wayground logo

Free Printable Worksheets

Font size

S
M
L
XL
Worksheets

Manufacturing of Sterile Dosage Forms

Total questions: 35

Worksheet time: 35mins

Name
Class
Date
1.

Which of the following sources are potential contaminants of the clean room?

a)

Human

b)

Raw material

c)

Air

d)

Processing method

2.

What does HVAC stand for?

a)

Heating, ventilation and air

b)

Heating, ventilation and air conditioning

c)

Heating , ventilation and air cooling

d)

Heating, ventilation and air solutions

3.

This picture shows an example of _______________.

a)

Personnel airlock

b)

Material airlock

c)

Isolator

d)

Cleanroom

4.

This is an example of _______________ laminar flow station.

a)

Turbulence

b)

Horizontal

c)

Vertical

d)

Diagonal

5.

This laminar flow station is suitable for the compounding/ reconstitution of __________________________.

a)

cytotoxic drugs

b)

total parenteral nutrition

c)

vaccine

d)

radiopharmaceuticals

6.

Which laminar flow station offers greater operator protection?

a)

Horizontal

b)

Vertical

c)

Both types

d)

None of them

7.
During high-risk level compounding, sterile ingredients or components are exposed to air quality ________________.
a)
equal to ISO Class 5
b)
higher than ISO Class 5
c)
higher than ISO Class 8
d)
lower than ISO Class 5
8.

Sterility assurance level (SAL) is also known as ___________.

a)

probability of non-sterile unit

b)

colony forming unit

c)

clinical microbiology unit

d)

sterility testing unit

9.

Sterility assurance level must be

a)

equal and smaller than 10-4

b)

equal and smaller than 10-5

c)

equal and smaller than 10-6

d)

equal and smaller than 10-7

10.

Limulus Amebocyte Lysate (LAL) test is specific for the detection of _________________.

a)

peptidoglycans

b)

biofilm

c)

lipopolysaccharides

d)

β-glucans

11.

European Pharmacopoeia permits production of WFI by

a)

reverse osmosis

b)

vapour-compression distillation

c)

ultrafiltration

d)

multiple-effect distillation

12.

The USP requires WFI must be used within _____ hour after collection.

a)

6

b)

12

c)

18

d)

24

13.

What is the USP test limit for WFI's total organic carbon ?

a)

< 300 ppb

b)

< 400 ppb

c)

< 500 ppb

d)

< 600 ppb

14.

What is biofilm?

a)

A dormant, tough, and non-reproductive structure produced by some bacteria and archaea in the phylum Firmicutes.

b)

A unit used In microbiology to estimate the number of viable bacteria or fungal cells in a sample

c)

A potent pyrogenic substances from the cell wall (lipopolysaccharides, LPS) of gram-negative bacteria

d)

An assemblage of microbial cells that is irreversibly associated with a surface and enclosed in a matrix of primarily polysaccharide material.

15.

All the following are terminal sterilisation methods except ______________.

a)

filtration

b)

moist heat

c)

dry heat

d)

radiation

16.

Which of the following sterilisation methods is suitable for protein solution?

a)

Moist heat

b)

Dry heat

c)

Ethylene oxide

d)

Filtration

17.

Sterilising filters have the pore size of __________.

a)

0.15 μm

b)

0.22 μm

c)

0.32 μm

d)

0.45 μm

18.

All the following methods can be used to sterilise glassware and metal instruments except __________________.

a)

Moist heat

b)

dry heat

c)

filtration

d)

gas

19.

Which of the following types of sterilisation by radiation methods is commonly found in WFI system?

a)

Gamma radiation

b)

UV radiation

c)

Electron beam radiation

d)

X-ray radiation

20.

What are the disadvantages of sterilisation by EtO?

a)

Highly explosive

b)

Carcinogenic

c)

Operating at low temperature

d)

EtO is a surface sterilant

21.

What is the major concern with radiation sterilisation?

a)

High cost

b)

Highly explosive

c)

Product degradation

d)

Carcinogenic

22.

The required time at a given temperature to kill 90% of the exposed microorganisms is known as _________________.

a)

D-value

b)

F-value

c)

Z-value

d)

Fo value

23.

All the following are advantages of moist heat sterilisation except ________________.

a)

shorter duration

b)

performed at lower temperature than dry heat

c)

cost effective

d)

effective method

24.

What is the sterilisation parameter of moist heat sterilisation?

a)

121°C for 30 min

b)

140°C for 4 hour

c)

160°C for 2 hour

d)

170°C for 1 hour

25.

Which sterilisation method is recommended for thermostable, large volume parenteral liquid?

a)

Dry heat

b)

Moist heat

c)

EtO

d)

Filtration

26.

Which sterilisation method is recommended for thermostable, dry powdered drugs?

a)

Dry heat

b)

Moist heat

c)

EtO

d)

Filtration

27.

Dry heat sterilisation is carried out in ______________; moist heat sterilisation is carried out in ______________.

a)

autoclave; oven

b)

autoclave; autoclave

c)

oven; oven

d)

oven; autoclave

28.

Moist heat sterilisation kills microorganisms by

a)

oxidation

b)

disruption of DNA

c)

coagulation of cell wall proteins

d)

free radical formation

29.

Dry heat sterilisation kills microorganisms by

a)

DNA disruption

b)

excitation of covalent bonds

c)

pyrolysis and oxidation

d)

coagulation of cell wall proteins

30.

Choose the common types of ophthalmic dosage forms.

a)

Solution

b)

Suspension

c)

Emulsion

d)

Ointment

31.

All are advantages of ophthalmic dosage products except

a)

local effect

b)

short retention time of the drugs

c)

higher concentration of drugs is achievable

d)

self-administration is possible

32.

What is the pH of human blood?

a)

5.5

b)

6.8

c)

7.4

d)

8.1

33.

In order to deliver the drug through cornea, the drug must be

a)

sterile

b)

ionised

c)

unionised

d)

low molecular weight

34.

Which of the following types of surfactant is commonly used in eye drop formulations?

a)

Anionic

b)

Cationic

c)

Amphoteric

d)

Non-ionic

35.

Which of the following bases are commonly used in ophthalmic ointment?

a)

Hydrocarbon bases

b)

Water-soluble bases

c)

Water-removable bases

d)

Non-emulsified absorption bases

Similar Resources on Wayground

YEAR END QUIZ

40 questions

YEAR END QUIZ

quiz

Worksheet

•

1st Grade - Professio...

Introduction to Research Methodology - Part A

40 questions

Introduction to Research Methodology - Part A

quiz

Worksheet

•

University

Introduction to OSHA

30 questions

Introduction to OSHA

quiz

Worksheet

•

University

Antibiotic quiz

30 questions

Antibiotic quiz

quiz

Worksheet

•

University

BUS1 PRELIM EXAM CHAVEZ

30 questions

BUS1 PRELIM EXAM CHAVEZ

quiz

Worksheet

•

University

Feca Quiz Competition

30 questions

Feca Quiz Competition

quiz

Worksheet

•

University

Chandrayaan Mahotsav

30 questions

Chandrayaan Mahotsav

quiz

Worksheet

•

University

Bài Thi ĐỐ EM KHỐI 12 - Vòng loại

40 questions

Bài Thi ĐỐ EM KHỐI 12 - Vòng loại

quiz

Worksheet

•

12th Grade - University