Sterile and non sterile compounding 7 Flashcards
Can non-Commercially formulations still be compounded?
yes
what should sterile preparations meet?
identity, potency, quality and purity
where should sterile preparations be made?
in a designated area
can sterile and nonsterile substances be compounded in the same area?
no
What is known as the control or the buffer area?
This is where the Laminar flow bench is located, this areas is kept separate from non-sterile compounding.
What is the anteroom used for?
used to decontaminate supplies and equipment
What are the compounding sterile preparations categories?
Low, Medium and High Risk
Which risk involves no more than three commercially available products, and two entries in the sterile compounding bag?
Low risk
Which Risk involves, compounding using aseptic manipulations in an ISO class 5 environment?
Low Risk
Which Risk involves, pooling multiple vials or containers to prepare a CSP for one or more patients
Medium Risk
Which Risk involves a long compounding process
Medium Risk
A high risk, contains ; using a non-sterile formulation to prepare CSP, T or F?
True
Which risk, poses a major threat when it involves mixing sterile ingredients in non-sterile devices?
High Risk
Can compatibility issues arise between a drug and an IV?
yes
What are some factors of incompatibility?
visible or chemical changes
What does the EPA set?
they set laws, on where you should and can dispose of pharmaceutical waste
What are the categories of hazardous waste?
P U K F
What are some characteristics of hazardous waste?
toxicity, corrosivity, ignitability and reactivity
What is labeled as commercial chemical products?
P and U, this includes drugs like chemotherapeutics agents, warfarin and nicotine
hazardous waste should have a seperate controls and have ?
negative pressure room to house engineering controls
What are some antimicrobial preservations?
IV solutions and ophthalmics
What is the meaning of antimicrobial preservations?
used for bacteriostatic preparations to prevent bacteria from growing
What is the meaning of Antioxidants?
prevent oxidation of the component drug
What are chelating agents?
they reduce the toxic effect on metals
emulsifiers?
used to create a uniformed concentrations of an active drug in a solution
pH buffers?
help stabilize a solution against degradation
solute?
a substance dissolved in a solvent
tonicity agent?
help adjust formulations to an appropriate isotonic range
vehicle
serves as solvent
What are some single use containers and what does that mean?
they do not contain microbial preservatives, they can be viles and or ampules
viles should not be used no more than ____ hours after the initial needle puncture
6
open ampules should be stored, True or False?
false; they should not be stored
Multiple use containers have what?
antimicrobial preservatives, this allows for withdrawal of contents over a period of time
what is the BUD on the multiple use container?
28 days
What is the most common glass container that is used in a sterile preparation?
borosilicate
