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CH 15 Flashcards

1
Q

parenteral medications

A

-small or large volume of inj preparation

-irrigation of fluid to bathe body wounds/ surgical openings

-dialysis solutions

-biological preparations (vaccines, toxoids, antitoxins)

-bloods replenished products

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2
Q

advantages of parenteral meds

A
  1. unconscious
  2. not actively oral
  3. rapid action
  4. nutrition (IV DSW)
  5. Depots - release the drug slowly over and extended period of time
  6. implantable pumps- increase the duration of solubility, they are placed under skin as a small reservoir

onset time: time of solubility effect
depot: formed on subcutaneous or IM side

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3
Q

disadvantages of parenteral meds

A
  1. difficult to make
    2 high cost
  2. specific equipments
    4.hard tor retrieve
  3. pain damage
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4
Q

parenteral route

A

is an injectable route of administration

means “outside intestine” - para enteron

denotes routes of admin except the ORAL route

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5
Q

injections are suitable when

A
  1. sterile (living microorganism absent/free)
  2. pyrogen free( endotoxin units, limited)- this means no organic metabolized product from microorganism
  3. administered by a health professional (*except insulin)
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6
Q

pyrogen

A

pyrogen are bacterial endotoxins, are organic products shed from gram negative bacteria, which cause fever and hypotension in patients
when there are excessive amounts in intravenous (iv) injections

it is a metabolized product from microorganism, it is organic

  • microbial contamination
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7
Q

parenteral routes of admin

A
  1. IV- intravenous (into the vein or into our circulation)
  2. IM-intramuscular (into the muscle mass: mid deltoid area and gluteus medius) - cant hit your capillary, it lasts for 7-10 days
  3. SC or Sub Q or SQ (hypodermic): subcutaneous (under the skin loose tissue, beneath the skin layers needs a larger gauge (24 and up)
    ex. arms or thigh
  4. ID intradermal route, into the skin or the most superficial skin layer. larger gauge and so its thinner and shorter
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8
Q

gauge and thickness and length

A

needles are regulated by length and gauge (thickness) related to the specific site of action

large gauge # means that it is thinner and less pain and needle is shorter

gauge- outside diameter of shaft

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9
Q

IV route

A

IV route: (3 plasma profiles)- immediate release, extended release, and delayed release.

had rapid action compared to other routes
1. bolus- single, small volume injection (rapid onset)

  1. infusion-slow large volume injection. it is continuous and intermittent . Infusion are 0 order and happens at a steady state
  2. Aqueous solution, meaning mixes with blood (NOT SUSPENSION)- no precipitated drug after injection (emboli, blood clot), fat emulsions for caloric sources vs glucose - provides nutrition

we don’t inject a IV suspensions because oils can be larger than the RBC

IV used for blood transfusions, diagnostic work, etc

thrombo- inflammation of vessel wall can cause blood clotting and be dangerous

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10
Q

infusion IV- continuous and intermittent

A

intermittent infusion involves administering medication or fluids at specific intervals over a set period of time, like every 1hr-30 min and the duration occurs for 8hrs

while continuous infusion involves administering medication or fluids continuously (consistently) over a longer period of time. (MEC and MTC range)

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11
Q

IM- route

A

not rapid action compared to IV, but have LONGER DURATION
-deltoid area or gluteus medius/ maximus or lumbar muscles

1) deep in skeletal muscles
- try to minimize hitting a blood vessel or nerve

2) solutions can be aqueous or oleaginous (fatty or oily) AND suspensions : low drug solubility (aqueous) , sustained drug action and suspensions of penicillin G benzathine (7-10 days)

suspension IM- have longer duration

drugs in solution are more RAPIDLY ABSORBED than in suspensions(precipate)

IM absorption is faster with aqueous solutions than non aqueous or oleaginous preparations

in infants or babies, muscles not fully developed we use the deltoid of the arm or the midlateral muscles of thigh

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12
Q

Subcutaneous route

A

loose subcanteous tissue, higher tissue compared to the IM
** small volumes (2mL or LESS)
more than 2ml causes pain

sites: forearm, upper arm and thigh

gauge: 24-26

if drug appears in syringe use a new site of injection

-aqueous solutions or nonaqeous
-suspensions: depot or repository for prolonged action
-pellets- implantations

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13
Q

intradermal route

A

coruim of skin - most superficial

0.1 ml or less VERY small volume smaller than SC

gauge: 24-26

sites: arm or back , horiztional insertion

diagnostic measure: tuberculin or allergy tests

imMUNIZATION

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14
Q

official injection types

A

“injection”
READY FOR USE
liquid preparations that are drug substances or solutions
ex. Insulin injection, USP

“For injection”
NOT READY FOR USE
drug solids upon added suitable vehicles yield a solution conforming in all respects to requirements of injections
ex. cefuroxime for injection, USP

“Injectable emulsion”
READY FOR USE
liquid preparations that are drug substances dissolved or dispersed in a suitable emulsion medium
happen in 2 phases water in oil or oil in water. drug in a oil phase or drug in a water phase.
ex. Propofol, USP

“Injectable suspension “
READY FOR USE
liquid preparations that is a Solid suspended in a suitable liquid medium substances
ex. methylprednisolone acetate suspension, usp

“for injectable suspension”
dry solid upon addition of suitable vehicle yields preparation conforming in all respects to requirements for injectable suspensions
ex. Imipenem and cilastatin for injectable suspension, USP

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15
Q

Insulin injection, USP

A

Injection
ready for use as a solution

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16
Q

Sterile Ampillcillin Sodium, USP

A

not ready for use and is a drug product to be combined with solvent “For Injection”

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17
Q

Sterile Dexamethosone Acetate Suspension, USP

A

Injectable suspension
ready for use

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18
Q

sterile ampicillin for suspension, USP

A

not ready for use
FOR injectable suspension

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19
Q

emulsions like Propofol USP

A

ready for use

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20
Q

parenteral injections list

A
  1. solvent or vehicle meets purity and safety standards
  2. buffers, stabilizers, and antimicrobial preservatives are under specific guidelines and use and coloring is PROHBITITED FROM products
  3. parenteral products are sterile and meets standards of sterility and do not exceed endotoxin limits *ELs- low limit pyrogen
  4. parental solutions meets standards for particulate matter, standards for particle size that does not distrust blood flow
  5. environmental controlled area and strict sanitation standards, trained personale and specific clothing
  6. special parenteral packaging: glass or plastic. hermetic containers are high quality and have seal (microogranisms)
  7. each container is filled to a volume in slight excess of the labeled volume to be withdrawn. this permits ease of withdrawal and admin.
  8. single or multiple dose containers and multiple dose volume are restricted
  9. specific labeling regulation
  10. powered sterile use to make solution are packages as lyophilized or freeze dry powders to allow ease
  11. USP 797 - facility safety standards
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21
Q

solvents and vehicle for injections

A

WATER:
purified water
water for injection, USP
sterile water for injection,USP
bacteriostatic water for injection, USP
sterile water for irrigation,USP

SODUIM CHLORIDE:
Sodium Chloride Injection, USP
bacteriostatic sodium chloride Injection, USP

RINGERS INJECTION, USP
- nacl, kcl, and, cacl2 (physiological fluids)- electrolytes of K and CL
-lactate ringers injection, USP

DEXTROSE (D5W)- sterile

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22
Q

Purified water, USP

A

Distillation or ion exchange
Pyrogen free NO
Sterile NO
tight containers

ACCEPTED AMOUNT OF SOLIDS IS 1mg/100ml (lessn than or equal too)

Ion exchange- does not kill any bactiera

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23
Q

Water for Injection USP

A

distillation or reverse osmosis or filtration

requirements:
pyrogen free YES
microorganism free NO

HIGH MELTING PT of the water is what we collect and there is no sterilization so microorganisms are there

it is pyrogen free- because heating or high melting pt gets rid of the chemical

packaging: need to use in 24hrs if not store below 5C or over 80C, or sterilize or discard (this inhibits the microorganism and makes it pyrogen free so we can get Sterile water for injection)

if you open it need to use within 6 hours or pyrogen regenerate

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24
Q

Sterile Water FOR INJECTION USP

A

Pyrogen free YES
Sterile YES (no microorganisms)
single dose containers (no preservative, no antimicrobial agents

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25
Q

Bacteriostatic Water for Injection USP

A

distillation and reverse osmosis
pyrogen free YES
Sterile yes
MUTIPLE DOSE- preservative or contains antimicrobial agents

no more than 5 mL of preservative for IV injection

NOT FOR NEONATES had benzyl alcohol can be poisoning

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26
Q

Sterile water for irrigation, USP

A

distillation and reverse osmosis
Pyrogen free yes
Sterile free yes

greater than 1 liter and labeled “not for injection,” wide mouth

ONE TIME USE
NO preservative -single dose
used for clearing, not for IV injection

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27
Q

a water injection can downgrade to purified water if not sterilized or stored at specific conditions or if it is sterilized by packaging requirements and temperatures (5c to 80c) then it is sterile and becomes sterile water for injection, USP

A
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28
Q

Sodium chloride injection, USP

A

sterile and isotonic
single dose, no antimicrobial or preservative

can be used a vehicle for suspensions or solutions

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29
Q

Bacteriostatic Sodium Chloride, USP

A

Multiple dose, contains preservative or has antimicrobial agents

no more than 5 mL of preservative for IV injection

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30
Q

Ringer Injection USP

A

-Sterile
-single dose
- nacl, kcl, and, cacl2 similar to our physiological fluids)

-can be used alone as a electrolytes replenisher of K and CL and plasma volume expander

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31
Q

Lactate ringers injection, USP

A

has NaCl,KCl, CaCl2, and lactate
used as a fluid and electrolyte replenisher and systemic alkalizer

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32
Q

(small volume) multiple dose

A

contains preservative and is less than or is 5mL (small volume)

ex. 500ml is single dose-no preservative

if more than 5ml we use STERILE WATER FOR INJECTION USP rather than bacteriostatic water for injection USP

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33
Q

Nonaqeous Vehicles for Injections

A

most for subcutaneous or IM
oleaginous injections is NOT IV

Aqueous vehicle are preferred
but we can use nonaqeous

FIXED OILS: USP restrictions:
-MUST be of vegetable origin, must be a liquid at room temperature or when cooled to 10 C (50F) (unsaturated), acids free (we know there is acid when muscles irritated), corn oil cottonseed oil, peanut oil, sesame oil. the oils cannot contain paraffin or mineral oil as these are not absorbed into body

when drug cannot dissolve very well we use a co-solvent system with small amount alcohol or PPG.

**Water is miscible substance (nonaqeous solvents)
-fixed oils, glycerin, polythelene glycols, propylene glycol, alcohol.- do not affect therapeutic efficacy

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34
Q

fluidity of a vegetable oil

A

depends on the amount of unsaturated fatty acids (oleic acid) to saturated fatty acids (saturated)

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35
Q

common vegetable oils that are used

A

corn oil, cottonseed oil, peanut oil, sesame oil,

caster oil, olive oil on occasion

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36
Q

common added substance (Excipents)

A
  1. control isotonicity (osmotic pressure): NaCl and dextrose. NaCl produce 2 ions more dextrose produce 1 more, and we know NaCl osmotic pressure is less than dextrose.
  2. Antioxidants: is the stability of drug. example. sodium bisulfite, (aq) and ascorbic acid (aq.)
  3. Buffer reagent: for parental we have suspension, solns, and powder dosage form. if it is a powder we need to dissolve and so there is no problem with using buffer. **antibiotics require suitable solvent but does not need buffer reagent cause it is NOT a soln (powder)
    **
    antibacterial, preservatives, buffers, solubilizes , antioxidants. agents employed for just coloring effect are NOT ALLOWED in a parenteral product.
  4. parenteral preservative (antimicrobial) needs to be less than 5mL (multiple dose). parenteral injection have less preservative compared to oral solns which is (0.1%). examples: thimersol, benzyl alcohol

benzyl alcohol: is not good for neonate cannot metabolize in liver and kidneys

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37
Q

preservative

A

the maximum limit is 0.01%

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38
Q

degradation (related to stability)

A
  1. hydrolysis
  2. photolysis
  3. oxidation

we put nitrogen in vial, so we have less oxygen in vial to avoid problems with stability

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39
Q

Sterlization

A
  1. sterility: is the absences of life (100% removal)
  2. sterilization: complete destruction of all viable organism and their spores (cure them all) 100% removal
  3. disinfectant: a substances used to inanimate objects to render them noninfectious. IT does not kill just used reduce the microorganisms activity. ex. alcohol. Does not cure.
  4. Antiseptic: reduced in introduced the microorganism in the patient. used to prevent sepsis.

5.pyrogen : fever producing substances

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40
Q

** on exam: consideration of Sterilization

A

verifications: quality assurance

  1. application of an adequate sterilization treatment (spores added to a carrier strip like filter paper and packaged to maintain physical integrity while allowing sterilization.
  2. verification that the materials are sterile.

3 protection of sterile material

  1. delivery, opening, and use of sterile material without entrance of contamination
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41
Q

biologic indicator

A

specific type of microorganism resistant to sterility

42
Q

methods of sterilization

A

steam
dry heat
sterilization by filteration
gas
ionizing radation

43
Q

steam sterilization (autocavin)

A

is in an also know as autocave and employs steam under pressure, the moist heat is in the form of saturated steam
most reliable method and first choice if a product can withstand it, can be used on all forms of microorganisms.

Mechanism of degradation: is protein coagulation/denaturation in the cell. (bacteria because it contains a large percentage of water is easier to kill than spores which contain less water )

it is the heated moisture that permits relatively low temperature compared to dry heat.

**121.5 C (250 F) for 20 mins, 15 psi (ib)
115.5C for 30 min, 10psi
126.5 for 15 mins, 20 psi
small pressure= when boiling pt is low and there is more time . (temp, time, pressure)

the penetration time of moist heat into a load will vary with the nature of the load and the exposure time must be adjusted to account for this time period.

a combination of air and steam will yield lower temperature rather than just steam alone under pressure.

use on: ampuls, because it is a solution that has moisture in a sealed container. sealed empty containers with small amount of water can as well. we can use on glassware, bulk solutions, surgical dressings, instruments.

** we cannot use moist heat and steam sterilization on oils and powders because the moisture cannot penetrate them

“water for injection” becomes “sterile water for injection.”

BENCH Top(small) AUTOCLAVIN- in dentists office/ lab setting

manufacturing autoclavin is larger

44
Q

Dry heat sterilization

A

in ovens
less effective then moist heat/steam so we need higher temperatures and more time for exposures

mechanism: dehydration and slow oxidation of the cell

used: fixed oils, dry glassware, petroleum jelly, mineral oils, talcum powder, some dry powders, glycerin, zinc oxide powders, paraffin. dry chemical, instruments or containers and nonaqeous solns

150-170C not less than 2hrs

if the chemical agents melts at 170c AND DOESNT melt or denature at 140c then we use the 140c so there is more time needed

not all drug stable at this temperature

45
Q

sterilization by filtration

A

ONLY SOLUTIONS NOT POWDER
example is used for eye solutions

we used this when a solution cannot be heated, or heat sensitive solutions

MECHANISM: reverse osmosis of smaller pore size and distallation
mechanism reverse osmosis removal by adsorption in a filter medium and virtue of interlacing bacteria pores or particles becoming entrapped in these pore and removed

MILLEX Filter unit
cell is 7um
bacterial pores: 0.22 um
polioviruses: 0.025um

it is used on a small scale in hospitals and not for manufacturing purpose

advantages: speed in filtering small quantities, sterilizing thermoliable materials, inexpensive equipment , complete removal of living and dead microorganisms, and particulate matter.we properly assembled the sterilized filter paper can have high flow rate

disadvantages: the membrane is fragile so if it is not properly assembled the membrane can rupture. more time is required for larger volume and viscous (high concentration) solutions. current evience show litte to no adsorption takes place with mebrane filters. small doses do not bond to filter paper (less than 5mg)
aphoterican B to ensures it passage the filter needs to be more than 1um.

we can use “ water for injection” by using small pore size of the filter membrane and remove large molecule of the pyrogen

the seridose membrane is fragile or membrane is fragile, high pressure when we push the needle the filter can break, the circumference can leak at high pressure

filter membranes: cellulose acetate or cellulose nitrate

46
Q

gas sterilization

A

gas sterilization: destruction of all living microorganism with a chemical in a gaseous or vapor state

at room temperature can generate oil or powder without dissolving them.

no heat involved. and we used gas vapor to kill microorganism (**example. ethylene oxide and proplyene glycol)

use on: oil, heat sensitive or oil compound, moisture sensitive compound and powders.

when we use a plastic syringe, surgical supplies, or plastics that are heat sensitive we use gas sterilization

47
Q

ionizing radiation

A
  1. UV light (thermometers)
  2. gamma radiation

disadvantages: limited because it has specific equipment and effects of irradiation on product and containers. vital components of the cell structure are destroyed like chromosomal nucleoproteins, not reversible.

48
Q

dollar bill

A

moist sterilization

49
Q

pyrogens

A

-cause febrile reactions
-gram negative bacteria - metabolizes the (endotoxins, lipolyssacharide)
-gram positive bacteria (endotoxins)

  • they can be destroyed at 250C for 4 hrs
  • this is different from microorganism it is a organic compound. compounds need higher heat to get rid of pyrogen

we are doing a chemical rxn (compound) to remove the organic compounds of fever

to speed it up we put in the solution: potassium permanganate and barium hydroxide filter( oxidizing agents)

other methods of removal: distillation and hydrolization

pyrogen test: USP rabbit test. after water for injection, is it pyrogen free or not.after we perform sterilization and reverse osmosis, does it contain pyrogen. because pyrogen are organic we remove them by oxidation and use oxidizing agents. inject 10ml of water for injection not increase more than 0.5C it is pyrogen free.

endotoxin test is faster and efficient than the pyrogen tests: limiulus polyphemus and horseshoe crab.

50
Q

endotoxins

A

are water soluble, pass through 0.2um filters are not destroyed by autoclaving, and are insoluble in organic solvents

51
Q

the industrial preparation of parenteral products

A
  1. formulation : solvents, and additives
  2. preparations: pyrogens and sterilization
    3.packing: type of dosing, type of packing
  3. special packing : Mix-O-vial and ADD vantage
52
Q

mix o vial and ADD-vantage

A

mix o vial: powder or liquid at the bottom and and liquid at the top .
it offer stability of the product until it is used and avoids touch contamination.
small volume single dose no preservative.

ADD vantage: UV plastic bag and a glass vial of powder or liquid drug, avoid contamination and hospital can reduce drug waste and helps to conserve labor and reduce material costs. single dose, no preservative.

52
Q

containers

A

type of dosing: single or multiple dose containers

types of packaging:
-ampuls
-vials
-pre-fill syringes

53
Q

Ampul

A

the oldest type of parenteral product containers and made entirely of glass.

ampul sealing (use heat the top of ampul and seals)
single dose or single use ONLY
-opened by breaking the glass at the score link on the neck

product must be sterile filtered before administration (filter needle) (because has glass) because the glass particles may become dislodged during the ampul opening

54
Q

Amber vials

A

undergoes photolysis

55
Q

Vials

A

can be glass or plastic and close with a rubber stopper and sealed with aluminium crip

multiple dosage form (preservative or bacteriostatic agent)

advantage over the ampul: easier to remove the product
eliminate the risk of glass particle during opening

disadvantage: the stopper may become cored and multiple withdrawals can result in microbial contamination

56
Q

vials-glass containers

A

type I (borosilicate): MOST chemically resistant, low thermal coefficient of expansion. we use this for iv injection

type II: soda lime treated glass.
-lower concentration of migratory oxides than type III. treated with sulfur oxide to dealkanize the internal surface, pH is less than 7 acidic.

type III: soda lime glass.
-good for anhydrous and dry substances (no interaction with the glass). we get under the hood.

plastic containers:
plastic polymers made up of PVC: polyvinyl chloride (soft flexible and no rigid) and polyloefin (semi-rigid and can be stored upright) helps to hold it.

advantage of plastic: is it unbreakable, easier to store, reduced weight, and improved safety. BUT if we have interaction between soln and container we cannot use plastic then use glass.

NS solution is the soft plastic container

57
Q

pre filled syringes and cartridges

A

-emergency (epinephrine and atropine are immediate injection)
-designed for maximum conivence
-improved sterility and accuracy

-metal or plastic cartilage holder
-prefilled with a needle attached
-premixed and remeasured

TUBEX

58
Q

packaging of Injections - infusion solutions

A

infusion solutions: for intermittent and continuous infusions of fluids or drugs

small volume: SVP
volume less than 100mL and has preservative

large volume: LVP
volume more than 100ml has no preservative and is for single dose.

59
Q

table 15.2 remember it is excess of volume of mobile liquid and excess of viscous liquid

A

if label says 0.5 ml and we have a excess of mobile liquid of 0.1 giving us total of 0.6 we calculated based on 0.5 not the 0.6 and have excess viscous liquid would be more than excess mobile so it would be 0.12

a very small amount of excess solution may be added as overfill to ensure that the stated dose volume will be fully extractable from the vial.

60
Q

**laminar flow hoods

A

required from USP. used to prepare a parental admixture in a laminar flow hood
high efficiency particulate air (hepa) filters
we perform under FEDERAL CLASS 100: no more than 100 particles sized 0.5 um or larger per cubic foot of air.

types: vertical laminar flow hood is for toxic compounds or chemoreagants

horizitional: no hazard drug or chemoreagants

61
Q

parentals Injections

A

free of pyrogens(small amount) and microorganisms, and no particles (limited)

62
Q

video on hoods

A

sterile products should be prepared in a class 100 environment and sized 0.5um or larger per CUBIC FOOT good of air

hospital setting

horizational- draw containmaed through a prefliter and pressurized

99.9% 0.3 um are removed

Nothing must interrupt the flow of air between the HEPA and the sterile object. if there is a foreign object can cause containments in the sterile object .

nothing should pass behind a sterile object in a horiztional hood or above a sterile object in a vertical hood

try to stay in deeper into hood without adjusting air flow don’t let your hands block air flow

63
Q

Labeling of Injections - Parenteral Product

A
  1. the name of preparation

2.for a liquid preparation, the percentage content of drug or the amount of drug in a specified volume.

  1. for a dry preparation, the amount of active ingredient present and the volume of liquid added to prepare a solution or suspension
  2. the route of administration (IM, IV, ETC).
  3. a statement of storage conditions an expiration date
  4. the name of manufactures and distributor
  5. an identifying a lot number capable of yielding the complete manufacturing history of the specific package including all manufacturing, filling, and sterilizing and labeling operations.

(5 is about the type of container it is in the temperature and the expiration and stability of the api.)

in hospital setting (labeling): patient name, which hospital and, which room

64
Q

Quality Control

A

is before the drug can be released these things are needs to ensure it is properly manufactured.

  1. Sterility Tests:
  2. Pyrogen Tests:
  3. Clarity Tests: size range, number of particles, methods to monitor- coulter counter (small amount allowed as long as it is smaller than RBC 7um)
  4. Leaker Test: (ONLY AMPULS) put the ampuls in a color dye and to check if the seal is on there or not
  5. USP official test for parenteral
65
Q

Quality Control

A

Injections :
1. clarity tests
2. definition
3. vehicles
4. added substances
5. containers
6. volume in containers /9overfill)
7. labeling
8. packaging and storage (expiration date)

sterilization: methods
1. biological indicators: a specific microorganism resistant to sterility
2. antimicrobial agents effectiveness
3. pyrogen test

  1. container specifications:
    -light transmission
    -chemical resistance (glass)
    -biological test (plastic)
    -physiochemical tests (plastic)
    -permeation

because we have a lot of tests to perform for the sterile form of injection it is more expensive
compared to non sterile injection

66
Q

Quality Assurance- USP 797

Pharmacy prepared sterile products

A

The objective of this chapter is to provide guidance (both environmental and practice) to prevent harm, including death, to patients that could result from nonsterility, excessive bacterial endotoxins, variations in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality. This chapter dis- cusses responsibilities and training/evaluation of all personnel as well as facility and equipment requirements, quality control, risk levels, verification, standard operating procedures, finished preparation release checks and tests, storage and beyond-use dating, and many other topics.

Pharma compounding for sterile products (CSP) published in fall 2003 and went into effect January 1 2004

addresses the compounding, preparations, labeling of sterile drug preparations

applies to all orgs that compounds sterile preparations like healthcare institutions, home infusion pharmacists, and other facilitates.

67
Q

(CSP) Compounded Sterile Preparations are abbreviated as CSPs

A

it is prepared based on the Rx of each patient.

68
Q

COMPOUNDED STERILE preparations

A

-use of cleaner facilities

-specific training and testing of compounding personnel in principles and practices of aseptic manipulations

-evaluation and maintenance of air quality in the compounding area

  • sound knowledge of sterilization
  • principle and practice of solution stability
69
Q

expiration date

A

to determine this it is based on 90% (next day expire) of the content remained in the product.

we determine based on 75% of API remaining in the dosage form.

70
Q

factors of CSP

A

the status of the components incorporated in the preparation ( we can use a non-sterile drug but needs to undergo sterilization)

the process utilized in preparing the preparation

the performance of the personnel involved in the preparation

environmental conditions under which the process is performed

71
Q

how to minimize the source of contamination

A

primary engineering control : laminar flow hoods
- horizontal flow clean benches
-vertical flow clean benches
-biological safety cabinets (similar to the vertical)

secondary engineering controls:
is the storage
- provide a buffer zone or a buffer system room as a core for the location of the workbenches or isolators .

-have the cleanest work surfaces
(horizontal or vertical work benches) and biological safety cabinets or isolators

72
Q

clean room- air quality

A

allow the manipulation of sterile products without contamination of microorganism pyrogens or particles

-dusts, smoke, bacteria

-sterile area should be cleaned daily

-avoid introduction of cardboard into the clean environment should be avoided

-traffic flow should be minimized

-special treatment and filter system for air
-UV radiation
-sticky mats for shoes particulate matter

-positive room air pressure to reduce contamination and the air blows out of this room

73
Q

Air quality

A

-must provide at least the ISO Class 5 quality of air to which sterile ingredients and Components are exposed

ISO Class 5 quality air means the number of particles having a particle size of 0.5 um and larger contained in the environment does not exceed 3520 particles per CUBIC METER

similar to the federal class 100 but: this is 100 particles and is 0.5 um per CUBIC FOOT but are the SAME THINGS SAME VALUES.

74
Q

USP 979

A
  • CSP Def
  • ISO CLASS 5
75
Q

compounding personnel

A

USP 797 requires personnel to be proficient in performing the following duties:

  1. perform antiseptic hand cleansing and disinfection of non sterile compounding surfaces
  2. select and appropriately on protective gloves, goggles gowns, masks, and hair and shoe covers.
  3. use laminar flow clean air hoods , barrier isolators and other contamination control devices
  4. identify, weigh, and, measure ingredients
  5. manipulate sterile products aseptically and label and quality inspect compounded sterile preparations
76
Q

sources of contamination

A

1.solid or liquid of the compounding personal and objects (person with jewelry)

yes u are allowed to use non sterile api (when we don’t have a sterile api of it)

  1. non sterile components
    employed and incorporated before terminal sterilization (we need to remove microorganism before use in the patient)
  2. innapprioate conditions within the compounding area ( yes, hospital can give a flu shot)
  3. prolonged pre-sterilization procedures with aqueous preparations (longer time can cause contaminates from the environment increases)
  4. non sterile dosage forms used in compounding (if we use a nonsterile dosage how can be preform it has microrg free, particle free, and pyrogen free
77
Q

low risk compounding

A

( under laminar flow hood)
no concern about pyrogen or microorganisms here

1.compounded with aseptic manipulation under ISO class 5 or better quality environment. ONLY sterile ingredients, products, and components and devices.

  1. ONLY transfer, measure, and mix manipulations with closed or sealed packaging system.
    (powder into he solvents in sterile products)

3.manipulations are limited to aseptically opening ampuls, penetrating sterile stoppers on vials with sterile needles and syringes and transferring sterile liquids into sterile syringes to sterile admin. devices and packages of other sterile products

78
Q

examples of low risk

A

SINGLE TRANSFER: OF STERILE dosage forms from containers like ampuls, bottles, bags, and vials, using a STERILE needle AND STERILE syringe

SINGLE transfer of sterile dosage form from other admin device and other sterile containers (IV infusion devices)

SINGLE transfer of sterile dosage forms from ampules and the contents of ampules require STERILE FILTRATION to remove any glass particles.

manually measuring and mixing NO MORE THAN 3 manufactured products to compound drug admixtures and nutritional solutions.
(NO MORE THAN 3 SINGLE TRANSFERS OF DRUG A, B, C )

79
Q

medium risk compounding

A

*(still ISO class 5 and laminar flow hood)

-MUTIPLE TRANSFER
-has preservative

it is multiple doses (preservative) or small doses of sterile products are combined or pooled to prepare a compounded sterile preparation that will be administrated either to multiple patients or to one patient on multiple occasions

compounding process included complex aseptic manipulations other than the single volume transfers.

Compounding process usually LONG duration, such as required to complete dissolution or homogeneous mixing (problem with solubility of the drug)

compounded STERILE preparations DO NOT contain a broad spectrum bacteriostatic substance and they are administrated over several days (internally worn or implanted infusion device).- (the catheter cannot be on there more than 72 hours )

DRUG, D5W, NSS- IV SOLUTION

80
Q

medium risk compounding examples

A

compounding of TPN fluids using manual or automated devices during which there are MULTIPLE INJECTIONS , detachments, attachments of nutrient source products to device or machine to deliver all nutritional components to the final sterile container

filling reservoirs of injections and infusion devices WITH MULTIPLE STERILE DRUGS products and evacuation of air from those reservoirs before the filled device is dispensed.

filling reservoirs of injections and infusion devices WITH volumes of sterile drug solutions that will be admin. over SEVERAL DAYS at ambient temp (25-40c). (no preservative and increase contamination)

Transfer (MORE THAN 3, SO 4) of volumes from multiple ampuls or vials into a single final sterile container or product.

81
Q

high risk compounding

A

not for IV usually a spray or eyes., ears
no a sterile environment In ISO CLASS 5

hospital setting- low volumes of flue shot or vaccine is high risk but the volume introduced in the human is little.

82
Q

high risk examples

A

all sterile ingredients, device, and compenets, abut expose to air quality a below ISO CLASS 5, storage below ISO CLASS 5, used or opened packages of sterile that lack antimicrobial preservative.

measure, mix sterile ingredients in NON STERILE device before we do terminal sterilization,

packages of bulk ingredients contain at least 95% by weight of their active chemical moiety and hav not been contaminated between uses

83
Q

available injections - small volume parenterals

A

-small volume parenteral are solution and suspensions and solids
-insulin preparations

84
Q

small volume parenteral: activity profiles and Compatibility

A
85
Q

rapid acting (small volume insulin)

A

1.Insulin Lispro:
onset 0.25H (15 min),
peak 0.5-1.0 ( 30 min-1hr),
3 hrs duration
(YES) compatible Ultralente and NPH

  1. Insulin Aspart:
    onset: 0.25H (15 min)
    duration: 0.5-1.0 (30min-1hr)
    3 Hrs duration
    NONE compatible
86
Q

Short Acting (small volume insulin)

A
  1. regular insulin
    onset 0.5H (30min)
    peak 2-5H
    duration 5-8H
    **YES compatible: ALL
87
Q

intermediate acting

A
  1. Isophane (NPH) Insulin
    onset 1-2 H
    peak 6-10 H
    duration 16-20H
    YES compatible : Regular
  2. Insulin Zinc (lente)
    1-2 H
    6-12H
    18-24H
    YES compatible : regular, semilente
88
Q

Long acting

A
  1. Insulin zinc extended (Ultralente)
    4-6
    10-18
    24-28
    yes compatible: REGULAR, SEMILENTE
  2. Insulin glargine
    ONSET 2
    peak NONE
    duration 24+H
    NONE compatiable
89
Q

Mixtures

A

Isophane/ regular insulin 70/30 and 50/50
ONSET 7-12Hrs
16-24 HRS
NO DURATION

NPH/lispro mix 75/25
onset 5 min
7-12 hr
1-24hr

90
Q

Large volume injections

A

2 types of glass for large volume one with air tube and one without air tube

Maintenance therapy:

electrolyte requirement:
cations(Na, K, Ca, Mg)
anions(Cl, Phosphate, Acetate)

caloric requirement:
5% dextrose to reduce the caloric deficit that usually occurs in patients undergoing maintenance or replacement therapy. The use of dextrose also minimizes ketosis and the breakdown of protein.

replacement therapy:
patient has undergone a heavy loss of water and electrolytes, as in severe diarrhea or vomiting, greater than usual amounts of these materials may be initially admin and then maintenance therapy provided. Patients with Crohn disease, AIDS, burns, or trauma are candidates for replacement therapy.

water requirement (25 to 40 mL/kg)

parenteral hyper alimentation

enteral nutrition:
Enteral nutrition products may be administered orally, via nasogastric tube, via feeding gastrostomy, or via needle-catheter jejunostomy. These products are formulated to contain a variety of vitamins, minerals, carbohydrates, proteins, fats, and caloric require ments to meet the specific needs of patients.

intravenous infusion devices

91
Q

large volume parenteral (no preservative)

A

amino acid injection: nutrition

dextrose Injection: (2.5, 5, 10) nutrition

dextrose and sodium chloride injection: nutrition and electrolyte

mannitol injection: diagnostic kidney filter (renal) and nutrition

ringer injection : na, k, cl, ca. electrolyte (contains Ca so not for tetracycline bc it will for kelade) - physiological fluid-electrolytes

lactated ringer injection: ca, k, na, lactate. alkalizer and electrolyte

Sodium chloride injection : nacl 0.9% - electrolyte and isotonic vehicle

92
Q

Irrigation and dialysis solutions:

A

sterile products and have same standards as IV prep.

NOT FOR INFUSION INTO IV

types:
1. topical admin: pour bottle, irrigating wounds, dressing, cleaning instruments in surgeries

2.infusion of irrigating solutions: surgical patients. perfuse tissues, remove blood, provide clear view . reduce risk of infection
(antibiotic prep: Neosporin irrigant)

  1. dialysis solutions: patients with renal failure, poisoning, electrolyte disturbance. remove waste, serum electrolytes, toxic products in body.
    **ex. peritoneal and hemodialysis
93
Q

hemodialysis

A

blood is filtered outside body and then returned to body when cleansed

patients blood is transfused through a dialyzing membrane unit that removes the harmful substances from the patients vascular system

after passing the dialyzer the blood reenters the body by the vein

94
Q

peritoneal dialysis

A

a hypertonic dialyaste is infused directly into the peritoneal cavity by a surgical implanted catheter

contains dextrose and electrolytes, removes harmful things by osmosis and diffusion.

after a dwell period the solution is drained

antibiotics and heparin may be added to dialysate

95
Q

vials (video)

A

has a plastic cap and most are not guaranteed sterility

pray and swab all vials with 70% alcohol

swabbing in one direction removes particles
alcohol- disinfect

to prevent core formation needs to penetrated with the tip and heal

Vital- glass container with rubber cap held together by aluminum cover-
Aluminum cover does not guarantee sterility and therefore rubber cap must be wiped with alcohol swap before use.

To prevent core formation, the needle should penetrate the rubber closer at the same point with both the tip and heel of the bevel

Since vials are enclosed containers, to prevent a vacuum, the same amount of air as fluid required should be released into the vial before uptake of fluid

96
Q

ampuls (video)

A

one open is a open system
higher ring is the point to where finger should be to avoid getting cut.
cleans with alcohol swab .

ampul is tilted horizontal and surface tension keeps the solution from spilling out bevel of needle corner space near opening. you need a filter needle 5um to rid of glass particles.

Amples- completely made up of glass, becomes open system when used- Not necessary to release air into amples-

Ample ring can tell you where to place your fingers or where the head will break

Ample is broken with alcohol swab around the neck and a quick firm snapping motion

Do not break the ampul toward the HEPA filter or other objects in hood

To uptake drug from ampul, it should be tiled and the bezel of the needed placed on the opening of the ampul

PVC bags used for IV fluid. Easier storage, less breakage, no need to vent container

Injection portal should be placed toward HEPA filter

2 diaphragms need to be pierced for drug to enter IV bag; therefore a needle longer than ⅜ inch should be used

Sterilization of ridge IV container portal and cap is not necessary

97
Q

PVC-IV BAGS

A

prevent water loss
injection portal is upright and disinfected, insert needle into portal. 2 injection parts so we need a needle longer than 3/8 inch

no protective cap needed on the polflin rigid iv bag.

98
Q

low risk level1

A

stored at room temp
admin within 28 hrs of prep

stored in refrigerator for 7 or less, not exceed 24hrs

30 days or less before, not to exceed 24 hrs.

99
Q

medium risk level 2

A

products beyond 7 days under refrig.
stored beyond 30 days frozen , admin beyond 28 hrs after prep

100
Q

high risk level 3

A

nonsterile ingredients or compounded with nonsterile compenet.

CF3 (6 decks)

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