ISO Classification Location

Question 1

What types of locations are there based on international organization for standardizations (ISO)

Answer 1

• Ante area / Ante room
• Buffer area / Clean room
• Laminar airflow hood (LAFH)

Question 2

The ante area / ante room location is based on what type of air quality?

Answer 2

ISO class 8

Question 3

The clean area / clean room location is based on what type of air quality?

Answer 3

ISO class 7

Question 4

The laminar airflow hood (LAFH) location is based on what type of air quality?

Answer 4

ISO class 5

Question 5

What are the five levels of risks associated with compounded sterile products?

Answer 5

1) Immediate-use category
2) Low-risk level
3) low-risk level with < 12 hour beyond-use date (BUD)
4) Medium-risk level
5) High-risk level

Question 6

What type of risk level association is defined within preparing compounding sterile products for emergency situations where low-risk compounding procedures would lead to an unreasonable delay in therapy, when preparing to use aseptic technique that take less than an hour to compound the formulation and administered in a non-sanitized room that has a BUD of 1 hour (refrigeration or room temperature)?

Answer 6

Immediate-use category

Question 7

What type of risk level association is defined within preparing compounded sterile products by using aseptic technique in a sanitized room with simple admixtures (up to 3 ingredients added with 2 entries into the infusion bag) that use closed system transfer methods that has BUDs of 48 hours (room temperature), 14 days (refrigeration), and 45 days (frozen at a temperature ≤ 10ºC)?

Answer 7

Low-risk level

Question 8

What type of risk level association is defined within preparing compounded sterile products in a ISO Class 5 LAFH of a non-sanitized room with simple admixtures (up to 3 ingredients added with 2 entries into the infusion bag) that use closed system transfer methods with sterile ingredients, and must be administered with 12 hours of preparation, and has a BUD of 12 hours (refrigeration of room temperature)?

Answer 8

Low-risk level with < 12 hour BUD

Question 9

What type of risk level association is defined within preparing compounded sterile products by aseptic technique in a sanitized room with complex manipulations (several ingredients and entries into the bag) or extensive amount of time required to compound (e.g. TPNs and batch compounded preparations) formulations that are used over several days with sterile ingredients that have a BUDs of 30 hours (room temperature), 9 days (refrigeration), and 45 days (frozen at a temperature ≤ 10ºC)?

Answer 9

Medium-risk level

Question 10

What type of risk level association is defined within preparing compounded sterile products in a sanitized room by using non-sterile ingredients (e.g. bulk powders), or using compounding method that involves open system transfers with a improper garb, and has BUDs of 24 hours (room temperature), 3 days (refrigeration), and 45 days (frozen at a temperature ≤ 10ºC)?

Answer 10

High-risk level

Question 11

What are the highlights of aseptic technique?

Answer 11

• Allow LAFH to run 30 minutes before compounding if not in continuous use
• Clean the LAFH with 70% isopropyl alcohol (wipe from top to bottom and back to front; clean all surfaces inside the hood except the screen housing the HEPA filter)
• Remove items from their packaging before placing them inside the hood
• Perform sterile manipulations at least 6 inches inside the outer edge of the hood
• Do not place any objects between the HEPA filter and work area
• Swab surfaces with 70% isopropyl alcohol prior to puncturing (e.g. rubber stopper on a vial)
• Do not block or disrupt the flow of air over the critical sites with hands/fingers when manipulating the objects inside the hood

Question 12

What type of opening method creates an opening pathway between the sterile product contents in a vial container and a syringe needle that to obtain the sterile product contents from the vial container, and commonly known as the rubber stopper?

Answer 12

Critical site

Question 13

Sterile alcohol swabs are soaked in what type of alcohol?

Answer 13

70% isopropyl alcohol

Question 14

What type of container must be used for the disposal of needles?

Answer 14

Red sharps container

Question 15

What is the purpose of of laminar airflow hood (LAFH)?

Answer 15

Creating an environment with very low concentration of particles and microorganisms so that formulations are safe and human infusion can be prepared

Note: LAFH can also be abbreviated as LAFW (laminar airflow workbench)

Question 16

How many air filters is a LAFH equipped with?

Answer 16

2 air filters (1 regular filter and HEPA filter)

Question 17

What type of strainer removes 99.97% of particles from the air that are 0.3 microns (micrometers) or larger?

Answer 17

High Efficiency Particulate Air (HEPA) filter

Question 18

How frequently should a HEPA filter be wiped or sprayed with alcohol?

Answer 18

Never (can cause damage to the filter membrane)

Question 19

The LAFH must be turned on and left running for how many minutes prior to use?

Answer 19

30 minutes

Question 20

Besides running the LAFH for 30 minutes, what else must be done prior to using it?

Answer 20

Cleaning the LAFH with 70% isopropyl alcohol

Question 21

How frequently should a LAFH be cleaned with alcohol when is constant use?

Answer 21

Every 30 minutes

Question 22

To assure that filtered air reaches the critical site, pharmacy technicians must work at least how many inches inside the LAFH?

Answer 22

6 inches

Question 23

In a LAFH, pharmacy technicians want to avoid placing their hands or other objects behind the materials they’re working with in-order to prevent?

Answer 23

Airflow obstruction

Question 24

What type of hood should be used for compounding chemotherapy?

Answer 24

Biological safety cabinet

Question 25

Infusion filters are available with many different pore sizes. Smaller poor sizes filter out more unwanted particles, but are more prone to clogging. What are some examples of unwanted particles that filters are helpful in removing?

Answer 25

• Glass particles
• Rubber fragments
• Dust
• Clothing fibers
• Fungi
• Bacteria

Question 26

What measure of length is equal to one one-millionth of one meter?

Answer 26

Micron

Question 27

What pore size is optional for removing microorganisms, such as bacterial and fungi?

Answer 27

0.22 µm (referred to as a “0.22 micron filter”)

Question 28

What sterile formulation of liquid is delivered by the intravenous infusion?

Answer 28

Total parental nutrition (TPN)

Question 29

What is the difference between total parenteral nutrition (TPN) and total nutrient admixture (TPA)?

Answer 29

• TPNs are a 2-in-1 mixture of amino acids and dextrose (plus electrolytes)
• TPAs are a 3-in-1 mixture of amino acids, dextrose, electrolytes, plus a fat (lipid) component

Question 30

What would happen if you used a 0.22 micron filter on a TNA (3-in-1)?

Answer 30

Filter would be clogged by the lipid component of the TNA

Question 31

What is the optimal pore size for filtering an infusion that contains lipids (as found in a TNA infusion)?

Answer 31

1.2 microns (1.2 µm)

Question 32

What are the benefits of a 1.2 micron filter?

Answer 32

• Good flow of emulsified fat and other contents through the filter
• Low probability of clogging
• Fungi are filtered out

Question 33

What are the drawbacks of a 1.2 micron filter?

Answer 33

Bacteria and other materials smaller than 1.2 microns are not filtered out

Question 34

What is the most important compatibility consideration in TNA preparation?

Answer 34

• Incompatibility between calcium and phosphate where insoluble precipitates will form if the concentration of these two ions are too high
• Described as white and opaque, making it impossible to see the calcium phosphate precipitates

Question 35

How can pharmacy technician minimize the risk of calcium phosphate precipitation?

Answer 35

• Adding phosphate early in the compounding process

- Adding calcium last

Question 36

What can happen when vitamin C (ascorbic acid) is included in a TPN or TNA?

Answer 36

Ascorbic acid degrades to calcium oxalate over time

Question 37

Why are pharmacy technician concerned about precipitate formation?

Answer 37

• Precipitates are solid particles
• Precipitates can get stuck in a blood vessel and block blood flow if infused into the bloodstream
• Patients can experience cardiovascular events (e.g. heart attack, stroke, pulmonary embolism)

Question 38

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 pharmacy technician to use the contents of the vial?

Answer 38

• 1 hour (if the vial is stored in less than ISO Class 5 air)
• 6 hours (if the vial is stored in ISO Class 5 or cleaner air)