University of Kentucky / NetLearning CBL 1 of 45 All materials on this template are Copyright ©...

University of Kentucky / NetLearning CBL 1 of 45

All materials on this template are Copyright © 2004 University of Kentucky Chandler Medical Center Learning Center unless otherwise noted. All rights reserved. Certain graphic images, text elements and logos are derived from The University of Kentucky and NetLearning and are used by permission.

Theoretical Principles and Practical Skills of Aseptic Manipulations

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

Curriculum: Pharmacy

Target Audience: Pharmacists and Pharmacy Technicians


Definitions

Background

Laminar Air Flow Hoods

Barrier isolator technology

Aseptic Technique

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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


Definitions (cont.)

• Contamination – any effect or action that has a negative impact on a product's integrity making it unfit for use– Chemical composition – pH – Sterility (e.g. microorganism contamination)– Pyrogenicity – Biological or therapeutic potency – Physical appearance – Particulate matter (e.g. dust, glass or precipitation)


• 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

Background


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


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


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


Laminar Air Flow Hoods (cont.)

HEPA Filter in Frame



• 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



Prefilter

Hepa Filter

Room Air

Filtered Air

Horizontal Laminar Air Flow HoodHorizontal Laminar Air Flow Hood



Vertical Laminar Flow Hood


Correct placement of items in a laminar flow hood


Incorrect placement of items in a laminar flow hood



• 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.



• 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



• 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



• 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 – NO cleaning solution– NO aspirate from syringes– NO glass from ampules– NO fluids, even if sterile– DO NOT touch HEPA filter



• Only products essential to product preparation should be placed in the laminar flow hood to minimize the potential for contamination



• 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


Barrier Isolator Technology


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



• Barrier Isolator Workstations consist of:– Physical Structure– Internal Environment– Transfer and Interaction Technology– Monitoring Systems



• Physical Structure– Hard shell or soft shell

• Hard shell (plastic, Plexiglas, stainless steel)• Soft shell (soft plastic film)

• Internal Environment– 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



• 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


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:– Syringes– Needles– Vials– Ampules– Removal of packaging– Assembling of sterile products– Hand placement


Aseptic Technique - Syringes

NEVER TOUCH

Tip or Plunger



1.5ml measured



• 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


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



• 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



• 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


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


Aseptic Technique - Vials and Ampules

Vials 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



• To break ampule– 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



• To withdraw medication from ampule– 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


1 2

3 4



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.


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.


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.


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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