Aseptic Technique and USP 797 Definitions Asepsis is the state
of being free from the presence of pathogenic microorganisms.
Septicemia is the presence of microorganisms in the blood Septic
shock is the condition of overwhelming infection of the blood by
septicemia. Aseptic technique is the procedure used to maintain an
aseptic environment in which to compound sterile products CSPs
Aseptic technique strives to maintain surgical asepsis. (meaning
complete sterility and lack of endotoxin )
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USP 797 rules United States Pharmacopeia 797 chapter on
compounding of sterile products (CSP) was published in the 27 th
revision to USP on January 1 st, 2004 USP 797 is applicable to all
facilities where compounded sterile products (CSP) are made, stored
and sent to the patient USP 797 applies to the aseptic technique
used to make CSPs as well as the environment in which it is done
(secondary engineering controls)
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Issues addressed by USP 797 Aseptic techniques used to prepare
CSP Evaluation of personnel in USP 797 standards Growth medium
testing (media fill test with soy/casein) Fingertip testing
Cleanroom and antiroom construction Class of BSC Air cleaness,
defined as ISO5 or in old terminology class 100
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Microbial Risk Levels in USP 797 Low risk CSP Made under ISO5
conditions Involves aseptic transfer of manufacturer based sterile
products using sterile equipment (i.e Needles and syringes) to
compound IV admixtures. Does not involve open systems and no more
than 3 components Medium Risk CSP More than three components are a
part of the IV admixture (i.e TPNs) CSP dont contain antimicrobial
preservative and product is given over more than 2 days Complex
preparation involved High Risk CSP Compounding of manufactured
ingredients that are non sterile and then performing terminal
sterilization Performing compounding in conditions outside
ISO5
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Risk Levels and Expiration Dating Low Risk CSP 48 hrs at room
temperature 14 days under refrigeration 45 days frozen state Medium
Risk CSP 30 hrs at room temperature 7 days at refrigeration 45 days
at a frozen state High Risk CSP 24 hours at room temperature 72
hours refrigerated 45 days at a frozen state.
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Hospital Compounding For the most part you may be preparing
only low or medium risk CSPs Example of a low risk CSP Making a 250
ml SVP with 1.25 gram of vancomycin under ISO5 conditions Example
of a medium risk CSP Compound a triple mix TPN with additional
additives of insulin, multiple vitamin injections, and other
electrolytes Example of high risk CSP Compounding a sterile
ophthalmic solution from a manufactured product that is not sterile
and passing solution through a 0.22 micron filter several
times
Slide 7
Air Quality and Cleanness ISO stands for international
organization for standardization ISO was formed in 1947 in Geneva
Switzerland Provides different levels of air quality cleanness ISO
5 means no more than 100,000 particulates micrometer or larger per
cubic meter of air. By contrast, room air is classified as ISO9
which is no more than 1,000,000,000 particulates per cubic meter.
(a ten thousand fold difference)
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Anteroom Usually consists of a storage area, an area for
records, computers and printers, an buffer area for gowning Has ISO
class 8 standard Has a sink equipped with surgical scrub soap
(Chlorhexidine), and has handfree or pedal activated water systems
Has the following characteristics: Smooth walls with panels locked
and sealed Vinyl covered floor with seals heated together Joints
and junctures between walls and ceilings must be chauked with no
visible cracks.
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Clean Room The room where the LAFW hoods are located Means same
physical characteristics as anteroom No sinks and floor drains If
facility only compounds low and/or medium risk CSPs the clean and
ante rooms need not be separated. Area immediately next to LAFW
hoods is called buffer area If all risk levels are compounded clean
and ante rooms must be separated. Must be maintained as a positive
room air pressure environment if separated.
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Structure of USP 797 defined Cleanroom REST OF THE PHARMACY
Cleanroom: Positively pressured, Houses BSC Vinyl flooring ISO 8
environment Negatively pressured for chemo or hazardous drugs
Anteroom Vinyl flooring Maybe ISO 8 environment Contains sink for
hand hygiene Gowning apparel
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Maintaining of ante and Cleanrooms Cleaning requirement BSC or
LAFW = beginning of shift, before each preparation, 30 minutes into
the procedure, when surface is visible contaminated Cleaning of all
floor surfaces daily from the buffer area outwards, from the clean
room out to anteroom. Countertops: daily Cleaning and disinfection
of all shelving surfaces at least monthly Walls, Ceilings: monthly
Documentation of such maintained Cleaning solvent required by USP
for ISO5 and countertops: Isopropyl Alcohol USP 70%
Slide 12
Laminar Air Flow Hoods and Workbenchs LAFH and workbenchs are
designed to blow parallel sheets of sterilized clean air over a
work surface The hood is usually washed and disinfected with 70%
isopropranol by a pharmacist at the beginning and end of the shift.
Washing is from top to bottom of the hood and back to front in the
direction of laminar flow. HEPA filters remove over 99% of
particles, including microorganism 0.3 microns or larger. When
cleaning the HEPA filter grill do not spray the filter always spray
the sterile gauze pads and clean the surface of the grill If the
HEPA Laminar flow hood is turn off for any reason then it must be
turn on for at least 30 minutes before commencing any IV
preparation. Horizontal Laminar Flow Hood: the HEPA filter is at
the back of the hood and blows laminar air towards the operator
Vertical Laminar Flow Hoods: the HEPA filter is on the top of the
hood and laminar air flow sheets are blown to the work surface and
not to the operator Also called a biological safety cabinet Must be
recertified every 6 months
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Biological Safety Cabinets Class I open system that draws air
from the cleanroom Class II air is recirculated through vents in
the front and back and passed though a HEPA filter on the top of
the cabinet back down to the worksurfaces. Four types A, B1, B2,
and B3 Type A is not vented to the outside Type B1,B2,B3 all
provide some or all exhaust to the facilitys external vent system.
Class III are completely enclosed system under negative pressure
which are vented. Manipulation by the operator are with a gloved
apparatus through the front of the cabinet
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Preparing to make an IV product Enter the antiroom with slow
and deliberate movement. Remove jewelry and tie back loose hair.
Put on shoe coverings (booties) and then proceed to anteroom. Don
hair cap, beard cover (if needed) and surgical mask if working with
a hood with no front panel then don lint free bunny suit. This
equipment is called Personal Protective Equipment (PPE) Wash hands
up to the elbows for 30 seconds and rinse hands first allowing
water to drip down to elbows Donn powder free surgical latex gloves
Enter cleanroom
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When in the cleanroom Before placing the drug product, IV bag,
etc in the BSC Clean the BSC From top to bottom From the inside
outside direction Clean with 70% isopropyl alcohol Clean the
surface of all IV vials, IV bags with 70% isopropyl alcohol
Sterilize gloves or replace
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Remove all caps to vials. Swab each vial with alcohol swab from
back to front once with swab. Swab medication port of the IV bag
that you will use. All products should be 6 inches inside the hood.
Arrange materials in such as way as to not block any of the laminar
flow air currents. Once inside the hood, your hands should not
leave the inside of the hood. If they do you will need to sanitize
your gloves before returning to the hood area. Always remember not
to touch critical areas
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The following are critical areas which must not be touched. All
parts of the needle. The hub of a luer lok syringe The ribs of the
piston of the syringe. The injection port of the IV bag. The rubber
entry port of the vial
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Remember, touch is the number one cause of product
contamination. Human skin harbors many organisms: Staphylococci,
Streptococci, Actinobacter, Candida, Tricophyton Rubrum fungi,
Pseudomonas, etc. Contaminated IV products can cause bacteremia and
fungemia, septic shock and death. I will demonstrate aseptic
technique in class with reference to drug manipulation.
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The Finished products If you are a pharmacy technicians that
will be performing IV admixtures. Always leave the following item
for the RPH to check: All vials used in the process All syringes
used in the process drawn back to the volume you used. All
information recorded in the IV prep log book: Patients name,
medical record number, drugs, concentrations, volumes used, lot
number and manufacturers expiration. Assigned a pharmacy expiration
date (usually 24 hours at room temperature)
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A great reference to use to determine drug-drug, drug-IV
solution compatibilities is a book called, Trissels Handbook on
Injectable Drugs Common causes of physical and chemical
incompatibilities are: Drugs mixed in low pH solutions, like D5W
Drugs mixed in hypertonic solutions, like D5WNS Drugs mixed in
incorrect IV mediums. Such drugs are not compatibility in the PVC
container of an IV bags; these drug are mixed in glass IV
containers. A class example is nitroglycerin which is used for
patients with acute MI. Drugs mixed with other drugs that complex
each other.
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Type of Parenteral Products Injections are products that are
already mixed into solutions. Solutions are pH buffered, sterile,
pyrogen free with methylparabens, benzyl alcohol preservatives
Packaged in Vials Ampules Single doses Vials Have no preservatives
Once open, use and discard Multiple Doses Vials Have preservatives
Once open 28 days exp Courtesy of
:http://www.hospira.com/en/products_and_services/drugs/FENTANYL_CITRATE
Slide 22
Type of Parenteral Products For Injections : products that are
lyophilized powders that require addition of water to form a
solution a given concentration. Usually these products are single
dose Courtesy of
:http://www.hospira.com/en/products_and_services/drugs/CEFTRIAXONE
Slide 23
IV Labeling Labeling rules are governed by the state, non
governmental agencies guidelines (JCAOH, USP797) Include the
following: Patients name, location in institution, MRN Drug and
strength Base fluid Name of other additives and quantities of The
intended time of administration of drug Rate of administration if
LVP (or hang time if SVP) Prep by field and Verified by field
Product expiration field In addition a nursing label may be
attached detailing: When product was hung (i.e. started) By whom
the product was hung
Slide 24
IV products that require special handling Some IV products
require special handling and precautions These drugs are loved to
be tested by PTCE Paclitaxel (Taxol) requires non PVC IV tubing
Nitroglycerin Injection requires glass container for IV and non PVC
IV tubing Nitroprusside Injections requires the same as
nitroglycerin and the IV tube must be covered by a light resistant
material to prevent from light degradation Lipid Emulsion also
require non PVC, non DHEP IV tubing
Slide 25
Parenteral Therapy Intravenous Therapy (IV) involves injecting
a medication directly into the blood via venous access devices IV
products must be sterile and pyrogen free with no particulate
matter in the solution Intramuscular Injection (IM) involves
injection into the large belly of a muscle Subcutaneous Injection
(SubQ) involves injection in the hypodermis of the skin Epidural
Injection involves injection next to the dura mater of the spinal
cord Intrathecal Injection involves injection into the subarchnoid
space of the meninges
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ALL THESE PRODUCTS MUST BE STERILE AND PYROGEN FREE IN ADDITION
EPIDURAL AND INTRATHECAL INJECTION MUST BE PRESERVATIVE FREE IN
ADDITION TO STERILITY Preservative free is required for epidural
injections Coutesy of: http://www.drugs.com/pro/duramorph.htm
l
Slide 27
Type of IV Therapy IVP or Intravenous push involves insert a
needle and syringe directly in a VAD (vascular access device) IV
Infusion Large Volume Parenteral involves a large volume of fluid
given IV over a long period of time (1,000 ml) Often called a drip
with given continuously SVP or a small volume parenteral is a small
volume of fluid (50 ml to 100 ml) given IV over a short period of
time (10 minutes or so) Often called an intermittent infusion IVPB,
intravenous piggyback is a type of SVP that is infused along with a
LVP
Slide 28
Source: wikimedia commons page
Slide 29
Venous Access Devices Catheters that are inserted into the
antecubital vein and is called a peripheral line The catheter is
usually made of Teflon (a material that does not trigger phlebitis)
Entry into the vein is evident with blood in the flash back chamber
The hub of the catheter is a female connection that is made to
receive a connection called a male luer lok connection Often a
short tube with a access port called a heparin or saline lock is
attached to the hub of the catheter to provide a port to inject IV
therapy http://www.youtube.com/watch?v=s-vTzQkUQd8
Slide 30
A larger catheter that is inserted into the larger vein of the
neck (commonly the subclavian vein) is commonly called a central
line Central Lines are used to deliver TPN, and larger volumes of
hypertonic fluids rapidly. Also it is meant to deliver vasopressor
agents in the ICU Types of Central Catheters Hickman Lines are
tunneled to the jugular vein under the skin and is used to deliver
chemo and other potent drugs. Broviac lines are similar and used in
children
Slide 31
Primary IV Infusion Sets These infusion sets are made of PVC
and DHEP and meant to carry the fluid from an IV bag to the hub of
a IV catheter or a saline/Heparin lock This tube consists of a
piercing pin, drip chamber, an in line filter and several Y site IV
ports for the administration of the secondary IV fluids through a
piggyback system Used to deliver a LVP over several hours
Slide 32
Secondary IV administration sets Secondary IV administration
sets are used to deliver smaller volumes of drug containing fluids
of about 50- 100 ml In general this tube has a piercing pin, drip
chamber, and a roller clamp and male luerlok. In general this
tubing has no Y site ports The connection is attached to the Y site
of a primary line
Slide 33
1 liter of NS or D5W Administration set port Addition port Drip
chamber INFUSION SET UP
http://www.youtube.com/watch?v=N0rCuC2XE1U