Question: Question 2: You are tasked with explaining to a new employee in an ISO Class 7 cleanroom what a cleanroom is, the behaviours required when
Question 2: You are tasked with explaining to a new employee in an ISO Class 7 cleanroom what a cleanroom is, the behaviours required when working in a cleanroom and the gowning requirements. Outline the explanations you would give 2 a. For a cleanroom (5 marks) 2 b. For the behaviours required in a cleanroom (10 marks) 2 c. The gowning requirements (10 marks)
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
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