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QC 2 LEC > M3L2 > Flashcards

M3L2 Flashcards

1
Q

is a microbiological test suitable for revealing the presence of viable forms of BACTERIA, FUNGI, and YEASTS in pharmaceutcial articles

A

STERILITY TEST

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2
Q

aqueous parenteral for ____ requires MOST CRITICAL evaluation for sterility

A

IV injection

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3
Q

TEST ORGANISM CULTURE MEDIA

A

Soybean Casein Digest Medium
Fluid Thioglycollate Medium

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4
Q

METHODS OF STERILITY TEST

  • DIRECT TRANFER method
  • method of choice for MEDICAL DEVICES, NON-FILTERABLE sterile products, PARENTERAL EMULSIONS
  • Turbidity/cloudiness in the test sample is an indication of microbial contamination
A

DIREECT INOCULATION METHOD

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5
Q

METHODS OF STERILITY TEST

DIRECT INOCULATION METHOD is also known as

A

direct transfer method

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6
Q

METHODS OF STERILITY TEST

DIRECT INOCULATION METHOD:
what indicates MICROBIAL CONTAMINATION

A

turbidity / cloudiness

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7
Q

METHODS OF STERILITY TEST

  • the method of choice for STERILITY, TESTING, ENDOSRSED byt he USP/FDA
  • applicable for AQUEOUS/FILTERABLE solutions
  • it involves the passage of a solution through a STERILE MEMBRANE FILTER. any contaminating microorganisms will be retained on the surface of the filter
  • the membrane is cut in half. then separately cultured and incubated. the filters are examined for microbial growth
A

MEMBRANE FILTRATION METHOD

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8
Q

METHODS OF STERILITY TEST

MEMBRANE FILTRATION METHOD:
applicable for ____ solutions

A

aqueous / filterable solutions

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9
Q

METHODS OF STERILITY TEST

MEMBRANE FILTRATION METHOD:
it involves the passage of a solution through a ____

A

sterile membrane filter

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10
Q

METHODS OF STERILITY TEST

MEMBRANE FILTRATION METHOD:
the membrane is cut in ____

A

half

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11
Q

METHODS OF STERILITY TEST

MEMBRANE FILTRATION METHOD:
the membrane that is cut in half are ____ cultured and incubation

A

separately

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12
Q

METHODS OF STERILITY TEST

MEMBRANE FILTRATION METHOD:
nominal porosity

A

0.45um

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13
Q

METHODS OF STERILITY TEST

MEMBRANE FILTRATION METHOD:
diameter

A

45um

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14
Q

METHODS OF STERILITY TEST

MEMBRANE FILTRATION METHOD:
flow rate

A

55-75 mL/minute at a pressure of 70cm Hg

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15
Q

METHODS OF STERILITY TEST

a method that determines the efficiency of the DIFFERENT METHODS of sterilization

A

USE OF BIOLOGICAL INDICATORS

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16
Q

METHODS OF STERILITY TEST

USE OF BIOLOGICAL INDICATORS:
MOIST heat

A

Bacillus stearothermophilus

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17
Q

METHODS OF STERILITY TEST

USE OF BIOLOGICAL INDICATORS:
DRY heat

A

Bacillus subtilis

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18
Q

METHODS OF STERILITY TEST

USE OF BIOLOGICAL INDICATORS:
Ethylene oxide

A

Bacilus stearothermophilus

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19
Q
A
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20
Q

USP REQUIREMENT FOR PARENTERAL STERILITY TESTING

absolutely NO GROWTH on the ____ of the membrane filter for the ENTIRE incubation period

A

SURFACE

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21
Q

USP REQUIREMENT FOR PARENTERAL STERILITY TESTING

absolutely ____ in the CULTURE TUBES for the entire incubation period

A

NO GROWTH / NO TURBIDITY

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22
Q

USP REQUIREMENT FOR PARENTERAL STERILITY TESTING

____ is required unless an evidence had been established that the ASEPTIC STERILE TECHNIQUE has been VIOLET

A

NO RETEST

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23
Q
  • are FEVER-CAUSING substances obtained from microorganisms which may be present from water, solute, and equipment or introduced from the manufacturing process
A

PYROGENS

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24
Q

PYROGENS

signs and symptoms

A

fever
malaise
chills
pain

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25
Q

PYROGEN TEST

  • Limulus Amoebocyte Lysate Test (LAL Test)
  • a test for estimating the concentration of BACTERIAL ENDOTOXINS that maybe present in a sample
  • it uses LAL obtained from aqueous extracts of the circulating amoebocytes of the HORSE-SHOE CRAB (Limulus polyphemus) which has been prepared and characterized as a LAL reagent
A

BACTERIAL ENDOTOXIN TEST

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26
Q

PYROGEN TEST

BACTERIAL ENDOXTOXIN TEST:
is also called ____

A

Limulus Amoebocytes Lysate Test (LAL Test)

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27
Q

PYROGEN TEST

  • in-vitro, QUANTITATIVE method of pyrogen test
  • it is based on the GEL-CLOT formation of a pyrogen-contaminated product, in the presence of LYSATE
A

LAL TEST (Limulus Amoebocyte Lysate)

28
Q

PYROGEN TEST

BACTERIAL ENDOTOXIN TEST:
it uses LAL obtained from aqueous extracts of the circulating amoebocytes of the ____

A

HORSE-SHOE CRAB
(Limulus polyphemus)

29
Q

PYROGEN TEST

  • detect ONLY pyrogens from gram-NEGATIVE bacteria
  • simpler, more rapid method taht QFRiR
  • QUANTITATIVE
A

LAL Methods

30
Q

PYROGEN TEST

LAL METHODS:
detect ONLY pyrogens from ____ bacteria

A

gram-NEGATIVE

31
Q

PYROGEN TEST

LAL TEST:
it is based on the ____ of a pyrogen contaminated product

A

GEL-CLOT formation

32
Q

PYROGEN TEST

LAL TEST:
it is based on the gel-clot formation of a pyrogen-contaminated product in the presence of ____

33
Q

PYROGEN TEST

LAL TEST:
THREE PRINCIPLES

A
  1. Gel-clot formation
  2. Chromogenic
  3. Kinetic
34
Q

PYROGEN TEST

  • an in-vivo method, PASS-FAIL test of pyrogens in AQUEOUS PARENTERAL
  • uses HEALTHY RABBITS weighing at least 1.5kg BW, temperature interval is NMT1C, NO rabbit has a temperature of 39.8C
  • 3 rabbits are used
A

QUALITATIVE FEVER RESPONSE IN RABBITS (QFRiR)

35
Q

PYROGEN TEST

QFRiR:
____ test of pyrogens in aqueous parenteral

36
Q

PYROGEN TEST

QFRiR:
uses ____

A

healthy rabbits

37
Q

PYROGEN TEST

QFRiR:
rabbits weigh at least ____

38
Q

PYROGEN TEST

QFRiR:
temperature interval

39
Q

PYROGEN TEST

QFRiR:
NO rabbit has a temperature of ____

40
Q

PYROGEN TEST

QFRiR (RABBITS USED):
POSITIVE control

A

Brewer’s Yeast

41
Q

PYROGEN TEST

QFRiR (RABBITS USED):
NEGATIVE control

42
Q

PYROGEN TEST

QFRiR (RABBITS USED):
TEST DRUG

A

not exceeding 10mL/kg BW dose

43
Q

PYROGEN TEST

  • conducted as PREPARATORY stage to the test proper
  • designed to establish a NORMAL of the BODY TEMPERATURE of the test rabbits
44
Q

PYROGEN TEST

SHAM TEST:
is injected into ____

A

marginal ear vein

45
Q

PYROGEN TEST

SHAM TEST:
accept

A
  • NO rabbit shows an individual rise in temperature that is ≥ 0.5C
  • SUM of three individual temp rise should NOT exceed 1.4C

otherwise, REPEAT using ADDITIONAL 5 RABBITS

46
Q

PYROGEN TEST

SHAM TEST:
reject

A
  • MORE tahan 3 of the 8 rabbits showed a temp rise of ≥ 0.5C
  • SUM of the readings of temp rise for 8 rabbits is more than 3.3C
47
Q

PYROGEN TEST

  • by classical BLOTTING PAPER
  • the sealed and filled ophthalmic ointment collapsile tubes are placed on an absorbent paper, heated in a 60C (∓3) oven for 8 hours
A

LEAKER’S TEST FOR OPTHALMIC OINTMENTS

48
Q

PYROGEN TEST

LEAKER’S TEST:
by classical ____

A

blotting paper

49
Q

PYROGEN TEST

LEAKER’S TEST:
the opthalmic ointment collapsible tubes are placed on an ____

A

adsorbent paper

50
Q

PYROGEN TEST

LEAKER’S TEST:
heated in a ____ oven

51
Q

PYROGEN TEST

LEAKER’S TEST:
heated in the oven for how many hours

52
Q

PYROGEN TEST

LEAKER’S TEST USP specifications

A
  1. NMT 1 out of 10 tubes should leak
  2. NMT 1 out of 30 tubes should leak
53
Q

PYROGEN TEST

LEAKER’S TEST USP specifications:
what to do if more than 1 out of 10 leaked

A

expand the test to 20 additional tubes

54
Q

PYROGEN TEST

  • a test done using WHITE MICE or GUINEA PIGS
  • it is used ofr determining the safety of the PLASTIC DEVICES used in parenteral products
A

SAFETY TEST

55
Q

PYROGEN TEST

SAFETY TEST:
uses ____ or ____

A

white mice or guinea pigs

56
Q

PYROGEN TEST

SAFETY TEST:
determines the safety of the ____ used in parenteral products

A

PLASTIC DEVICES

57
Q

PYROGEN TEST

a test for the presence of PARTICLES or PARTICULATES

A

PARTICULATE MATTER TETS

58
Q

PYROGEN TEST | PARTICULATE MATTER TEST | METHODS

  • measures the size and number of particulates by means of SHADOW CAST as is pass through the high intensity of light beams
  • DISADVANTAGE: it cannot distinguish the shadow cast by a particle and a bubble
A

USE OF ELECTRONIC PARTICULATE COUNTER

59
Q

PYROGEN TEST | PARTICULATE MATTER TEST | METHODS

  • it collects particles LARGER than the rated pore size
  • DISADVANTAGE: slow counting
A

MEMBRANE FILTRATION TECHNIQUE

60
Q

PYROGEN TEST

  • prevent the distribution and use of parenteral products that contain ANY PARTICULATE MATTER
  • AQUEOUS PARENTERAL for IV are required to undergo this test
  • FIRST METHOD: visual examination, using a well-lit BLACK and WHITE panel
A

CLARITY TEST

61
Q

PYROGEN TEST

CLARITY TEST:
____ are required to undergo this test

A

aqueous parenteral for IV

62
Q

PYROGEN TEST

CLARITY TEST:
first method

A

visual examination

63
Q

PYROGEN TEST

CLARITY TEST:
first method uses ____

A

well-lit black and white panel

64
Q

REQUIREMENT FOR THE ANALYST | CLARITY TEST

vision

A

20/20 vision

65
Q

REQUIREMENT FOR THE ANALYST | CLARITY TEST

should be capable of detecting particulate contaminants as small as ____

A

20um to 30um

66
Q

MINIMUM FILL TEST FOR SEMISOLIDS

USP SPECIFICATIONS:
if the product weighs < 60g or 60mL, it’s net content should be ____ of the labeled amount

67
Q

MINIMUM FILL TEST FOR SEMISOLIDS

USP SPECIFICATIONS:
if the product weighs BETWEEN 60g or mL and 150 g or mL, it’s net content should be ____ of the labeleed amount

QC 2 LEC (7 decks)

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