Question 6: Describe the Risk Management of Contamination (RMC) system in Clean Room, outlining the steps to be followed and giving an explanation of each (25 marks)

Please can you use diagrams/sketches/charts to illustrate or add to your explanation? Diagrams will help the evaluator for a quick understanding of the answers we are providing.

FYI: This is part of Clean Room Management, this question has 25 marks and I have 30 mins of time to answer this question in exam. Please can you provide appropriate pictures (images) in relation to this question, it makes a good impression on the evaluator in the actual exam. You can copy, paste pictures from the sources you found.

Please refer to the following Text books and References:

1. Whyte, W (2010) Cleanroom technology: fundamentals of design, testing and operation. Wiley (free ebook on this can be downloaded from here: https://phongsach.files.wordpress.com/2010/04/clean_room_technology_whyte_2001.pdf if you have difficulty in downloading book, please let me know, I can send you ebook) 2. Denyer, SP & Baird, RM (2007). Guide to microbiological control in pharmaceuticals and medical devices. CRC Publishing 3. Peine, I (2001) Quality Assurance Compliance: Procedures for Pharmaceutical and Biotechnology Manufacturers. Interpharm Press.

4. American Health Research Institute (1995). Medical Devices and Equipment Design, Supplies, Failures, Control, Contamination and Alarms

5. Ljungqvist, B & Reinmuller, B (1997) Clean room design: minimizing contamination through proper design. Interpharm press

Thank you.

Look forward to hearing from you.

Best Regards