Diagnostics Contract Manufacturing Facility Features

diagnostics Manufacturing facility includes:

• Sterile clean room that has HEPA filtered air that complies with Grade A and B air. The clean room has an associated air lock that meets Grade C air
• Laminar Flow Work Stations fitted with HEPA filters that meet Grade A air requirements
• Air Containment: Entry/Exit airlocks and 7 air handling systems to control cross contamination
• Room Pressure Control: Positive and Negative Pressure Control for dispensing suite, containment area and QC lab
• Temperature control & humidity monitoring: The temperature of the facility is fully computer controlled by a state of the art computer system. It is monitored 24/7 to comply with and exceed regulatory requirements for day-to-day operation and audit traceability
• Secure Building Entry System: access to the facility can only be obtained using a: swipe FOB entry card and is computer controlled
• Reverse osmosis purified water system that meets USP/EP/BP Purified Water requirements. The ROPW system also has a heater that can dispense the ROPW at 90ºC as required
• Pallet access: 2 meter wide corridors to allow pallet access to all rooms
• SAP Business 1 is used for inventory control, MRP, production orders and managing work in progress.

Facility Floor Plan (28K PDF file)