Chapter 12 Flashcards
what are parenteral dosage forms?
sterile preparations intended to be administered by injection through the skin or other external boundary tissue rather than through the alimentary canal
T or F: sterile compounding differs from non sterile compounding primarily by requiring a test of sterility
T
what are the requirements of sterile compounding?
- use of cleaner facilities
- specific training and testing of compounding personnel in principles and practices of aseptic manipulations
- evaluation and maintenance of air quality in the compounding area
- sound knowledge of sterilization
- principles and practices of solution stability
How does the compounding of sterile preparations differ from the compounding of non sterile preparations?
- requires a test for sterility of the finished product
- requires that the principles and practices of aseptic manipulation must be followed
- requires air quality evaluation and maintenance
What chapter is that of pharmaceutical compounding sterile preparations?
USP Chapter 797
Compounded Sterile Preparations is abbreviated as
CSPs
What factors does achieving and maintaining sterility of a sterile product and overall freedom from contamination of a pharmaceutical product depend on?
- the status of components incorporated in the preparation
- The process utilized in preparing the preparation
- The performance of the personnel involved in the preparation
- Environmental conditions under which the process is performed
The standards required for the environmental conditions are governed by
engineering controls
what are the two types of engineering controls that are used to minimize and reduce the potential for airborne contamination in workspaces?
primary and secondary engineering controls
how do primary and secondary engineering controls work?
by limiting the amount of size of contaminants in the compounded sterile preparation processing environment
What do the primary engineering controls generally include?
a. horizontal flow clean benches
b. vertical flow clean benches
c. biological safety cabinets
d. barrier isolators
the primary environmental control must provide at least ___________ quality of air to which sterile ingredients and components are exposed
ISO class 5
what does ISO class 5 air quality mean
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
what is ISO class 5 environment also known as
US class 100 environment
What do the secondary engineering controls generally provide?
a buffer zone or buffer room as a core for the location of the work benches or isolators
In general, the compounded sterile preparation work environment is designed to have ____
the cleanest work surfaces
What do the work surfaces in the compounded sterile preparation work environment include?
horizontal and or vertical work benches, biological safety cabinets, or isolators
Compounding personnel is required by USP to be proficient in performing the following duties:
- perform antiseptic hand cleansing and disinfection of non sterile compounding surfaces
- select and appropriately don protective gloves, goggles, gowns, masks, and hair and shoe covers
- use laminar flow clean air hoods, barrier isolators, and other appropriate contamination control devices
- identify, weigh, and measure ingredients
- manipulate sterile products aseptically, and label and quality inspect compounded sterile preparations (minimize contamination)
Of all the extemporaneously compounded sterile preparations, the most common compounded sterile preparations are
aqueous injections that are solutions
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
T
What are the three microbial contamination risk levels?
low, medium, and high
What are risk levels based on?
the probability of the level of contamination during compounding
microbial contamination means the contamination of the compounded sterile preparation due to
microbial organisms including contamination due to spores and endotoxins
physical contamination means contamination of the compounded sterile preparation due to
foreign chemicals and physical matter
What are the sources of contamination?
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
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?
low risk compounding
Which type of compounding involves only transfer, measuring, and mixing manipulations with closed or sealed packaging systems that are performed promptly and attentively?
low risk compounding
low risk compounding manipulations are limited to ______, ______, and __________.
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
according to USP, controlled room temperature is between
20 and 25 C or 68 and 77 F
for a low risk preparation, the storage at a controlled room temperature should be
no more than 48 hours
for a low risk preparation, the storage at a cold temeperature should be
not more than 14 days
according to USP a cold temperature is considered a
temperature not exceeding 8C or 46F
a low risk preparation, can be kept in a solid frozen state for
not more than 45 days
what is considered a frozen state temperature according to USP
-20C or 4F or colder
what are some examples of low risk preparations?
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
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?
medium risk compounding
on _______ compounding, the compounding process includes complex aseptic manipulation other than the single volume transfer
medium risk compounding
in medium risk compounding, compounding process requires unusually _________, such as that required to complete dissolution or homogenous mixing
long duration
