Engineering and Maintenance

 
The Engineering and Maintenance Department at Arwan is responsible for smooth plant operations. All activities performed by the department are executed in accordance with the Good Engineering Practices (GEP). Smooth Plant Operations are ensured from the design phase all the way through the project lifecycle by applying the concept of Quality by Design.

Production equipment suppliers are selected from internationally renowned companies that provide the highest level of quality:
B&S (Germany): Washing, Depyrogenation and Filling Line
IMA (USA/Netherland): Lyophilizer
Stilmas (Italy): Water System
Seidenader (Germany): Inspection Machine
M+W Zander (Germany): Utilities/Mechanical and Electrical Facility Installations
Air Liquide (France): Critical Gases and Installation

Quality by Design Considerations

The manufacturing plant is monitored 24/7 by a Building Management System operated by trained professionals. The Building Management System is an automated computerized system that monitors and controls critical utilities at Arwan along with environmental conditions inside the classified cleanroom areas. Temperature, relative humidity and differential pressure inside classified areas is also monitored by the EMS (Validated Environmental Monitoring System) to record and report conditions and alarms in real-time.

Separate air handling units and exhaust fans are installed for dedicated areas in the cleanroom to avoid cross contamination through the ducting system. Furthermore, interlocks utilizing pressure cascade ensure airflow from the higher to the lower classified area.

Utility design incorporates system redundancy which ensures that plant operations are not disrupted in case of any utility failure:
Boilers (1 running + 1 standby)
Chillers (1 running + 1 standby)
Backup Power Sources (3 Backup Generators and 3 Dedicated UPSs)
Buffer Tanks (For Water & Compressed Air)

Site Maintenance

The Engineering and Maintenance Department is responsible of maintaining the site in good working condition. Maintenance work is governed by the Internal Procedure for Site Master Maintenance which describes all activities related to preventive and breakdown maintenance. All maintenance work, preventive and breakdown, is performed according to approved procedures, and records are updated regularly and signed for GMP compliance and traceability.