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    Watch Your Step:IV Room Flow with USP 797

    Eric Kastango MBA, RPh, FASHP

    ClinicalIQ, LLC

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Disclaimer

    Although I am a member of the USP CompoundingExpert Committee, I am speaking today in my

    individual capacity and not as a member of the

    Committee or as a USP representative.

    The views and opinions presented are entirely my own.They do not necessarily reflect the views of USP, nor

    should they be construed as an official explanationor interpretation of .

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    The sculptor produces the beautiful statue

    by chipping away such parts of the marble

    block as are not needed -

    it is a process of elimination.

    - Elbert Hubbard

    ClinicalIQ content,2011 ClinicalIQ, LLC

    Food for Thought

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    Question

    How do you apply best practice recommendations,

    In your particular physical plant,

    With your particular equipment,

    To your particular types of CSPs,

    Using a thoughtful, deliberate and consistentapproach,

    In a way that eliminates waste,

    And results in predictable outcomes?

    ClinicalIQ content copyright 2011

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    Answer

    Theres not one right way.

    Since the characteristics of theCSPs you compound, the types ofequipment you use and theattributes of your physical plantconfigurations may be different,then solutions may be different.

    Today, well explore someexamples of how to step throughthe compounding process takingall of these factors into account.

    ClinicalIQ content copyright 2011

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    CSP Compounding Workflow

    Before

    DuringAfter

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Examples of Steps in a the CSP Workflow

    BeforeFormulary Development

    Drug/Supply procurement

    Inventory Control

    ReceivingTracking

    Storage

    Rotation

    Quarantine

    Recall events

    Compounding processstandardization

    Development batch andpatient-specificcompounding records

    Check orders

    DuringUse batch and patient

    specific documentation topull and stage components

    Label printing

    Component fulfillmentdouble check

    Removal of packaging andouter wraps

    Disinfect components

    Controlled movement of

    personnel, equipment andcomponents into thecleanroom

    Area clearance procedures

    Compounding

    AfterArea Clearance

    Reconciliation procedures

    Final CSP labeling

    CSP storageQuarantined awaiting final

    testing results

    CSPs approved fordispensing

    Quarantined for anyfailures

    Pull product from readyinventory

    Quality check beforedispensing

    CSP transport

    CSP delivery

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Map Out Your Workflow

    Map it out in a way that makes sense to you.

    On the following slides, we will show you twoexamples of a workflow map which are used withpermission.

    Notice the diagrams on the following page portraythe same physical plant.

    The first diagram portrays personnel-related SOPsand the 2nd portrays product-related SOPs.

    During this webinar well use an example of each asa means of discussing how to think about and designyour own process flow.

    ClinicalIQ content copyright 2011

  • 7/31/2019 i Vroom Flow

    9/42BD, BD Logo and all other trademarks are property

    of Becton, Dickinson and Company 2008 BD.

    Personnel-Related

    SOPs

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    Product -related

    SOPs

    BD, BD Logo and all other trademarks are property

    of Becton, Dickinson and Company 2008 BD.

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    Personnel Related SOP

    What is garbing order?

    Generally dirtiest to

    cleanest

    May differ depending

    on how your ante-areais laid out

    May be foot covering

    first or maybe hair

    covering first. Where is your sink

    located?

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Why is Proper Garbing Important?

    People are particle generators.

    Even though we cant see it, weshed over 1 million skin cells perhour and those cells containmicroorganisms!

    The human body harbors an averageof 150-200 different classes ofbacteria.

    The body sheds 5 grams of skin

    fragments each day along withshedding 1 layer of skin every 5 days(size range 10 to 300 micron 1000th

    of a mm).

    ClinicalIQ content,2011 ClinicalIQ, LLC

    Stratum Corneum: surface of skin

    composed of dead skin cells

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    Poll Question

    YES OR NO Do you wear two pairs of shoe covers when compounding

    hazardous drugs?

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Suggested Best-Practice Garbing Order

    1 Don shoe covers (or dedicated shoes) one at a time stepping over the line of demarcation as each

    shoe cover is donned.*If doing HD compounding, don an extra pair of shoe covers

    2 Don Head Cover (a second hair cover?)

    3 Don Facial Hair Cover (as required)

    4 Don Eye Shields (optional unless working with HDs or irritants such as cleaning ceilings with designated disinfectingagent)

    5 Don Facial Mask (check in mirror to make sure that all hair is covered)

    6 Remove debris from under nails and wash hands up to the elbows with (non-antimicrobial or

    antimicrobial) soap and warm water for at least 30 seconds

    7 Don Low-Shedding Gown

    8 Perform antiseptic hand cleansing with waterless alcohol-based surgical hand scrub with

    persistent activity according to manufacturers recommendations. Allow hands to dry.

    9 Don Sterile Gloves (may optionally be performed in Buffer Area)

    *donning shoe covers may be performed before stepping over LOD but before performing hand hygiene

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    Suggested Best-Practice Degarbing Order

    1 Walkout of buffer area into the ante area before removing and discarding sterile gloves.

    2 Remove face mask and gown.

    3 Keep hairnet, facial hair cover and shoe covers on until on the other side of line of

    demarcation (dirty side).

    4 Wash hands.

    5 Exit the area and discard the remaining cleanroom garb.

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    Huh? Does this make sense?

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Poll question

    YES or NO Should this garbed person be allowed to go back into the

    buffer area to continue compounding without re-garbing?

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Line ofDemarcation(LOD)

    ClinicalIQ content,2011 ClinicalIQ, LLC

    Product Related Metric

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    Line of Demarcation

    Proposed Definition A visible line on the floor that separates the room into

    areas for different purposes. For example, in the ante area,the line separates the clean and dirty sides of theroom. When the line of demarcation separates twodifferent ISO classification areas, it must be accompaniedby a minimum air velocity of 40 fpm from the cleaner areato the less clean area.

    USP PF 36(3)

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    What is a LOD?

    Air quality same on both sides

    LOD is the line in the sand wherewe begin to systematically reducelevels of bioburden and

    particulates.

    If there is no pass through, thenthe LOD can act as the point oftransfer for supplies or

    compounding batches beingtransferred IN and OUT of theclean area.

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Suggested SOPs

    Carts used to bring supplies from the storeroom cannot berolled beyond the demarcation line in the ante-area, and cartsused in the buffer area cannot be rolled outward beyond thedemarcation line unless cleaned and disinfected beforereturning.

    Generally, supplies required for the scheduled operations ofthe shift are wiped down with an appropriate disinfectingagent and brought into the buffer area, preferably on one ormore movable carts.

    Supplies that are required for back-up or general support ofoperations may be stored on the designated shelving in thebuffer area, but excessive amounts of supplies are to beavoided.

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    USP Proposed Changes

    797 Pharmaceutical CompoundingSterile Preparations,USP 32 page 318.As a result of frequentlyasked questionsfrom compounding practitioners and continuousreassessment of the chapter by the USP Sterile CompoundingExpert Committee, the following sections contain revisions:

    Immediate-Use CSPs,

    Hazardous Drugs as CSPs,

    Radiopharmaceuticals as CSPs,

    and the subsection Viable and Nonviable Environmental Air Sampling

    Testing of Environmental Quality and Control.

    Two additional definitions have also been requested.

    ClinicalIQ content,2011 ClinicalIQ, LLC

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    Free Access to Pharmacopeial Forum

    www.usp.org/USPNF/pf/

    ClinicalIQ content,2011 ClinicalIQ, LLC