Download pharm tech 2016-2017 class 7 ch 34 thru 37

Ch 34: Sterility
O What is sterility?
O The absence of pathogenic bacteria
O Why is sterility so important?
O When a product is given parenterally we bypass the
body’s normal defenses
O some areas of the body have a limited ability to fight
bacterial infection, (ie, the eye)
© 2013-2015
Pyrogenic Contamination
O Pyrogens are endotoxic products of bacteria
O You may have a product that is free of bacteria, yet still
contains these pyrogenic compounds
O Pyrogens cause a fever in the host body
O Our goal is for our product to be both sterile and non-
pyrogenic
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Aseptic Technique
O The process of assuring sterility through our actions
O Everything we do during sterile product compounding
must insure that contamination of the product does
not occur
O The primary contamination factor in the process is
the operator
© 2013-2015
Basic Tools of the Trade
O The Syringe
O Needles and Filters
O The Medication Bottle
O The Laminar Flow Hood
O The IV Bag
O IV Administration Sets
O Personal Protective Equipment
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The Syringe
O Meant to measure, deliver, and administer sterile
fluids
O Parenteral syringes are packaged sterile in a
protective wrapping that is also sterile inside
O Syringes may be packaged with or without a needle
attached
O Available in sizes from 0.5 ml to 50 ml
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The Parts of a Syringe
Tip
Barrel
Scale of
Measurement
Ring of Piston
used to read
the volume
Plunger Piston
Collar
Plunger
Thumb Lip
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Scales used on a syringe
O Depends on the intended purpose of the syringe
O May be marked in milliliters or “units”
O Be sure you are using the correct type and size of
syringe
O select the scale based on the type of material
O select the size based on the amount of material
© 2013-2015
Reading a Syringe
O Always use the plunger
ring closest to the tip to
read the volume
contained in a syringe
4ml
1
2
3
4
5
O This syringe contains 4
ml of liquid
© 2013-2015
Needles
O Come in various
lengths and diameter
O The measure of a
needle’s diameter is
called its “gauge”
O The more viscous the
solution to be drawn
into the syringe, the
smaller the gauge
number on the
needle should be
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The Parts of a Needle
Bevel
Shaft
Hub
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The Bevel of a Needle
This is what the tip of
a needle looks like
when magnified
approximately 150
times
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Needles
O Remember, the LARGER the gauge number, the
THINNER the needle
O Therefore, a 29g needle will be much thinner than an
18g needle
O Length has nothing to do with diameter
O You can have a 3 inch 22g needle or a 1 inch 18g
needle
O Shorter doesn’t mean larger diameter
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Special Types of Needles
O There are many special types of needles
O We will normally only see two types of specialty
needles in the pharmacy:
O Filter needles
O Safety needles
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The Filter Needle
O Looks just like a normal needle except in the hub of
the needle there is a filter
O Can catch contaminants either when drawing into
the syringe OR when discharging from the syringe,
BUT..
O The same filter needle should never be used to both
withdraw and discharge because the filter action
would be nullified
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The Safety Needle
O Meant to help minimize accidental needle sticks
O Comes in more than one type:
O Retractable needle and syringe
O Once the contents of the syringe are completely
discharged, a harder press on the plunger causes the
needle to retract into the hub and body of the syringe
O Mechanical needle guard
O Sliding mechanism attached to the needle hub that
slides down and covers the point of the needle
© 2013-2015
Safety Precautions with Needles
O NEVER try to recap a
needle if there is a sharps
container that you can use
immediately
O ALWAYS dispose of
needles in a biohazard
sharps container
O NEVER put them in a
general trash container
© 2013-2015
The Multiple Use Vial
O The most common
O Plastic or glass with a rubber
stopper secured by a metal ring
O Has preservatives that allow safe
use after the stopper has been
punctured
O Once it has been punctured a
maximum of a 30 day expiration
date should be written on the
bottle
© 2013-2015
Removing Medication from a
Multiple Use Vial
O Flip off the protective plastic cap from the top of the
rubber stopper
O Swab the rubber stopper with a 70% isopropyl
alcohol swab and let dry
O Since the internal chamber of the vial is sealed, air
must be added to the vial to allow the material
inside to come out without creating too big of a
vacuum
© 2013-2015
Problem of “Coring”
O Whenever a needle pierces a rubber stopper, rubber
“cores” from the stopper may be produced
O You NEVER want a rubber core in the final product!
O Cores will appear as little rubber specks inside your stock
bottle or product
O always check the stock bottle & finished product
against a white background to look for these dark
colored specks
O We must minimize the production of cores
© 2013-2015
Preventing Cores
O Always pierce the stopper
with the bevel of the needle
facing UP
O Always apply pressure
backward and down as you
push the needle through the
stopper
© 2013-2015
What if our Stock Bottle
Already has a Core?
O The vial should be marked to indicate its presence
O Use a filter needle to withdraw the contents from the
stock bottle, then replace the needle with a regular
needle before injecting the solution into the product
© 2013-2015
Adding Air to the Vial
O You never want to add so much air into the vial that
you create a positive pressure inside
O if you did, the pressure would shoot the contents out of
the vial, and into the air, as you withdraw the needle
O Always add slightly less air than the volume you wish
to remove
O this will keep a slight negative pressure in the vial
O If too much vacuum develops, you can pierce the
stopper with a needle by itself allowing the inner and
outer pressure to equalize
O this will keep a slight negative pressure in the vial
© 2013-2015
Reconstitution in Vials
O Drugs contained in vials that require reconstitution
give us another procedure for equalizing pressure
O With these drugs a volume of water or other diluent
must be added to reconstitute the drug
O To do this without leaving pressure in the vial, first
inject the liquid, then while leaving the needle in the
stopper, allow the excess air to return into the
syringe and equalize the pressure
© 2013-2015
Glass Ampules
O Made entirely of glass
O Only for a single use
O Any excess medication must
be discarded
O The internal chamber is not
closed to the outside
environment
O Manufactured so that there is
a fracture line around the neck
of the ampule
© 2013-2015
Before Opening a Glass
Ampule
O Be sure all of the medication is out of the head of
the ampule and contained in the main body
O If it is not, you can move it using one of these
methods
O swirling the ampule in an upright position
O tapping the head with you finger
O turning the ampule upside down and then righting it
with a swift swinging motion
© 2013-2015
Opening a Glass Ampule
O Swab the neck with 70% isopropyl alcohol
O Leave the alcohol swab wrapped around the neck
O Place the head of the ampule between the thumb
and first finger of one hand
O Hold the body of the ampule with the thumb and first
finger of the other hand
© 2013-2015
Opening a Glass Ampule
O Quickly “snap” the top off the
ampule by applying pressure with
both thumbs away from yourself
O If the ampule does not open easily,
rotate it so that a different side of
the neck is facing you and try again
O The ampule should open easily
O Be careful not to apply so much
pressure as to crush the glass
between your thumb and finger
© 2013-2015
Withdrawing the Contents
O Since the internal chamber is not sealed, no injection
of air is necessary
O In order to eliminate any risk of glass fragments or
paint chips being withdrawn from the container, a
filter needle or filter straw must be used
© 2013-2015
USP 797 Standards and
Requirements
O Covers
O Technique
O Equipment
O Quality control
O Requirements depend on the type of compounding
done
O Concepts
O Clean room= holds compounding area
O Ante room= supplies, storage, sink
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Requirements to Compound
Sterile Products
O Clean Room
O Air cleanliness
O Microbial contamination
O Preparation Area
O Laminar Flow Hood
O Compounding Equipment
O Sterile Materials
O All materials used to compound or package sterile
products must be sterile themselves
© 2013-2015
Sterile Compounding Environment
O The environment present during sterile compounding
has a great influence on the final product.
O The room where the compounding takes place is
called the “Cleanroom”
O The actual compounding will take place within a
specialized piece of equipment known as the
“Biological Safety Cabinet” or “Laminar Flow Hood”
© 2013-2015
Reducing the Risk of Contamination
O Cleanroom practices
O separate room
O no unnecessary traffic
O proper attire
O proper cleaning
O positive air pressure
O Biological Safety Cabinet / Laminar Flow Hood
O creates a protected work environment
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ISO Standards
O ISO Class refers to the number of particles of a
certain size contained in a cubic meter of air
O ISO Class depends on area
O Ante Room= ISO Class 8
O Clean Room= ISO Class 7
O Critical Areas= ISO Class 5
O Air quality must be tested every 6 months or
whenever equipment is moved in the room
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Laminar Flow Hoods
O First efforts at maintaining
an environment suitable for
sterile compounding
O Provides columns of purified
air blown across the work
area
O High Efficiency Particulate
Air Filter (HEPA)
O All sterile product work
should be conducted within
the hood
© 2013-2015
Types of Laminar Flow Hoods
O Horizontal Flow Hoods
O first type used
O airflow blows horizontally across the work surface
O not appropriate for hazardous chemicals or biological
products
O Vertical Flow Hoods
O airflow blows vertically down onto the work surface
O protects the user more than the horizontal flow does
O Not the best choice for hazardous chemicals or
biological products
© 2013-2015
Workspace
HEPA Filter
Horizontal Flow Hood
© 2013-2015
Vertical Flow Hood
HEPA Filter
Workspace
© 2013-2015
Biological Safety Cabinets
O Newer hoods than the horizontal or vertical laminar
flow hoods
O Still functions using columns of air blown through
filters
O Adds filtration of air exhausted either to the room or
outside through the exhaust duct
O There are three classes of BSCs
© 2013-2015
Class I BSC
O Incoming air in a Class I BSC
is NOT filtered
O NEVER use a Class I BSC to
prepare a compound where
sterility is desired
© 2013-2015
Class II BSC
O There are three categories of
Class II BSCs
O Vary by how much air is
recirculated inside the workspace
O ALL Class II BSCs are suitable for
sterile product preparation
O Still has an opening in front where
the operators arms enter the work
area
© 2013-2015
Class III BSC
O Totally enclosed and leak proof
systems that are exhausted
through the building’s external
exhaust system
O No air is returned to the room
O Access to the work area is only
through arm length gloves built
into the unit, or double door passthrough boxes on the side
O Very expensive to purchase and
operate
© 2013-2015
Isolators
O Similar in appearance to Class III
BSC
O Exhausted outside the work area
O Has solid front with arm length
gloves and pass-through
O Isolators recirculate more of the
air inside the workspace than do
Class III BSCs
© 2013-2015
HEPA Filter
O Thin pleated sheets of boron silicate fibers separated
by aluminum
O Removes 99.997% of all particles 0.3 microns or
larger
O NEVER touch the HEPA filter with anything
O NEVER spray anything on the filter
© 2013-2015
HEPA Filter
O Health of the filter is tested by air flow rates coming
through the filter surface
O Filter should be inspected every 6 months by a
professional service
O The filter blower should run 24 hours a day
O if, for some reason, the blower has been shut off, the
unit must run for at least 20 minutes before work can
commence
© 2013-2015
ULPA Filter
O “Ultra-Low Particle Air Filter”
O Newer filter design that is closely related to the HEPA
filter, yet offer more efficient filtration
O Designed to remove 99.999% of all particles 0.12
microns or larger
O BSCs are available with HEPA and ULPA filters
© 2013-2015
Personal Protective Equipment
- Scrubs
- Shoe covers
- Hair covers
- Face mask
- Hand washing facility
- Sterile gown
- Foaming isopropyl alcohol hand
sanitizer
- Sterile gloves
PPE also protects the patient from you!
© 2013-2015
Proper Hand Washing
O Correct Equipment Needed
O Sink the appropriate size, preferably with foot controls
for water flow
O Surgical scrub/brush package
O Contains antibacterial soap and aseptic lint-free paper
towels
O Correct method to wash hands
© 2013-2015
Working in the Hood
O Remove unnecessary jewelry or personal articles
O Wash your hands with antibacterial scrub
O Put on the appropriate protective equipment
O Assemble the necessary stock bottles, syringes,
and other equipment OUTSIDE the hood
O Wipe the hood down with alcohol and allow to dry
© 2013-2015
Working in the Hood
O Whenever working in the hood or BSC,
remember the concept of “First Air”
O First air is the un-disrupted air flow coming
directly from a HEPA or ULPA filtration source
O It is the “cleanest” air in the workspace
O Anything that interrupts the flow of clean air
causes turbulence in the air flow and
introduces the chance of particles in the air
O ALWAYS work in areas containing First Air
© 2013-2015
Working in the Hood
O Arrange all of the materials inside the hood, to the
O
O
O
O
right or left of the area in which you will work
Bring all of the materials in at once – do not keep
reaching in and out of the hood
Never block airflow to an item with your hands
(maintain First Air conditions)
Swab all rubber stoppers and IV ports with alcohol
swabs
Anytime a syringe is uncapped, the point should
always be facing the HEPA filter
© 2013-2015
Working in the Hood
O Draw up all ingredients into separate syringes and let
the pharmacist check your work
O Once approved, and with the pharmacist’s consent,
you may inject the ingredients into the IV bag
O Immediately label the IV bag and place a protective
cap over the admixture port of the bag
© 2013-2015
Cleaning the Hood
O At least daily
O wet all surfaces with bactericidal cleaner, let stand
for the appropriate time and wipe clean
O Several times throughout the workday
O wipe all the hood surfaces down with 70% isopropyl
alcohol
REMEMBER – NEVER TOUCH, OR SPRAY
ANYTHING ON, THE HEPA FILTER
© 2013-2015
Wiping Procedure
O When wiping down the hood, always follow the proper
sequence:
O use a side to side wiping motion beginning with the
area closest to the HEPA filter and proceed towards
the open edges
O all side walls and hanging racks should be wiped
similarly
O if the hood has been used to compound
chemotherapy drugs, discard the cleaning towels in
a biohazard bag
© 2013-2015
Administration of an IV
Product
The IV Administration Set
Can be for manual
calibration or for use
with an infusion pump
© 2013-2015
Infusion Pumps
O Infusion pumps
electronically control the
flow of IV fluid through
the tubing
O Each manufacturer uses
their own pump design
and their own
corresponding
administration sets
© 2013-2015
Filtering Parenteral Solutions
O Can be contained within the
administration set or as a
separate entity
Separate Filter
O Filters out particles as small as
0.22 microns
O Provides final insurance of a
product’s sterility (filter traps
bacteria)
In-Line Filter
© 2013-2015
Ch 35: It’s time for MATH!
O Often times we are expected to calculate a dose of
medication that is appropriate for a particular patient
O You need to be able to calculate a dose for an adult
or a pediatric patient for the examination
© 2013-2015
Calculating Adult Doses
O Simple mathematical process
O Be sure that you read the question CAREFULLY and
calculate for the correct units and time periods
O Is the weight and recommended dose in the same
units of weight?
O Is the question asking for the amount per dose, the
daily dose, or the total amount to be dispensed?
© 2013-2015
Adult Doses
O The recommended adult dose of “Drug X” is
40mg/kg/d
O What does this mean?
O for every kilogram the patient weighs, they will receive
40mg of the drug per day
© 2013-2015
Adult Doses
O Let’s say the patient weighs 110 kg. Calculate the
daily dose
Weight
x
Dose
= Answer
110 kg
X x 40mg = 4,400mg = 4,400mg
1
1X
kg
1
© 2013-2015
Try Another
Recommended dose = 25mg/kg/q8°
Patient’s weight = 80kg
O What is the amount to give for each dose?
O What is the total amount given in 24 hours?
© 2013-2015
Answer
Weight
x
Dose
= Answer
80 kg
X x 25mg = 2,000mg = 2,000mg
per dose
1
1 kg
1
X
Since there are 3 doses in 24 hours, to get the total
daily dose you multiply by 3
2,000mg x 3 doses = 6,000 mg per day
© 2013-2015
Example
What if the units of weight don’t match?
Recommended dose = 45mg/kg/q8°
Patient's weight = 230 lb
What is the correct amount to give per dose?
© 2013-2015
Example
O First use a conversion to calculate the weight in the
appropriate units, then calculate the dose
Pounds  Kilograms
Weight
x
Conversion
= Answer
230 X
lb
1 kg
230
x
=
= 104.5 kg
1
2.2 lb
X 2.2
© 2013-2015
Example
O Now finish the problem as before
Weight
x
Dose
= Answer
104.5 X
kg 45 mg 4,702.5mg
x
=
= 4,703mg
1
1 kg
1
X
© 2013-2015
One More Example
If you feel adventurous, you can combine all of the
conversion factors into one long equation
Patient’s weight = 198 lb
Recommended Dose = 2 mg/kg/d
What is the daily dosage?
© 2013-2015
Example
198 lb
X
1
x
1 kg
X
2.2 lb
X
x
2 mg
1 kg
X
=
396 mg
= 180 mg
2.2
© 2013-2015
CH 36: Calculating
Pediatric Dosage
O Many drugs do not have doses that are
recommended for pediatric patients
O There are several calculations used to convert adult
doses to pediatric doses
O We will cover two of the most frequently used
methods
© 2013-2015
Young’s Rule
O Based on the child’s AGE
Age in Yrs
x
adult dose = pediatric dose
(Age in Yrs + 12)
© 2013-2015
Example
Our patient is 4 years old
The recommended adult dose = 250mg
Calculate the child’s dose using Young’s Rule
4
(4 + 12)
x
250 mg =
62.5 mg
© 2013-2015
Clark’s Rule
O Uses the WEIGHT of the child to calculate the dose
O ALWAYS use pounds to calculate
Weight in lb.
x
adult dose = pediatric dose
150
© 2013-2015
Example
Our patient weighs 40 lbs
Recommended adult dose = 250mg
Calculate the child’s dose using Clark’s Rule
40 lb
x
250 mg
= 66.7 mg
150
© 2013-2015
Ch 37: Parenteral
Calculations
O Parenteral calculations deal with administration
of IV fluids
O Two main concepts you will learn
O Flow Rate
O Dose per Time
© 2013-2015
Flow Rate Calculations
O Flow rate is the speed at which an IV solution is
delivered
O Function of Volume per Time
O usually reported in milliliters per hour
O The magical formula
volume ÷ time = flow rate
Always be sure which time and volume units you are being
asked to solve for!
Is it ml/min ? Or l/hr? Something else?
© 2013-2015
Flow Rate Calculations
A patient receives 1 L of IV solution over a 3 hour
period. Calculate the flow rate in ml/hr.
Note: the volume given is in liters, but the answer asks
for milliliters. If the conversion wasn’t so obvious, we
would first need to do a conversion of L  ml.
volume ÷ time =
flow rate
1000 ml ÷ 3 hours = 333 ml/hr
© 2013-2015
Another Rate Problem
A patient receives 0.75L of IV solution over a
4hour period. Calculate the flow rate in ml/hr.
Now the conversion is a bit harder, so we do the math
0.75 X
L 1000ml 750ml
x
=
= 750 ml
1
1L
1
X
750 ml ÷ 4 hours =
188 ml/hr
© 2013-2015
Solve for Time
By manipulating the rate formula, we can solve for time
The equation becomes:
volume ÷ rate = time
© 2013-2015
Solving for Time
If an IV is run at 125ml/hr, how long will 1 L last?
© 2013-2015
Solving for Time
If an IV is run at 125ml/hr, how long will 1 L last?
volume ÷ rate = time
1000 ml
X
= 8 hr
125 X
ml / hr
Milliliters cancel and you are left with the units of hours
© 2013-2015
Solving for Volume
Play with the formula some more, and now we can
solve for volume
The equation becomes:
rate x time = volume
© 2013-2015
Solving for Volume
How many ml of IV solution would be required to
run an IV for 12 hours at a rate of 60 ml/hr?
© 2013-2015
Solving for Volume
How many ml of IV solution would be required to run
an IV for 12 hours at a rate of 60 ml/hr?
rate x time = volume
IT’S REALLY JUST A CONVERSION PROBLEM!
60 ml
1 hr
X
12 hr
720 ml
X
x
=
= 720 ml
1
1
© 2013-2015
Solving for Volume
What volume would we need to have on hand if an IV
solution is to be run for 100 ml/hr for 8.3 hrs?
© 2013-2015
Solving for Volume
What volume would we need to have on hand
if an IV solution is to be run for 100 ml/hr for
8.3 hrs?
100 ml
8.3 hr
830 ml
X
x
=
= 830 ml
1 hr
1
1
X
© 2013-2015
How is the Fluid Measured?
O We have spoken of rate in terms of ml per time
period
O How do we measure this milliliter?
O IV Pumps
O Automatically measure the volume with matching
administration sets
O Calibrated Administration Sets
O Can be used without an IV pump
O Sets will be marked with the calibration
10 gtts / ml
15 gtts / ml
60 gtts / ml
© 2013-2015
Fluid Measurement
O By knowing the calibration (gtt/ml) and the flow rate
ordered, we can calculate the necessary rate in drops
per minute
O Don’t get all discombobulated!
O it is simple conversion calculations!
O like any conversion problem, arrange your units so they
cancel to give the final unit required by the question
© 2013-2015
Example
A drug order calls for D5W to be
administered at a rate of 125ml/hr. Our
administration set is calibrated to deliver 10
gtt/ml. How many gtt/min should the nurse
use?
Ok, thinking caps on…..
First we need to convert ml/hr  ml/min
Then we multiply times the calibration factor in gtt/ml
© 2013-2015
Example
Convert ml/hr  ml/min x calibration = gtt/min
125 ml
10 gtt
X 1 hr
X
x
x
= 20.8 gtt/min
1 hr
60 min
1 ml
X
X
Since there is no such thing as a partial drop, we round
the answer to 21 gtt/min
© 2013-2015
Let’s Try Another
An IV is ordered to be run at 80 ml/hr. Our
administration set is calibrated at 10 gtt/ml.
What rate in gtt/min should be used?
© 2013-2015
Let’s Try Another
An IV is ordered to be run at 80 ml/hr. Our
administration set is calibrated at 10 gtt/ml.
What rate in gtt/min should be used?
80 ml
X x 10 gtt = 13.3 gtt/min
X x 1 hr
1 hr
1 ml
X or 13 gtt/min
X 60 min
© 2013-2015
Now for One More Twist….
O Dose per Unit Time Calculation
O used when a specific dose in weight is needed to be
run over a certain time period
O Don’t Fret!
O it’s still the same type of calculation you just did, but
with one twist
O you do a proportion calculation first to find out how
much volume of fluid contains the desired amount of
drug
© 2013-2015
Dose per Time
250 mg of a drug is dissolved in 500 ml of NS.
The drug order states that 250 mg is to be
administered at a rate of 50 mg/hr. Our
administration set is calibrated to 15 gtt/ml.
Calculate the necessary rate in gtt/min.
What are we looking for first?
O The volume of solution that contains 50 mg
© 2013-2015
Dose per Time
250 mg of a drug is dissolved in 500 ml of NS. The drug
order states that 250 mg is to be administered at a rate of
50 mg/hr. Our administration set is calibrated to 15 gtt/ml.
Calculate the necessary rate in gtt/min.
Use a proportion calculation to find the volume
500ml
250mg
=
x
25,000
50mg
250
=
100 ml
SO NOW YOU KNOW THE RATE IN HOURS (100ml/hr)
© 2013-2015
Dose per Time
Now we just finish as we have been doing
100 ml
X x 1 hr
X x 15 gtt = 25 gtt/min
1 hr
60 min
1 ml
X
X
© 2013-2015
One More Time
10,000 units of Heparin are contained in a bag of
500 ml D5W. The order calls for 1,000 units per
hour. Our administration set is calibrated to 15
gtt/ml.
What is the resulting flow rate in gtt/min?
Give it a try…
© 2013-2015
The Answer
First, a proportion to find the volume per hour
500 ml
x
=
10,000u 1,000u
500,000
= 50 ml
10,000
Then, the usual finale
50 ml
X
1 hr
X
1 hr
15 gtt
X
x
x
= 13 gtt/min
60 min
1 ml
X
© 2013-2015
Questions?
© 2013-2015