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Pharm 125 > Sterile dosage forms > Flashcards

Sterile dosage forms Flashcards

1
Q

Sterile assurance level (SAL)

A

probability that a single unit subjected to sterilization remains non-sterile

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2
Q

SAL of 10^-2

A

produce 100 units expect 1 to be non-sterile

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3
Q

what is the value of SAL for GMP

A

10^-6

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4
Q

what is the SAL for compounding

A

10^-3

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5
Q

methods of sterilization (5)

A 
steam
dry heat
gas 
radiation
filtration
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6
Q

steam sterilization

  • name of machine
  • how work
  • mechanism
  • what does steam need touch
A
  • autoclave
  • water create steam in high pressure chamber (121degC for 15 minutes @~100kPa)
  • superheated water transfers heat to microorganisms and kills via denaturation and coagulation of proteins
  • steam needs come into contact with material you want to sterilize
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7
Q

limitations of steam sterilization (autoclave)

  • plastic
  • chemicals (compounding consideration)
  • typical use
A

plastic melts

chemicals break down
- cant be used for most compounded products

typically used to sterilize equipment
-ex. mops for clean room

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8
Q

validation for steam sterilization (autoclave)

A

bacterial spore (typically bacillus)

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9
Q

dry-heat sterilization/depyrogenation

  • heat
  • filter
  • duration
  • mechanism
A

heated to 200-250degC

HEPA filtered air

30-60min

dry heat dehydrates and burns (oxidizes) organisms

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10
Q

validation of dry-heat sterilization/depyrogenation

A

3 log (or better) pyrogen reduction

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11
Q

advantage of dry-heat sterilization/depyrogenation

A

use for powders and heat-stable items that are adversely affected by steam
-DOES NOT RUST METAL

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12
Q

gas sterilization

  • how work
  • temperature
  • gas concentration
  • duration
A

pressure and vacuum chamber fills with gas

30-60degC

200-800 mg/I

several hours

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13
Q

advantage of gas sterilization

A

materials that cannot withstand high temperature

-ex. disposable plastic syringe

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14
Q

gas sterilization

  • what gas
  • what need gas to contact
A

gas such as ethylene oxide

must contact all surfaces

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15
Q

mechanism of gas sterilization

A

alkylating agent interfering with cell metabolism

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16
Q

disadvantages of gas sterilization

A

gas is flammable, toxic, and carcinogenic

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17
Q

validation of gas sterilization

A

use biological indicator

- ex. bacillus atrophaeus

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18
Q

types of ionizing radiation

A

radioisotope decay (gamma radiation)

electron-beam radiation (beta radiation)

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19
Q

advantages of sterilization by ionizing radiation

A

low measurable residues

20
Q

purpose of sterilizing by ionizing radiation

A

products unable withstand heat sterilization

concerns about safety of ethylene oxide

21
Q

mechanism of sterilization by ionixing radiation

A

radiation ionizes water forming free radicals

free radicals react with organic cellular components (esp DNA)

leads to cell damage and death

22
Q

sterilization by filtration

-what is

A

physical removal of microorganisms

23
Q

sterilization by filtration advantages

A
  • less equipment,

- heat/gas/radiation labile solutions

24
Q

sterilization by filtration

- what determines use

A

pore size determines use

range 10micrometer to ultra-filter (small molecules)

25
Q

parenteral definition

  • para
  • enteral
A 
para = outside
enteral = intestine
26
Q

where are parenterals given

A

preparations that are given outside the intestine

- parenterals intended for injection through sin or other external boundary tissue rather than through alimentary canal

27
Q

what are the “must”s of parenterals (5)

A

sterile

no pyrogenic contamination

no visible particulate matter

stable

compatible with diluents, delivery systems, other co-administered other drug products

28
Q

the should of paenterals

A

should be isotonic

29
Q

osmolarity

  • what is/ what measure
  • units
A
  • osmolarity (osmotic concentration) is a measure of solute concentration

units = osmoles of solute/L of solution

30
Q

osmolarity of 1 mole glucose

A

1 mol/L = 1osmole/L

31
Q

osmolarity of NaCl

A

1mol/L = 2osmole/L

32
Q

Question: what is osmotic concentration of normal saline? (0.9%w/vNaCl,M=58.5g/mol)

A

0.9% w/v = 0.9g/100mL = 9g/L

Moles = mass/M, 9g/58.5g/mol = 0.154moles

Since 1mole = 2 osmole/L , 0.154moles = 0.308osmol/L

Answer = 0.308 osmol/L

33
Q

Tonicity

  • what is
  • is it unique to specific membs
A

measure of effective osmotic concentration across a semi permeable membrane

property of solution in reference to a particular membrane (ex. RBC)

34
Q

does solute permeability affect tonicity

A

permeable solutions dont affect tonicity

impermeable solutions do affect tonicity

35
Q

hypertonic solution

A

water flow out -> crenation

solute conc higher in solution

36
Q

hypotonic solution

A

water flow in -> lysis

solute conc higher in cell

37
Q

isotonic solution

A

no net movement of water

38
Q

storage and handling: expiration date

  • who sets
  • what ID
  • how det
A
  • set by manufacturer
- ID time which conventionally manufactured drug prod expected maintain labelled:
\+identity
\+ strength
\+quality
\+ purity

determined based on product-specific studies

39
Q

storage and handling: BUD

  • what is
  • who assign
  • base BUD on what
A

date and time after which a cpd’d sterile preparation (CSP) cant be used and must be discareded

assigned by pharmacy for a compounded preparation

based on stability and sterility

40
Q

NAPRA BUD statement thing

A

date and time after which a compounded sterile preparation cannot be used and must be discareded because of a risk of loss of sterility

administration of a compounded sterile preparation must begin before the BUD has passed

41
Q

USP797 (proposed revisions) for BUD

A

the date and time after which a CSP cannot be used bec its required characteristics (sterility, str, purity) cannot be ensured

42
Q

storage and handling: establishing BUD

  • what is critical factor
  • what is it based on
A

time is crit factor
+ more time = more risk of compromising stability/sterility

based on shorter of stability and sterility

43
Q

watch video slide 7-11 and make cards fatass

A
44
Q

NAPRA: sterile unit

A

sterile unit: vial, ampoule, bag, drug, diluent

2 bag of solute represents 1 sterile unit

2 vials of cefazolin represents 2 sterile units

1 vial of sterile water for injection represents 1 sterile unit

45
Q

low contamination risk

A

final product compounded using up to 3 sterile units

no ore than 2 septum punctures at the injection site for each sterile unic

simple aseptic transfer technique

drug prepared for one patient (patient-specific dose)

46
Q

medium contamination risk

A

final product compounded using 4 or more sterile units

Pharm 125 (5 decks)

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