What does the international organization for standardization do?
defines air-quality based on the number of particles in the air
There are how many classes of air-quality relevant to pharmacy?
Three (ISO class 8, ISO class 7, ISO class 5)
What is ISO class 8 ?
3,520,000 particles or less (of size .5 microns or larger) per cubic meter of air (Ante room)
What is ISO class 7?
352,000 particles or less (of size .5 microns or larger) per cubic meter of air (Buffer area)
What is ISO class 5?
3520 particles or less (of size .5 microns or larger) per cubic meter of air (Laminar Flow Hood)
The principles of sterile compounding are referred to as what?
Aseptic technique
What is the critical site?
And editing that provide a pathway between the contents of a sterile product container and the environment. A common example of this is the rubber stopper on a file in the needle of a syringe used to obtain the contents from the vile. When the needlepunch
Sterile alcohol swabs are soaked and what type of alcohol?
70% isopropyl alcohol
What type of container must be used for the disposal of needles?
A red sharps container
What is the purpose of a laminar air flow hood?
To create an environment with a very low concentration of particles in micro organisms said formulations safe enough for human infusion can be prepared
How many air filters is a laminar air flow hood equipped with?
2 air filters (one regular filter & one HEPA filter)
What is a HEPA filter?
High efficiency particulate air. It removes 99.97% of particles from the air that are .3 microns or larger
How frequently should you wipe or spray a HEPA filter with alcohol?
Never. This would damage the filter membrane
The laminar air flow hood must be turned on and left running for how many minutes prior to use?
30 minutes
Besides being running it for 30 minutes, what else must be done prior to using a LAFH?
It must be cleaned with 70% Isopropyl alcohol
How frequently should a LAFH be cleaned with alcohol when in constant use?
Every 30 minutes
To assure that air reaches the critical site, you must work at least how many inches inside the laminar air flow hood?
6 inches
In a LAFH, you want to avoid placing your hands or other objects behind the materials you are working with to prevent what?
Airflow obstruction
What type of hood should be used for compounding chemotherapy infusion?
A biological safety cabinet
Infusion filters are available with many different pore sizes. Smaller pore sizes filter out more unwanted particles, but are more prone to clogging. What are some examples of unwanted particles that filters are helpful removing?
Glass particles, rubber fragments, dust, clothing fibers, fungi, bacteria
What is a micron?
a measure of length equal to one-millionth of one meter
What pore size is optimal for removing microorganisms, such as bacteria and fungi?
0.22 micron filter
What is total parenteral nutrition?
A sterile formulation of liquid nutrients delivered by intravenous infusion.
What is the optimal pore size for filtering an infusion that contains lipids (as found in a TNA infusion?)
1.2 microns
What are benefits of a 1.2 micron filter?
Good flow of emulsified fat and other contents though the filter, low probability of clogging, fungi are filtered out
What are drawbacks of a 1.2 micron filter?
Bacteria and other materials smaller than 1.2 �m are not filtered out
What is the most important compatibility consideration in TNA preparation?
The incompatibility between calcium and phosphate. If the concentration of these two ions is too high, insoluble precipitates will form. Due to the lipid content, TNA are white and opaque, making it nearly impossible to see calcium phosphate precipitates
How can you minimize the risk of calcium phosphate precipitation?
By adding phosphate early in the compounding process and adding calcium last
What issue must be considered when including insulin in a TNA or TPN?
Up to 50% of the insulin will bind to the surface of the inside of the bag and administration set (tubing)
What can happen when vitamin C (ascorbic acid) is included in a TPN or TNA?
over time, ascorbic acid degrades to oxalate, which quickly binds with calcium to form an insoluble precipitate called calcium oxalate
Why are we concerned about precipitate formation?
Precipitates are solid particles. If a solid particle is infused into a patients bloodstream, it can get stuck in a blood vessel and block the flow of blood. Tis can lead to a cardiovascular event
Many vials say "single dose" on the label, indicating that the contents are preservative free. Once the stopper of a single-dose vial is punctured, in what time frame must you to use the contents of the vial?
-if the vial is stored in less than ISO Class 5 air, you have 1 hour to use it
-if stored in ISO Class 5 or cleaner air, you have 6 hours to use it
The higher the gauge......
the thinner the needle
What sizes do syringes range?
1, 3, 5, 10, 20, 30, 60
What are you never supposed to do with used needles?
recap then
What are some common signs of incompatibility when mixing meds for IV administration?
gas formulation (bubbles), precipitate formation (solid particles), turbidity (cloudiness), color change
What are beyond-use dates (BUDs)important for?
Non-sterile repackaged drug products, compounded preparations, and open vials containing sterile medication for injection.
Multi-dose vials (insulin) have a BUD of how many days after initial use?
28 days
Which chapter of the USP Compounding Compendium provides guidance on good compounding practices in preparing non-sterile compounded drug products?
USP Chapter 795
What is a diluent?
An inactive product used to dilute an active pharmaceutical ingredient
What is trituration?
The process of reducing the particle size of a powder, usually by use of a mortar and pestle
What is "sensitivity requirements"?
The mass needed to move the balance marker by one space. For a Class A prescription balance, the sensitivity requirement is 6 mg
What is geometric dilution?
The process of expanding the weight of the active pharmaceutical ingredient by adding an inert substance (i.e. diluent) in a fashion that yields a homogeneous mixture. In more simplified terms, you dilute he active ingredient and mix it well to ensure eve
What is the purpose of geometric dilution? (see example on page 169)
Many drug doses are very small (in the microgram to milligram range). Accurately measuring these small doses can be difficult. To obtain an accurate measurement, you have two options: 1) use a highly sensitive analytical balance or 2) dilute the drug to m
How do you perform geometric dilution?(see example on page 169)
Take the active pharmaceutical ingredient and add an equal amount of diluent. Triturate the mixture until you are convinced it is homogeneous. Then add an equal amount of diluent to the mixture and triturate as before. Repeat the steps until all of the in
What is the percent error? (% error)
it refers to the accuracy of a measurement. For instance, 5% error means that the measurement is within +/- 5% of the actual value. In pharmacy, the highest acceptance percent error is usually 5% but can be even less in some cases
How are the "sensitivity requirement" and "percent error" related?
in the following equation:
Sensitivity requirement
% error= --------------------------------- x 100%
Desired weight