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IP 126 Manufacturing > Unit Operations > Flashcards

Unit Operations Flashcards

1
Q

A process designed to achieve one or more changes in the physical and/or chemical properties of the raw material/s

A

Unit Operation

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2
Q

11 unit operations

A
  • Weighing and Dispensing
  • Size Reduction
  • Mixing and Blending
  • Granulation
  • Drying
  • Compression
  • Coating
  • Encapsulation
  • Filtration and Clarification
  • Sterilization
  • Packaging
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3
Q

Consists of two or more unit operations

A

Pharmaceutical Processing

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4
Q

series of steps to prepare a batch or lot

Production with interruption

Low demand, slow moving products

A

Batch

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5
Q

RMs continuously fed and
FP continuously discharged

Production with minimal or
no interruption

Work shifts

Large volume, fast-moving
products

A

Continuous

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6
Q

First crucial operation

RMs weighed and transferred to clean containers

A

Weighing and Dispensing

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7
Q

entry point to manufacturing

A

Weighroom

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8
Q

process of reducing larger size solid unit masses to smaller

size unit masses by mechanical means

A

Size Reduction

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9
Q 
Size reduction occurs by
fracture of particles
between two sets of knives
which have a clearance of a
few millimeters
A

Cutting or shearing

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10
Q 
Consists of a series of
4 or more hammers,
hinged on a central
shaft which is enclosed
within a rigid metal
case

During milling the
hammers swing out
radially from the
rotating shaft

A

Hammer mill

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11
Q

Filled to approximately
80% of total volume
with porcelain or steel
balls.

size reduction occurs by
repeated impaction

A

Vibration Mill

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12
Q

Weighed pestle is turned by
the friction of material
passing beneath it as the
mortar rotates under power

A

End-runner mill

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13
Q

Pestle equivalent (muller)
mounted horizontally and
rotating against a bed of
powder

A

Edge runner mill

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14
Q 
Two cylindrical rolls
mounted horizontally and
rotated about their long
axes. One of the rolls is
driven directly while the
second is rotated by friction
as material is drawn through
the gap between the rolls
A

Roller mill

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15
Q

Size reduction of solids in
suspensions, pastes, and
ointments

A

Roller mill

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16
Q

Consists of a narrow cylinder
mounted such that it can be
rotated on its horizontal
longitudinal axis.

Contains balls of different
diameters that occupy 30-50%
of the total volume

A

Ball mill

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17
Q

Consists of 2 discs with closely
spaced pins which rotate
against one another at high
speeds

Size reduction occurs by
impaction with the pins and by
attrition between pins as the
particles travel outwards due to
centrifugal force
A

Pin mill

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18
Q

Micronizer

Consists of a hollow toroid
which has a diameter of 20-200
mm, depending on the height
of the loop which may be up to
2 m.
A fluid is injected as a high
pressure jet through nozzles at
the bottom of the loop. The
high velocity of the air gives
rise to zones of turbulence into
which solid particles are fed.
This causes the particles to
impact with other particles
A

Fluid energy or jet mill

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19
Q

Factors in Choosing a Mill

A
  1. properties of feedstock

2. specification of product

20
Q

properties of feedstock

A
  • hardness
  • physical nature
  • water content
  • production of heat during milling
21
Q

specification of product

A
  • Fine

* coarse

22
Q

fibrous
wet mass
dry powder/granulation

cutting and some attrition

4 - 80 mesh

A

cutter mill

23
Q

non-abrasive to mod.
abrasive
brittle and dry

impact and some attrition

10 - 325 mesh

A

hammer mill

24
Q

mod. hard and abrasive

attrition and impact

5 - 100 μm

A

ball or rod mill

25
Q

raw materials
wet and dry granulation

shear and attrition

A

hand screen

26
Q

dry granulation

attrition and shear

10 - 60 mesh

A

oscillating granulator

27
Q

wet granulation

shear

A

extruder

28
Q

mod. hard

attrition and impact

5 - 30 μm

A

fluid energy mill

29
Q

pregranulation and/or post granulation stage of tablet manufacturing

A

Mixing

30
Q

combines several processing steps to optimize the

manufacturing process particularly in wet granulation

A

granulator shear mixer

31
Q

Classification of Mixing Equipment

A

Batch type

Continuou type

32
Q

keeps the residual moisture low enough
– to prevent product deterioration
– ensure free flowing properties

A

Drying

33
Q

Methods of Granulation

A
  • Wet Granulation
  • Dry Granulation
  • Fluid Bed Granulation
  • Hot Melt Granulation
34
Q

Granulation wherein there is massing of the powder mix using a solvent (alone or with a granulating agent)

A

Wet Granulation

35
Q

For drugs which do not compress well after wet

granulation and are sensitive to moisture

A

Dry granulation

36
Q

two processes of dry granulation

A

slugging

roller compaction

37
Q

forces fine powders between two counter rotating rolls and presses the raw
material into a solid compact or sheet, so called flakes. Finally these flakes
are then reduced in size to the desired grain size.

A

roller compactor

38
Q

Adapted for wet granulation
and dry granulation using a
fluid bed un

A

Fluidized Bed Granulation

39
Q

single-step granulation process suitable to manufacture high-energy solids

No solvents, sustained release

Chemical stability problems due to high temperature involved, limited polymers

A

Hot Melt Granulation

40
Q 
means of providing products the following:
– presentation
– protection/preservation
– identification/information
– containment
– convenience
A

Packaging

41
Q

direct contact with the product or direct effect on shelf-life

A

Primary Package system

42
Q

external to the primary pack

additional physical protection

A

Secondary Package system

43
Q 
one that is difficult for
most children under 5
years of age to open or
gain access to the
contents or obtain a
harmful amount of the
contents
A

Child resistant

44
Q 
uses an indicator or
barrier to entry that
provide visible evidence to
consumers that tampering
has occurred
A

Tamper Rasistant/Evident

45
Q

designated area for storing supplies so that products are always available, accessible, and in good condition

A

Warehouse

IP 126 Manufacturing (3 decks)

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