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Manufacturing > A1 WG - Experiment > Flashcards

A1 WG - Experiment Flashcards

Learn about the parameter in a TSG HSG- effect of L/S of torque measurement FBG, granules size

1
Q

Name equiment with which granulation is possible

A

Twin screw Granulator
High shear Granulator
Fluid-bed granulator

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2
Q

Name the processes which leads to granules in TSG

A

Nucleation, layering growth

agglomeration and breakge

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3
Q

Name the elements of a TSG and their functions

A

Coneveying elements important for transportation

Kneading elements important for compaction and distribution

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4
Q

the feeding system in a TSG

A

powder feeding and the liquid feeding system

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5
Q

how can you describe the screw?

A

they are coroating, having temperature jacket for coolin for heating

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6
Q

What is the importance of composition of the screw?

A

the screws elements determines the process characteristics

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7
Q

what’s the different between the longer and shoter pitch in the conveying element?

A

longer pitch, faster transportation, material is evenly distributed

shorte pitch length, smaller volume in the length, unevenly distribtion

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8
Q

How does the pitch length affects the granuales porosity?

A

the porosity of the granules decreases with increase pitch length, due to higher densification

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9
Q

what’s the disadvantges of the shoter pitch?

A

it leads to oversized granules and fines

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10
Q

What’S the advantage of TSG?

A

it can be used for continues manufacuring

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11
Q

What are the properites of the wet mass for TSG

A

The wet mass should be self-lubricanting, fluidity ad rigidit properties and not adhesive

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12
Q

lower angles of the kneading element in TSG

A

they have a forward flow propeties, more a conveying element

less shear fore, better distribution

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13
Q

higher angles of the kneading element in TSG

A

reversing kneading, higher pressure and compaction

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14
Q

How does the angle of the kneading element influence the granules properties?

A

they do not have any significant impact on the PSD of the granules. Nevertheless, increasing kneading elements will produced granules with high density and longer dissolution time

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15
Q

Which parameter were investiged in the A1 experiment?

A

L/S, feeding rate and srew speed

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16
Q

What is the most siginicant paramter in granulation

A

L/S ratio, because it affects the mean PSD of the granules.

Low L/S: non-homogeneous weeting of the powder mass. (bimodal granules size distribution

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17
Q

Low L/S affect on the PSD

A

Low L/S: non-homogeneous wetting of the powder mass. (bimodal granules size distribution

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18
Q

moderate high L/S affect on the PSD

A

more liquid available for distribution, more wetted and deformation of granules with monomodal size distribution

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19
Q

What’s the affect of the binding viscosity?

A

too high binder viscosity leads to poor distribution of the liquid, increase of fines
But the viscoity should be high enough to decrease the porosity of the granues, increase stickness

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20
Q

how does the FR and SS affect the granules?

A

Both impact the barrel fill that can change the shear and compaction forces , theryb influencing the granules size, density and structure

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21
Q

How the MRT affected by the FR and SS

A

the increasee if the SS leads to descreas of the MRT

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22
Q

why do the MRT reduces by high SS

A

increasing the SS increase the axial transport rate of the powder, thereby reducing the time the powder spedns in the granulator

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23
Q

Relation between the high MRT and throughput forces?

A

the decrease of the SS and the FR, leads to an increase of the MRT, due to low throughput force. therefore, the powder stays longer in the barrel

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24
Q

On what does the powder rfeed rate depends?

A

it depends on the fill level and the throughput force

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25
Q

Why does the increase of the SS and FR doesn’t affect the GS?

A

due to the no translation of the MRT into the change in the GS, therefore the GS can be maintained at varying screw speed

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26
Q

What is the effect of the low SS on a wet mass?

A

at low SS, the peak shear rate, axial mixing and the centrifugal force acting on the wet granules are low

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27
Q

Which forces is dominant at a lowe SS to push the granules?

A

the transport of te granules are mainly through a convective and less disoerive type of transport

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28
Q

What is the affect of the high SS on a wet mass?

A

the peak shear rate, axial mixing and the centrifugal force acting on the wet granules increase

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29
Q

What is the affect of a high centrifual force

A

it results in more dispersion transport and a stronger impact of wet granules

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30
Q

what could be the reasons for a small Gs while using MCC

A

high shearing and friction between the granules-barrel wall and granules-granules

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31
Q

Why does the MRT has an Impact on the GS when using MCC compared to lactos, using water as granulation solution

A

MCC is insoluable in water less duration for powder-liquid interactions

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32
Q

Why was the peristaltic pump calibrated before using?

A

Pump speed is shown in rpm, therefore no direct knwoledge about the transport mass which is needed

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33
Q

What does a positive of negative effects means in a main efffect plot?

A

positive: increase of a factor leads to an increase of the response. For a negative it is just vice visa

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34
Q

What is Flowac 100

A

it is a spray-dried suspension of fine alpha-lactose monohydrate crstals in a lactose solution. the crstals are bound by amprohous lactose

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35
Q

PVP K30, what does the K stands for?

A

it represents a functions of the average molecular weight and the degree of polymerization, characterized by it viscosity in aqueous solution

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36
Q

Sieve Anaylsis, in which oder are the sieve set?

A

in ascending degress of coarseness

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37
Q

How is the mesh of the sieve size defind?

A

as the number of openings in one square inch of a screen

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38
Q

Out of what are sieve made?

A

out of woven wire mesh

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39
Q

When is the sieve analysis test complete?

A

when the mass does not change by more than 5% of the previous mass

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40
Q

Which data must be include in the evaulation?

A

mass of the test sample, total sieving time and precise sieving methodology

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41
Q

What could impact the sieving process?

A

humidity, electrostatic properties

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42
Q

the used of Scanning electron Microscopy

A

it is used for PSD, particle morphology (shape, surface and structure)

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43
Q

how does the SEM functions?

A

it focused eletrons beams over the surface to create an image.
the eletrons are scatered and absorbed within a teardrop-shaped volumne (interaction volume)

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44
Q

what the results of the SEM process

A

the eletrons in the beam interact with the sample, producing various signals that can be used to obtain information about the surface topography and composition

45
Q

How do you caculate the solid mass?

A

feed rate * t process

46
Q

How do you caculate the liquid mass?

A

L/S * m

47
Q

Pump rate calculation

A

ml/t pto

48
Q

pump speed calculation

A

pump rate + b/m

49
Q

how do you calculate the fraction in a SA

A

mass /total mass * 100

50
Q

Q3 is the..

calculation

A

cumulative distribution

the first fraction + the scond fraction

51
Q

q3 is the

calculation

A

q3 is the probability density distribution

fraction / different in the sieve width

52
Q

learn the DOE part

A

have you done so?

53
Q

how is the process in the HSG called

A

it is a bottom-up granulation process

54
Q

composition of the HDG

A

Mixing bowl with an impeller

copper

55
Q

function of the impeller

A

it keeps the granulation material in constant movement

56
Q

function of the copper?

A

it is use to beak down larger agglomerates

57
Q

what is the big ad of the HSG

A

it is possible to monitor the granule formation, which makes it easier to determine the end point of the granulation process

58
Q

what does the senor measured

A

it measures the resistance of the wet flowing material against rotation of the impeller

59
Q

Why do we measure the torque?

A

it gives information about the particle size and density of the granules

60
Q

What are the processes in the granulation?

A
  1. Formation of the nucleaus
  2. consolidation
  3. agglomeration
  4. breakages
61
Q

nuclei phase?

A

it is the phase where the granulation liquid is constantly distrubted over the granulation material

62
Q

Why do consolidation happends

A

Due to the impacts of the impeller and the wall of the machine on the granulation material

63
Q

What happend during consolidation?

A

Water is pushed to the outer surface of the granules, leading to densification and so to particles growth

64
Q

which forces act for further growth of the particles?

A

cohesive force between the wet surface of the particles

65
Q

what is the equilibrium in the granulation process?

A

it is an equilibrium between growth of the particles and the breakages of the agglomerates

66
Q

When is the end of the granulation process?

A

at the equilibrium point, no futher growth is possible

67
Q

What are the 5 different phases of a granulation process

A 
Phase 1
Phase 2 ( funicular)
p3: transition
p4: capillary
p5: suspension
68
Q

Describe phase 1

A

adding of the liquid, no measurement of torque due to less resistance of the dry powder against the impeller

69
Q

describe phase 2 (funicular)

A

a rapid increase in torque, due to the occurences of agglomeration. Particles are weakly bound to each other

70
Q

phase 3 (transition state)

A

No change in the cohesive force between the particles.

the reached of the equilibrium of torque

71
Q

Phase 4 ( capillary state)

A

shape increse of torque with increasing liquid volume (filling up of the pores spaces)

Flututation of the torque

72
Q

Phase 5 (suspension state)

A

slurry formation, no resistance of the wet mass against the impeller

73
Q

Learn to draw the diagram of the torque measurement

A

Do you know how to do it?

74
Q

what are the parameter that influences torque?

A

Granules size

liquid amount, deformation property of the granules material and the stickines ability of the wet mass

75
Q

How is torque defind?

A

as the measure of the amount of energy needed to rotet the impeller during the granulation process

76
Q

Stickiness and torque

A

Stickiness has the highest impact on the increase in torque

77
Q

Why is stickiness important

A

it increases the capillary force between the granules and the wall or bewteen granules and another granules

78
Q

influence of plastic material of torque?

A

the deformation of platsic material is time dependent, which increases the deformability and the surface properties of the wet granules, leading to increase stickiness–> increase of torque

79
Q

when happend to granualtion process if a plastic material is used?

A

the increase of the torque and so reaching the torque equilibrium sate, will require a higher amount of liquid

80
Q

what’s the ad of using a plastic material?

A

the equilibrium state stays longer when using plastic material, making it more robust to variation in L/S ratio

81
Q

which parameter are important to obtained a narrow granule size distribution?

A

binder selection, its concentration, physical chemical properties of excipeints
process parameters such as impeller speed

82
Q

PSD granules produced via TSG and HSG

A

granules from TSG has a narrow PSD than that of HSG

83
Q

ada of the TSG compared to HSG

A

TSG, more uniform and efficient distribution at the surface of granules

84
Q

the two behaviour of the granules growth (learn how to draw them)

A 
Steady growth (easy to control, high deformation system)
Induction behaviour (low deformation system
85
Q

FBG, process

A

Charging process
fluidization
spraying
drying

86
Q

Which material can and can’t be be used in FBG

A

Used:
aeratable material and larger particles with low density

Not used: very small particles, cohesive

87
Q

Learn how to draw the FBG proces and describe it

A

inlet air passes the bed with high pressure,
increase air velocity leads to a decrease of the pressure –> increase of the pressure drop

Fuidize motion, where every particle is surrounded by air (faster drying)

88
Q

What is the boiling fluid bed’?

A

describe the point, where an increase air velocity doesn’t change the pressure drop.

89
Q

What are the three ways to apply the nozzle in a fluided-bed?

A

Top spray fluid
Tangential spray
bottom spray

90
Q

What are the process variables in TSFB diagram (learn how to draw it)

A 
liquid addition rate
inlet air temperature
fluidization air volume
process air humdity
Atomization air pressure
91
Q

Why is FBG a one-step enclosed operation?

A

Because serval ingredients can be mixed, granulted, and dried in the same vessel.

92
Q

what is the ad von FBG- granules?

A

there are highly dispersible, having porous structure that enhances wettability

93
Q

for what is the BSFB used?

A

mainly for coating, because it produces a superior film

94
Q

Process for the FBG

A
  1. Spraying,
  2. Mositening ( liquid bridge)
  3. solidification
  4. finisch agglomerates
95
Q

what happend after spraying is stopped?

A

the liquid evaporates, creating solid binder bounds.

96
Q

what is the property of the agglomerates?

A

void, as such permitting modified size ad porosity of the agglomerates

97
Q

Components of the TSFB

A

air-handling system
product container and expanion chamber
an exhaust system

98
Q

What is the key parameter in the TSFB

A

the atomization air volume

99
Q

what is the effects of the a faster rate of liquid binder addition?

A

it result in a larger average granules size and less-friable granules

100
Q

increase in the inlet air temp.

A

leads to an decrease in average granules size

101
Q

increase in the atomization air pressure

A

it leads in a decrease in average granules size because of smaller liquid droplet size

102
Q

What are the two most significant parameters in TSFB

A

atomization air pressure and the liquid addition rate

103
Q

Binder in Wet granulation

A

gelatin, starch, polyvinylpyrrolidone

104
Q

On what does the formation of granules depends?

A

it depends on the type of binder, concentration

105
Q

how are the granules produced with water as binder solution?

A

they have loose structure and are friable

106
Q

What is the main ad von using water as binder solution?

A

it improves the flowability and disperibility of the powder

107
Q

what are the three main forces in the TSTB and what are their function?

A

centriifugal, lifting and gravity force. Thoes forces provide good mixing and results in granules with good content unformity

108
Q

draw the levels of the FFD have 3 factors

A

A:-+-+
B: –+–+
C—-++++

Manufacturing (7 decks)

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