Chapter 12

Question 1

what are parenteral dosage forms?

Answer 1

sterile preparations intended to be administered by injection through the skin or other external boundary tissue rather than through the alimentary canal

Question 2

T or F: sterile compounding differs from non sterile compounding primarily by requiring a test of sterility

Answer 2

T

Question 3

what are the requirements of sterile compounding?

Answer 3

1. use of cleaner facilities
2. specific training and testing of compounding personnel in principles and practices of aseptic manipulations
3. evaluation and maintenance of air quality in the compounding area
4. sound knowledge of sterilization
5. principles and practices of solution stability

Question 4

How does the compounding of sterile preparations differ from the compounding of non sterile preparations?

Answer 4

1. requires a test for sterility of the finished product
2. requires that the principles and practices of aseptic manipulation must be followed
3. requires air quality evaluation and maintenance

Question 5

What chapter is that of pharmaceutical compounding sterile preparations?

Answer 5

USP Chapter 797

Question 6

Compounded Sterile Preparations is abbreviated as

Answer 6

CSPs

Question 7

What factors does achieving and maintaining sterility of a sterile product and overall freedom from contamination of a pharmaceutical product depend on?

Answer 7

1. the status of components incorporated in the preparation
2. The process utilized in preparing the preparation
3. The performance of the personnel involved in the preparation
4. Environmental conditions under which the process is performed

Question 8

The standards required for the environmental conditions are governed by

Answer 8

engineering controls

Question 9

what are the two types of engineering controls that are used to minimize and reduce the potential for airborne contamination in workspaces?

Answer 9

primary and secondary engineering controls

Question 10

how do primary and secondary engineering controls work?

Answer 10

by limiting the amount of size of contaminants in the compounded sterile preparation processing environment

Question 11

What do the primary engineering controls generally include?

Answer 11

a. horizontal flow clean benches
b. vertical flow clean benches
c. biological safety cabinets
d. barrier isolators

Question 12

the primary environmental control must provide at least ___________ quality of air to which sterile ingredients and components are exposed

Answer 12

ISO class 5

Question 13

what does ISO class 5 air quality mean

Answer 13

that the number of paritcles having a particle size of 0.5 um and larger contained in the environment does not exceed 3520 particles per cubic meter

Question 14

what is ISO class 5 environment also known as

Answer 14

US class 100 environment

Question 15

What do the secondary engineering controls generally provide?

Answer 15

a buffer zone or buffer room as a core for the location of the work benches or isolators

Question 16

In general, the compounded sterile preparation work environment is designed to have ____

Answer 16

the cleanest work surfaces

Question 17

What do the work surfaces in the compounded sterile preparation work environment include?

Answer 17

horizontal and or vertical work benches, biological safety cabinets, or isolators

Question 18

Compounding personnel is required by USP to be proficient in performing the following duties:

Answer 18

1. perform antiseptic hand cleansing and disinfection of non sterile compounding surfaces
2. select and appropriately don protective gloves, goggles, gowns, masks, and hair and shoe covers
3. use laminar flow clean air hoods, barrier isolators, and other appropriate contamination control devices
4. identify, weigh, and measure ingredients
5. manipulate sterile products aseptically, and label and quality inspect compounded sterile preparations (minimize contamination)

Question 19

Of all the extemporaneously compounded sterile preparations, the most common compounded sterile preparations are

Answer 19

aqueous injections that are solutions

Question 20

T or F: according to USP, personnel who prepare compounded sterile preparations must be provided with appropriate training in the theoretical principles and practical skills of aseptic manipulation before they begin to prepare compounded sterile preparations

Answer 20

T

Question 21

What are the three microbial contamination risk levels?

Answer 21

low, medium, and high

Question 22

What are risk levels based on?

Answer 22

the probability of the level of contamination during compounding

Question 23

microbial contamination means the contamination of the compounded sterile preparation due to

Answer 23

microbial organisms including contamination due to spores and endotoxins

Question 24

physical contamination means contamination of the compounded sterile preparation due to

Answer 24

foreign chemicals and physical matter

Question 25

What are the sources of contamination?

Answer 25

solid and liquid matter from compounding personnel and objects

non sterile components employed and incorporated before terminal sterilization

inappropriate conditions within compounding area

prolonged pre sterilization procedures with aqueous preparations

non sterile dosage forms used in compounding

Question 26

Which type of microbial contamination risk level is compounded with aseptic manipulation entirely within ISO class 5 or better quality environment using only sterile ingredients, products, components, and devices?

Answer 26

low risk compounding

Question 27

Which type of compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are performed promptly and attentively?

Answer 27

low risk compounding

Question 28

low risk compounding manipulations are limited to ______, ______, and __________.

Answer 28

aseptically opening ampuls
penetrating sterile stoppers on vials with sterile needles and syringes
transferring sterile liquids in sterile syringes to sterile administration devices and packages of other sterile products

Question 29

according to USP, controlled room temperature is between

Answer 29

20 and 25 C or 68 and 77 F

Question 30

for a low risk preparation, the storage at a controlled room temperature should be

Answer 30

no more than 48 hours

Question 31

for a low risk preparation, the storage at a cold temeperature should be

Answer 31

not more than 14 days

Question 32

according to USP a cold temperature is considered a

Answer 32

temperature not exceeding 8C or 46F

Question 33

a low risk preparation, can be kept in a solid frozen state for

Answer 33

not more than 45 days

Question 34

what is considered a frozen state temperature according to USP

Answer 34

-20C or 4F or colder

Question 35

what are some examples of low risk preparations?

Answer 35

single transfers of sterile dosage forms form such containers as ampules, bottles, bags, and vials using sterile syringes with sterile needles

single transfers of sterile dosage forms from other administration devices and other sterile containers

single transfers of sterile dosage forms from ampules and the contents of ampules require sterile filtration to remove any glass particles

manually measuring and mixing no more than three manufactured products to compound drug admixtures and nutritional solutions

Question 36

What type of compounding involves multiple individual or small doses of sterile products combined or pooled to prepare a compounded sterile preparation that will be administered either to multiple patients or to one patient on multiple occasions?

Answer 36

medium risk compounding

Question 37

on _______ compounding, the compounding process includes complex aseptic manipulation other than the single volume transfer

Answer 37

medium risk compounding

Question 38

in medium risk compounding, compounding process requires unusually _________, such as that required to complete dissolution or homogenous mixing

Answer 38

long duration