Module 3 - Strategic case studies in practice

3.2.P.3.3 Description of Manufacturing Process and Process Controls

3.2.P.3.3. Description of Manufacturing Process and Process Controls The phenylephrine hydrochloride, caffeine and starch are premixed using a ribbon blender for 10 minutes. The premix and the remaining ingredients are added to a mixer and mixed for 25 minutes. The bulk is run into drums with samples being taken at the beginning, middle and end for laboratory analysis. The mix is encapsulated using standard machinery with samples being taken randomly throughout the run to a total of about 300 capsules for laboratory analysis. Maximum batch size : 667kg

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