Post on 15-Jan-2016
Theoretical Principles and Practical Skills of Aseptic Manipulations
Maulita Cut Nuria, M.Sc., Apt
Page 1
Definitions
Background
Laminar Air Flow Hoods
Aseptic Technique
Free Powerpoint TemplatesPage 2
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 compoundedsterile products and parenteral preparations thatprevents contamination
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Definitions (cont.)
• Contamination – any effect or action that has a negativeimpact 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)
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Background
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
• Internal generation
– Walls, floors, ceilings, packaging, equipment
Laminar Air Flow Hoods
• The underlying principle of a laminar air flowhood is that a constant flow of HEPA filtered airat a rate of approximately 90 linear feet perminute physically sweeps the work area andprevents the entry of contaminated air
• The hood workspace is used to prevent thecontamination of compounded sterile products.
• HEPA filter - High Efficiency Particulate Air filterremoves 99.97% of all air particles 0.3 mm orlarger
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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
• Vertical Flow (Biological Safety Cabinet orChemotherapy Hood)
– Air blows from top down to maintain sterility andprotect the worker
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Laminar Air Flow Hoods (cont.)
• The HEPA filter is located in the fragile mesh betweenthin metal strips at the back of the hood behind theHEPA filter screen
• Nothing should be permitted to come in contact with theHEPA filter
– 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 preparationshould be placed in the laminar flow hood tominimize the potential for contamination
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No Paper, Pens, Calculators, or Labels in the Hood
Laminar Air Flow Hoods (cont.)
• Eating, drinking, and smoking is alwaysprohibited
• Talking or coughing should be directed awayfrom the hood to minimize air flow turbulence
• A mask covering mouth and nose must be wornwhile working in the hood
• The use of a laminar flow hood alone without theobservance of aseptic technique, cannot insureproduct sterility
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AutoclavesSafe and Effective Use
Principles of Steam Sterilization
Sterilization: the complete destruction of allforms of microbial life, including bacterial spores
Steam under pressure reaches hightemperatures
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Principles of Steam Sterilization (cont.)
The “killing power” of steam is due to its latentheat of vaporization
– 80 calories: 1 L water to boilingg
– 540 calories: 1 L boiling water to steam
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Action of Steam
Steam contacts a cooler surface,condenses, causing a huge decrease involume and setting up a negativepressure that draws more steam
Condensation occurs as longg as there isa temperature differential
Action of steam ensures: Surfaceheating, penetration, and proteincoagulation
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Standard Temperature and Pressure
250 °F (121 °C) and 15 p.s.i.
Berapa atm ?
How Long to Autoclave
Dry goods @ 121 °C
Glassware, empty, inverted
Instruments, wrapped
Utensils, wrapped
Time (min)
15
30
30
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Special Situations
Media boils out of bottles
– differs among media
Very dense or closed dry objects
– beaker full of microfuge tubes with aluminumfoil covering
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TERIMAKASIH
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