Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

• Process Flow Diagram (Day Capsules) Stage I

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

Sieve the following ingredients through a 1000 μm screen into a blending bin: Croscarmellose Sodium, Magnesium Stearate, Phenylephrine Hydrochloride, Sodium Laurilsulfate, Talc, Maize Starch

Blend for 10 minutes *

Stage II

Sieve approximately half the Paracetamol through a 1000 μm screen into a blender bin

Sieve approximately half of Premix 1 from Stage I through a 1000 μm screen into the blender bin

Sieve the Caffeine through a 1000 μm screen into the blender bin

Sieve the remainder of the premix from Stage I through a 1000 μm screen into the blender bin

Sieve the remainder of the Paracetamol through a 1000 μm screen into the blender bin

Blend for 20 minutes *

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