Bioburden & Gamma Sterilization Quiz

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1. ISO 11137 is an internationally recognized standard.

a) True

b) False

2. The number of samples required for the bioburden test must be 3 lots of 10 each.

a) True

b) False

3. The MPN method tests the eluent of the product.

a) True

b) False

4. The bioburden test should be carried out under the condition of level 100 purification.

a) True

b) False

5. Sterilization and disinfection have the same meaning.

a) True

b) False

6. The most suitable culture temperature for mold is 30-35℃.

a) True

b) False

7. Sterility test should be carried out in the sterile room (refers to the ultra-clean studio, locally up to grade 100).

a) True

b) False

8. Products with a higher number of bioburden (> 1000 CFU) should choose a Repetitive Method.

a) True

b) False

9. Chemical indicators (such as red before sterilization, blue after sterilization) can prove that sterilization is qualified.

a) True

b) False

10. When determining the degree of sterilization, it is not appropriate to include the peak of the bioburden.

a) True

b) False

1. Which of the following is the correct sequence of an irradiation sterilization process?

a) Determining the maximum dose > Determining product bioburden > Determining Dose Mapping > Dose validation

b) Determining Dose Mapping > Determining the Maximum Dose > Determining product bioburden > Dose validation

c) Determining Dose Mapping > Determining product bioburden > Determining the Maximum Dose > Dose validation

d) Determining the Maximum Dose > Dose Validation > Determining product bioburden > Determining Dose Mapping

e) None of the above

2. Which of the following should be considered when dividing product families?

a) Product Design

b) Intended use

c) Production environment

d) Raw materials

e) All the above

3. The purpose of dose mapping is to:

a) To show how the sterilizer box operates

b) Determine if dosages are consistent at different locations in the sterilizer

c) Verify that the dose in the sterilizer is greater than the minimum dose required for the product and less than the maximum dose that the product can withstand

d) None of the above

4. Which of the following products is suitable for the VDmax25 method?

a) The average bioburden of the product is 1.2 CFU

b) The average bioburden of the product is 200 CFU

c) The average bioburden of the product is 1200 CFU

d) The average bioburden of the product is 12000 CFU

5. Internal packaging materials such as blister bags may also need to be tested for biological loading in the following cases:

a) When the packaging is part of the overall product

b) For specific evaluation purposes

c) Inner packaging in double sterile packaging

d) All of the above

6. For products with a number of bioburden greater than or equal to 1.5, the maximum interval for bioburden testing is?

a) 1 month

b) 2 months

c) 3 months

d) 1 year

e) 2 years

7. The maximum time interval for dosing reviews is?

a) 3 months

b) 6 months

c) 1 year

d) 2 years

e) 3 years

8. Which of the following is the removal by elution in the removal of microorganisms?

a) Contact Plating

b) Agar Overlay

c) Most Probable Number (MPN)

d) Ultrasonication

e) None of the above

9. What temperature do aerobic bacteria need to hatch?

a) 15 to 20 ℃

b) 20 to 25 ℃

c) 25 to 30 ℃

d) 30 to 35 ℃

10. Which of the following is not a measurable value for colony in a plate?

a) 300

b) 200

c) 100

d) 50

11. Which of the following are factors in determining the frequency of bioburden monitoring?

a) Historical data

b) How often the product was produced

c) The nature of the manufacturing process

d) The purpose for generating data

e) All of the above

12. After the sample has been diluted at 1:10,000, there are 32 colonies on the plate, so which is the amount of bacteria?

a) 320,000 bacteria

b) 32,000 bacteria

c) 3,200 bacteria

d) 320 bacteria

e) 32 bacteria

13. What is the maximum number of positive products that can be accepted for sterile testing after a dose-validation experiment when using the VDmax method?

a) 1

b) 2

c) 3

d) 4

14. Which of the following is the VDmax validation process?

a) Determine Product Bioburden > Determine Validation Dose > Irradiated Sample > Sterile test

b) Determine the validation dose > Determine Product Bioburden > Irradiated Sample > Sterile test

c) Irradiated Sample > Determine Validation Dose > Determine Product Bioburden > Sterile test

d) Irradiated Sample > Determine Product Bioburden > Determine Validation Dose > Sterile test

e) None of the above

15. Which is the number of samples required for a VDmax revalidation audit?

a) 10

b) 20

c) 30

d) 40

16. Sample Item Portion (SIP) used when the bioburden of the entire product cannot be determined. When the product is an implant (absorbable), what is the basis for the Sample Item Portion?

a) Surface Area

b) Mass

c) Length

d) Volume

17. Which of the following is the correct sequence of a bioburden test?

a) Selection of testing method > Removal of microorganisms > Transfer to culture media > Microorganisms incubation > Microbial count > Characterization of bioburden

b) Removal of microorganisms > Transfer to culture media > Microorganisms incubation > Selection of testing method > Microbial count > Characterization of bioburden

c) Removal of microorganisms > Selection of testing method > Transfer to culture media > Microorganisms incubation > Microbial count > Characterization of bioburden

d) Selection of testing method > Removal of microorganisms > Characterization of bioburden > Transfer to culture media > Microorganisms incubation > Microbial count

18. Which of the following is not a step in a bioburden testing?

a) Neutralizing inhibitory substances

b) Microorganisms' incubation

c) Removal of microorganisms

d) Microbial count

e) All of the above are steps in a bioburden testing

19. What are the inoculators usually used for medical devices?

a) Lactobacillus

b) Bacillus

c) Yeast

d) Nitrifying bacteria

20. The most widely used method for determining sterilization dosage according to ISO 11137 is?

a) The VDmax method

b) Method 1

c) Method 2A

d) Method 2B

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