Compounding 1 Flashcards
Who sets the standards for compounding?
USP
USP 795, 797, and 800 are considered the
minimal acceptable standards
Hospital pharmacists rely on the __________for guidance on implementing USP standards
American Society of Health-System Pharmacists (ASHP)
Non-Sterile compounding is used to:
1.) Prepare a dose or formulation that is not commercially available.
2.) Avoid an excipient.
3.) Add a flavor
Non sterile compounded preparations
PO, via tubs, rectally, vaginally, topically, nasally, in the ear
Simple non sterile compounding
Requires following instructions (using a compounding kit, etc.)
Moderate non sterile compounding
Involves specialized calculations or procedures or making a product with no established stability data
Complex non sterile compounding
Requires specialized training, equipment, facilities, or procedures
Example- transdermal
Non sterile compounding physical space requirements
Space should be specifically designed for non-sterile compounding.
Can be ambient (room) air, but must be separated from the dispensing part of the pharmacy.
Everything must be stored off the floor.
Two types of water needed
What is purified water used for in non sterile compounding?
Water-containing formulations, rinsing equipment and utensils
Which formulations require sterile compounding?
IV
IM
SC
Eye drops
Radiopharmaceuticals
Irrigations
Inhalations
Who sets the standards for air quality?
ISO
What is air quality determined by?
Particles per volume of air.
The lower the particle count, the cleaner the air
Air quality in critical areas for sterile compounding
ISO 5
(closest to exposed drug)
Particles are included in the air quality count if the are
0.5 microns or larger
Buffer area for sterile compounding
ISO 7
Anteroom for sterile compounding
ISO 8 if non hazardous
ISO 7 if hazardous
Particles in ISO 5 environment
3,520
Particles in ISO 6 environment
35,200
Particles in ISO 7 environment
352,000
Particles in ISO 8 environment
3,520,000
HEPA filters are ___________efficient at removing particles ______
> 99.97%
as small as 0.3 microns
Where is the HEPA filter in a vertical airflow BSC or CPEC?
At the top
Where is the HEPA filter in a laminar airflow workbench or PEC?
At the back
Horizontal airflow