Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

Night Capsules

3.2.P.3.3.2

• Manufacturing Process Three 144 kg pilot-scale batches of Night capsules have been manufactured and details are provided below. The proposed maximum full-scale batch size is 1000 kg. Actual mixing and processing times for full-scale manufacture will be defined during full-scale manufacturing trials.

• Equipment 250 µm screen 1000 μm screen Tumble Blender Blending Bin Capsule Filler Blister Packer

• Manufacturing Procedure The following manufacturing procedure was used for production of the 144 kg pilot scale batches. The proposed maximum full-scale production batch size is 1000 kg. Blending times may need to be adjusted accordingly for validation of the full-scale processes. Stage I 1. The Maize Starch is sieved through a 250 micron screen and dried at 75°C for a minimum of 5 hours. 2. Croscarmellose Sodium, Magnesium Stearate, Phenylephrine Hydrochloride, Sodium Laurilsulfate, Talc and the Maize Starch are sieved through a 1000 micron screen into a blender. 3. The dry powder premix is blended for 10 minutes.