Design Study	2000
Bulk Intermediate Pharmaceuticals

ChiRex Limited; Dudley, Northumberland

Process Engineering

Summary of Process

ChiRex (Dudley) Ltd intended to increase its production capability within the Dudley 1 building at its Northumberland site. It was proposed to do this by re-engineering the existing facility to provide the capability for producing Penultimate APIs (Active Pharmaceutical Intermediates) and increasing the overall flexibility of the facility. The facility therefore needed to be designed to the current GMP standards for this class of manufacturing.

The ChiRex Re-Engineered processing facility was designed with two modules each based on 4 independent reactor vessels operating in a batch or semi-batch manner.

The fully automatic plant, monitored from a central control station was designed to have an operating life of 20 years.

Reactors were capable of being charged with liquids and solids. Drummed liquids were to be charged from the charging booths as will solids. The design also enabled bulk solvents to be charged from Client’s bulk solvent storage.

Solid products were to be recovered as a wet product via a centrifuge or as a dry product via this centrifuge and a pan dryer.

Alternatively solids could be recovered via filter dryer.

Solid products would be collected in kegs.

Specific Responsibilities

• Checking P&IDs.
• Checking Process data sheets.

Achievements

• An introduction into pharmaceutical plant design.
• Awareness of GMP requirements.

Materials of Construction Glass lined carbon steel, hastelloy. Documents Produced Revised P&IDs. Summary of anomalies. eg line routing, equipment specifications, heat balances around reactors.

Hazards Contamination. Liaison Piping Department.

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