Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Manufacturing > B1. Tableting > Flashcards

B1. Tableting Flashcards

1
Q

Why do we use the six-sigma process?

A

use to improve the quality of product and so having a productivity and efficiency of the manufacturing process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

what’s the aim of the SS-process?

A

it is to eliminate defects and reducing variation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What’s the DPMO

A

is the 3.4 defects per million opportunities, which is the results of using SS-proces

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What’s the ad von SS instead of 3 S

A

the UCL and LCL are within the operation window, whereas in 3-S they are not

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is the DPMO of 3-sigma?

A

66810

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Definition of SS

A

a methodology for eliminating variability, defects and waste in a product or process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is the approach in SS

A

a data-driven approach

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

How are defects reduce

A

By six standard deviation between the mean and the nearest specification limits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What are the two methodology of the SS- process?

A

DMAIC, DMADV

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

DMAIC?

A

Define (control chart) , Measure ( plots), Analysis (DoE, FMEA), Improve and Control (CC)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

DMADV

A

Define, Measure, analysis, Design and Validate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What is a statistical process control (SPC)

A

it is a tool to translate the variation of a process into values

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What kind of variation?

A

Special cause and common cause variation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Special cause variation?

A

Variation which are larger in magnitude and can be identified

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Common cause variation?

A

Sum of multitude of effects of a complex interaction

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

control charts are used to

A

use to analyses variation causes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What are the three zones in CC?

A

Zone 1: no actions should be taken
Zone 2: Collection of more information

Zone3: Action required

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Zone 2 and 3 are, and zone 1

A

Zone 2 and 3 are Special causes variation

and zone 1 common cause vairation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Of what does a CC consist?

A 
Central line (average values)
UCL and LCL
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

UCL and LCL are set

A

3-standard deviation, which is only true when the SD is knwon for the giving process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What is a start-up phase?

A

where data are collected to create CC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Categorization of Data into?

A

Attribute data and continous data

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Which CC are used in continous data?

A

x-bar, range and s-charts

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

x-bar and R are

A

charts use to defined the stability of the process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

x-bar and s-chart?

A

used for checking mean and variation of a process

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

What is the equation for LCL and UCL for x-bar?

A

LCL: mean - A3 *sd
UCL: mean+ A3 * sd

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

What is the equation for LCL and UCL for s-cart?

A

LCL: B3 *sd
UCL: B4 * sd

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

Why do we used the anti-biasing constants and on what does it depends?

A

ULC and LCL are 3-sd from the mean, although the sample size is low
the empirical standard deviation can only be used with high sample size.

it depends on the sample size, used to create the CC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

IPC is use for?

A

Testing of various quality characterist of intermediates and statistical evaluation of results via control chart

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

MSPC?

A

multivariate statistical PC

statistical evaluation of process data or by comparison of to histrical data

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

PAT?

A

Process analytical technology

Analysis of quality characteristics by PA in real time

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

IPC and guidline?

A

No information in the guidlines what has to be tested, how and where and how frequently

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

What is the product life cycle?

A

lap phase, pilot phase

validation phase

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

lap and pilot phase?

A

Process design, IPC testing
identify CCP and CMA
Defination of OP limits and inprocess monitoring strategies

–> Data Accumulation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

Validation phase?

A

modification of IPC
process qualification

Focus on critical paramater

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

What are process capability index?

A

measures the ability of a process to produce output within specification limits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

When is a process capable?

A

when “ almost all” meansurements of a feature produced by the process fall inside the specification limits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

what are typical process capability indices?

A

Cp, Cpk and Cpm

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

Cp

A

process mean (scattering of the process results)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

limits of Cp?

A

Cp >1 process meets specification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

what’s the benchmark?

A

Cp > 1.33

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
42
Q

When happend if the mean is not centered?

A

it leads to Cp overestimates process capability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
43
Q

Equation for Cp

A

Cp= UCL-LCL /6 sd

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
44
Q

Cpk is?

A

adresses data centering, can be positive, zero or negative

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
45
Q

What happend if the Cpk is asymmetric?

A

underestimation of the proces capability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
46
Q

Cpm?

A

is a measure of the overall process capability

comparing the specification spread to the spread of your process data while taking into accout the deviation from the target value

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
47
Q

Shewhart chart?

A

Singel (raw) data points

not sensitve to small shifts, can easily detect large changes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
48
Q

EWMA chart

A

exponential weighted moving averages of all prior sample means.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
49
Q

Cusum chart?

A

cumulative sum of differences

detects small shifts over time

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
50
Q

Calibration and validation of charts?

A

Calibration: statistical analysis of common variation in the process (UCL, LCL)

Validation: test the charts to distinguish common variation from uncommon variation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
51
Q

different between the shewhart and EWMA chart

A

Shewhart is not senstve to small shifts, can easily detect larger changes

whereas, EWMA can easily detect small shifts in process means, but not suitable to monitor process variability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
52
Q

Rule of seven?

A

When 7 points are below or above the limits, assignable cause that needs to be investigated

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
53
Q

MSpC is important for?

A

QA but not the sole indicator of product quality

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
54
Q

lean manufacturing

A

minimizing waste by getting rid of activites that don’t directly generate values for the customer

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
55
Q

TIM WOODs?

A

Transport, Inventory, Motion, Waiting, Overproduction, Overprocessing, Defects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
56
Q

5S?

A

sort, set in order, shine, standardize, sustain

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
57
Q

Poka-Yoke

A

mistake proofing

elimimation, facilitation, mitigation ( reduce the impact of a failure) and flagging (mak a failure visible)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
58
Q

Tablets machines?

A

eccentric, rotary or a IMA press

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
59
Q

excentre press

A

disc is fixed excentre
UP–> densification
LP–> fixed during compression

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
60
Q

How is the densification on the excentre press?

A

asymetric, having a sinusidal movement of UP velocity profile

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
61
Q

the used of excentre press?

A

use of high CF, production of larger tablets, more in development and partly veternary tablets production

62
Q

Rotary press is use for?

A

for large scale industrial production

63
Q

Componenen of the RP?

A 
serval punches, 
stationary hopper, 
die table (circular die plate or matric table)
filling by feed feed frame
compression rolls
64
Q

what’s the feeding sytem in RP

A

a gravity feeding system with a funnel or force feedig

65
Q

when do we used the force feeder

A

at higher tableting speed

66
Q

what are the circular motion?

A

compression rolls, the filling and ejection cam

67
Q

Compression stage in RP?

A

pre compression, done by small rolls

Main compression densification

68
Q

how is the compaction process in RP?

A

it is symmetric

69
Q

what’s the aim of the pre-compression process

A

to remove entrapped air, which could lead to capping due to negative binding of the tablet material

70
Q

How can entrapped air also be remove?

A

by reducing the tabletting speed

71
Q

How is the densification process in EP and RP?

A

densification on the EP is one side, leading to different degrees tablet hardness

72
Q

what are the CPP in filling?

A

particle shape, surface and size, which affects the flowability of the tablets material and the density of the particles

73
Q

Compaction:

A

Application of pressure with Upper and Lower punch–> particle deformation or fragmentation

74
Q

Ejection:

A

overcoming of frictional and adhesion force, elastic recovery

75
Q

What are the parameter of creating compression force in RP

A

immersion and fill depth

76
Q

immersion depth

A

distance between the punchtips at the maximum compaction pressure.

77
Q

the final tablet thickness, porosity and hardness is determine by?

A

immersion depth

78
Q

how does the ID affects the CF

A

small ID leads to high CF, higher densification

79
Q

Fill depth?

A

influences the tablet mass, depends on the position of the LP

80
Q

small fill volume leads to

A

increase of compression force by a deeper immersion depth

81
Q

when is the force constant ?

A

For a constant volume at a specified immersion depth

82
Q

press speed?

A

number of revolution execute within 1h

83
Q

TS affects?

A

affects die filling and dwell time

84
Q

when can be obtained a constant mass?

A

when the filling volume is constant

85
Q

what is the relationship between the tablet weight and thickness?

A

tablet weight is directly proportion to the tablet thickness

86
Q

What is the indication of mass variation?

A

variation of the CF

87
Q

which 3 parameter are interdependent

A

tablet weight, thickness and hardness

88
Q

name of forces during compression

A

UPF, LPF, die wall, stripping, pressure rollers

89
Q

type of Displacement?

A

UP, LP

inductive displacement transducers and incremental displacement

90
Q

What are some reversible changes during compaction?

A

Punch compression, die widening and machine fram streching

91
Q

instrumentation used to control the compression force?

A

Strain gauge, piezoelectric force transducers and inductive displacement sensor

92
Q

Strain gauge is a?

A

metallic conductance track glued onto a puch holder

93
Q

How CF monitored with strain gauge?

A

they covert changes in electrical resistance into an electric signal which can be measured.

the electrical resistance changes is proportional to change in length

94
Q

disad of strain gauges?

A

they are prone to temeperature changes (friction) wherefor correction factors are necessary

95
Q

which law is applied?

A

OHM law

96
Q

the piezoelectric force transducers

A

recording the electric potential occuring from a force induced charge shift in the crystal. the shift is then amplified to measure the force

97
Q

inductive displacement sensor?

A

detecting the change in alternating-current reistance which is based in the depth dependent movement of the punch into the die

98
Q

why is the force detection efficient?

A

due to the proportionality to the tablet mass, meaning that a constant compression force leads to constant tablet mass

99
Q

how is the proportionality of the Cf and Tw in a strain gauge

A

the compression is propertional to the voltage measured and therewith for the force applied

100
Q

which two parameter are proportional to the TM in the strain gauge?

A

the Cf and voltage for a certain immersion and filling depth

101
Q

what is the ideal case in strain gauge?

A

high change in voltage for a small change in mass (higher slope in a voltage-mass-diagram) to adjust the tablet mass precisely

102
Q

three stages of deformation

A

elastic, plastic and fragmentation

103
Q

on what does the deformation depends?

A

on the applied compression force

104
Q

Which diagram can be used to describe the deformation behaviour?

A

the stress-strain-diagram

105
Q

elastic deformation?

A

a reversible process, occure at the beinning of the apllied CF.
has a linear relation to the strain

106
Q

what do elastic material have?

A

they have a very high young’s modulus yield strength , only in the linear part

107
Q

what does high young modulus means?

A

high stress is need for a certin deformation of the elastic material

108
Q

defination of the young modulus?

A

it is a measurement used to describe the ability of material to withstand changes in length when under lengthwise tension or compression

109
Q

plastic deformation?

A

inrreversible and time- dependent process, permanent change of the particle shape

110
Q

when do plastic deformation takes place?

A

when the yied limit is exceeded

111
Q

hock’s law

A

it is the linear relation between the stress and strain, can only be applied for elastic and not for plastic material

112
Q

when does the material starts to flow?

A

when the yield limit is exceeded, leading to platic deformation

113
Q

Brittle fragmentation

A

breaking of the original particles into smaller units

114
Q

Ductile frature

A

after plastic deformation has taken place

115
Q

deformation depends on?

A

particle size and morphology and the excients properties

116
Q

what is viscolasticity?

A

a property of material that exhibits both viscous and elastic characteristics when undergoing defomation

117
Q

Monitoring of compression process

A

Force-time-diagram and Force displacement diagram

118
Q

Force-time-diagram excenter and rotary press (draw it)

A

do knwo how to draw it?

119
Q

Whats the main different between the F-T-D in EP and RP?

A

the plasticity of a mixture can be obtained in the RP by calculating the dwell time coefficient

120
Q

what is the residual force?

A

the force which is still applied on the tablet, eventhough the upper punch has left the die

121
Q

what are the phase in the FTD in a RP?

A

A1: compression phase
A2 / A3: Dwell phase
A4: Decompression phase

122
Q

A1 phase?

A

compression phase, consolidation time.

123
Q

what affect the area of the A1 phase?

A

high fluctuation of the CF
tabletting speed
material properites

124
Q

when is A1 are big?

A

high CF, low TS and palstic material (more consolidation time)

125
Q

what affects the CF?

A

flowability, high tableting speed

126
Q

A2/ A3 phase?

A

Dwell phase

127
Q

dwell time definition?

A

is the time at which the tablet material is exposed to the maximum pressure, when both head punches are on contact with the material

material begins to flow, resluting to plastic deformation

128
Q

Dwell phase is affected by?

A

machine parameter, dwell time.

129
Q

what is an indication of the dwell time in the FTD

A

the slightly decrease of force

130
Q

what affects the plastic deformation?

A

since it is time-dependen, its affect by high tableting speed–> short dwell time

131
Q

what is the affect of a short dwell time on the properties of the tablets?

A

short dwell time, leads to no time for plastic deformation. Therefore, less bonding of the tablet material, high elastic recovering, leading to capping

132
Q

Decompression phase?

A

Ejection of the tablets

133
Q

how does the FTD at higher and slower tableting speed looks like?

A

the compression force peaks at higher TS are narrower and the time before decompression takes places get shorter

134
Q

Force-displacemnet diagram, draw of the excenter and rotary press

A

do you know how to draw it?

135
Q

explain E1, E2 and E3 in a FDD of a excentre press

A

E1: mechical engery into the heat energy
E2: elastic to plastic deformation
E3: force is apply to the tablet, but not stored in the tablet

136
Q

why is the maximum of the up displacement and lp force lower than up displacement and force

A

due to the friction

137
Q

draw the FDD for rotary pres for ideal elastic, plastic and combination of both bodies

A

do you know how to draw it

138
Q

what is a hysterisis area

A

the area between the elastic and plastic deformation

139
Q

the use of the FDD

A

is used to say something about the properties of the material

140
Q

Probleme during tableting

A

tablet weight variation
insufficient tablet hardness
capping and lamination
tablet sticking

141
Q

tablet weight vaiation?

A

inconsistent filling
moisture content
stickiness

142
Q

insufficient tablet hardness

A

inadequate binding properties
excessive elastic recovering
over lubrication
compression force and speed

143
Q

capping and lamination

A

capping: the slpiting of the tablets
lamination: creaking

144
Q

why do capping and lamination occur

A

interparticulate bonding
high moisture content
air entrapped
high residual wall pressure

145
Q

tablet sticking

A

inadequate lubrication
high adhesive force
high moisture content

146
Q

what is corrosion?

A

irreversible damage of material due to chemical or electrochemical reaction

147
Q

how corrosion be prevented?

A

routinely washing the surface
sealing any cervices with rubber
passivation

148
Q

different between MBR and BR?

A

MBR: exist for each product, whereby BR ia an approved copy of the MBR with filled in data enteries

149
Q

Name some requirement for the MBR?

A

name of the prouct, reference product with its sepfication
pharmaceutical form, strength of the products and batch size
statement of the expected final yield with AL
location and the principle equipment
SOP
instruction for IPC
a single continuous document

150
Q

who gives the MBR?

A

QA

151
Q

issuing of MBR

A
  • resonsible to generate a copy for a production
  • MBR have to be stamped by QA to ensure the currently valid version
  • is issued batch by batch on production orders
  • changes made, document have to be review and approval again
  • QA have to print out and sign, making sure that the aproved current MBR
152
Q

BR?

A
  • includes the record sheet of all the prodcution record and support records
  • should be kept for a each batch processed
  • before processing begins, check for all equipment and workstation
  • have be date and sign by the person responsible for the processing operations

Manufacturing (7 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions