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QC 2 LEC > M3L2 > Flashcards

M3L2 Flashcards

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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
# **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
BACTERIAL ENDOTOXIN TEST
26
# **PYROGEN TEST** BACTERIAL ENDOXTOXIN TEST: is also called ____
Limulus Amoebocytes Lysate Test (LAL Test)
27
# **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**
LAL TEST (Limulus Amoebocyte Lysate)
28
# **PYROGEN TEST** BACTERIAL ENDOTOXIN TEST: it uses **LAL** obtained from aqueous extracts of the circulating amoebocytes of the ____
HORSE-SHOE CRAB (*Limulus polyphemus*)
29
# **PYROGEN TEST** * detect ONLY pyrogens from **gram-NEGATIVE** bacteria * **simpler**, **more rapid** method taht QFRiR * **QUANTITATIVE**
LAL Methods
30
# **PYROGEN TEST** LAL METHODS: detect **ONLY** pyrogens from ____ bacteria
gram-NEGATIVE
31
# **PYROGEN TEST** LAL TEST: it is based on the ____ of a pyrogen contaminated product
GEL-CLOT formation
32
# **PYROGEN TEST** LAL TEST: it is based on the **gel-clot** formation of a pyrogen-contaminated product in the presence of ____
LYSATE
33
# **PYROGEN TEST** LAL TEST: **THREE PRINCIPLES**
1. Gel-clot formation 2. Chromogenic 3. Kinetic
34
# **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
QUALITATIVE FEVER RESPONSE IN RABBITS (QFRiR)
35
# **PYROGEN TEST** QFRiR: ____ test of pyrogens in **aqueous parenteral**
pass-fail
36
# **PYROGEN TEST** QFRiR: uses ____
healthy rabbits
37
# **PYROGEN TEST** QFRiR: rabbits **weigh** at least ____
1.5kg BW
38
# **PYROGEN TEST** QFRiR: **temperature interval**
NMT1C
39
# **PYROGEN TEST** QFRiR: **NO** rabbit has a temperature of ____
39.8C
40
# **PYROGEN TEST** QFRiR (RABBITS USED): **POSITIVE** control
Brewer's Yeast
41
# **PYROGEN TEST** QFRiR (RABBITS USED): **NEGATIVE** control
NSS
42
# **PYROGEN TEST** QFRiR (RABBITS USED): **TEST DRUG**
not exceeding **10mL/kg** BW dose
43
# **PYROGEN TEST** * conducted as **PREPARATORY stage** to the test proper * designed to establish a **NORMAL** of the **BODY TEMPERATURE** of the **test rabbits**
SHAM TEST
44
# **PYROGEN TEST** SHAM TEST: is **injected** into ____
marginal ear vein
45
# **PYROGEN TEST** SHAM TEST: **accept**
* 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
# **PYROGEN TEST** SHAM TEST: **reject**
* **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
# **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**
LEAKER'S TEST FOR OPTHALMIC OINTMENTS
48
# **PYROGEN TEST** LEAKER'S TEST: by classical ____
blotting paper
49
# **PYROGEN TEST** LEAKER'S TEST: the opthalmic ointment collapsible tubes are placed on an ____
adsorbent paper
50
# **PYROGEN TEST** LEAKER'S TEST: heated in a ____ oven
60C ∓3
51
# **PYROGEN TEST** LEAKER'S TEST: heated in the oven for how many hours
8 hours
52
# **PYROGEN TEST** LEAKER'S TEST USP specifications
1. **NMT 1** out of 10 tubes should leak 2. **NMT 1** out of 30 tubes should leak
53
# **PYROGEN TEST** LEAKER'S TEST USP specifications: what to do if **more than 1 out of 10** leaked
expand the test to 20 additional tubes
54
# **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**
SAFETY TEST
55
# **PYROGEN TEST** SAFETY TEST: uses ____ or ____
white mice or guinea pigs
56
# **PYROGEN TEST** SAFETY TEST: determines the safety of the ____ used in parenteral products
PLASTIC DEVICES
57
# **PYROGEN TEST** a test for the **presence** of **PARTICLES** or **PARTICULATES**
PARTICULATE MATTER TETS
58
# **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**
USE OF ELECTRONIC PARTICULATE COUNTER
59
# **PYROGEN TEST | PARTICULATE MATTER TEST | METHODS** * it collects particles **LARGER** than the **rated pore size** * DISADVANTAGE: **slow counting**
MEMBRANE FILTRATION TECHNIQUE
60
# **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**
CLARITY TEST
61
# **PYROGEN TEST** CLARITY TEST: ____ are **required** to undergo this test
aqueous parenteral for IV
62
# **PYROGEN TEST** CLARITY TEST: **first method**
visual examination
63
# **PYROGEN TEST** CLARITY TEST: **first method** uses ____
well-lit black and white panel
64
# **REQUIREMENT FOR THE ANALYST | CLARITY TEST** vision
20/20 vision
65
# **REQUIREMENT FOR THE ANALYST | CLARITY TEST** should be **capable** of **detecting particulate contaminants** as small as ____
20um to 30um
66
# **MINIMUM FILL TEST FOR SEMISOLIDS** USP SPECIFICATIONS: if the product weighs **< 60g** or **60mL**, it's **net content** should be ____ of the labeled amount
NLT 90%
67
# **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
NLT 95%

QC 2 LEC (7 decks)

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