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1904 Tower Plaza, Sheikh Zayed Road, opp. The Future Museum, Dubai, UAE
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business@hawklandglobalfz.com
1904 Tower Plaza, Sheikh Zayed Road, opp. The Future Museum, Dubai, UAE
business@hawklandglobalfz.com
A dedicated sterile IV production workstream planned inside a wider multi-line pharmaceutical facility, bringing container formation, filling, sterilisation, utilities and controlled environments together.
IV manufacturing carries different process, environmental and qualification requirements from the site's other product lines. The IV scope therefore needed to be engineered as its own coordinated system.
The programme includes multiple dosage forms. The IV line therefore needed clear boundaries for procurement, engineering and commissioning.
PP bottle forming and filling, autoclave sterilisation, labeling, flow packing, pharmaceutical water, dispensing, cleanroom and HVAC are organised around a common URS.
Injection moulding and blowing for the 100 mL PP IV container route.
IV filling equipment specified around the selected container and URS.
Sterilisation equipment with cycle and load planning defined during validation.
100 mL PP IV labeling and downstream flow-packing packages.
Water system, storage tanks, manufacturing vessels and dispensing support.
PU-panel controlled environments with sterile areas separated from non-sterile production.
DX air-handling units and supporting environmental-control infrastructure.
FAT/SAT, DQ/IQ/OQ/PQ and process and cleaning validation planning.
The IV workstream is treated as a distinct sterile manufacturing package while remaining connected to the larger facility's utility, engineering and infrastructure systems.
Established container basis for the reference IV workstream.
IV cleanroom zoning separated from non-sterile production areas.
Equipment and utilities connected through a defined validation lifecycle.
From URS development and technical planning through equipment integration, qualification and training.