3: Sterile compounding Flashcards
assure continuation of the quality guaranteed by the manufacturers of parenteral drugs and solutions which are compounded by the clinical, hospital, and home healthcare pharmacy
institution objective
Most direct parenteral =
IV
environmental contaminants include
particulate matter microorganisms allergens pyrogens drug residues
line clearance
sanitizing environment for drug residues
fever causing residues of dead and decomposing microorganisms
pyrogens
2 main systems of demonstrating product quality
quality control
quality assurance
_________: Release test for sterile products: pyrogen free + sterility test (requires 2 weeks of incubation- not practical in hospital setting)
quality control
system’s demonstrated ability to produce good produces that meets specifications
proof of quality or validation
Validation is accomplished by performing a
simulation of the actual process using microbiological growth media in place of the product = indirect
is quality assurance direct or indirect
indirect- also known as validation
T or F: Quality assurance also requires proof that the validated system is continuing to operate as it should
T
the product is acceptable if the process and personnel have been validated and regular monitoring detects no deterioration of operating conditions
process auditing
process auditing is part of
quality assurance
T or F: validation alone is enough to prove product acceptability
F- also requires process auditing
_______ controls: reduce contamination potential
Engineering
______ controls: to reduce contamination transfer
Barrier
_______ control: to reduce contamination events
Personnel
Used to produce work environment that is free of airborne contaminants that is easy to clean and disinfect
enginnering controls
primary engineering controls
Produce a critical work zone with sterile supply air where aseptic manipulations are done
secondary engineering controls
Used to create a buffer zone between the critical work zone and outside environment
2 primary engineering controls in pharmacies (hood)
Laminar flow cleaning bed (LFCB)
Laminar flow workbench (BSC)
what can’t you use in hoods
hazardous things, cytotoxic powders
HEPA filter efficiency
at least 99.95%
HEPA filter made with
fiberboard frame and continuous neoprene gasket
filter medium of HEPA filter
paper link material made of borosilicate glass which is pleated around aluminium separator to increase filtration area
uninterrupted clean air issuing directly from the HEPA filter face
first air