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93 Cards in this Set
- Front
- Back
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Parenterals
Para- Enteron- |
outside the intestines
Outside intestines |
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injectable substances must be ____ and ____ free
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Sterile
Pyrogen |
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These can survive in tough conditions and then grow when conditions are favorable
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Endospores
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Fever producing organic substance arising from microbial contamination.
Febrile=fever |
Pyrogens
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definition of sterility
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absence of microbial contamination.
colony forming units (CFU's) microbes killed, no growth but there are remnants of microbes |
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Lipopolysaccharides from bacterial cell wall (LPS)
Bacterial endotoxins Heat stable, water soluble --> hard to remove |
Pyrogens
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Methods of sterilization
(4) |
Heat- most common. Dry or Moist
Filtration Gas Ionizing radiation |
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Dry heat (oven sterilization)
Temp and time range? |
usually 150-170 deg C for at least 2 hours
higher temp --> shorter time of exposure |
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Exposure time starts from the time vial is placed in the oven and turned on
True or False |
False
Exposure time starts when the substance reaches the desired temp |
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how can you ensure even temp distribution in an oven to prevent uneven heating?
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can use fans to circulate the heat
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Dry heat is used if the substance is not...
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effectively sterilized by moist heat
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Examples of some substances that need to be sterilized by dry heat?
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fixed oils (glycerin, mineral oil)
Heat stable powders |
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What is egg albumin?
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coagulating proteins to kill MO's with moisture
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Moist heat sterilization aka
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steam, autoclaving,
"pressure cooking" |
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how is a higher temp achieved with moist heat?
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by increasing the pressure
At atmospheric pressure temp of steam is 100 degrees C |
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why would it be necessary to remove air from steam?
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air mixture with steam lowers the effective temp
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efficiency is affected by steam _____ and container ____ and _____
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steam penetration
material and thickness |
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Latent heat (540kcal/mol) gives off energy when steam _____
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condenses
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Latent heat
10psi ____ 30 min 15psi 121.5C ____ 20psi _____ 15 min |
115.5 Degrees C
20min 126.5 Degrees C |
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More effective at killing microbes
Lower temperature Heat sensitive sub. still a prob aq. materials |
Moist sterilization
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Less efficient
Higher temperatures Not for heat sensitive substances Non aq. materials Takes longer |
Dry heat sterilization
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How are the following sterilized?
Surgical equipment Glassware Cloth Dry or moist |
Surgical equip and glassware - either
Cloth- only moist |
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Filtration
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physical removal of microorganisms
liquids only |
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Adsorption
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surface phenomenon, accumulation on surface
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Particle size is larger than the size of the pore
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Sieving
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These membranes have
uniform pore size (14-.025 microns) occupy 80% of filter High porosity for high flow rate |
Cellulose ester membranes
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What are the factors influencing filtration process
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Electrical charge of filters vs charge of microorganisms.
pH of solution being filtered Pressure differential applied (too much=bad for membrane) |
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Advantages of filtration
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quick method for small volumes
suitable for heat sensitive meds Complete removal of microbes and remnants is possible |
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Disadvantages of filtration
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Membranes are fragile and require validation
Large volumes and higher viscosity increase time Adsorption of drug onto membrane |
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Gas Sterilization
what kind of gas? |
Exposure to ethylene oxide or propylene oxide
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Gas must be diluted with ____ gases because they are highly flammable when mixed with air
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inert
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How many hours of exposure?
sometimes.. humidity ___% and temp of ____ improves efficiency |
4-16 hours
60% humidity 50-60 degrees C |
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What is gas sterilization useful for?
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catheters
disposable syringes needles some enzyme prep. and antibiotics (hard to filter, large molecules) |
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things like ___ can be sterilized in a plastic/permeable paper package.
Disadvantage? |
needles etc
can have gas residue left over, reaction with drug or person. must test |
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Ionizing sterilization
electromagnetic radiation by exposure to ______ from radioisotopes |
Gamma rays γ
highly specialized process |
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advantages of ionizing sterilization?
Disadvantage? |
Leave no residue
high penetration used when no other system works Expensive |
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UV radiation can be used to sterilize with deep penetration
True or false |
False
it may be used for surface sterilization |
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Validating sterilization
all sterilized products must be tested for absence of MO's |
Method testing using a biologic indicator.
Pulling samples is hit or miss |
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method testing with Biological indicator-
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using MO's resistant to process, put spores on filter paper or add to representative preparations and sterilize
if they all die --> all vials should be sterile |
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some spores used in method testing
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Bacillus stearothermophilus
B subtilis B pumulis |
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Time required to kill a particular organism under particular conditions
(F value) |
Thermal death time
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D value
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conditions needed for 90% reduction in microbial content (1 log)
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microbial load b4 sterilization <--reduced by aseptic processing
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Bioburden
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Problems with pyrogen removal and testing
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Pyrogens are heat stable, water soluble
resist all methods, even filtration is hard |
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Solution to pyrogen removal and testing
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oxidize pyrogens to volatile substances or non volatile substances that are easily removed by distillation
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method to oxidize and distill pyrogens
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KMnO4 and BaOH
or High Heat 250 C for 30 min |
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Validation for pyrogen removal
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Pyrogen test USP
alternative LAL test |
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Pyrogen test USP
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inject healthy rabbits with product and check for increase in temp
3-8 rabbits for one test naivee rabbits (havent been tested on b4) |
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Alternative LAL test
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Limulus Amebocyte Lysate
collect blood from horseshoe crab (dont have to kill) FDA approved in 1970 |
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Advantages of LAL
Problems? |
Quicker and very sensitive
Some parenteral ingredients interfere with results -->solved by diluting sample |
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4 major routes of parenteral injection?
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Intravenous
Subcutaneous Intramuscular Intradermal |
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Intravenous
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into the vein in antecubital region
needle inserted bevel up Backflow checked Small volumes (bolus injection) large volumes (infusion) |
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IV injections have ____ drug action and ___% bioavailability.
once administered, cannot be retrieved |
immediate
100% |
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infusion of irritant drugs increases the risk of ___ formation and subsequent embolism
(blockage of vessel) |
Thrombus (clot formation)
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Intramuscular
where? |
Deep skeletal muscle (gluteus maximus, deltoids)
as far as possible from major nerves and vessels |
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improper administration of IM?
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paralysis
abscess (puss) cyst embolism |
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Aspiration?
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technique to check that needle is not in blood vessel. back draw
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Max volume for IM
deltoid Gluteus |
2ml
5ml |
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IM has a longer _____ and duration of action with a systemic effect
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onset
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what is the ztrack method for IM injections?
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Stretch skin in on direction, inject, release. this is so the holes in the muscle and skin layers dont line up.
prevent oozing back up needle hole |
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Subcutaneous
where? max volume? |
beneath the skin, loose interstitial tissue or outer upper arm, anterior thigh, lower abdomen.
max=1.3ml (more than 2=painful pressure) |
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Subcutaneous is not suitable for ____ drugs or ____ suspensions.
Outcome from aspiration? |
irritating drugs
thick suspensions No blood entering syringe |
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Intradermal (allergen tests, tb)
where? |
into vascular layer, just below epidermis (corium)
anterior of fore arm |
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volume?
how is needle inserted? |
up to .1 ml
needed inserted horizontally into skin, bevel up |
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Official types of injections according to USP
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Injection
For injection Injectable emulsion Injectable suspension For injectable suspension |
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Liquid preparations that are drug substances or solutions
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Injection
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Dry solids that upon addition of suitable vehicle, yield solutions conforming to requirements
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For injection
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Liquid preparation of drug substance dissolved or dispersed in medium
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Injectable emulsions
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liquid preparation of solid in a suitable liquid medium
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Injectable suspension
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Dry solid that upon addition of suitable vehicle, yields a preparation conforming to the requirements
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For injectable suspension
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requirements of injectable liquid preparations
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solvents and additives must meet requirments, no coloring agents
Sterility, nonpyrogenicity, particle matter. preparation, procedure, packaging, facilities and personnel- strict standards. overfilling necessary, ease of removal |
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what are the aqueous vehicles for injectables?
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Water for injection USP
Sterile water for injection USP Bacteriostatic water for injection USP Sodium chloride injection Bacteriostatic sodium chloride injection Ringers injection USP Lactated ringers injection USP |
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Pyrogen free but allowable endotoxin level less than .25 USP units/ml
No other added substance Slightly higher limit for solid content. Single dose containers <1L Reconstitution or injection |
Sterile water for injection USP
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Purified by distillation or reverse osmosis.
same standards for solids as purified water usp No mention of sterility but must be pyrogen free. must be used within 24 hrs of collection. |
Water for injection USP
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Sterile water for injection containing antimicrobial agent
allows multiple use not for large volume injections if more than 5ml solvent required, use sterile water for injection. cannot be used in neonates Packaged in volumes 30ml or less |
Bacteriostatic water for injection USP
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sterile isotonic solution
no antimicrobial agent sterile vehicle or suspension agent Used to flush catheters and IV lines |
Sodium chloride injection
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Allows multiple use
has antimicrobial content, can only be used for small volumes. if more than 5ml solvent required, use sterile water for injection cant be used in neonates 30ml or less packaging |
Bacteriostatic sodium chloride injection
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Sterile solution of NaCl potassium chloride and calcium chloride in water for injection.
electrolye replenisher and plasma volume expander |
Ringers injection USP
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different concentrations of salt constituents in ringers solution and contains sodium lactate
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Lactated ringers injection USP
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Nonaqueous vehicles
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used when lack of aq solubility or hydrolysis are associated with AI
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Requirements for nonaqueous vehicles
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non-toxic
non-irritating inert and non-reactive with AI suitable for use in syringes High BP for heat sterilization miscible with body fluids |
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Examples of nonaq vehicles
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Fixed oils
glycerin PEG Propylene glycol |
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Vegetable oils (only for IM)
requirements |
remain clear on cooling to 10C
Fluidity depends on ratio of unsaturated to saturated fatty acids. Iodine number(amount of unsaturation) saponification value (average chain length) |
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examples of vegetable oils
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corn oil
cottonseed oil peanut sesame |
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Packaging
type of material? # doses? |
Type of glass stated in individual monograph. type I, II, III, pyrex
Single does container Multiple dose container |
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Single dose container
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Hermetic container holding a single dose
cannot be resealed with assurance that sterility has been maintained |
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Multiple dose container
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Hermetic container that permits withdrawal of successive portions of contents without changing strength, quality, or purity of remaining portion
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What must be stated on the label?
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Name of preparation
liquid- % content of drug amount or amount in a specified volume. dry- amount of AI and volume of liquid to be added. Route of admin, storage, expiration name of manufacturer and distributor. Identifying lot # linked to history |
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you must also allow sufficient area on container to remain free of label to allow____
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visual inspection of contents
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Storage conditions
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room temp for most pure medicinal agents.
Refrigeration for biological products Consult monograph with in doubt |
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Quality assurance for pharmacy prepared sterile products.
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American society of health-system pharmacists guidelines to assure quality by using aseptic procedures
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acceptance or rejection of materials
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Quality control
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systemic method to
identify problems resolve problems ensure final product/outcome meets applicable specifications |
Quality assurance
Risk level classification 1-->3 based on risk to patient |
