Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

• Process Flow Diagram (Night Capsules) Stage I

The Maize Starch is sieved through a 250 micron screen and dried at 75°C for a minimum of 5 hours

The following ingredients are sieved through a 1000 micron screen into a suitable blender: Croscarmellose Sodium, Magnesium Stearate, Phenylephrine Hydrochloride, Sodium Laurilsulfate, Talc, Maize Starch

Blend for 10 minutes *

Stage II

Approximately half the Paracetamol is sieved through a 1000 micron screen into a suitable blender bin

The Premix from Stage I is sieved through a 1000 micron screen into the blender bin

The remainder of the Paracetamol is sieved through a 1000 micron screen into the blender bin

Blend for 20 minutes *

Stage III

The blend from Stage II is encapsulated into dark blue capped, light blue bodied Size 0 hard gelatin capsules

The finished capsules are packed into blisters

* Note: Actual blending times will be determined during full scale manufacturing trials prior to process validation