The Sterile Compounding Environment

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Chapter 2

The Sterile Compounding Environment

2012 Paradigm Publishing

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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.


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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


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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


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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 washinga place to stage components and supplies prior to entering

the clean roomserves as a transition area that helps to maintain required

air pressure levels


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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


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Most sterile compounding pharmacies secure a sticky mat to the floor at the doorway leading into the clean roomplaced on the less sterile side of that doorwayintended 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 surfacerefer to your pharmacy’s Policy and Procedure (P&P)

manual


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Limit storage items to materials that are directly required for sterile compound preparationsyringes, 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


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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.


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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


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Clean Room Setup and Characteristics…/3

PECs, such as horizontal laminar airflow hoods, should be placed within the clean roomwithin 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


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Cleaning of the Anteroom and Clean Room

USP Chapter <797> provides clear guidelines for the cleaning of the pharmacy’s anteroom and clean roomdisinfect countertops and other surfacesmop floors with a nonshedding mop designate cleaning supplieswipe down the walls, ceilings, and storage bins


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Maximum Particle Count

ISO Class Name (in particles of 0.5 micron and larger per cubic meter of air)

3 35.24 3525* 35206 35,2007 352,0008 3,520,000


Cleaning of the Anteroom and Clean Room…/2

*The ISO Class 5 rating is synonymous with “Class 100.”

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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 airnumbered from Class 3 to Class 8, with a higher number

designating a greater allowance for particulate matter


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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


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You must record the same information about the clean-room-cleaning procedures as you record about anteroom-cleaning proceduresdo so on separate clean-room-cleaning log sheets


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Your Turn


1) This a place where sterile compounding personnel can garb and perform aseptic hand washing.a. clean roomb. employee loungec. anteroomd. supply room

2) The particulate matter in the clean room should be no more thana. ISO Class 4.b. ISO Class 5.c. ISO Class 6.d. ISO Class 7.

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Types of Hoods Requiredfor 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


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Types of Hoods Requiredfor Sterile Compounding…/2

The most widely used sterile compounding hood in the pharmacy is the horizontal LAFW


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CAI and CACI Hoodsmost 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


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Advantages of the CAI and CACI Hoodstwo 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 Hoodslimited capacity, increased demand on the worker’s time,

and logistical issues or costs associated with proper venting


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BSC Hoodspecial 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


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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 filterkeep the prefilter-replacement

checklist in a plastic sheet protector in the anteroom


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USP Chapter <797> Guidelines for Hoods…/2


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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


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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


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Risk Levels in Sterile Compounding…/2

Low-Risk CSPsinvolves 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


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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


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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


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Immediate-Use CSPsaccording 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


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Potential Contaminants in the Sterile Compounding Environmentpathogenic contaminants may include bacteria, viruses,

fungi, hair, dander, or particulate mattertouch contamination carries the potential for serious harm

to the patientshadowing is caused by incorrect techniquethe area immediately behind an item within the hood is a

zone of turbulence and is considered to be contaminated


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Potential Contaminants in the Sterile Compounding Environment…continuedthe six-inch band along the outer edge of the hood is a

poor environment for preparing sterile productsyou may hear this area referred to as the six-inch zone or

the contamination zone of the hoodinspect all parenteral preparations for precipitates and

particulate matterincorrect needle insertion can lead to coringadditives that are incompatible might form a precipitate or

show other evidence of incompatibility


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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


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Your Turn


3) All of the different hood types may be referred to asa. 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. shadowingb. touch contaminationc. zone of turbulenced. pathogenic contaminants

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The Sterile Compounding Environment

Health & Medicine

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