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QC lab > unit 5 > Flashcards

unit 5 Flashcards

1
Q

dosage forms of therapeutic agents that are free of viable microorganisms.

A

Sterile products

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2
Q

unique dosage forms of drugs as they are injected through the skin or
mucous membranes into the internal body compartments.

A

Parenteral products

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3
Q

Sterile preparations

A

parenteral, ophthalmic and irrigational preparations

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4
Q

sterile liquids, semisolids, or solid preparations
intended for the administration upon the eyeball and/or conjunctiva
in the conjunctival sac

A

Opthalmics

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5
Q

pH: Ideally for opthalmic

A

pH 7.4) or slightly more alkaline

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6
Q

Opthalmic prep. tolerate solutions with pH as low as___to improve absorption and stability

A

3.5

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7
Q

used to treat local disorders of the eye

A

EYe drops

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8
Q

are used to treat
intraocular disorders like glaucoma.

A

Ocular solutions

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9
Q

are used for rinsing the eye or impregnating eye
dressings

A

Eye lotions

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10
Q

sensitive to microorganisms which is why ocular solutions must be sterile.

A

Occular tissues

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11
Q

Injectable route of administration, drugs are commonly injected
into the veins, muscles or skin butcan also be injected in the
arteries, joints, joint fluid areas, spinal column, spinal fluid or heart.

A

Parenteral

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12
Q

included under
certain conditions such as in multidose products.

A

Benzyl alcohol

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13
Q

pH of most licensed parenteral
solutions is between __

A

3and 9

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14
Q

Parenteral solutions must be ___ and ___

A

sterile and pyrogen-free.

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15
Q

important to ensure that theproduct is in its optimum shape to produce its
desired therapeutic outcome

A

(isotonicity testing

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16
Q

Used when wider range of tonicity can be tolerated as dilutionwith
body fluid occurs.

A

Smaller volume

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17
Q

- the solution must be aqueous, as oildroplets can occlude the pulmonary
microcirculation.

A

Intravenous

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18
Q

- the solution canbe aqueous or non-aqueous.

A

Intramuscular and subcutaneous

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19
Q

- are sterile solutions, emulsions or suspensions prepared by dissolving emulsifying or suspending the active ingredients and other
additives in water for injection or other suitable non-aqueous vehicle
or in mixture of two, if they are miscible.

A

Injections

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20
Q

are sterile solid substances (including freeze- dried or lyophilized materials) which
are distributed in their final containers which, when shaken with the prescribed volume of the
appropriate sterile liquid, rapidly form clear and practically particle-free solutions or uniform suspension.

A

Powder for injections

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21
Q

These are sterile aqueous solutions or emulsions with water as continuous phase.

A

Intravenous Infusion

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22
Q

When a drug is infused intravenously at a constant rate, a __
will be reached progressively in the most frequently most of the cases follows first
order kinetics.

A

plateau concentration

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23
Q

True or false
The amount of drug in the body then rises, but as the drug concentration increases, so does the rate of elimination.

A

True

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24
Q

True or false , the rate of elimination will keep rising until it matches the rate of infusion.

A

True

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25
Q

amount of drug in the body is then constant and is said to have reached a ___

A

steady state or plateau.

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26
Q

sterile solid preparations of size and shape for implantation into
body tissues so as to release active ingredient over an extended period of time.

A

Implants

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27
Q

man-made devices, in contrast to a transplant, which is
a transplanted biomedical tissue.

A

Implants

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28
Q

are sterile solutions that are intended for administration by
injection or by IV infusion only after dilution with suitable dilution with a suitable liquid.

A

Concentrated solutions for injections

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29
Q

Aqueous Vehicles for Sterile Products

A

Water for Injection
Sterile Water for Injection
Bacteriostatic Water for Injection

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30
Q

It is intended to be
used within 24 hours
after collection

A

Water for Injection

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31
Q

Single dose containers not
larger than 1 liter

A

Sterile for water injection

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32
Q

agents such as
benzyl alcohol may cause gasping
syndrome (multiorgan failure).

A

Bacteriostatic

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33
Q

Use Not more than 30 ml of the water

A

Sterile water for injections

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34
Q

Total solid contents
not more than 1
mg/100 ml

A

Water for Injection

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35
Q

It is packaged in prefilled syringes
or in vials

A

Bacteriostatic water for injections

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36
Q

Single dose units:

A

ampoules, infusions and prefilled disposable syringes

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37
Q

multiple dose vials types of packaging

A

Multiple dose units:

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38
Q

production and control of Small volume parenterals:

A

volume < 100 ml

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39
Q

: volume ≥ 100 ml

A

Large volume parenterals

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40
Q

are topical preparations used intra-operatively during procedures.

A

Irrigation solutions

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41
Q

indicated for washing or bathing surgical incisions, wounds, and body tissues, including
body cavitie

A

Irrigation

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42
Q

most important
requirement of irrigation preparation.

A

sterility

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43
Q

Processing of Parenteral Preparations

A

1.Cleaning of Containers and
Equipment
2. Collection of Materials
3.Preparation of Parenteral Products
4. Filtration
5. Filling the preparation in the final container
6. Sealing the container
7. Sterilization and Evaluation
8. Evaluation of the parenteral preparation
9. Labeling & packaging

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44
Q

Physical and Chemical Tests for Sterile Products are Categorized into:

A

1. Identity tests
2. Quality tests
3. Purity tests
4. Potency tests

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45
Q

used to conform the actual presence of compound for
example color formation, precipitatio

A

Identity test

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46
Q

These tests are the physical methods used to measure accurately the characteristic properties of drug.
For example: Absorbance, refractive index.

A

Quality tests

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47
Q

designed to estimate the level of all known and significant impurities and contaminants
in the drug substance under evaluation. For example: Tests for clarity of solutions, Acidity, Alkalinity.

A

Purity tests

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48
Q

are assays that estimate the quantity of an active ingredient in the drug.

A

Potency tests

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49
Q

is employed to test the package integrity.

A

Leakage test

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50
Q

reflects its ability to keep the product in and to keep potential
contamination out

A

Package integrity

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51
Q

employed to detect incompletely sealed ampoule so that they may be discarded.

A

Leakers test

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52
Q

Types of Leaker Test:

A

(Visual Inspections, Bubble Test, Dye Test, Vacuum Ionization)

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53
Q

easiest leaker test method to perform.
§ The method is used for the evaluation of large volume parenterals.

A

Visual Inspections

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54
Q

The test package is
submerged in liquids.
§ A differential pressure
is applied on the
container.

A

Bubble Test

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55
Q

location of the leaks can be observed in this method.

A

Bubble test

56
Q

The test container is
immersed in a dye bath.

A

Dye test

57
Q

dye used in dye test

A

0.5% to 1% methylene blue

58
Q

The dye test can be optimized by use of a ___

A

surfactant and or a low viscosity fluid

59
Q

Disadvantages: destructive and slow

A

Dye test

60
Q

useful for testing leakage in the
vials or bottles sealed under
vacuum

A

Vacuum ionization

61
Q

used for testi

A

Vacuum ionization

62
Q

presence of residual gas

A

present will glow

63
Q

for
stability purposes

A

Freeze-dried products

64
Q

function of headspace vacuum level in vacuum ionization

A

Glow intensity

65
Q

indicative of vacuum while the purple glow indicative of no
vacuum.

A

Blue glow

66
Q

method is used for the lyophilized vials of biopharmaceuticals.

A

Vacuum ionization

67
Q

aka: Particle Containment Test or Detection of Particulate Matter

A

Clarity test

68
Q

defined as the quality of transparency or purity

A

Clarity

69
Q

test is performed to check the particulate contamination of injections and infusions
consists of extraneous, mobile and undissolved particles, other than gas bubbles, unintentionally
present in the solution.

A

Clarity test

70
Q

Small volume injections (<100 ml) in ≥ 10 um and ≥ 25 um Particle size

A

3000 per container 300 per container

71
Q

Large volume injections
(>100 ml) in ≥ 10 um and ≥ 25 um Particle size

A

12 per ml 2 per ml

72
Q

Visual inspection by naked eye

A

Test for Visible Particles

73
Q

gives the qualitative estimation of
the particulate matter

A

Visual inspection

74
Q

• This test is performed to check particulate contamination of injections and infusions (ie: presence of
extraneous, mobile undissolved particles, other than gas bubbles)

A

Test for Sub-visible Particles

75
Q

This test is based on the principle of light
blockage which allows an automatic
determination of the size of particles and the
number of particles according to size.

A

• Method 1: Light Obscuration Particle Count

76
Q

equipped with an ocular micrometer calibrated with an objective micrometer, a mechanical stage and, 2 suitable illuminators. in MICROSCOPIC PARTICLE COUNT
TEST

A

binocular microscope

77
Q

true or false;
ACCEPTANCE STANDARDS of Light Obscuration Particle Count ;if the average number of particles present in the units tested does not exceed 25 per milliliter equal to or greater than 10 µm and does not exceed 13 per milliliter equal to or greater than 25 µmin more than 100ml

A

false

78
Q

true or false;
ACCEPTANCE STANDARDS of Light Obscuration Particle Count if the
average number of particles present in the
units tested does not exceed 6000 per
container equal to or greater than 10 µm
and does not exceed 600 per container
equal to or greater than 25 µm in LESS than 100 mL:

A

true

79
Q

true or false
ACCEPTANCE STANDARDS of MICROSCOPIC PARTICLE COUNT
TEST in MORE than 100 mL:
The preparation complies with the test if the
average number of particles present in the
units tested does not exceed 24 per milliliter
equal to or greater than 10 µm and does not
exceed 2 per milliliter equal to or greater
than 25 µm

A

false

80
Q

true or false
ACCEPTANCE STANDARDS of MICROSCOPIC PARTICLE COUNT
LESS than 100 mL:
The preparation complies with the test if the
average number of particles present in the
units tested does not exceed 3000 per
container equal to or greater than 10 µm
and does not exceed 100 per container
equal to or greater than 25 µm

A

false

81
Q

are fever producing substances. They are metabolic by-products of microbial growth and
death.

A

Pyrogens

82
Q

produce more potent endotoxins

A

Gram negative bacteria

83
Q

are heat stable lipopolysaccharides (LPS) present in bacterial cell walls, not present in cellfree bacterial filtrates.

A

Endotoxins

84
Q

doses of Pyrogen: asymptomatic inflammation reaction Moderate doses: fever & changes in plasma
composition

A

low dose

85
Q

doses of Pyrogen: asymptomatic inflammation reaction Moderate doses: fever & changes in plasma
composition

A

low dose

86
Q

doses of Pyrogen: cardiovascular dysfunction, vasodilation, vasoconstriction, endothelium dysfunction, multiple
organ failure & finally death.

A

High doses

87
Q

This test consists of measuring the rise in body
temperature evoked in rabbits by the injection of a
sterile solution of the substance being examined.

A

IN VIVO PYROGEN TEST (RABBIT TEST)

88
Q

The thermometer is inserted into the rectum of the rabbit to a depth of about ----------(B.P specification) or ------- (USP specification)

A

5 cm or 7.2cm

89
Q

All the glassware, syringes and needles must be thoroughly washed with water and heated
in a hot air oven at -------- for 30 minutes or at ----------for an hour.

A

250°C and 200°C

90
Q

test Before using a
rabbit for the first time in a pyrogen test, condition it not more than seven days before use

A

sham test

91
Q

true or false
record the temperature at 1-minute intervals between 1 and 3 hours subsequent to the
injection and determine the maximum temperature.

A

false - 30 minutes

92
Q

the mean of two temperature readings (recorded at an interval of 30 minutes)

A

Initial Temperature

93
Q

the highest temperature recorded three hours after the injection of the
preparation

A

Maximum Temperature

94
Q

True or falseTotal of 8 rabbits is used in pyrogen in vivo

A

true

95
Q

true or false
Product passed the test if no rabbit from the three showed an individual rise of
more than 0.6°C, and the sum of the rise in temperature of the three rabbits did not exceed 2.4°C otherwise, test the product in 5 more rabbits (Stage 2).

A

false 1.4 C

96
Q

true or false
Product passed the test if no rabbit from the eight showed an individual rise of
more than 0.6°C, and the sum of the rise in temperature of the eight rabbits did not exceed 3.7°C otherwise, the test failed.

A

true

97
Q

aka: Bacterial Endotoxin Test (BET)

A

IN VITRO PYROGEN TEST (LIMULUS AMEBOCYTE LYSATE TEST)

98
Q

aqueous extract of blood cells
(amoebocytes) from the horseshoe crab,
Limulus polyphemus.

A

LIMULUS AMEBOCYTE LYSATE TEST

99
Q

true or false;
The concentrated pyrogens make the gel more turbid and thicker.

A

true

100
Q

true or false;
proteins must be diluted to
appropriate concentration before the test to avoid false positive results.

A

true

101
Q

Methods of LAL Test

A

1. Gel- Clot Method
2. Turbidimetric Method
3. Chromogenic Method

102
Q

provides very simple positive or negative result and a qualitative LAL test for detection of Gram-negative bacteria endotoxins.

A

Gel Clot LAL test

103
Q

used to adjust the pH of in vitro test
sample at 7.

A

potassium phosphate 2mEq/ml

104
Q

true or false in pyrogen in vitro gel;
If precipitate or solid remains are
intact, the sample is considered to contain endotoxin. If the liquid flows down the side
of the tube, the result is negative for endotoxins.

A

true

105
Q

quantitative LAL test that works on the principle
of measuring the wavelength of light passing through the solution using spectrophotometric
methods.

A

Turbidimetric Method

106
Q

turbidity wavelength of
light passing through the solution is measured using

A

spectrophotometric methods.

107
Q

true or false';
More turbidity= lower concentration of pyrogens

A

false

108
Q

quantitative LAL test that mixes the LAL reagent with a chromogenic
reagent to produce a synthetic chromogenic substrate which is then added to the test sample and incubated.

A

chromogenic method

109
Q

in chromogenic test, thepresence of endotoxins is indicated by the formation of a ----------- of the solution.

A

yellow coloration

110
Q

true or false;
The more endotoxin present, the more yellow the solution will become.

A

true

111
Q

Chromogenic test can be quantitated using a ------------- or ---------------- to reveal
the specific endotoxin concentration.

A

spectrophotometer or absorbance plate reader

112
Q

true or false;
LAL test does not detect non-endotoxin pyrogens

A

true

113
Q

defined as the freedom from the presence of viable microorganisms.

A

sterility test

114
Q

carried out under strict aseptic conditions in order to avoid accidental
contamination of the product during test.

A

sterility test

115
Q

2 methods of Sterility Testing

A

(1) Membrane Filtration Method and (2) Direct Inoculation Method

116
Q

true or false:
Membrane Filtration Method
After filtration the membrane is removed aseptically from the metallic holder and divided into two halves.
The first half is transferred into 100 ml of culture media meant for fungi and incubated at 20 ̊to 25 ̊c for not
less than seven days.
The other half is transferred into 100ml of fluid thioglycolate medium and incubated at 30 to 32 ̊c for not
less than 7 days.

A

false 35

117
Q

true or false:
Membrane Filtration Method;
(More colonies/ More
turbidity= greater concentration of viable microorganism

A

true

118
Q

true or false:
DIRECT INOCULATION METHOD
Incubate the inoculated media for not less than 14 days, unless otherwise specified in the monograph at
300c - 350c in the case of ---------

A

fluid thioglycolate medium

119
Q

true or false:
DIRECT INOCULATION METHOD
Incubate the inoculated media for not less than 14 days, unless otherwise specified in the monograph at 200c - 250c for ----------

A

soybean casein digest medium.

120
Q

primarily intended for culture of anaerobic
bacteria
can also detect aerobic bacteria

A

FLUID THIOGLYCOLATE MEDIUM

121
Q

suitable for culture of both fungi and
aerobic bacteria

A

SOYBEAN CASEIN DIGEST MEDIUM

122
Q

INCUBATION TIME
AND
TEMPERATURE
14 days at 30-35°C

A

FLUID THIOGLYCOLATE MEDIUM

123
Q

Final pH = 7.1

A

FLUID THIOGLYCOLATE MEDIUM

124
Q

contains L-cysteine
trypticase peptone
dextrose
yeast extract
sodium chloride
sodium thioglycolate
resazurin
agar
purified water

A

FLUID THIOGLYCOLATE MEDIUM

125
Q

contains
Trypticase soya broth
Trypticase peptone
Phytone peptone
Sodium chloride
Dipotassium phosphate
Dextrose
Purified water

A

SOYBEAN CASEIN DIGEST MEDIUM

126
Q

Final pH = 7.3

A

SOYBEAN CASEIN DIGEST MEDIUM

127
Q

are used as a Quality Control measure which helps in the monitoring of
conditions necessary to kill a specified number of microorganisms by a given sterilization process

A

Biological Indicators (BI)

128
Q

are used as a Quality Control measure which helps in the monitoring of
conditions necessary to kill a specified number of microorganisms by a given sterilization process

A

Biological Indicators (BI)

129
Q

Moist Heat (autoclave)

A

B. stearothermophilus

130
Q

Method of Sterilization used in B. subtilis

A

Dry Heat (oven)

131
Q

Method of Sterilization used in B. stearothermophilus

A

Ethylene oxide

132
Q

Bacteria Used inRadiation

A

Both B. stearothermophilus & B. subtilis + B. pumilus

133
Q

Apparatus Used
pH

A

pH meter

134
Q

apparatus Viscosity

A

Ostwald viscometer

135
Q

Osmolality apparatus (count of the number of particles in a fluid sample)

A

Osmometer

136
Q

Conductivity apparatus (conductivity of vehicle used in sterile preparation)
(Pure Water 0.55mS/cm)

A

Conductometer

137
Q

Temp. for Heat Sterilization apparatus (To maintain the constant temperature during heat sterilization of product)

A

Thermometer, Digital Thermometer

QC lab (1 decks)

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