Stability And Sterility, Assigning Beyond Use Dates Flashcards
A beyond use date for a compounded sterile preparation is assigned by the compounder and is based on _____.
Stability and sterility factors
The 5 different types of stability are:
Chemical, physical, microbiological, therapeutic and incompatibility
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?
Crystallization or precipitation (physical or chemical)
The consequences of temperature excursions on drugs can include: (4)
Loss of assay, increase of impurities, separation of layers of liquid products, discoloration
Drugs exposed to excessive heat greater than 40C can be used if ___
The manufacturer instructs
Flexible plastic fluid containers removed from their overwrap are subjected to:
Evaporation, with resultant over concentration of solution
Aseptic sterilization methods include:
Filtration
The most common cause of compounded sterile preparation microbial contamination is:
Personnel contaminants
For a 3in1 TPN a ___ sized filter will remove C. albicans
1.2 micron
Membrane filtration and direct innoculation are two methods for sterility tests per USP <71>. WhaT is the incubation period for each method.
Both methods, 14 days
2008 USP <797> outlines various risk factors for assigning beyond use dates, which is primarily based on ___. Name these categories.
Potential for microbial contamination; High, Medium, Low risk
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>?
24 hours
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?
30 hours
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?
45 days
A compounding compendium of compounded sterile preparations beyond use dates should be site specific. What three elements are needed?