Term
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Definition
-obtain quality raw materials
-clean/sterilize equipment and containers
-control environment
-prepare bulk product
-filter
-fill
-lyophilize (only for lyophile products)
seal
-sterilize (if not feasible, aseptic process) |
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Term
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Definition
| water removal via sublimation from the frozen product |
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Term
| lyophilization advantages |
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Definition
-processed as a liquid
-stability (processed without elevated temperature and under vacuum)(final product sealed under N2)
-rapid reconstitution
-flexibility in final concentrations |
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Term
| lyophilization disadvantages |
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Definition
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Term
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Definition
| -destruction or removal of all living organisms and their spores |
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Term
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Definition
-steam
-dry heat
-filtration
-gas
-ionization radiation |
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Term
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Definition
-METHOD OF CHOICE
-conducted under an autoclave
-steam under pressure to reach 100+degrees C
-N/A for heat labile products, powders (may be damaged), oleaginous products (not penetrated by moisture) |
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
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Definition
-conducted in ovens
-higher temp and longer duration than moist heat
-150-170 deg C for 2+ hours
-used when moist heat is not effective or suitable
-powders, oils
-dry apparatus or containers are required |
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Term
| sterilization by filtration |
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Definition
-physical removal by membranes (0.2 micrometer pore size)
-suitable for heat labile drugs
-removes live/dead microbes and particles
-filter compatibility?
-low cost and fast? |
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Term
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Definition
-ethylene oxide or propylene oxide
-mixed with CO2 (less flammable)
-interferes with cell metabolism
-conducted in chambers or bags
-requires 4-16 hours |
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Term
| sterilization by ionizing radiation |
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Definition
-electromagnetic radiation (gamma radiation)
-particle radiation (electron beam)
-requires special equipment and facility
-used for heat/moisture sensitive products
-damage biomolecules through energy activation and free radicals
-can distort/destroy some containers and products |
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Term
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Definition
-biological indicators
-filter integrity |
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Term
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Definition
-for terminal sterilization methods
-specifics? |
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Term
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Definition
-if terminal sterilization not feasible
-a process that maintains sterility and particle free
-sterilize raw/intermediate materials separately
-process the remaining steps under aseptic conditions (controlled environment, trained operators with aseptic techniques) |
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Term
| terminal sterilization steps |
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Definition
-dissolve drug in buffer
-polishing filtration
-fill vials
-autoclave |
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Term
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Definition
-dissolve drug in buffer
-sterile filtration
-fill vials aseptically (autoclaved vials) |
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Term
| aseptic air quality specification |
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Definition
-ISO class 5 (req for all parenterals)
-100 particles/ft3 greater than .5 micrometers |
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Term
| how to achieve ISO class 5 air quality? |
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Definition
-HEPA filters
-Laminar Air flow |
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Term
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Definition
-high efficiency particulate air
-efficiency of 99.97% for removing 0.3 micrometer or larger particles |
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Term
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Definition
-entire body of air moves with uniform velocity along parallel flow lines
-average velocity 100ft/min |
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Term
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Definition
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Term
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Definition
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Term
| tests unique to parenteral products |
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Definition
-sterility
-pyrogen
-particulates
-preservative efficacy (multi dose)
-container/closure integrity (ampules) |
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Term
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Definition
-USP 71
-membrane filtration method (preferred)
-direct inoculation method
-growth media (fluid thioglycollate medium for bateria and soybean-casein digest medium for fungi)
-incubation 7 to 14 days
-minimum sample quantity and number of test articles
-antibiotic products
-validation
-do not replace sterilization procedure validation |
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Term
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Definition
-USP 151
-in rabbits
-inject product (10ml/kg)
-observe change in temperature
-not suitable for products which are pyretic or antipyretic |
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Term
| bacterial endotoxins test |
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Definition
-USP 85
-limulus amebocyte lysate (LAL)
-gel or color formation in the presence of endotoxings
-simpler, faster, and more sensitive than rabbit test
-ONLY DETECTS ENDOTOXINS from gram negative bacteria
-endotoxin unit (EU) |
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Term
| particular matter visual inspection |
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Definition
-manual or automated
-particles greater than 50 micrometers
-100% product inspection |
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Term
| particulate matter in injections |
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Definition
-USP 788
-subvisible particles
-light obscuration method (ex. HIAC/Royco)
-microscopy method |
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