Assessment 2 Cleanroom & Pharmaceutical Industry

**Assessment 2 Weighting 30%** **Exercise A: Cleanroom Design** A diagram of a building Description automatically generated From the diagram above, describe what can be seen. **Exercise B:** Plant Utilities in the Pharmaceutical Industry Answer the following questions with an explanation for yo...

**Assessment 2 Weighting 30%** **Exercise A: Cleanroom Design** A diagram of a building Description automatically generated From the diagram above, describe what can be seen. **Exercise B:** Plant Utilities in the Pharmaceutical Industry Answer the following questions with an explanation for your answer. **1. Which utility is primarily used to provide sterile steam for autoclaves and sterilization processes?** A. HVAC system B. Purified Water (PW) C. Clean Steam D. Compressed Air **2. What is the main purpose of the Heating, Ventilation, and Air Conditioning (HVAC) system in a pharmaceutical manufacturing facility?** A. To regulate building temperature B. To filter contaminants and control the cleanroom environment C. To provide energy for equipment D. To monitor humidity **3. What type of water is used for preparing injectables and other pharmaceutical formulations?** A. Potable Water B. Purified Water (PW) C. Water for Injection (WFI) D. Distilled Water **4. Which of the following is commonly used to remove moisture from compressed air systems?** A. Filter B. Dehumidifier C. Desiccant dryer D. Air cooler **5. In a pharmaceutical cleanroom, what is the primary role of High Efficiency Particulate Air (HEPA) filters?** A. To regulate air temperature B. To trap microorganisms and particles C. To sterilize the room D. To humidify the air **6. Which of the following is a key utility used for the refrigeration of pharmaceutical products?** A. Compressed air B. Purified water C. Chilled water system D. Steam generator **7. Which type of steam is considered safe for direct contact with pharmaceutical products or equipment surfaces?** A. Dry steam B. Clean steam C. Superheated steam D. Process steam **8. What is the primary purpose of a Water for Injection (WFI) system in a pharmaceutical facility?** A. Cooling B. Cleaning equipment C. Product formulation and sterile injectables D. Air humidification **9. Which of the following is used to monitor and control the environmental conditions in pharmaceutical manufacturing, such as temperature and humidity?** A. Process control system B. HVAC system C. Water system D. Building Management System (BMS) **11. Which of the following gases is commonly used in pharmaceutical production for purging and blanketing purposes?** A. Carbon dioxide B. Argon C. Nitrogen D. Oxygen **12. In pharmaceutical manufacturing, why is it essential to use clean steam rather than regular process steam?** A. To avoid heat loss B. To prevent contamination of products C. To increase energy efficiency D. To reduce maintenance costs **13. What is the purpose of a deionization (DI) unit in water purification systems?** A. To remove microorganisms B. To remove particulate matter C. To remove dissolved ions and minerals D. To lower water pH **14. Which of the following systems is typically responsible for maintaining differential pressure between cleanrooms?** A. Compressed air system B. HVAC system C. Chilled water system D. Water purification system