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36 Cards in this Set
- Front
- Back
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characteristics of an ideal container
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inert
no interaction w/ drug no particulate contamination (coring etc) no loss of drug or solution maintain sterility allow for visual inspection maintain nonpyrogenicity |
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what are the materials in which parenteral products can be packaged
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glass or plastic
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what are the advantages of glass
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clarity
inert less prone to punture and contamination |
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what are the disadvantages of glass
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leeching of ions
break-ability coring of rubber stopper venting required |
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what are the types of plastic polymers
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PVC (flexible)
polyolefin (semirigid) |
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what are the advantages of plastic over glass
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durability
storage/safety inexpensive no venting required |
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what are the disadvantages of plastic
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can puncture
poor visibility adsorption |
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the process of attracting and holding other substances or particles to a surface
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adsorption
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what results from adsorption
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loss of drug
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how do you prevent drug from adsorbing to container or tubing in IV set
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shorten the tub or use inert plastics or glass bottles
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what are the types of containers
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ampules
vials cartridges bottles bags |
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types of dose containers
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single dose
multiple dose ampules vials |
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what are the types of single dose containers
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ampules and vials
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what are the types of multiple dose containers
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vials
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what are the properties of single dose containers
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once opened can't be resealed with assurance of sterility
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this is a container that holds a quantity of sterile drug intended for parenteral administration as a single dose
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single dose container
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this container permits withdrawal of successive portions of the contents without changing the strength, quality, or purity of the remaining portion
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multiple dose container
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what is the volume of multiple dose containers
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volume can't exceed 30 mL
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what is the oldest type of parenteral container
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ampule
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what are ampules made of
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glass
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are ampules single use or multiple use
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single
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what are the disadvantages of ampules
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product must be filtered before use
unsuitable for multidose use |
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what are vials
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glass or plastic containers closed with rubber stoppers/sealed with aluminum crimp
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what are the advantages of vials
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can be designed for multiple doses
easy to remove product plastic vials more advantageous b/c low risk of glass breakage |
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what are the disadvantages of vials
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coring of ruber stopper
microbial contamination in multi-dose vials |
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when USP 797 become effective
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January 1, 2004
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what was the purpose of USP 797
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prevent harm and fatality to patients
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what are the risk levels
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high, low, medium
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what define a clean room
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USP 797
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what can be used if the clean room is not in accordance w/ 797
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barrier isolators
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a decontaminated unit supplied with HEPA filtered air that provides uncompromised continuous isolation of its interior from the external environment
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barrier isolator
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what are the properties of laminar airflow workbench
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provide clean air in the clean zone
provide a constant air flow which prevents unclean room air from entering into clean zone remove and prevent any particle matter .3 microns are larger from entering clean zone |
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what are the types of laminar air flow workbenchs
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horizontal hood
vertical hood |
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what can not be prepared in horizontal hood
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hazardous chemicals and chemotherapy agents
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where can chemotherapy agents be prepared
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vertical hood
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what is the needle size designated by
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measuring gauge and length
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