art new manufacturing plant has HPL-class cleanrooms with all needed systems, equipment, accessories and related facilities to manufacture and package sterile and OSD drugs.

AUSTAR provided a facility turnkey completed solution to PHILEX for its new advanced plant fully customized to its environment for manufacturing OSD products and others. The clean room facility has a built-up area of over 12000m2 and meets EU GMP and FDA requirements. The facility will be expanded in the near future for sterile drug manufacturing. 

AUSTAR managed, coordinated, and led the design review activities and execution of the turnkey project. The main service scope included procurement, installation, qualification and commissioning, HVAC, De-humidifiers, Electromechanical and Low Voltage (LV) equipment/ instruments, SCADA, BMS/ EMS, Information Systems, BU systems and equipment, Dispensing Booths, the extended role of design review and re-engineering.  

The project team included design review at starting, construction, and supply chain vendors from Europe, Middle East, China, and partners in the UK, Germany, Sweden, Belgium, Spain, Saudi Arabic, Jordan, Oman, etc., who were committed to collectively delivering the project.

The new plant is located in Salalah, an important gateway of Oman, only a few hundred meters away from the sandy beach resorts of Salalah, where the area’s relative humidity easily rises above 90% consecutively for 3 months every year. To ensure the humidity is less than 35% for the OSD manufacturing process, our project team applied the dynamic humidity control and dehumidify system through the AUSTAR BMS system, which can manage the AHU, VAV, Chiller, and dehumidifiers systematically, and then monitor the GMP data on EMS system. 

The facility turnkey project was built at an unprecedented speed, developed in 2021, and fully operational by 2022, despite the challenges of COVID-19, global supply chain, and shipping constraints. AUSTAR has received an appreciation letter from PHILEX Pharmaceuticals for the hard work and professionalism.