Transcript Aseptic Preparation of Parenteral Products

Theoretical Principles and Practical Skills of Aseptic Manipulations
Curriculum: Pharmacy
Target Audience: Pharmacists and Pharmacy Technicians
Authors:
Philip Trapskin, PharmD
Rebecca Reagan, RPh
Kimberley Hite, MS, PharmD
John Armitstead, MS, RPh, FASHP
Service Area: Pharmacy Services
Phone: 859 257-8414
Email: [email protected]
Date Developed
Or Revised: April, 2005
All materials on this template are Copyright © 2004 University of Kentucky Chandler Medical Center Learning Center unless
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Menu
Definitions
Background
Laminar Air Flow Hoods
Barrier isolator technology
Aseptic Technique
Exit
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Definitions
• Enteral
– Of or relating to the intestines
(e.g. by mouth, orally, per tube)
• Parenteral
– Introduced other than by way of the intestines
(e.g. intravenous, intramuscular, subcutaneous)
• Aseptic Technique
– The technique for manipulations of compounded sterile products
and parenteral preparations that prevents contamination
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Definitions (cont.)
• Contamination – any effect or action that has a negative
impact on a product's integrity making it unfit for use
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Chemical composition
pH
Sterility (e.g. microorganism contamination)
Pyrogenicity
Biological or therapeutic potency
Physical appearance
Particulate matter (e.g. dust, glass or precipitation)
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Background
• Why do we give medications parenterally?
– Patients who are not able to take medications by
mouth
– Need for rapid action of the medication as in
emergency situations
– Medication not available in a suitable dosage form to
be given by mouth
– Patients with difficulty absorbing medications
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Background (cont.)
Sources of product contamination
• People (most common)
– Touch contamination
– Generation of particulates from shedding cells or hair
• Supply air
– Heating Ventilation and Air Conditioning (HVAC)
• Infiltration
– Particles from adjacent spaces (e.g. anteroom)
• Internal generation
– Walls, floors, ceilings, packaging, equipment
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Background (cont.)
• Importance of Aseptic Technique
– Parenteral administration bypasses the skin and
gastrointestinal tract, the bodies natural barriers to
infection
– Giving a patient a contaminated product can cause
serious adverse effects including DEATH
– Parenteral medications account for >40% of all
medications administered in institutional practice
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Laminar Air Flow Hoods
• The underlying principle of a laminar air flow hood is that
a constant flow of HEPA filtered air at a rate of
approximately 90 linear feet per minute physically
sweeps the work area and prevents the entry of
contaminated air
• The hood workspace is used to prevent the
contamination of compounded sterile products and
parenteral preparations
• The space between the HEPA filter and sterile product
being prepared is referred to as the critical work surface
• HEPA filter - High Efficiency Particulate Air filter removes
99.97% of all air particles 0.3mm or larger
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Laminar Air Flow Hoods (cont.)
HEPA Filter in Frame
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Laminar Air Flow Hoods (cont.)
• Horizontal Flow (Laminar Flow Hood)
– Air blows towards worker
– Used for non-chemotherapy preparations
• Vertical Flow (Biological Safety Cabinet or
Chemotherapy Hood)
– Air blows from top down to maintain sterility and protect the
worker
– Used to make chemotherapy
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Laminar Air Flow Hoods (cont.)
Horizontal
Laminar
Air Flow
Hood
Horizontal
Laminar
Air
Flow
Hood
Hepa Filter
Filtered Air
Room Air
Prefilter
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Laminar Air Flow Hoods (cont.)
Vertical Laminar Flow Hood
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Correct placement of items in a laminar flow hood
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Incorrect placement of items in a laminar flow hood
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Laminar Air Flow Hoods (cont.)
• All aseptic manipulations should be performed at
least SIX inches within the hood to prevent the
possibility of contamination from room air
entering the hood.
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Laminar Air Flow Hoods (cont.)
• A laminar flow hood should be left operating continuously
• If hood is turned off it must run for 30 minutes to
reestablish laminar air flow and then be cleaned prior to
use
• Before use, all interior working surfaces of the laminar
flow hood should be cleaned from back to front away
from the HEPA filter
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Laminar Air Flow Hoods (cont.)
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Laminar Air Flow Hoods (cont.)
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Laminar Air Flow Hoods (cont.)
• At UKCMC the procedure for cleaning a hood should
occur in the following order:
• Obtain 4X4 gauze
• Clean the hood with sterile water for irrigation (bar, sides,
base)
• Obtain new 4x4 gauze
• Clean the hood with 70% isopropyl alcohol (bar, sides,
base)
• Hoods should be cleaned at the beginning of each shift
and as needed throughout the shift
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Laminar Air Flow Hoods (cont.)
• The HEPA filter is located in the fragile mesh between
thin metal strips at the back of the hood behind the
HEPA filter screen
• Nothing should be permitted to come in contact with the
HEPA filter
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NO cleaning solution
NO aspirate from syringes
NO glass from ampules
NO fluids, even if sterile
DO NOT touch HEPA filter
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Laminar Air Flow Hoods (cont.)
• Only products essential to product preparation should be
placed in the laminar flow hood to minimize the potential
for contamination
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Laminar Air Flow Hoods (cont.)
• Eating, drinking, and smoking is always prohibited
• Talking or coughing should be directed away from the
hood to minimize air flow turbulence
• A mask covering mouth and nose must be worn while
working in the hood
• The use of a laminar flow hood alone without the
observance of aseptic technique, cannot insure product
sterility
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Barrier Isolator Technology
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Barrier Isolator Technology (cont.)
• Closed system: workers manipulate compounding
through gloved ports
• Personnel are the primary source of contamination of
compounded preparations
• Barrier Isolator removes personnel from environment
where parenteral products are prepared
• Good aseptic technique is still required
– Barrier isolators are exempted from placement restrictions of
materials within the workspace
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Barrier Isolator Technology (cont.)
• Barrier Isolator Workstations consist of:
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Physical Structure
Internal Environment
Transfer and Interaction Technology
Monitoring Systems
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Barrier Isolator Technology (cont.)
• Physical Structure
– Hard shell or soft shell
• Hard shell (plastic, Plexiglas, stainless steel)
• Soft shell (soft plastic film)
• Internal Environment
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Less airflow required to achieve ISO 5 (Class 100) conditions
Entering and exiting air is to be HEPA filtered
Isolators for cytotoxic preparations should capture vapor
Positive pressure maintained for non-chemotherapy products
Negative pressure is maintained for chemotherapy products
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Barrier Isolator Technology (cont.)
• Transfer and interaction technology
– Transfer
• Rapid transfer ports
• Air-lock
• Laminar-airflow interfaces
– Interaction
• Glove ports (most common)
• Half-suits
• Monitoring Systems
• Gauges to monitor positive pressure environment
• Surface sampling for contamination
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Aseptic Technique
• Aseptic technique is the technique for manipulations of
compounded sterile products and parenteral
preparations that prevents contamination
• Aseptic technique requires specific manipulations for:
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Syringes
Needles
Vials
Ampules
Removal of packaging
Assembling of sterile products
Hand placement
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Aseptic Technique - Syringes
NEVER TOUCH
Tip or Plunger
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Aseptic Technique - Syringes
1.5ml measured
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Aseptic Technique - Syringes
• Syringes are available in sizes ranging from 0.5 to 60
milliliters (ml)
• Graduation marks on syringes represent different
increments depending on size of syringe
• DO NOT use syringes whose gradations are greater
than twice the volume being measured
• To maintain sterility, neither the syringe tip or plunger
should be touched
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Aseptic Technique - Needles
• Hub
– Where the needle attaches
to the syringe tip and
allows the fluid in the
syringe barrel
• Bevel
– The tip of needle is slanted
to a point and the slanted
part of the needle is the
bevel. The bevel allows for
smooth insertions through
stoppers and ports with
minimal coring
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Aseptic Technique - Needles
• Coring
– The development of a core
or hole in the rubber of a
vial
– To prevent coring insert
needle as shown
– Insert the bevel tip first,
then pressing downward
and toward the bevel so
the bevel tip and heel enter
at the same point
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Aseptic Technique - Needles
• Needle size is determined by two numbers
– Gauge
– Length
• The larger the gauge number the finer the diameter of
the needle’s bore
– 27 gauge needle finer than 13 gauge needle
– Common needle sizes at UK include
• 16G 1&1/2 inch
• 18G 1&1/2 inch
• 20G 1 inch
• Needle length is measured in inches
• Never touch any part of the needle
• Open needle package within hood to maintain sterility
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Aseptic Technique - Needles and Syringes
• It is important that when using needles and syringes in
product preparation that they not be removed from the
hood workspace
• Needles and syringes must be properly disposed in a
sharps container located near the hood to prevent injury
to others
• Never dispose of needles or syringes in regular trash
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Aseptic Technique - Vials and Ampules
Vials
Ampules
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Aseptic Technique - Vials and Ampules
• To prevent contamination
– Swab rubber closure with 70% alcohol using firm strokes in the
SAME direction
• To prevent core formation
– Insert needle to penetrate the rubber closure at same point with
both tip and heel of bevel
• To prevent vacuum formation
– Inject an equal amount of air for the volume of fluid to be
removed
• Reconstituting drug powder
– Remove an equal amount of air for the volume of diluent added
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Aseptic Technique - Vials and Ampules
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Aseptic Technique - Vials and Ampules
• To break ampule
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Clean ampule neck with alcohol swab
Leave swab in place
Grasp ampule neck with thumb and index finger
Use quick, firm, snapping motion away from body towards side
wall of hood
– DO NOT BREAK TOWARD HEPA FILTER
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Aseptic Technique - Vials and Ampules
• To withdraw medication from ampule
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Tilt ampule
Place needle bevel in corner space near opening
Pull back syringe plunger
Do NOT use a filter needle to remove ampule contents
• To avoid glass contamination of ampule solution
– Use 5 micron filter needle to filter glass as solution is pushed out
of the syringe
– A filter needle can only be used in one direction, otherwise glass
particles originally filtered are reintroduced
– For UK consistency always use the filter needle as the second
needle
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Aseptic Technique - Vials and Ampules
1
3
2
4
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Aseptic Technique - Removing Packaging
• Any sterile component or supply (e.g., syringes, needles,
and ampules) should only be opened and/or removed
from their packaging within the laminar-flow workspace.
• When opening the wrapper on a needle, it should be
peeled open.
• Tearing paper introduces paper particles into the hood
which could lead to product contamination.
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Aseptic Technique - Assembling
• Great care must be exercised to prevent any touch
contamination of critical edges or component surfaces.
• The syringe tip and plunger and all parts of the needle
are critical surfaces.
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Aseptic Technique - Hand Placement
• It is important that hand placement during any aseptic
manipulation is such that laminar airflow is not
interrupted around any of the critical sterile fluid
pathways.
• Great care should be taken to avoid contact with the
syringe plunger, especially during multiple manipulations
using the same syringe. Since the plunger enters the
barrel of the syringe during repeated uses,
contamination can be accidentally introduced into the
barrel.
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Summary
• Aseptic technique is the manipulation of sterile products
to prevent contamination
• Giving a patient a contaminated product can cause
serious adverse effects including DEATH
• Discard any potentially contaminated product and inform
the pharmacist that product was discarded
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