Professional Documents
Culture Documents
View Attempt 1 of 1
Title:
Quiz 1
Started:
1.
Which of the following drug forms are called oral solid dosage forms?
Feedback
A. tablets
B. hard-shell
capsules
with dry
powder
C. soft
gelatin
capsules
D. all of the 0%
above
E. a and b
Score: 0/1
New
1/1 This score has been adjusted by the grader.
score:
2.
Excipients may be added to a pharmaceutical powder blend to:
Student
Response
A. increase the
weight of
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
each tablet
B. ensure the
tablet's fast
disintegration
in the human
body
C. ensure the
tablet's slow
disintegration
in the human
body
D. improve the
tablet's visual
appearance
E. all of the
above
100%
Score: 1/1
3.
Granulation of a powder blend is required
Student
Response
Value Correct
Answer
100%
Feedback
Student
Response
Value Correct
Answer
Feedback
powder
blends that
cannot
produce
acceptable
quality
tablets or
capsules
without a
granulation
step.
Score: 1/1
4.
If a particular product blend can be successfully granulated either by wet
granulation or by roller compaction, which technology would you choose based
on the economic factors (cost of equipment and labor):
Student
Response
A. roller
compaction
B. wet
granulation
C. either, they
are equal
economically
D. can't say
without doing
detailed
evaluation
Score: 1/1
5.
Value Correct
Answer
100%
Feedback
Which of the following methods may be used to increase the shelf life of a
tableted drug product?
Student
Response
Value Correct
Answer
Feedback
A. coat the
tablets with
protective
film
B. package the
tablets into a
lightresistant
container
C. hermetically
seal the
container
with the
tablets
D. all of the
above
100%
Score: 1/1
6.
Why is tamper-evident packaging widely used for drug products?
Student
Response
A. to better
protect the
drug from
environmental
factors
B. to protect the
consumer by
providing
evidence of
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
tampering
with the
package
C. because it is
mandated by
cGMP and
enforced by
the FDA
D. all of the
above
E. b and c
100%
Score: 1/1
7.
A label attached to a drug package must:
Feedback
Feedback
100%
E. a and c
Score: 1/1
8.
You ordered pre-printed drug labels from a supplier and he sent you a batch of
labels with all of the correct information, but the background color is white
instead of the green you normally use for that product. Is it okay to use those
labels for your next product batch.
Student
Response
Value Correct
Answer
A. Yes.
B. Yes, but the
deviation
must be
noted in the
batch
record.
C. Yes,
provided
that the
consumer
(drug
wholesaler)
agrees to it
in writing.
D. No.
Score: 1/1
9.
100%
Feedback
Feedback
10.
GMP regulations require
Student
Response
Value Correct
Answer
A. visual
examination
of 100% of
the labels
that have
been applied
to drug
containters.
B. electronic
examination
of 100% of
the labels
that have
been applied
to drug
containters.
C. either visual 50%
or electronic
examination
of 100% of
the labels
that have
been applied
to drug
containters.
D. examination
of 100% of
the labels
that have
been applied
to drug
containters
is required
only under
certain
conditions,
Feedback
Student
Response
Value Correct
Answer
Feedback
not in all
cases.
Score: 0.5/1
View Attempt 1 of 1
Title:
Quiz 2
Started:
1.
The term "mixing" may be applied to describe:
Student
Value Correct
Response
Answer
A. the
blending of
two or
more
powder
materials
B. the mixing
of powder
and liquid
materials
C. the wet
granulation
process
D. all of the
above
Score: 1/1
100%
Feedback
2.
The effectiveness of a powder mixing process can be evaluated by:
100%
Score: 1/1
3.
The term "mesh size" refers to:
Feedback
Feedback
A. the
maximum
size of
powder
particles
B. the size of 100%
the
opening in
a screen or
sieve used
for
processing
powders
C. all of the
above
D. none of
the above
Score: 1/1
4.
What type of powder is more likely to have poor flow properties?
Feedback
Feedback
particles
shaped as
fibers
D. all of the
above
E. a and c
100%
Score: 1/1
5.
You have two V-blenders in your plant with nominal working columes of 30 and
100 cubic feet. The new product being introduced has 50 cu.ft. batch size. Which
of the two blenders would you pick for making the final blend for that product?
Student
Value Correct
Response
Answer
A. the 100
cu.ft.
blender filled to
50%
capacity
B. the 30
cu.ft.
blender filled with
50 cu.ft.
because the
full
capacity of
a blender is
much
higher than
its nominal
capacity
C. make two
sub-
0%
Feedback
You'll get poor blend uniformity.
Student
Value Correct
Response
Answer
Feedback
batches (25
cu.ft. each)
in the 30
cu.ft.
blender
D. all of the
above
approaches
are
acceptable
E. Both
existing
blenders
are poor
choices for
the 50 cu ft
batch - so I
would
change the
batch size
to either be
close to 30
or 100 cu
ft.
Score: 0/1
6.
The wet granulation of powders may be conducted in:
Feedback
Feedback
equipped
with a
low shear
agitator
C. a mixer
equipped
with a
low
and/or
high shear
agitator
D. fluid bed
processor
E. b, c, and d 100%
F. all of the
above
Score: 1/1
7.
Which of the following formulations are less likely to present problems with the
blend uniformity?
Student
Response
Value Correct
Answer
A. formulation
with 5% of
active
ingredient
in the blend
B. formulation 50%
with 50%
of active
ingredient
in the blend
C. formulation
Feedback
Student
Response
Value Correct
Answer
Feedback
with 90%
of active
ingredient
in the blend
D. b and c
Score: 0.5/1
8.
Powder segregation may be avoided or reduced by:
Student
Value Correct
Response
Answer
Feedback
A. modifying
the powder
properties
such as the
particle size
distribution
B. modifying
the
equipment
design
C. using lower
transfer
rates
D. all of the
above
100%
Score: 1/1
9.
Can wet granulation be conducted in a V-shaped blender?
Feedback
A. Yes.
B. No.
100%
C. Only if
the
blender is
equipped
with a
high-shear
agitator
and liquid
dispenser.
D. Only in
the
special Vshaped
processor
designed
for
vacuum
operation
Score: 1/1
10.
Can a ribbon mixer be used for blending dry powders?
100%
Feedback
View Attempt 1 of 1
Title:
Quiz 3
Started:
1.
Which benefits may be achieved by the particle size reduction?
Student
Value Correct
Response
Answer
A. improved
flow of
materials
with
needleshaped
particles
B. reduced
powder
segregation
due to
uniform
particle
sizes
C. uniform
drying of
wet
granules
with
narrow size
distribution
D. all of the
above
Score: 1/1
100%
Feedback
2.
In a hammer mill:
Feedback
Student
Response
Value Correct
Answer
Feedback
A. particle size
enlargement
by wet
granulation
B. particle size
enlargement
by dry
granulation
C. particle size
reduction of
wet
granulations
D. particle size
reduction of
dry
granulations
E. c and d
100%
Score: 1/1
4.
Bulk density of a powder blend
Student
Response
A. is defined as
the weight
of the
powder
divided by
the true
volume
occupied by
the particles
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
(not
including
the air
spaces
between
them)
B. is defined as
the weight
of the
powder
divided by
the apparent
volume of
the powder
(including
the air
spaces
between the
particles)
C. depends
only on the
composition
of the
powder
blend
D. may vary
for the same
powder
blend
depending
on the
process
conditions
E. b and d
F. a and c
Score: 1/1
5.
100%
Feedback
Student
Response
Value Correct
Answer
Feedback
A. passing the
blend through
a series of
sieves
B. electronic
scanning of
powder
stream
C. sedimentation
in gas or
liquid
D. manual
counting with
microscope
E. all of the
above
100%
Score: 1/1
6.
Dry granulation is a process of:
Student
Response
Value Correct
Answer
A. blending
various
powder
ingredients
in a mixer
without
liquid
addition
B. compacting 100%
powder
Feedback
Student
Response
Value Correct
Answer
Feedback
blend in a
roller
compactor
with
subsequent
milling of
the
resulting
sheet or
flakes
C. mixing of
powder
ingredients
in a
granulator
with small
amount of
liquid
solution
and
subsequent
drying of
that mixture
D. all of the
above
Score: 1/1
7.
Bulk density of the granulate produced by a roller compactor is
Feedback
Feedback
100%
C. about the
same as
that of the
original
powder
blend
D. may be
higher or
lower
depending
on the
specific
material
Score: 1/1
8.
Fine powder particles that passed through the compaction rollers intact are
Feedback
Feedback
classifying
screen and
may be
reused in
the next
product
batch
C. separated 100%
from the
granulated
material
and
recycled to
the feed
hopper for
repeat
processing
within the
same batch
D. any of the
avove,
depending
on the
machine
design
Score: 1/1
9.
Utilities required for an automated roller compactor machine are:
Student
Response
A. electric
power
B. compressed
air
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
C. cooling
water
D. all of the
above
100%
Score: 1/1
10.
Which parameters are automatically controlled (directly or indirectly) in a
modern roller compactor?
Student
Response
Value Correct
Answer
Feedback
A. compression
force
B. powder feed
rate
C. roller gap
width
D. all of the
above
100%
Score: 1/1
w Attempt 1 of 1
Title:
Quiz 4
Started:
1.
Which of the following processes happen in any dryer?
Feedback
A. heat
transfer
B. mass
transfer
C. a and b
100%
D. depends
on the
type of
dryer
Score: 1/1
2.
Which conditions affect the drying rate in a fluid bed dryer?
Student
Response
Value Correct
Answer
A. temperature
of the
supply air
B. relative
humidity of
the supply
air
C. moisture
content in
the particles
being dryed
D. all of the
above
E. a and b
Score: 1/1
100%
Feedback
3.
What is the limiting factor for the drying rate during the constant rate period?
Student
Response
Value Correct
Answer
Feedback
100%
A. heat
transfer
from the
heating
source to
the surface
of
evaporating
moisture
B. mass
transfer of
the
moisture
from the
inside of
each
particle to
its surface
C. can be
either a or b
depending
on the
specific
process
conditions
Score: 1/1
4.
You have a fluid bed dryer with a simple air preparation system capable of
heating the air to a preset temperature of 90 deg. F. but without humidification or
dehumidification equipment. How would the particle drying rates in such a
system vary during the year in a moderate climate such as New Jersey?
Feedback
Feedback
Yes, because of the low air humidity in the
winter.
C. drying
rates will
not
change
with the
season
Score: 1/1
5.
What keeps the solid particles in the solid bed dryer from "flying away" with the
exhaust air stream?
Feedback
Feedback
lowered
on its way
up the
chamber
C. a and b
100%
Score: 1/1
6.
Supply air temperature in a fluid bed dryer with heat-sensitive product is usually
Student
Response
Value Correct
Answer
A. maintained
constant
throughout
the drying
process
B. slowly
increased
throughout
the drying
process
C. slowly
decreased
throughout
the drying
process
D. maintainted 100%
constant
during the
"constant
rate"
period, then
decreased
E. maintainted
Feedback
Student
Response
Value Correct
Answer
Feedback
constant
during the
"constant
rate"
period, then
increased
Score: 1/1
7.
Why are some of the fluid bed dryers designed to withstand 10-Bar pressure?
Student
Response
Value Correct
Answer
A. to allow
drying
products at
elevated
temperatures
and
pressures
B. to allow
pneumatic
transfers of
the product
into and out
of the drying
chamber
C. to enable the
dryer to
contain
powder
explosion in
the chamber
withough
damage
D. to enable the 100%
dryer to
Feedback
Student
Response
Value Correct
Answer
Feedback
contain
powder
explosion in
the chamber
withough
damage to
surrounding
structures
and
personnel.
Score: 1/1
8.
Advantages of the vacuum drying of solids:
Student
Response
Value Correct
Answer
A. faster than in
tray drying
B. ability to dry
products at
low or
ambient
temperatures
C. dust
containment
D. reduced
oxidation of
the product
E. all of the
above
Score: 1/1
9.
100%
Feedback
Hard gelatin capsules are used to hold the following drug forms:
Feedback
A. Powders
B. Granules
C. Pellets
D. Tablets
E. All of the 100%
above
Score: 1/1
10.
Most modern capsule fillers:
Feedback
Feedback
capsule
D. Measure
the dose
by
volume,
then fill it
into the
capsule.
Automatic
weighnig
device is
used to
weigh
filled
capsules
and adjust
the fill
volume
settings.
E. b or d
100%
Score: 1/1
View Attempt 1 of 1
Title:
Quiz 5
Started:
1.
Particles in a tablet are held together due to:
Student
Response
A. intertwining of
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
particles
caused by
compression
B. intermolecular
forces
C. binding by
liquid
produced by
melting the
material at the
points of
contact
100%
D. all of the
above factors
may have
effect
Score: 1/1
2.
The final shape of each tablet is determined by:
Feedback
Feedback
distance
between
the upper
and lower
punches
E. all of the 100%
above
Score: 1/1
3.
Amount of powder filled into each die cavity in a tablet press is determined by:
Student
Response
Value Correct
Answer
Feedback
4.
After the die cavity is filled with exact amount of material, the lower punch is
lowered by 2-4 mm. Why?
Student
Response
Value Correct
Answer
Feedback
A. to increase
the
compression
force
B. to reduce the
compression
force
100%
C. to avoid
spilling over
material
when upper
punch enters
the die
cavity
D. to reduce the
compression
speed
Score: 1/1
5.
Tablet press compession rollers of a larger diameter result in:
Student
Response
A. higher
compression
force
B. lower
compression
force
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
Feedback
7.
Modern tablet presses produce tablets of relatively constant weight by:
Student
Response
Value Correct
Answer
Feedback
A. measuring
the weight
of the
powder
being filled
into each die
cavity before
compression
B. using
constant
compression
force
C. periodically 100%
measuring
the weight
of sample
tablets and
adjusting the
parameters
affecting the
die cavity
volume
Score: 1/1
8.
Tablet quality problems such as capping, lamination, picking, sticking, jamming,
are more likely to occur
100%
Feedback
Feedback
tablet
press is
used
B. when lowspeed
tablet
press is
used
C. machine
speed
does not
affect the
likelihood
of tablet
quality
problems
Score: 1/1
9.
In order to pass the tablet content uniformity test in the first stage all 10 tablets
tested shall meet the following criteria:
Feedback
Feedback
the label
claim
dose
D. 75 to
125% of
the label
claim
dose
Score: 1/1
10.
Drug dissolution testing is conducted:
Feedback
Feedback
for
selected
batches of
immediate
release
tablets
D. only for
the scaleup and
validation
batches
Score: 1/1
ttempt 1 of 1
Title:
Quiz 6
Started:
1.
What is the purpose of tablet coating?
Feedback
Feedback
C. to control
the drug
release
rate
D. to make
the tablet
easier to
swallow
E. any of the 100%
above
Score: 1/1
2.
Which of the two coating processes is more labor-intensive?
100%
Feedback
3.
The main mechanism for the uniform distribution of the coating solution in sugar
coating process is:
Student
Response
Value Correct
Answer
Feedback
A. uniform
spraying of
atomized
coating
solution
over the
tablet bed
100%
B. tablet-totablet
transfer of
the coating
solution in
the tumbling
bed
C. both
mechanisms
are of equal
importance
Score: 1/1
4.
The main mechanism for the uniform distribution of coating solution in a film
coating process is:
Student
Response
Value Correct
Answer
100%
A. uniform
spraying of
atomized
coating
solution
over the
Feedback
Student
Response
Value Correct
Answer
Feedback
tablet bed
B. tablet-totablet
transfer of
the coating
solution in
the tumbling
bed
C. both
mechanisms
are of equal
importance
Score: 1/1
5.
Film coating applied to a tablet:
Student
Response
Value Correct
Answer
A. delays the
release of
the drug in
the human
body
compared to
uncoated
tablet
B. does not
substantially
delay the
release of
the drug in
the human
body
C. can be either 100%
(a) or (b)
Feedback
Student
Response
Value Correct
Answer
Feedback
depending
on the type
of coating
used
Score: 1/1
6.
Majority of modern tablet coating processes use water-based versus organic
solvent-based coating solutions because:
Student
Response
Value Correct
Answer
A. water-based
coating
processes
produce
higher
quality
tablets with
fewer defects
B. water-based 100%
coating
processes are
safer; no
need to
worry about
the solvent's
flammability
C. water-based
coating
processes are
faster (have
higher
productivity)
than solventbased
processes
Feedback
Student
Response
Value Correct
Answer
Feedback
D. all of the
above
Score: 1/1
7.
Film coating of tablets is usually perfromed in:
Student
Response
Value Correct
Answer
Feedback
A. conventional
coating pans
B. perforated 100%
coating pans
C. fluid bed
processors
D. any of the
above
Score: 1/1
8.
The spray rate of coating solution is selected based on:
Student
Response
A. type of the
coating
solution
used
B. the droplet
size
C. the
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
evaporating
capacity of
the coating
pan
D. the
moisture
content of
incoming
air
E. all of the
above
100%
Score: 1/1
9.
During the testing of a new film coating process you found that tablets are overwetted, resulting in picking of the coating film. Which changes you will try to
make in order to resolve the problem?
100%
Feedback
10.
Which of the following may be likely reasons for poor coating uniformity?
Student
Value Correct
Response
Answer
Feedback
A. wide
distribution
of the spray
droplet
sizes
B. different
spray guns
on the same
manifold
have
different
spray rates
C. adjacent
spray
patterns
overlap
D. any of the 100%
above
Score: 1/1
Midterm
part 1
Started:
1.
Which of the following methods may be used to increase the shelf life of a
tableted drug product?
Student
Response
Value Correct
Answer
Feedback
A. coat the
tablets with
protective
film
B. package the
tablets into a
lightresistant
container
C. hermetically
seal the
container
with the
tablets
D. all of the
above
100%
Score: 2/2
2.
Granulation of a powder blend is required
Student
Response
Value Correct
Answer
100%
Feedback
Student
Response
Value Correct
Answer
Feedback
blends that
cannot
produce
acceptable
quality
tablets or
capsules
without a
granulation
step.
Score: 2/2
3.
If a particular product blend can be successfully granulated either by wet
granulation or by roller compaction, which technology would you choose based
on the economic factors (cost of equipment and labor):
Student
Response
A. roller
compaction
B. wet
granulation
C. either, they
are equal
economically
D. can't say
without doing
detailed
evaluation
Score: 2/2
4.
Value Correct
Answer
100%
Feedback
Feedback
A. a tumble
blender
without
an
agitator
B. a mixer
equipped
with a
low shear
agitator
C. a mixer
equipped
with a
low
and/or
high shear
agitator
D. fluid bed
processor
E. b, c, and d 100%
F. all of the
above
Score: 2/2
5.
What type of powder is more likely to have poor flow properties?
Feedback
Feedback
B. powder
with 200250
micron
particles
C. powder
with
particles
shaped as
fibers
D. all of the
above
E. a and c
100%
Score: 2/2
6.
The term "mesh size" refers to:
100%
Feedback
Feedback
D. none of
the above
Score: 2/2
7.
Oscillating granulator is a device used for
Student
Response
Value Correct
Answer
Feedback
A. particle size
enlargement
by wet
granulation
B. particle size
enlargement
by dry
granulation
C. particle size
reduction of
wet
granulations
D. particle size
reduction of
dry
granulations
E. c and d
100%
Score: 2/2
8.
Dry granulation is a process of:
Student
Response
A. blending
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
B. compacting 100%
powder
blend in a
roller
compactor
with
subsequent
milling of
the
resulting
sheet or
flakes
C. mixing of
powder
ingredients
in a
granulator
with small
amount of
liquid
solution
and
subsequent
drying of
that mixture
D. all of the
above
Score: 2/2
9.
Bulk density of the granulate produced by a roller compactor is
Feedback
Feedback
powder
blend
B. higher
than that
of the
original
powder
blend
100%
C. about the
same as
that of the
original
powder
blend
D. may be
higher or
lower
depending
on the
specific
material
Score: 2/2
10.
Which parameters are automatically controlled (directly or indirectly) in a
modern roller compactor?
Student
Response
A. compression
force
B. powder feed
rate
C. roller gap
width
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
D. all of the
above
Feedback
100%
Score: 2/2
11.
Advantages of the vacuum drying of solids:
Student
Response
Value Correct
Answer
Feedback
A. faster than in
tray drying
B. ability to dry
products at
low or
ambient
temperatures
C. dust
containment
D. reduced
oxidation of
the product
E. all of the
above
100%
Score: 2/2
12.
What is the limiting factor for the drying rate during the constant rate period?
Student
Response
A. heat
transfer
Value Correct
Answer
100%
Feedback
Student
Response
Value Correct
Answer
Feedback
from the
heating
source to
the surface
of
evaporating
moisture
B. mass
transfer of
the
moisture
from the
inside of
each
particle to
its surface
C. can be
either a or b
depending
on the
specific
process
conditions
Score: 2/2
13.
Which of the following processes happen in any dryer?
100%
Feedback
Feedback
D. depends
on the
type of
dryer
Score: 2/2
14.
Which conditions affect the drying rate in a fluid bed dryer?
Student
Response
Value Correct
Answer
Feedback
A. temperature
of the
supply air
B. relative
humidity of
the supply
air
C. moisture
content in
the particles
being dryed
D. all of the
above
100%
E. a and b
Score: 2/2
15.
Modern tablet presses produce tablets of relatively constant weight by:
Student
Response
A. measuring
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
B. using
constant
compression
force
C. periodically 100%
measuring
the weight
of sample
tablets and
adjusting the
parameters
affecting the
die cavity
volume
Score: 2/2
16.
After the die cavity is filled with exact amount of material, the lower punch is
lowered by 2-4 mm. Why?
Student
Response
Value Correct
Answer
A. to increase
the
compression
force
B. to reduce the
compression
force
100%
C. to avoid
spilling over
material
when upper
punch enters
the die
cavity
Feedback
Student
Response
Value Correct
Answer
Feedback
D. to reduce the
compression
speed
Score: 2/2
17.
Amount of powder filled into each die cavity in a tablet press is determined by:
Student
Response
Value Correct
Answer
Feedback
Feedback
A. reduce
process
air flow
B. increase
process
air flow
C. reduce the
solution
spray rate
D. a or c
E. b or c
100%
Score: 2/2
19.
The spray rate of coating solution is selected based on:
Student
Response
A. type of the
coating
solution
used
B. the droplet
size
C. the
evaporating
capacity of
the coating
pan
D. the
moisture
content of
incoming
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
air
E. all of the
above
100%
Score: 2/2
20.
The main mechanism for the uniform distribution of the coating solution in sugar
coating process is:
Student
Response
Value Correct
Answer
0%
A. uniform
spraying of
atomized
coating
solution
over the
tablet bed
B. tablet-totablet
transfer of
the coating
solution in
the tumbling
bed
C. both
mechanisms
are of equal
importance
Score: 0/2
View Attempt 1 of 1
Title:
Midterm Part 2
Started:
Feedback
1.
You need to buy a new blender for your solid dosage plant. Describe the features
you want to see in that blender: type, size, shape, material of construction,
hygienic requirements, what kind of operations it will be used for, and any other
features you can think of. There are hundreds of blenders on the market, so you
need to explain to a salesperson what are you looking for.
Student Ill go with V-CONE blender as In "V" Blender the powders comes
Response: from all sides due to the "V" shape of the product container, hence
requirement of RPM is medium. This is what ill look for:- The
Blender shall be used to combine a dry bulk active pharmaceutical
ingredient (medium active) with two inert dry compounds to produce
a uniform blend to meet formulation requirements SPECIAL
FEATURES : > Suitable for dry mixing of products in powder form. >
Easy for loading and unloading. > Easy for cleaning. > All contact
parts are made out of SS304 / SS316 or SS316 L quality material, >
minimum maintenance. > General structure & safety guards made out
of mild steel & painted in Standard Model and made out of SS304 &
polished to the matt finish in GMP Model. > The "V" shape gives
sufficient contineous movement to the granules, result in good quality.
> Maximum care has been taken to ensure safe operation of the unit. >
Manual rotating facility with hand wheel for inching. > Vacuum
Loading facility for material charging. > Flame proof drive motor
along with flame proof starter. > Contact parts made out of SS316 or
SS316 L instead of SS304. Size will be dependent on the batch size,
these are some of the sizes available in market {1} Model Gross Cap.
In Litres Working Cap. In Litres Overall Dimn. lxwxh rpm hp VB 50
50 30 1700x1100x2200 20 2 VB 100 100 65 2000X1250X2400 20 3
VB 200 200 125 2400X1350X2700 20 5 VB 300 300 175
2600X1450X2900 20 5 VB 500 500 300 2900X1600X3300 20 7.5
The operational requirements for a blender can include one or more of
the following: Even distribution of components Wet granulation
Agglomeration Drying Temperature control Variable speed drive Soft
start High speed chopper Spray nozzles Describe any constraints
required by the process application, such as maximum tip speed
and/or RPM limitations. Describe any portability requirements such as
casters, utility connections, etc. Describe drive location or acclimation
requirements. Describe any platform height requirements. Describe
the number of recipes and recipe parameters that will be required.
Describe the method of defining recipe parameters. If the machine
19/20
2.
List all major steps in a process of making a batch of pharmaceutical tablets from receiving raw materials to having tablets in bulk containers ready for
packaging. Give very brief description of the purpose of each step.
Student Tablet manufacturing process:- Dispensing and sieving
Response: Blending:Homogeneity of powder blend (on-line NIR, at-line HPLC
or UV-visible and/or imaging techniqus) Moisture content (on-line
near infra-red and/or ERH probes) Near infra-red monitoring of
powder blend process a)Concentration of analyte versus time
b)Replication of spectra (moving block of 12 samples) Powder blend
imaging using spectroscopy Granulation and milling:Granulation endpoint Flow characteristics, bulk density etc Homegeneity of granule
Moisture content Particle size Drying Compression Film coating
Packaging Final process 1. A tablet manufacturing method comprising
the steps of: preparing a first table including a plurality of filling
holes, and a second table including a plurality of mold cavities, which
second table partially contacts with the first table and relatively moves
with respect to the first table; said filling holes and said mold cavities
being of the same diameter; supplying a predetermined amount of
moist powder in said filling holes of said first table; filling the moist
powder supplied in said filling holes, into said mold cavities of said
19/20
3.
You plan to use a fluid bed dryer to dry a granulate of a heat-sensitive product.
Tell the process control engineer how he shall set up the unit's control system which parameters to monitor, what to adjust based on what etc.
Student primary process parameters affecting granule size include the bed
Response: bowl charge, binder spray rate, air flow rate, and input air
temperature. Sensitivity analysis of model results suggest the binder
spray rate accounts for approximately 65% of the predicted variance,
with the next most sensitive parameter the binder droplet diameter
17/20
ew Attempt 1 of 1
Title:
Quiz 8
Started:
1.
Which of the following aspects of a pharmaceutical facility is NOT covered by
the GMP regulations?
Student Response
Value Correct
Answer
A. heating and
ventilation system
B. lighting of the
production areas
C. maintenance
operations for
production
equipment
100%
D. design of the
office/administrative
areas
E. warehouse
operations
Score: 1/1
Feedback
2.
Which of the following measures can be taken to avoid cross-contamination
between various products manufactured in the same facility? Use your own
judgment.
100%
Feedback
Score: 1/1
3.
Transfer of the powdered raw materials from the shipping containers is normally
conducted:
Student
Response
Value Correct
Answer
Feedback
A. in the main
process area
- materials
are
transferred
directly into
the blender
B. in a special 100%
dispensing
area materials are
transfered
into
intermediate
containers
that are later
sent to the
production
area
C. it depends
on the
facility
design and
on the
operations
approach
Score: 1/1
4.
Contained systems for transfer of powdered raw materials are prefered because:
Student
Response
Value Correct
Answer
Feedback
A. they protect
the operator
from the dust
B. they protect
the product
from external
contamination
C. they minimize
the losses of
active and
other
ingredients
D. all of the
above
100%
Score: 1/1
5.
Is it acceptable to use a single air handling system to serve several tableting
rooms in a multi-product solid dosage plant?
Student
Response
Value Correct
Answer
A. No
B. Yes
C. Yes, but only
if air is not
recirculated
(once-through
ventilation)
D. Yes, as long as 100%
the
recirculated
air is filtered
to prevent
cross-
Feedback
Student
Response
Value Correct
Answer
Feedback
contamination
Score: 1/1
6.
What percentage of particles larger than 0.3 micron can be removed passing
room air through HEPA filter?
Feedback
A. 70%
B. 90%
C. 98%
D. 99%
E. 99.97%
100%
Score: 1/1
7.
The soil removal from vessel surfaces during CIP with fixed spray balls is
achieved primarily by:
Student
Value Correct
Response
Answer
A. dissolution 100%
of the soil
in the
detergent
solution
B. mechanical
removal by
highvelocity
Feedback
Student
Value Correct
Response
Answer
Feedback
stream of
water or
detergent
solution
C. mechanical
removal of
soil by
brushes
with
assistance
by
detergent
solution
D. all of the
above
Score: 1/1
8.
Packaging area in a multi-product facility shall have:
Student
Response
A. partitions to
segregate
individual
packaging
lines
B. dust collection
in the filling
area of each
line
C. measures for
protection of
the exposed
product from
external
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
contamination
D. all of the
above
100%
Score: 1/1
9.
Which of the following steps is NOT required when a packaging line is being
prepared for a batch of product different from the one in the previous run?
Student
Response
Value Correct
Answer
Feedback
A. cleaning
and
vacuuming
of the
packaging
equipment
B. removal of
all
components
used in the
previous
batch
(unless the
same
components
can be used
in the next
batch)
C. checking of
labels,
components
and lot
numbers
D. re-training 100%
of operators
Student
Response
Value Correct
Answer
Feedback
operators almost every day!
E. all above
steps are
required
Score: 1/1
10.
Which of the following factors affect the size of each production batch?
100%
Score: 1/1
View Attempt 1 of 1
Title:
Quiz 9
Started:
Feedback
1.
What is the purpose of unscrambling machine in a packaging line?
Student
Response
Value Correct
Answer
Feedback
A. to separate
bottles or
other
containers
from
closures
(i.e. caps)
B. to remove
defective
components
C. to change
the spacial
orientation
of empty
bottles or
other
containers
D. to transfer
the
containers
from a bulk
hopper to a
conveyor
E. c and d
100%
Score: 1/1
2.
Which of the following types of tablet counters require change parts specific for
the size and shape of tablets?
Feedback
A. slat
counters
B. rotary
wheel
counters
C. electronic
tablet
counters
D. vibratory
feed
counters
E. a and b
100%
Score: 1/1
3.
Which type of the tablet-filling machine would be your first choice for a
packaging line designed to process 300 plastic bottles per minute?
Feedback
A. slat
counter
B. rotary
wheel
counter
C. vibratory
feed
counter
D. a or c
Score: 1/1
100%
Correct. This is the best type for highspeed lines. With other types you would
probably need two or more machines in
parallel to fill 300 bpm.
4.
What does a modern tablet filling machine do?
Feedback
A. fill bottles
or other
containers
with exact
number of
tablets
B. reject
broken
tablets,
preventing
them from
entering
into bottles
C. reject
bottles
with
incorrect
number of
tablets
D. all of the
above
100%
Score: 1/1
5.
A capping machine applies continuous thread (screw-on) caps to bottles. How
does it ensure that each cap is tight, but not over tightened?
Student
Response
A. each cap is
turned by the
exact number
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
of
turns/degrees
to ensure
proper
tightness
B. a mechanical
or pneumatic
chuck
releases the
cap when it is
tightened to
correct
torque based
on a signal
from torque
sensor
C. proper torque 100%
is controlled
by a
pneumatic or
spring-loaded
clutch
D. any of the
above
Score: 1/1
6.
Bottles on a chain conveyor:
Feedback
Feedback
chain
B. always
move
slower
than the
conveyor
chain
C. can move 100%
at the
same
speed as
the chain,
at lower
speed or
can stop
while the
chain
continues
to move
Score: 1/1
7.
Which of the following shall be included into an inquiry specification for a piece
of packaging equipment?
Student
Response
A. required
scope of
supply
B. project
description
C. performance
requirements
D. requirements
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
100%
for
integration
with other
equipment
E. all of the
above
Score: 1/1
8.
What kind of "qualification/validation requirements" shall be included into a
purchasing spec for a piece of packaging equipment to ensure successful
qualification effort?
Student
Response
A. approved
qualification
protocols for
that piece of
equipment
B. list of
documents
that vendor
has to
provide to
support
qualification
C. requirements
that affect
the vendor's
scope of
work (for
example, a
need for a
service
technician
during start-
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
up and
qualification
at the buyer's
site)
D. performance
acceptance
criteria for
the machine
E. all of the
above
F. b, c and d
100%
Score: 1/1
9.
A vendor offers you a choice of three tablet fillers capable of the maximum
filling speeds of 150, 200 and 300 bottles per minute respectively. Which one
would you choose if your typical batch consists of one million tablets filled at 10
tablets per bottle, and scheduled run time (excluding set-up and clean-up) for
each batch is 8.5 hours?
Feedback
A. 150 bpm
filler
B. 200 bpm
filler
C. 300 bpm 100%
filler
Score: 1/1
10.
Student
Response
Value Correct
Answer
Feedback
A. a sensor
capable of
distinguishing
empty bottles
from filled
ones
B. a photo eye
for bottle
detection
installed
upstream of a
particular
machine
C. a photo eye 100%
for bottle
detection
installed
downstream
of a particular
machine
Score: 1/1
View Attempt 1 of 1
Title:
Quiz 10
Started:
1.
What is the purpose of an induction sealer in a bottle packaging line?
Feedback
A. to insert
an elastic
seal into
the caps
B. to attach a
plastic or
foil seal to
the
bottle's
neck
before
putting on
the screw
cap
C. to attach a 100%
foil to the
bottle's
neck after
the cap
has been
screwed
on
D. to seal the
bottle's
cap with
plastic
overwrap
Score: 1/1
2.
What does an induction sealer do?
Feedback
Feedback
to the
bottle's
neck by
using
induction
forces
B. it heats up 100%
aluminum
foil by
induced
electric
current,
causing its
attachment
to the
bottle's
neck
C. it heats up
the bottle's
cap by
induced
stream of
hot air,
causing its
attachment
to the
bottle's
neck
D. all of the
above
Score: 1/1
3.
How is the integrity of the sealed bottles tested?
Student
Response
A. seal integrity
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
Student
Response
A. to print
identifying
information
on labels
B. to apply
selfadhesive
labels to the
drug
container
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
100%
C. to check for
correct
application
of labels
D. all of the
above
Score: 1/1
5.
Which types of printers/coders can be used for printing information on the
package labels?
Feedback
A. ink-jet
printers
B. laser
printers
C. thermaltransfer
printers
D. all of the 100%
above
Score: 1/1
6.
Shall an automatic vision inspection system be used to check the labels before or
after they have been applied to the drug containers?
Feedback
Feedback
100%
C. any of the
above
Score: 1/1
7.
Sometimes shrink sleeves embracing the product container are used instead of or
in addition to labels. What is their purpose?
Student
Response
Value Correct
Answer
Feedback
A. aesthetic
B. it provides
more space
for printing
information
compared
to a label
C. it may be
used as a
tamperevident
feature
D. any of the
above
100%
Score: 1/1
8.
When a shink sleeve is applied to a bottle, how is it made to be tight, fitting the
bottle's contour?
Student
Response
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
B. the plastic
sleeve is first
pulled over the
container,
which then goes
into a heat
tunnel where
the sleeve
shrinks due to
applied
electromagnetic
induction forces
100%
C. the plastic
sleeve is first
pulled over the
container,
which then goes
into a heat
tunnel where
the sleeve
shrinks under
the influence of
hot air stream
D. any of the
above
Score: 1/1
9.
What happens when conveyor transporting the drug containers through the
heating tunnel is stopped by emergency stop button?
Student
Response
A. containers
remaining
inside the
tunnel
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
become
overheated
and are
rejected
when the
conveyor is
re-started
B. the power
to the
electric
heaters in
the heat
tunnel gets
cut-off to
avoid
overheating
of the drug
containers
C. the heating
tunnel is
physically
lifted above
the
conveyor to
remove the
drug
containers
from the
heat zone
D. b and c
100%
Score: 1/1
10.
What happens when a vision inspection system detects a non-conforming
container label?
Student
Response
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
B. the container
is
immediately
pushed into
the reject bin
at the
inspection
station
C. the system 100%
"remembers"
the nonconforming
container and
rejects it
later, when it
reaches the
reject station
located
downstream
of the
inspection
station
Score: 1/1
View Attempt 1 of 1
Title:
Quiz 11
Started:
1.
Which of the following operations are considered secondary packaging?
Student
Response
A. overwrapping
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
B. placing filled
bottles into
cartons
C. placing filled
blister packs
into cartons
D. re-packaging
of tablets
from large
containers
into smaller
containers
E. all of the
above
F. a, b, and c
100%
Score: 1/1
2.
Corrugated cardboard shipping cases are normally supplied to the packaging line:
Feedback
Feedback
that require
cutting,
erection
and sealing
D. any of the
above
Score: 1/1
3.
Packages are loaded into cardboard cases:
Feedback
A. from the
top
B. from the
side
C. from the
end
(shorter
side)
D. any of the 100%
above
Score: 1/1
4.
Which of the following machines would be your first choice for loading
rectangular containers into cases?
Feedback
Feedback
sideloading
machine
B. toploading
machine
with
grippers
or vacuum
cups
C. any of the 50%
above
Score: 0.5/1
5.
Which of the following machines would be your first choice for loading
irregularly-shaped containers into cases?
Feedback
6.
Which of the following shall be included in an inquiry spec for a piece of
packaging equipment?
Student Response
Value Correct
Answer
Feedback
A. description of
products/components
to be handled
B. required operating
speed
C. requirements for the
interface with infeed
and outfeed
conveyors
D. all of the above
100%
Score: 1/1
7.
Which of the following does NOT need to be included into an inquiry spec for a
case packer?
Student
Response
Value Correct
Answer
Feedback
100%
A. description
of the
machine
function
B. description
and/or
drawing of
the cases to
be loaded
C. detailed
description
of the
Student
Response
Value Correct
Answer
Feedback
machine
construction
and
operation
D. requirements
for
interfacing
with a
central
control
system
Score: 1/1
8.
Packed cases with product are palletized for:
Student
Response
Value Correct
Answer
Feedback
A. ease of
transporting
them within
the facility
B. convenient
storage
C. transportation
to customers
D. all of the
above
100%
Score: 1/1
9.
Stretch or shrink wrapping of the pallet load is done primarily for:
Feedback
A. additional
protection
of the
product
from
moisture
B. improving 100%
the load
stability
C. prevention
of the
product
theft
D. all of the
above
Score: 1/1
10.
Erection of the cardboard cases and loading them with products is conducted
Title:
Quiz 12
Feedback
Started:
1.
Packaging line integration includes (check all answers that apply):
Feedback
A. design of 25%
conveyors
B. installation 25%
of guide
rails
C. selection of 25%
proper
speeds and
loads for
machinery
D. integration 25%
of manual
and
automatic
operations
Score: 1/1
2.
Speed of conveyors on a packaging line
Feedback
Feedback
B. may be 100%
different
for
different
sections
C. must be
within 5%
of each
other
Score: 1/1
3.
Buffers used in a packaging line are:
Student
Response
Value Correct
Answer
A. devices used
to soften the
impact of
cases or
boxes on the
guard rails
100%
B. conveyor
sections used
for
accumulating
product
before or
after certain
machines
C. both a & b
Score: 1/1
4.
Feedback
Student
Response
Value Correct
Answer
Feedback
A. access doors
used for
servicing a
packaging
machine
B. a central
computer
that collects
information
about
packaging
line
performance
100%
C. a panel,
keypad,
monitor, or
other device
used to read
and enter
information
into control
system
D. all of the
above
Score: 1/1
5.
Which way of purchasing packaging equipment is generally advantageous for a
project where short timeline is critical?
Student
Response
A. Sending
requests for
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
quotations
to multiple
bidders.
100%
B. Working
directly
with a
single
supplier
without
competitive
bidding.
C. The two
approaches
listed may
affect the
project cost,
but
generally
not the
schedule.
Score: 1/1
6.
Which of the following shall be included into a purchase order? (check all that
apply)
Student
Response
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
D. performance 20%
and
acceptance
criteria
E. commercial 20%
terms
Score: 1/1
7.
Packaging line shall be qualified:
Student
Response
Value Correct
Answer
100%
A. after it has
been
commisioned
B. before it has
been
commisioned
C. at the same
time as it is
commisioned
D. the order of
commisioning
and
qualification
activities does
not matter
Score: 1/1
8.
The term "product stability" means:
Feedback
Student
Response
Value Correct
Answer
Feedback
A. the atability
of the bottle
or other
container to
be handled
in a stable
manner (not
to fall, get
dented,
etc...)
B. the ability
of the
packaged
drug
product to
be stored
for
extended
time
without
degradation
100%
C. can be
either a or b
Score: 1/1
9.
Machines located in series in a packaging line are typically designed
Feedback
Feedback
B. to operate 100%
at
different
speeds
Score: 1/1
10.
Packaging line output rate
Feedback
A. equals
design
speed
B. equals set
run speed
100%
C. is less
than set
run speed
D. is
between
design
speed and
set run
speed
Score: 1/1
Quiz 13
Started:
1.
Computer simulation is used in (check all that apply)
Student
Response
Value Correct
Answer
Feedback
25%
C. scheduling of 25%
manufacturing
operations
D. system
operations
analysis
25%
Score: 1/1
2.
Simulation can be used to study (check all that apply)
Student
Response
A. dynamic
models
Value Correct
Answer
20%
B. continuous- 20%
change
models
C. discretechange
models
20%
D. stochastic
models
20%
E. deterministic 20%
models
Score: 1/1
Feedback
3.
Model that describes a system with elements of uncertainty is called (select one
answer)
Student
Response
Value Correct
Answer
Feedback
A. dynamic
model
B. probability
model
C. stochastic
model
D. deterministic
model
E. either b or c 100%
Score: 1/1
4.
Which of the following systems can be modeled and simulated? (check all that
apply)
Student
Response
Value Correct
Answer
20%
A. tablet
manufacturing
plant
B. packaging line 20%
C. airport
20%
D. restaurant
20%
E. computer
network
20%
Score: 1/1
Feedback
5.
Computer simulation is most effectively used for models
Student
Response
Value Correct
Answer
Feedback
A. that can be
solved
analytically
B. that do not 100%
allow
analytical
solution
Score: 1/1
6.
Simulation of a complex system (check all that apply):
Student
Response
Value Correct
Answer
A. results in
deterministic
(nonrandom)
output even
when some
of the
outputs are
random
50%
B. results in
random
output when
some of the
inputs are
random
50%
C. allows
evaluation of
Feedback
Student
Response
Value Correct
Answer
Feedback
the output's
variability
due to the
random
inputs
Score: 1/1
7.
Which of the following parameters may be considered performance outputs for a
manufacturing system? (check all that apply)
Feedback
8.
Cumulative distribution function for a random variable can take:
Feedback
A. values
from zero
to infinity
B. any real
values
100%
C. values
from zero
to one
Score: 1/1
9.
Standard deviation of a random variable X:
Feedback
Score: 1/1
10.
The term "replication" is used in computer simulation to describe:
Student
Response
Value Correct
Answer
A. simulation of
the same
model with
different
initial
conditions
B. simulation of
the same
model with
different
assumptions
about the
random
variables'
distributions
C. multiple runs 100%
of the same
simulation
model
without any
changes to
the input
specifications
D. any of the
above
Score: 1/1
Title:
Final - Part 1
Started:
Feedback
1.
Transfer of the powdered raw materials from the shipping containers is normally
conducted:
Student
Response
Value Correct
Answer
A. in the main
process area
- materials
are
transferred
directly into
the blender
B. in a special 100%
dispensing
area materials are
transfered
into
intermediate
containers
that are later
sent to the
production
area
C. it depends
on the
facility
design and
on the
operations
approach
Score: 3/3
2.
Feedback
Which of the following factors affect the size of each production batch?
Feedback
A. marketing
demand
B. sizes of
available
production
equipment
C. process
scale-up
limitations
D. product
stability
period
E. all of the
above
100%
Score: 3/3
3.
Which of the following measures can be taken to avoid cross-contamination
between various products manufactured in the same facility? Use your own
judgment.
Feedback
Feedback
parallel
B. maintain
pressure in
the
production
rooms
lower than
in the
adjacent
corridor
C. maintain
pressure in
the
production
rooms
higher than
in the
adjacent
corridor
D. a and b
E. a and c
F. a, b, or c
100%
Score: 3/3
4.
Packaging area in a multi-product facility shall have:
Student
Response
A. partitions to
segregate
individual
packaging
lines
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
B. dust collection
in the filling
area of each
line
C. measures for
protection of
the exposed
product from
external
contamination
D. all of the
above
100%
Score: 3/3
5.
Contained systems for transfer of powdered raw materials are preferred because:
Student
Response
Value Correct
Answer
A. they protect
the operator
from the dust
B. they protect
the product
from external
contamination
C. they minimize
the losses of
active and
other
ingredients
D. all of the
above
Score: 3/3
100%
Feedback
6.
Which of the following types of tablet counters require change parts specific for
the size and shape of tablets?
Feedback
A. slat
counters
B. rotary
wheel
counters
C. electronic
tablet
counters
D. vibratory
feed
counters
E. a and b
100%
Score: 3/3
7.
What does a modern tablet filling machine do?
Feedback
Feedback
entering
into bottles
C. reject
bottles
with
incorrect
number of
tablets
D. all of the
above
100%
Score: 3/3
8.
Which of the following shall be included into an inquiry specification for a piece
of packaging equipment?
Student
Response
Value Correct
Answer
Feedback
100%
A. required
scope of
supply
B. project
description
C. performance
requirements
D. requirements
for
integration
with other
equipment
E. all of the
above
Score: 3/3
9.
What kind of "qualification/validation requirements" shall be included into a
purchasing spec for a piece of packaging equipment to ensure successful
qualification effort?
Student
Response
Value Correct
Answer
A. approved
qualification
protocols for
that piece of
equipment
B. list of
documents
that vendor
has to
provide to
support
qualification
C. requirements
that affect
the vendor's
scope of
work (for
example, a
need for a
service
technician
during startup and
qualification
at the buyer's
site)
D. performance
acceptance
criteria for
the machine
E. all of the
above
F. b, c and d
100%
Feedback
Score: 3/3
10.
A capping machine applies continuous thread (screw-on) caps to bottles. How
does it ensure that each cap is tight, but not overtightened?
Student
Response
Value Correct
Answer
Feedback
A. each cap is
turned by the
exact number
of
turns/degrees
to ensure
proper
tightness
B. a mechanical
or pneumatic
chuck
releases the
cap when it is
tightened to
correct
torque based
on a signal
from torque
sensor
C. proper torque 100%
is controlled
by a
pneumatic or
spring-loaded
clutch
D. any of the
above
Score: 3/3
11.
Student
Response
Value Correct
Answer
Feedback
A. seal integrity
testing is
incorporated into
the induction
sealer unit, which
rejects all bottles
with
defective/leaking
seals
B. seal integrity for
all bottles is
tested online by a
separate device
installed
downstream of
the induction
sealer
C. Seal integrity is 100%
tested off-line by
taking a few
sample bottles
and placing them
into a bath with
dye solution or
other test
methods. Only a
small number of
bottles are tested.
D. any of the above
Score: 3/3
12.
What is the purpose of an induction sealer in a bottle packaging line?
Feedback
Feedback
B. to attach a
plastic or
foil seal to
the
bottle's
neck
before
putting on
the screw
cap
C. to attach a 100%
foil to the
bottle's
neck after
the cap
has been
screwed
on
D. to seal the
bottle's
cap with
plastic
overwrap
Score: 3/3
13.
Sometimes shrink sleeves embracing the product container are used instead of or
in addition to labels. What is their purpose?
Student
Response
A. aesthetic
B. it provides
more space
for printing
information
compared
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
to a label
C. it may be
used as a
tamperevident
feature
D. any of the
above
100%
Score: 3/3
14.
What happens when a vision inspection system detects a non-conforming
container label?
Student
Response
Value Correct
Answer
A. the conveyor
is stopped,
allowing the
operator to
remove the
nonconforming
container
B. the container
is
immediately
pushed into
the reject bin
at the
inspection
station
C. the system 100%
"remembers"
the nonconforming
Feedback
Student
Response
Value Correct
Answer
Feedback
container and
rejects it
later, when it
reaches the
reject station
located
downstream
of the
inspection
station
Score: 3/3
15.
Shall an automatic vision inspection system be used to check the labels before or
after they have been applied to the drug containers?
Feedback
A. before
B. after
100%
C. any of the
above
Score: 3/3
16.
Which of the following operations are considered secondary packaging?
Student
Response
A. overwrapping
of filled
bottles with
plastic film
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
B. placing filled
bottles into
cartons
C. placing filled
blister packs
into cartons
D. re-packaging
of tablets
from large
containers
into smaller
containers
E. all of the
above
F. a, b, and c
100%
Score: 3/3
17.
Stretch or shrink wrapping of the pallet load is done primarily for:
Feedback
Feedback
D. all of the
above
Score: 3/3
18.
Which of the following shall be included in an inquiry spec for a piece of
packaging equipment?
Student Response
Value Correct
Answer
Feedback
A. description of
products/components
to be handled
B. required operating
speed
C. requirements for the
interface with infeed
and outfeed
conveyors
D. all of the above
100%
Score: 3/3
19.
Corrugated cardboard shipping cases are normally supplied to the packaging line:
Feedback
Feedback
Feedback
A. horizontal
sideloading
machine
50%
B. toploading
machine
with
grippers
or vacuum
cups
C. any of the
above
Score: 1.5/3
21.
Which of the following shall be included into a purchase order? (check all that
apply)
Student
Response
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
A. Sending
requests for
quotations
to multiple
bidders.
B. Working
100%
Feedback
Student
Response
Value Correct
Answer
Feedback
directly
with a
single
supplier
without
competitive
bidding.
C. The two
approaches
listed may
affect the
project cost,
but
generally
not the
schedule.
Score: 3/3
23.
Packaging line shall be qualified:
Student
Response
Value Correct
Answer
100%
A. after it has
been
commisioned
B. before it has
been
commisioned
C. at the same
time as it is
commisioned
D. the order of
commisioning
and
qualification
Feedback
Student
Response
Value Correct
Answer
Feedback
activities does
not matter
Score: 3/3
24.
Machines located in series in a packaging line are typically designed
Feedback
A. to operate
at the
same
speed (i.e.
number of
bottles per
minute)
B. to operate 100%
at
different
speeds
Score: 3/3
25.
The term Human Machine Interface (HMI) means:
Student
Response
A. access doors
used for
servicing a
packaging
machine
B. a central
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
computer
that collects
information
about
packaging
line
performance
100%
C. a panel,
keypad,
monitor, or
other device
used to read
and enter
information
into control
system
D. all of the
above
Score: 3/3
26.
Model that describes a system with elements of uncertainty is called (select one
answer)
Student
Response
Value Correct
Answer
A. dynamic
model
B. probability
model
C. stochastic
model
D. deterministic
model
E. either b or c 100%
Feedback
Score: 3/3
27.
Which of the following systems can be modeled and simulated? (check all that
apply)
Student
Response
Value Correct
Answer
Feedback
20%
A. tablet
manufacturing
plant
B. packaging line 20%
C. airport
20%
D. restaurant
20%
E. computer
network
20%
Score: 3/3
28.
Cumulative distribution function for a random variable can take:
Feedback
29.
Which of the following parameters may be considered performance outputs for a
manufacturing system? (check all that apply)
Feedback
25%
A. total
number of
parts
produced
per shift
B. average 25%
waiting
time a
part
spends in
queue
C. average 25%
total time
in the
system
(a.k.a.
cycle
time)
D. machine 25%
utilization
factor
Score: 3/3
30.
The term "replication" is used in computer simulation to describe:
Student
Response
A. simulation of
the same
model with
Value Correct
Answer
Feedback
Student
Response
Value Correct
Answer
Feedback
different
initial
conditions
B. simulation of
the same
model with
different
assumptions
about the
random
variables'
distributions
C. multiple runs 100%
of the same
simulation
model
without any
changes to
the input
specifications
D. any of the
above
Score: 3/3
Title:
Final - Part 2
Started:
1.
Write a brief executive summary for a new tablet manufacturing facility you plan to build.
Include the list of main areas/rooms, and the main equipment to be located in those rooms.
Packaging area is not required (it will be done at another plant).
Student The Manufacturing facility I am going to build will be having following areas:
Response: Ware house Weighing Mixing compression Granulation Coating Printing.
The production output of one day at this facility sometimes equals to a month or
even an entire years output at typically smaller pharmaceutical laboratories in the
region. To coordinate all production activities, the firm deployed an automation
system. The ware house: is the area where all the raw material will be brought and
kept, it also acquires the finished product, but will be separated from the raw
material space. Each production batch starts with a request for materials to the
warehouse, originated by a production order raised by the planning department.
From the warehouse, all supplies go to the area called traspaletizado, where raw
materials are taken away from wooden pallets and placed in clean aluminium pallets,
which are deemed more hygienic to enter the clean rooms. An airlock system also
prevents air from these two rooms passing to each other. I am planning ti have an
automatic ware house, and the list of equipment ill be requiring are Linde E15
1500kg Electric Fork Lift Truck, Linde R16FFL 1600kg Narrow Aisle Fork Lift
Truck, Climax R.18 1800kg Narrow Aisle Fork Lift Truck, Pallet Trucks, Large
Range of Pallet Racking 8 Section High Density Storage Rack, BVC IV20 Vacuum
Cleaner, Taski M400 Floor Scrubbers, Steel 40 and 20 Containers ,Waste
Compactor. A giant service lift then moves the requested materials from the ground
to the second floor. There, the Dosage process takes place, with each of the
ingredients needed to fabricate the tablets automatically loaded into dedicated
dispenser stations (one for each ingredient, to avoid cross-contamination). The exact
amounts specified by the formula are extracted from the internal network via
infrared technology. The dispenser stations then release the ingredients (which are all
solid, powder based) to the floor below using gravity, as if they were giant sand
clocks. Weighing and Mixing: On the first floor, a robotic moving scales system
capable of measuring up to 2500kg and running exactly Underneath the line of
dispensers collects and weighs the different ingredients, which are loaded into a
metal, 4m3 container. Some formulae require that only a small amount of certain
components is added (such as flavorings or colorings) and, for those, precision
scales are used instead. Each container will later become an individual production
batch, with its own expiry date and manufacturing information. This information is
stored in a solid memory unit attached to each container The container is then fitted
into a massive mixer, The formula stored on the solid memory unit will indicate the
mixer the exact revolutions per minute and operation time required. The mix is dried
if necessary and the container is taken to a different section on the first floor, where
its content is emptied onto one of six possible receptacles (one for each of the six
robotic production lines running underneath on the ground floor). Some of the
mixers: Aeschenbach Artofex VT410 Enclosed Pan Hydraulic Mixing Machine,
Apex 58FF 850 Liter Cone Blender, Winkworth GU430SSCW Ribbon Mixing
Machine, Manesty Rotogran Mk IV Granulator & Russell Vibratory Sieve Manesty
Express FX25 25 Station Tablet Compression Machine, Manesty Casburt Express
25 Station Tablet Compression Machine, Manesty B3A Tablet Compression
Machine, Range of Tablet Compression Tooling Schleuniger 4M Tablet Tester,
Manesty Boots Tablet Deduster, King BR6 Tablet Deduster RMS Tablet Deduster,
JCMCO Tablet Deduster, Manesty Boots Tablet Deduster I will also have Dry
Blending suites : Wet Granulation suites Fluid Bed Granulation suites Compounding
rooms with overhead feeds Coating suites Tableting suites Tablet inspection and
printing suites For tablet coating polishing and printing ill require following
instruments: Skerman CP2 Copper Polishing Pan, Manesty Accela-Cota Tablet
Coating Machine, Markem 156ANB Mk III Tablet Printing Machine, Kirkby
Devon KII Tablet Counter Schleuniger 6D Tablet Tester Greasby Goring Kerr
DSI & TEK2 Metal Detectors (Qty 2) CI Electronics Tablet Precision Weighing
Machine In addition to all this Ill also have compression department which will
have following machines: Donaldson Torit DCE D225C8R3 Dust Extraction and
Collection Unit HPC BS50 Air Compressor & Compressed Air Dryer Nederman
Extract Technology Laminar Flow Booth and Dust Extraction System, Laminar
Flow
Dust
Extraction
System
Score:
29/30
2.
Given our company's new manufacturing philosophy (JIT or Pull System), convince
management that running our packaging lines at a slower speed will produce our products
more efficiently, reduce changeover times, and thereby reducing direct costs of our products.
Student
Response:
the only job that is left in this case is to make the managment understand the
following criteria: In this age of technology there is no surprise that one is
demanding everything to be fast, pharmaceutical industry being no less, here
also people are demanding from vendor that how fast a machine can run
before they inquire about throughput or efficiency. Speed is not the right
answer. How far you travel is the right answer. What you put in the
warehouse is the right answer. You wouldn't believe the number of people who
are focused on the rate and not the reliability. But in case of packaging line is
not same, its like the old adage haste makes waste. When packaging lines
speed up, efficiency decreases, and repairs, rejects, downtime and overuse of
materials all increase. It doesnt mean that you have to turn your packaging
line to the slowest speed, but effective speed need to be decided. It is
dependent on four variables that change minute-to-minute on a packaging
line. These variables are the four Ps: product, packaging materials, people
and packaging machinery. When the amount of product running through the
line is consistent and is meeting the company's needs, the line has achieved its
sweet spot. If you want to achieve more efficiency, reduce changeover times,
and thereby reducing direct costs of our product, we need to understand
delicate balance between speed and efficiency, that can only lead us to the
target. If entire line isn't flowing smoothly and at the appropriate speed, the
probability of going to get the most out of that machine is very slim. "THE
REALITY IS, IF YOU PUSH PACKAGING MACHINERY AND IT
BREAKS DOWN, YOU'LL NEED TO REPAIR IT SOONER, FROM A
TECHNICIAN'S POINT OF VIEW, FASTER MEANS MORE DOWNTIME
AND MORE REJECTS. ... THE NUMBERS SHOW THAT IF YOU SLOW
THE LINE DOWN, YOU CAN INCREASE THOUGHPUT."
Score:
28/30