Chapter 14: Sterile Preparations and
Admixture Programs
Introduction
Increased attention to high-risk
medicationshave greatest potential to
cause adverse drug events ( drug toxicity
& route )
High-Alert Medications: Safeguarding
against Errors intravenous route was
the most common in med errors detected
in pediatric inpatients
USP IV route often results in most
serious medication error outcomes
IV route by =pass 3 physiologic
safeguards:
o Gut breakdown medications
o Liver protects pts from toxic
doses & safeguard pt from 1st
pass effect
o Skin protects pts from
pathogenic microoganisms
Patterson concerns about drug
incompatibilities, length of time bet
preparation & administration
Flack reported being asked of
technical help from pharmacy service
Thur nurses preparing parenterals with
an error rate of 21%
Most hospitals use the minibag system to
administer medications by IV route
Sanders RPh had an error rate of 7.24%
& contamination of 7% ( higher than of
PharTech )
USP Chap 797: Pharmaceutical
Compounding-Sterile preps establishes a
national enforceable std.
compounding non-hazardous
hazardous sterile preparations
o Mandates RPh to take
responsibility
Quality Assurance in Compounding Sterile
Preparations
Pyrogens ( bacterial endotoxins )
o Metabolic products of living / dead
microorganisms that cause a pyretic
( rise in body temp ) response upon
injection
Components
Compounded Sterile Preparations
( CSPs ) dose od medication that are
prescribed for a patient that must be
prepared for adminis. and is sterile
o Comprised of Components that are
clean. Sterile, and pyrogen-free as
purchased from phar.manuf.
Individual ingredients,
containers and closures
used to compound sterile
preps.
For high-risk compounding:
o Not sterile and may not be pyrogen-
free
o Use a USP grade chemical or
o Obtain a certificate of quality
analysis
Standard Operating Procedures (SOPs)
o Set of instructions someone follows
to complete a job safely, w/ no
adverse impact on the environment,
meets standards, optimizes
operational & production
requirements
Sterility must be achieved: by Filtration
( sterile, disposable, nonreactive, 0.2
micron porosity membrane filter )
Low & medium risk preparations:
Maintain quality level built into product
by manufacturer
Low risk levels involves only transfer,
measuring, & mixing manipulations using
not more than 3 packages of sterile
products & not more than 2 entries into
any 1 sterile container
Medium risk level multiple indiv / small
doses of sterile products are combined to
prepare a CSP ; includes a complex
aseptic manipulations other than single-
vol transfer & in a long duration
High risk level contains nonsterile ingre,
including manuf, products not intended
for strile routes ; or a nonsterile device is
employed before sterilization ; exposed
to air quality worse than ISO Class 5 for
more than 1 hour ; not verified by
examination of labeling, chem purity
for Compatibility and Stability
& Most widely used reference: Trissels
handbook of Injectable Drugs
Unexpected compatibility problems may
be visible immediately of w/in a few
hours
Stability considerations are broader and
include overall assurance of integrity of
formulation
Batch Formulas and Records
Master formula sheets provide exact
directions on the standard compounding
Batch control record documents the
completion of these tasks & identifies
each step has been followed for each
indiv. Batch
Environmental Controls
Primary Engineering Controls (PECs)
a device / room that provides an ISO
class 5 envi.
USP Chapter 797 requires all sterile
compdg, regardless of risk level, be done
in an ISO class 5 environment ( fewer
than 100 airborne particles larger than
0.5 microns per cubic foot )
 Key engineering control devices designed
to sweep the Direct Compounding Area
o A critical area w/in ISO Class 5
PEC where critical sites are
exposed to HEPA filter or First Air
air from HEPA filter in an
unidirectional air stream
that is particle free
Laminar Airflow Workbench (LAFW)
o Primary engineering control
created by a high-efficiency
particulate air (HEPA) filter to
retain airborne particles and
microorganisms
o Decreases the chance of microbial
contamination during
compounding
** Biological Safety Cabinet (BSC)
o Ventilated cabinet for CSPs,
personnel, product,
environmental protection having
an open front w/ inward airflow for
personnel protection, downward
HEPA-filtered laminar airflow for
product, & HEPA-filtered
exhausted air for environmental
protection
Compounding Aseptic Isolator (CAI)
o Isolator designed
compounding pharmaceutical
preparations
o Designed to maintain an aseptic
compounding environment w/in
isolator
o Air exchange into isolator from
environment should not occur
( unless air has first passed a
microbially retentive filter
HEPA )
** Compounding Aseptic Containment
Isolator (CACIs)
o Provide worker protection from
exposure to airborne drugs
o Air exchange bet envi. Should not
occur unless first passed to a
HEPA filter
o ** Hazardous drugs are prepared
(air should be removed 100% by
ventilation)
If studies in animals /
humans indicate that
exposure has potential for
causing cancer,
developmental toxicity,
harm
99.97% efficiency of HEPA filter
Secondary Engineering Controls
USP chap 797 requires a buffer area
around PECs that meets ISO class 7
( fewer than 10,000 airborne particles
larger than 0.5 microns per cubic foot )
Buffer area
o Area where PEC is physically located
; preparation and staging of
components and supplies used
when compounding CSPs
Ante area
o ISO class 8 or better air quality area
where personnel perform hand
hygiene, & garbing procedures,
staging of components, order entry,
CSP and other high particulate-
& generating activities
Low & medium risk prep may be
compounded w/o physical separation bet
ante & buffer area
High-risk require anteroom separate from
buffer
Surfaces should be smooth, impervious,
free from cracks & crevices &
nonshedding
for Junctures of walls should be coved /
caulked
No dust collective ledges, pipers,
Stainless steel or molded plastic
Clean air flow should be outward from
DCA through the buffer, then through
ante area by cascading differential air
pressures
Cleaning & Disinfecting
Cleaning floors, walls, ceilings should be
performed w/ a mild detergent solution
( hospital disinfectant ) using a
nonshedding, absorbent mop, wipe /
sponge
Sterile 70% isopropyl alcohol: for LAFW,
BSC or CAI
Cleaned & disinfected at least monthly:
shelves, carts, countertops
Cleaned daily: floors
Traffic Control