Pharmaceutical Environmental Control Tutorial PDF
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Uploaded by UncomplicatedTennessine1728
Nanyang Polytechnic
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Summary
This document presents a tutorial on environmental control within the context of pharmaceutical manufacturing, likely for a course at Nanyang Polytechnic. The tutorial explores key topics such as air pressure differentials, cleanroom airflow patterns, and microbial sampling methods. The questions are designed to develop an understanding of environmental control in the pharmaceutical industry.
Full Transcript
ASB210/ASC210 Quality Systems & GMP Topic 5: Environmental Control 1. Why is it important to control the environment for a pharmaceutical manufacturing plant? 2. Explain the use of the following application to maintain the cleanliness of a room: (a) air pressure differentials (b) airlocks 3...
ASB210/ASC210 Quality Systems & GMP Topic 5: Environmental Control 1. Why is it important to control the environment for a pharmaceutical manufacturing plant? 2. Explain the use of the following application to maintain the cleanliness of a room: (a) air pressure differentials (b) airlocks 3. What is the preferred airflow pattern in a clean room? Why? 4. Describe the impact that humidity control has on the cleanroom environment. 5. Describe 2 microbial sampling methods and explain their limitations. 6. State the different types of compressed air (CA) used in pharmaceutical industry and their applications. 7. Compare purified water (PW) and water for injection (WFI). Class Discussion: If you have been asked to come up with an environmental monitoring program. Describe what you would need to define in the program. 5
