Stability And Sterility, Assigning Beyond Use Dates

Question 1

A beyond use date for a compounded sterile preparation is assigned by the compounder and is based on _____.

Answer 1

Stability and sterility factors

Question 2

The 5 different types of stability are:

Answer 2

Chemical, physical, microbiological, therapeutic and incompatibility

Question 3

Metronidazole and acyclovir are examples of drugs which are sensitive to cold temperatures. When drugs are exposed to colder temperatures what type of instability occurs?

Answer 3

Crystallization or precipitation (physical or chemical)

Question 4

The consequences of temperature excursions on drugs can include: (4)

Answer 4

Loss of assay, increase of impurities, separation of layers of liquid products, discoloration

Question 5

Drugs exposed to excessive heat greater than 40C can be used if ___

Answer 5

The manufacturer instructs

Question 6

Flexible plastic fluid containers removed from their overwrap are subjected to:

Answer 6

Evaporation, with resultant over concentration of solution

Question 7

Aseptic sterilization methods include:

Answer 7

Filtration

Question 8

The most common cause of compounded sterile preparation microbial contamination is:

Answer 8

Personnel contaminants

Question 9

For a 3in1 TPN a ___ sized filter will remove C. albicans

Answer 9

1.2 micron

Question 10

Membrane filtration and direct innoculation are two methods for sterility tests per USP <71>. WhaT is the incubation period for each method.

Answer 10

Both methods, 14 days

Question 11

2008 USP <797> outlines various risk factors for assigning beyond use dates, which is primarily based on ___. Name these categories.

Answer 11

Potential for microbial contamination; High, Medium, Low risk

Question 12

A CSP is Aseptically prepared in a cleanroom suite using some nonsterile starting ingredients, which have been passed through a 0.22 micron filter into final container. In the absence of conducting a sterility test, what is the maximum BUD that can be applied at room temp per 2008 <797>?

Answer 12

24 hours

Question 13

Per 2008 <797>, what is the maximum room temp BUD that can be assigned to a aseptically prepared TPN with 10 sterile ingredients assuming no stability issues?

Answer 13

30 hours

Question 14

Per 2008 <797>, what is the maximum BUD that can be assigned to a high risk admixture prepared in a cleanroom without performing a sterility test?

Answer 14

45 days

Question 15

A compounding compendium of compounded sterile preparations beyond use dates should be site specific. What three elements are needed?