Depyrogenation (P3.160)

1. The depyrogenation (dpy) process of glassware and reusable devices must be done

A) 1
B) biweekly
C) once per month
D) prior to each use in sterile compounding
E) once weekly

2. To verify each depyrogenation cycle and it's efficacy

A) repeat process every 6 months
B) use endotoxin challenge vial after depyrogenation commissioning
C) all options are correct
D) use chemical integrator

3. Which type of glassware and/or reusable devices may be placed in the depyrogenation oven?

A) only glassware or devices that can withstand 250 degrees celcius
B) none since everything comes sterile
C) all glassware that will be used for compounding

4. Excluding warm up or cool down times, the dpy process be done:

A) at 375 degrees for 30 minutes or more
B) 2-3hrs at 250 degrees
C) at 250 degrees for 30 minutes or more
D) at 250 degrees for couple of seconds is sufficient

5. Regarding chemical integrator

A) must be the appropriate integrator for depyrogenating
B) must be placed in the hardest to heat location within oven
C) must clearly indicate that desired critical conditions were reached
D) all options are correct

6. When verifying results of dpy cycle, the baked and unbaked vials must have a difference of 1000 fold reduction in endotoxin units.

A) false
B) true

7. After placing temperature probes at the specified test sites for dyp or mimicking such process, the next steps include

A) ensure the difference in temperature between each test site and the set temperature is less than +,- 20 degrees
B) start dpy cycle and allow oven to warm up
C) try to remember temperature measurements by repeating them more than 3 times
D) all options are correct

8. A chemical integrator is a reusable technology that confirms in a quantitative manner in response to a combination of several critical sterilization parameters

A) true
B) false

9. A chemical indicators a disposable technology that confirms in a non-quantitative manner that a given temperature was reached inside of sterilization chamber

A) false
B) true

10. What corrective measures must be taken if the endotoxin challenge vial does not reach a 3-log (1000 fold) reduction in endotoxin units?

A) all options are correct
B) ensure dyp oven is not used for further dyp until cycle efficacy has been verified
C) repeat process
D) contact vendor for appropriate corrective actions when necessary

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