Chapter 2

2. Topics2
Chapter 2
The Sterile Compounding
Environment
2012 Paradigm Publishing

3. Topics3
Learning Objectives
 Identify the origin of the pharmacy clean room and procedures
for sterile compounding.
 Describe anteroom and clean room setup and characteristics.
 Understand the various ISO levels that are appropriate for
sterile compounding.
 Identify the different types of hoods used for sterile
compounding.
 Classify the four sterile compounding risk levels.
 Recognize potential contaminants in the sterile compounding
environment.
2012 Paradigm Publishing

4. Topics4
Topics
 Learning Objectives
 Introduction
 Anteroom Setup and Characteristics
 Clean Room Setup and Characteristics
 Cleaning of the Anteroom and Clean Room
 Types of Hoods Required for Sterile Compounding
 USP Chapter <797> Guidelines for Hoods
 Risk Levels in Sterile Compounding
 Chapter Summary
2012 Paradigm Publishing
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5. Topics55
Introduction
 Some changes necessitated by USP Chapter <797>
have required pharmacies to undergo extensive and
costly renovations
 Specialized HVAC equipment, clean rooms
constructed of nonporous materials, and strictly
regulated air pressure and humidity control serve to
create appropriate anteroom and clean-room
environments that are low in particulate matter
2012 Paradigm Publishing

6. Topics66
Anteroom Setup and Characteristics
 The anteroom, which may also be called the
transition area or ante-area, provides a space where
sterile compounding personnel can garb and perform
aseptic hand washing
a place to stage components and supplies prior to entering
the clean room
serves as a transition area that helps to maintain required
air pressure levels
2012 Paradigm Publishing

7. Topics77
Anteroom Setup and
Characteristics…/2
 Most sterile compounding
pharmacies have an
anteroom that is separate
from the clean room
small facilities that perform
only low- or medium-risk
sterile compounding may
create an ante-area that is
separated from the clean
room by a simple line of
demarcation
2012 Paradigm Publishing

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Anteroom Setup and
Characteristics…/3
 Most sterile compounding pharmacies secure a
sticky mat to the floor at the doorway leading into
the clean room
placed on the less sterile side of that doorway
intended to help compounders avoid tracking dirt into the
sterile compounding area
 At a designated frequency, you must remove the top
layer of the mat to expose a fresh sticky surface
refer to your pharmacy’s Policy and Procedure (P&P)
manual
2012 Paradigm Publishing

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Anteroom Setup and
Characteristics…/4
 Limit storage items to materials that are directly
required for sterile compound preparation
syringes, needles, vials, and supplies used in aseptic hand
washing or hood cleaning procedures
 Avoid storing compounding supplies long-term
 Never store materials with a high potential for
shedding
 Wipe down all supplies with sterile 70% isopropyl
alcohol (IPA) prior to transporting them
2012 Paradigm Publishing

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Anteroom Setup and
Characteristics…/5
2012 Paradigm Publishing

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Clean Room Setup and
Characteristics
 The clean room is the innermost room
also referred to as the IV room or the buffer area
 Access is restricted to properly trained and garbed
personnel
 Bring only those supplies needed
 Do not locate computers, printers, or other devices
into the clean room
 Surfaces must be smooth, nonporous, and easy to
clean.
2012 Paradigm Publishing

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Clean Room Setup and
Characteristics…/2
 A pharmacy-designated HVAC system should pump
HEPA-filtered air into the clean room to create a
positive-pressure environment
ensures that the airflow moves from the clean room
outward, through the anteroom, and continuing in the
direction of the outer pharmacy area
helps to minimize the travel of dust, spores, and other
particles from the outer rooms into the clean room
2012 Paradigm Publishing

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Clean Room Setup and
Characteristics…/3
 PECs, such as horizontal laminar airflow hoods, should
be placed within the clean room
within each airflow hood, the area closest to the hood’s
HEPA filter is called the direct compounding area (DCA) and
also referred to as “first air”
you perform sterile compounding procedures in the DCA
 To avoid disrupting the airflow from the HEPA filter,
personnel working in the hood should minimize their
movements
2012 Paradigm Publishing

14. Topics1414
Cleaning of the Anteroom and Clean
Room
 USP Chapter <797> provides clear guidelines for the
cleaning of the pharmacy’s anteroom and clean
room
disinfect countertops and other surfaces
mop floors with a nonshedding mop
designate cleaning supplies
wipe down the walls, ceilings, and storage bins
2012 Paradigm Publishing

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Maximum Particle Count
ISO Class Name (in particles of 0.5 micron and larger per cubic meter of
air)
3 35.2
4 352
5* 3520
6 35,200
7 352,000
8 3,520,000
2012 Paradigm Publishing
Cleaning of the Anteroom and Clean
Room…/2
*The ISO Class 5 rating is synonymous with “Class 100.”

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Cleaning of the Anteroom and Clean
Room…/3
 The International Organization for Standardization
(ISO) creates worldwide industrial and commercial
standards that often become law
 USP Chapter <797> identifies several ISO categories,
or classes, that classify the amount of particulate
matter in room air
numbered from Class 3 to Class 8, with a higher number
designating a greater allowance for particulate matter
2012 Paradigm Publishing

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Cleaning of the Anteroom and Clean
Room…/4
 In general, the particulate matter contained in
regular room air within a pharmacy should be at or
above the ISO Class 8 range
 At the next level of stringency, the particulate matter
in the pharmacy anteroom must be no greater than
ISO Class 8
 Stricter still, the particulate matter in the clean room
should be no more than ISO Class 7
 The air within the DCA of a hood must be ISO Class 5
2012 Paradigm Publishing

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Cleaning of the Anteroom and Clean
Room…/5
 You must record the same information about the
clean-room-cleaning procedures as you record about
anteroom-cleaning procedures
do so on separate clean-room-cleaning log sheets
2012 Paradigm Publishing

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Cleaning of the Anteroom and Clean
Room…/6
2012 Paradigm Publishing

20. Topics2020
Cleaning of the Anteroom and Clean
Room…/7
2012 Paradigm Publishing

21. Topics21
Your Turn
2012 Paradigm Publishing
1) This a place where sterile compounding personnel can garb and
perform aseptic hand washing.
a. clean room
b. employee lounge
c. anteroom
d. supply room
2) The particulate matter in the clean room should be no more than
a. ISO Class 4.
b. ISO Class 5.
c. ISO Class 6.
d. ISO Class 7.
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22. Topics2222
Types of Hoods Required
for Sterile Compounding
 All of the different hood types may be referred to as
primary engineering control (PEC)
 Sterile compounding personnel perform their work in
the following hood types: the compounding aseptic
isolator (CAI), the compounding aseptic
containment isolator (CACI), the biological safety
cabinet (BSC), and the laminar airflow workbench
(LAFW)
the hoods’ design, function, and operation differ in a
number of important ways
2012 Paradigm Publishing

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Types of Hoods Required
for Sterile Compounding…/2
 The most widely used
sterile compounding
hood in the pharmacy
is the horizontal LAFW
2012 Paradigm Publishing

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Types of Hoods Required
for Sterile Compounding…/3
 CAI and CACI Hoods
most useful in sterile compounding
environments where relatively few
preparations are made each day
may also be called a barrier isolator
or an isolator cabinet
personnel place their hands inside
the gloves and reach through the
inner pass-through window
CACI provides greater protection for
the worker
2012 Paradigm Publishing

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Types of Hoods Required
for Sterile Compounding…/4
 Advantages of the CAI and CACI Hoods
two primary advantages: offers a safer environment for the
worker, and it is not mandatory to place them in an ISO
Class 7 environment
 Disadvantages of the CAI and CACI Hoods
limited capacity, increased demand on the worker’s time,
and logistical issues or costs associated with proper
venting
2012 Paradigm Publishing

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Types of Hoods Required
for Sterile Compounding…/5
 BSC Hood
special hood for preparing
hazardous compounds such
as antineoplastic drugs and
other chemotherapy
medications
the worker stands behind
the shield and places the
hands into the cabinet to
manipulate the sterile
compound
2012 Paradigm Publishing

27. Topics2727
USP Chapter <797> Guidelines for
Hoods
 Most hoods share a
common design such that
room air enters the cabinet
through a prefilter that
filters out large particles
that might damage the
HEPA filter
keep the prefilter-
replacement checklist in a
plastic sheet protector in the
anteroom
2012 Paradigm Publishing

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USP Chapter <797> Guidelines for
Hoods…/2
2012 Paradigm Publishing

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USP Chapter <797> Guidelines for
Hoods…/3
 Each hood should have its
own, separate checklist
 Keep the checklists inside a
plastic sleeve or sheet
protector that can be
wiped down to prevent
dust buildup
 Always place the checklists
in the same designated
location in the anteroom
2012 Paradigm Publishing

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Risk Levels in Sterile Compounding
 USP Chapter <797> defines four microbial
contamination risk levels associated with the
creation of CSPs
 The risk levels are provided as a guide for sterile
compounding personnel to determine the potential
for contamination in various compounding scenarios
 The pharmacy supervisor is responsible for
determining the risk level of CSPs
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/2
 Low-Risk CSPs
involves the mixing of no more than three commercially
packaged sterile products, and no more than two separate
injections into the sterile container, all done aseptically,
within an ISO Class 5 workbench
many low-risk CSPs are prepared daily in every IV room
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/3
 Medium-Risk CSPs
meets all of the conditions associated with low-risk sterile
product preparation and also involve other, more complex,
sterile compounding procedures
the preparation of a total parenteral nutrition (TPN)
solution is a medium-risk activity because it involves
multiple injections of several medications into an IV bag
that is designed to be administered over a 24-hour period
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/4
 High-Risk CSPs
meet all of the conditions of the low- and medium-risk
groups and also involve the preparation of medications
wherein one or more of the products being prepared is not
sterile or the product is prepared in an environment that is
less stringently controlled, or more risky, than ISO Class 5
the two most common sterilization methods include
filtration sterilization, which is accomplished by passing
the liquid medication through a 0.2-micron filter, or heat
sterilization, which is achieved by autoclaving the
compounded solution
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/5
 Immediate-Use CSPs
according to the USP <797> Guidebook, are “intended only
for those situations where there is a need for emergency,
or immediate, patient administration of a CSP
must be administered within one hour of preparation
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/6
 Potential Contaminants in the Sterile Compounding
Environment
pathogenic contaminants may include bacteria, viruses,
fungi, hair, dander, or particulate matter
touch contamination carries the potential for serious harm
to the patient
shadowing is caused by incorrect technique
the area immediately behind an item within the hood is a
zone of turbulence and is considered to be contaminated
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/7
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/8
 Potential Contaminants in the Sterile Compounding
Environment…continued
the six-inch band along the outer edge of the hood is a
poor environment for preparing sterile products
you may hear this area referred to as the six-inch zone or
the contamination zone of the hood
inspect all parenteral preparations for precipitates and
particulate matter
incorrect needle insertion can lead to coring
additives that are incompatible might form a precipitate or
show other evidence of incompatibility
2012 Paradigm Publishing

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Risk Levels in Sterile
Compounding…/9
 Excellent aseptic technique is the foundation of
sterile parenteral product preparation
 As an IV technician, you must ensure that all policies
and procedures are followed at all times
 Failure to follow aseptic technique guidelines may
lead to contaminated parenteral products that could
transfer pathogens to patients
 Appropriate conduct in the clean room, combined
with correct technique and careful inspection of final
products, will help to guarantee the sterility of CSPs
2012 Paradigm Publishing

39. Topics39
Your Turn
2012 Paradigm Publishing
3) All of the different hood types may be referred to as
a. primary engineering control.
b. secondary engineering control.
c. primary engineering class.
d. secondary engineering class.
4) This is caused by incorrectly placing objects within the hood.
a. shadowing
b. touch contamination
c. zone of turbulence
d. pathogenic contaminants
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