Bioburden Failure Analysis Exam
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Please answer the following questions by checking the appropriate box or by filling in the blank. This exam is open book and open notes (Hint: Notes pages in the webinars slide deck have important information not specifically stated in training webinar). A passing score is 7 out of 10 questions correct. Completed exams should be emailed to .
1. What is the best way to document containment of product suspected of having higher than acceptable bioburden?
2. All gowning and de-gowning should be performed inside the gowning area of a controlled environment.
a. True
b. False
3. Which of the following records should be collected as part of the bioburden failure analysis (check all that apply)?
a. Sterilization process records
b. Temperature data logs
c. Previous bioburden measurement reports
d. Design History File
e. None of the above
4. The most important thing to do immediately after a bioburden failure is to clean the controlled environment thoroughly.
a. True
b. False
5. Which of the following is a possible recommended corrective action for bioburden failure?
a. Increasing frequency of cleaning
b. Rotating cleaning agents
c. Retraining personnel
d. Changing packaging of raw materials in storage
e. All of the above
6. Product exceeding bioburden limits must be scrapped.
a. True
b. False
7. Section of ISO 13485 that is applicable to environmental monitoring:
8. Which of the following is a common source of bioburden failures?
a. Equipment failure
b. Humidity or temperature is too high
c. Cleaning agents are expired
d. Failure to comply with procedures
e. all of the above
9. Cleaning logs only need to be completed when cleaning occurs.
a. True
b. False
10. Which method best demonstrates effectiveness of corrective actions?
a. comparison of bioburden measurements pre- and post-implementation
b. training exams to ensure retraining was understood
c. re-audit of environmental monitoring 30 days after implementation
d. no evidence of excursions outside limit during next 3 monitoring cycles