Op 4

Op 4 is located on the southern side of the Facility. It consists of 6 process areas (Process 1, 2, 3, 4, 6 and Gram Lab) that were commissioned over a number of years from 1974 to 2000. It is an EMEA and FDA approved Multiproduct Organic synthesis plant with multiproduct flexibility and a range of batch size and containment capabilities.

Reactor volumes vary from 10 L to 4,000 L and, as illustrated in the above diagram, with batch size capability ranging from 200g to 300kg. Process areas 1, 2 and the Gram Lab have pilot plant and product launch capability with equipment pools from 50 L to 1,600 L. Process Area 4 and the Gram Lab are designed to handle products with OELs in the range 1-10µg/m3. Process area 4 has full recipe driven DCS process automation. Process 3 has PLC automation on the main equipment. There are a range of driers in Op 4, including vacuum conical screw, vacuum horizontal paddle, vacuum tray and convection tray driers.

HVAC systems are in place to provide air flow rates and pressure differentials throughout the Facility. Process areas 1, 2, 3 and 6 have manual heating and cooling control of vessels through cooling water, low temperature coolant and steam.

Process 4 and the Gram Lab have indirect single fluid heating and cooling systems with automated controls. Purified water is supplied from a dedicated low endotoxin water system.

Process area 4 has a full recipe driven Procos DCS process automation system. Vessels are inerted with nitrogen and solvents are supplied from drums and from bulk storage in the Tank Farm. Op 4 & Op 5 have a shared laboratory for In-Process Testing.

Op 5

Op 5 is located on the southern side of the Facility and was commissioned in 1990. It is an EMEA and FDA approved multiproduct organic synthesis plant and used to manufacture intermediates and API for an Oncology product. Flexible containment technology (along with glovebox technology) is used to provide containment to an OEL level of 1 - 10µg/m3. It is a fully automated facility (Procos Distributed Control System). As indicated in the diagram below, typical batch size currently ranges from 10kg to 100kg indicating the range of scale to which the Facility can manufacture depending on the process.

Op 5 has a fully automated single fluid glycol heating / cooling system (capability of -15ºC to +90ºC) which operates using cooling water, a glycol low temperature coolant and steam. One vessel has a liquid nitrogen supply that can be used to achieve vessel temperatures of -40ºC. Purified Water is supplied from the Op 4/5 generation system. Solvents are supplied from the Op 4/5 Tank Farm. Op 5 has a dedicated HVAC system that maintains air flow rates and pressure differentials within the building.