Module 3 - Strategic case studies in practice

PL 12063/0073

CONFIDENTIAL

Description of Manufacturing Process and Process Controls

3.2.P.3.3

Day Capsules

3.2.P.3.3.1

• Manufacturing Process Three 150 kg pilot-scale batches of Day 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 150 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 (i)

Sieve the Maize Starch through a 250 micron screen and dry at 75°C for a minimum of 5 hours. (ii) Using a 1000 μm screen, sieve the raw materials into a Tumble Blender in the following order: Croscarmellose Sodium, Magnesium Stearate, Phenylephrine Hydrochloride, Sodium Laurilsulfate, Talc and Maize Starch. (iii) Blend the premix for 10 minutes.