Country : Ireland

Assignment Task

 

 

Task
QUESTION 1
Outline and discuss the four main steps in a typical biotechnology process. Outline the primary difference between biopharmaceuticals and traditional pharmaceuticals.In a typical cleanroom environment, outline which parameters are controlled and what controls are in place. Explain the Cleanroom Grades and illustrate your answer with examples of the typical areas covered by the Grade.
QUESTION 2
Discuss the reasons why it is necessary to formulate a tablet.
Outline the purpose of a typical coating process. As part of the In-Process Control Testing, identify the critical process parameters that can be measured and monitored to ensure operation.
Using a schematic diagram, outline the key features and method of operation of a film coating machine.

QUESTION 3
Outline the generation, purpose and application of ‘Clean Steam’ in pharmaceutical manufacturing. Illustrate your answer with some well-formed examples.
Discuss the purpose and application of an ‘Autoclave’ in a typical pharmaceutical operation. Illustrate your answer with some example applications.
QUESTION 4
Outline the purpose of a Quality System. Outline the major elements which jointly constitute a Quality System.
Outline the purpose of ASTM E2500. Describe the key principles and their application, as proposed.

 

    

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  • Uploaded By : Roman
  • Posted on : February 15th, 2020
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