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Improved Tablets Production
System
10/29/2024 1
 Regulatory compliance
 -Current good manufacturing practices(CGMPs)
 -Occupational safety and health administration
(OSHA)
 -Environmental protection agency(EPA)
 Increased production capacity and flexibility
 Decreased product throughout time
 Reduced labor cost
 Increased energy savings
 Broadened process control or automation for control,
operator interface, and reporting
Benefits of Improved production systems
10/29/2024 2
MATERIAL HANDLING
10/29/2024 3
Objectives
A. Reduce Unit Material Handling Cost
® Eliminate Unnecessary Handling
® Handle Material in Batch Lots
® Minimize Required Handling Time
® Handling Equipment Appropriately
B. Reduce Production Time
® Minimize Delays of Machine Operations
® Maintain Uniform, Appropriate
Movement of Material
® Use Automatic Processing When
Appropriate
C. Reduce Overhead
® Minimize Non-Productive Labor
® Prevent Damage to Materials
® Coordinate All Material Handling
Systems
D. Conserve Floor Space
→ Avoid Excessive Stock Storage
→ Move Materials in a Position to
Save Space
→ Use Equipment Requiring No
Floor Space
E. Prevent Accidents
→ Reduce Physical Load Required
→ Insure Handling Equipment is Safe
F. Improve Employee Morale
→ Provide Proper Relationship
Between Employee & Work
G. Regulatory compliance
10/29/2024 4
10/29/2024 5
MATERIAL HANDLING RISKS
➢ Increased product costs
➢ Customer dissatisfaction
➢ Employee safety liability
➢ Place employee in physical danger and
cause loss of morale
RAW MATERIAL NOT MOVED AS REQUIRED DELAYS OCCUR
MACHINE/PERSONNELTIMEWASTED INVENTORY COST
INCREASED AND LOSSES
10/29/2024 6
Basic principle of material
handling
1.Short distance- Raw material used in the production
process should only be moved over the shortest possible
distances. Moving materials over excessive distances
increases the possibility of delays, and adds to the labor
costs if material is moved by hand.
2.Short terminal times- When material is being transported,
the means of transportation should not have to spend time
waiting on the material to be packed. Material should
always be ready when transportation is available.
3.Two way payloads- The transportation mechanism for
material should never be moved empty. It means return
trip could be used.
10/29/2024 7
4.Avoid partial loads: It means partial use of
total capacity of transportation system is a
waste of time and energy. Therefore it should
be avoided.
5.Avoid manual handling: The manual handling of
raw materials is most expensive way of moving
them. So, it should be avoided.
6.Move scrap cheaply: The movement of scrap
material is a nonproductive function and scrap
material should not be a primary work for a
transportation system. Therefore scrap should
be moved inexpensively as possible.
10/29/2024 8
7.Gravity is the cheapest power: The movement of
material from top to bottom through multielevated
facilities.
8.Move in a straight lines: The most efficient
movement of material is along the straightest and
most direct path to its destination.
9.Unit loads: Raw material should be delivered to their
ultimate destinations in loads. It will eliminate need
for excessive raw material to be handled at point of
use and to be returned to the storage place.
10.Label Thoroughly: It eliminate improper raw
material handling. Much time and effort is waste in
correcting raw materials errors.
10/29/2024 9
Factors affecting material- handling
decisions:
A no. of material handling system are available
however use of material handling system depends on-
➢A manufacturing unit whether it is a Batch or
Continuous process.
➢The type and quantity of product and physical
appearance of raw material effect the material handling
system.
➢The type of building
10/29/2024 10
10/29/2024 11
10/29/2024 12
REASON FOR PROCESSING STEP
COMBINATION OR ELIMINATION
1 . Improve the old process
2 . Produce high quality finished products
3 . Least handling of materials
4 . Some times involves no drying steps
5 . Fastest production of finished products
6 . Economical
7 . Reduce contamination
8 .Time and energy savings
10/29/2024 13
Processing step combination or elimination
1. Raw material
2. weighing & measuring
3. screening
4. manual feeding
5. blending
6. wetting
7. Subdivision
8. drying
9. subdivision
10. premixing
11. batching & lubrication
12. manual feeding
13. compression
14. solvent film coating
15 tablet inspection
1. Raw material
2. weighing & measuring
3. gravity feeding
4.blending
5. gravity feeding from storage tank
6. Compression
7. aqueous coating
Old tablet
manufacturing process
( wet granulation)
New tablet manufacturing
process
( direct compression)
10/29/2024 14
EQUIPMENTS OF PROCESSING
10/29/2024 15
Unit operation improvement
 There may be improvement in various unit
operation which may constitute the overall
manufacturing process.
 Various processes may be:
WET GRANULATION
TABLETING
COATING
 These improve overall process
10/29/2024 16
WET GRANULATION
 It is a fundamental process.
 To obtain reproducible granulations and
minimize lot to lot variations traditionally
amount of granulating solution added and
total mixing time was considered
 Recently more sophisticated techniques are
used to investigate granulation process
10/29/2024 17
THESE ARE:
 INDIRECT METHODS
➢Power consumption
➢Torque
➢Rotation rate
➢Motor load analyzer
• DIRECT METHODS
➢Beam deflection
➢Bending moment
➢Probe vibrational analysis
10/29/2024 18
COMPUTER PROCESS CONTROL
 Computer control of the process is now
being used for the control of all processes
 E.g.-automatic tablet counter
10/29/2024 19
Tablet Production
 Powders intended for compression into
tablets must possess two essential
properties
◦ Powder fluidity
 The material can be transported through
the hopper into the die
 To produce tablets of a consistent weight
 Powder flow can be improved
mechanically by the use of vibrators, or
by the incorporation of glidant
10/29/2024 20
◦Powder compressibility
The property of forming a stable,
intact compact mass when pressure
is applied
10/29/2024 21
Tableting Procedure
Granulation and mixing
Filling
Compression
Ejection
10/29/2024 22
 Compression- reduction in bulk volume of
material due to displacement of gaseous phase
 Consolidation- increase in mechanical strength
of material due to particle-2 interaction
 Compaction- is compression & consolidation of
2 phases (solid & Gas) system due to applied
force
 Powder Compression- reduction in volume of
powder owing to the application of force. Bonds
are formed b/w the particles due to which
compact mass is formed10/29/2024 23
GRANULATION METHODS
METHODS OF PREPARATIONS
1. Dry methods
a. Direct Compression
b. Granulation by compression
2. Wet methods
a. Wet granulation
b. Special procedures/related
granulation processes
10/29/2024 24
CHARACTERISTICS OF DI0SNA
MIXER:
✓ The speed of mixing blades
vary with the size of mixer. The tip
speed is kept at 3-4/10 m/sec on
low and 6-8/10 m/sec on high
✓ Chopper blade speed=1750-
3500 rpm, function as a lump and
agglomerate reducer
✓The shape of particles produced
by the diosna were more spherical
✓Complete mixing may be
obtained in 30-60 sec.
DIOSNA MIXER
10/29/2024 25
CHARACTERISTICS OF GRAL
MIXER/GRANULATOR:
➢Large scale mixing motion in
the powder
➢Time control equipment
➢Explosion proof
➢Equipment available in 5 size
ranges from 10-1200 lt.
10/29/2024 26
GRAL MIXER
A no. of pharmaceutical manufacturers use this because:
Drying efficiency high
Easily cleaned
Solvent vapors can be recovered
Solvent vapor not discharged to the atmosphere
DOUBLE CONE MIXER
27
ADVANTAGE:
Producing very uniform powder
mixtures
Not force to rely on vacuum for
drying, but can use hot air.
MODIFIED DAY – NAUTA
MIXER:
Effective way of producing drying
with in the conical unit.
DAY NAUTA MIXER
10/29/2024 28
Tablet compression machines
 Hopper for holding and feeding granulation
to be compressed
 Dies that define the size and shape of the
tablet
 Punches for compressing the granulation
within the dies
 Cam tracks for guiding the movement of the
punches
 Feeding mechanisms for moving granulation
from the hopper into the dies
10/29/2024 29
Single Punch Machine
The compression is applied by
the upper punch
10/29/2024 30
Upper and
Lower Collar
Collar locker
Single Punch Machine
(Tablets)
10/29/2024 31
10/29/2024 32
10/29/2024 33
Multi-station rotary presses
 The head of the tablet machine that holds
the upper punches, dies and lower punches
in place rotates
 As the head rotates, the punches are guided
up and down by fixed cam tracks, which
control the sequence of filling, compression
and ejection.
 The portions of the head that hold the
upper and lower punches are called the
upper an lower turrets
10/29/2024 34
10/29/2024 35
 The portion holding the dies is called the die
table
 The pull down cam (C) guides the lower
punches to the bottom, allowing the dies to
overfill
 The punches then pass over a weight-control
cam (E), which reduces the fill in the dies to
the desired amount
10/29/2024 36
 A swipe off blade (D) at the end of the feed
frame removes the excess granulation and
directs it around the turret and back into
the front of the feed frame
 The lower punches travel over the lower
compression roll (F) while simultaneously
the upper punches ride beneath the upper
compression roll (G)
10/29/2024 37
 The upper punches enter a fixed distance into
the dies, while the lower punches are raised to
squeeze and compact the granulation within the
dies
 After the moment of compression, the upper
punches are withdrawn as they follow the upper
punch raising cam (H)
 The lower punches ride up the cam (I) which
brings the tablets flush with or slightly above the
surface of the dies
10/29/2024 38
 The tablets strike a sweep off blade affixed
to the front of the feed frame (A) and slide
down a chute into a receptacle
 At the same time, the lower punches re-
enter the pull down cam (C) and the cycle is
repeated
10/29/2024 39
10/29/2024 40
10/29/2024 41
10/29/2024 42
THANK YOU
10/29/2024 43

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Material Handling + Combination-Elimination Steps.pdf

  • 2.  Regulatory compliance  -Current good manufacturing practices(CGMPs)  -Occupational safety and health administration (OSHA)  -Environmental protection agency(EPA)  Increased production capacity and flexibility  Decreased product throughout time  Reduced labor cost  Increased energy savings  Broadened process control or automation for control, operator interface, and reporting Benefits of Improved production systems 10/29/2024 2
  • 4. Objectives A. Reduce Unit Material Handling Cost ® Eliminate Unnecessary Handling ® Handle Material in Batch Lots ® Minimize Required Handling Time ® Handling Equipment Appropriately B. Reduce Production Time ® Minimize Delays of Machine Operations ® Maintain Uniform, Appropriate Movement of Material ® Use Automatic Processing When Appropriate C. Reduce Overhead ® Minimize Non-Productive Labor ® Prevent Damage to Materials ® Coordinate All Material Handling Systems D. Conserve Floor Space → Avoid Excessive Stock Storage → Move Materials in a Position to Save Space → Use Equipment Requiring No Floor Space E. Prevent Accidents → Reduce Physical Load Required → Insure Handling Equipment is Safe F. Improve Employee Morale → Provide Proper Relationship Between Employee & Work G. Regulatory compliance 10/29/2024 4
  • 6. MATERIAL HANDLING RISKS ➢ Increased product costs ➢ Customer dissatisfaction ➢ Employee safety liability ➢ Place employee in physical danger and cause loss of morale RAW MATERIAL NOT MOVED AS REQUIRED DELAYS OCCUR MACHINE/PERSONNELTIMEWASTED INVENTORY COST INCREASED AND LOSSES 10/29/2024 6
  • 7. Basic principle of material handling 1.Short distance- Raw material used in the production process should only be moved over the shortest possible distances. Moving materials over excessive distances increases the possibility of delays, and adds to the labor costs if material is moved by hand. 2.Short terminal times- When material is being transported, the means of transportation should not have to spend time waiting on the material to be packed. Material should always be ready when transportation is available. 3.Two way payloads- The transportation mechanism for material should never be moved empty. It means return trip could be used. 10/29/2024 7
  • 8. 4.Avoid partial loads: It means partial use of total capacity of transportation system is a waste of time and energy. Therefore it should be avoided. 5.Avoid manual handling: The manual handling of raw materials is most expensive way of moving them. So, it should be avoided. 6.Move scrap cheaply: The movement of scrap material is a nonproductive function and scrap material should not be a primary work for a transportation system. Therefore scrap should be moved inexpensively as possible. 10/29/2024 8
  • 9. 7.Gravity is the cheapest power: The movement of material from top to bottom through multielevated facilities. 8.Move in a straight lines: The most efficient movement of material is along the straightest and most direct path to its destination. 9.Unit loads: Raw material should be delivered to their ultimate destinations in loads. It will eliminate need for excessive raw material to be handled at point of use and to be returned to the storage place. 10.Label Thoroughly: It eliminate improper raw material handling. Much time and effort is waste in correcting raw materials errors. 10/29/2024 9
  • 10. Factors affecting material- handling decisions: A no. of material handling system are available however use of material handling system depends on- ➢A manufacturing unit whether it is a Batch or Continuous process. ➢The type and quantity of product and physical appearance of raw material effect the material handling system. ➢The type of building 10/29/2024 10
  • 13. REASON FOR PROCESSING STEP COMBINATION OR ELIMINATION 1 . Improve the old process 2 . Produce high quality finished products 3 . Least handling of materials 4 . Some times involves no drying steps 5 . Fastest production of finished products 6 . Economical 7 . Reduce contamination 8 .Time and energy savings 10/29/2024 13
  • 14. Processing step combination or elimination 1. Raw material 2. weighing & measuring 3. screening 4. manual feeding 5. blending 6. wetting 7. Subdivision 8. drying 9. subdivision 10. premixing 11. batching & lubrication 12. manual feeding 13. compression 14. solvent film coating 15 tablet inspection 1. Raw material 2. weighing & measuring 3. gravity feeding 4.blending 5. gravity feeding from storage tank 6. Compression 7. aqueous coating Old tablet manufacturing process ( wet granulation) New tablet manufacturing process ( direct compression) 10/29/2024 14
  • 16. Unit operation improvement  There may be improvement in various unit operation which may constitute the overall manufacturing process.  Various processes may be: WET GRANULATION TABLETING COATING  These improve overall process 10/29/2024 16
  • 17. WET GRANULATION  It is a fundamental process.  To obtain reproducible granulations and minimize lot to lot variations traditionally amount of granulating solution added and total mixing time was considered  Recently more sophisticated techniques are used to investigate granulation process 10/29/2024 17
  • 18. THESE ARE:  INDIRECT METHODS ➢Power consumption ➢Torque ➢Rotation rate ➢Motor load analyzer • DIRECT METHODS ➢Beam deflection ➢Bending moment ➢Probe vibrational analysis 10/29/2024 18
  • 19. COMPUTER PROCESS CONTROL  Computer control of the process is now being used for the control of all processes  E.g.-automatic tablet counter 10/29/2024 19
  • 20. Tablet Production  Powders intended for compression into tablets must possess two essential properties ◦ Powder fluidity  The material can be transported through the hopper into the die  To produce tablets of a consistent weight  Powder flow can be improved mechanically by the use of vibrators, or by the incorporation of glidant 10/29/2024 20
  • 21. ◦Powder compressibility The property of forming a stable, intact compact mass when pressure is applied 10/29/2024 21
  • 22. Tableting Procedure Granulation and mixing Filling Compression Ejection 10/29/2024 22
  • 23.  Compression- reduction in bulk volume of material due to displacement of gaseous phase  Consolidation- increase in mechanical strength of material due to particle-2 interaction  Compaction- is compression & consolidation of 2 phases (solid & Gas) system due to applied force  Powder Compression- reduction in volume of powder owing to the application of force. Bonds are formed b/w the particles due to which compact mass is formed10/29/2024 23
  • 24. GRANULATION METHODS METHODS OF PREPARATIONS 1. Dry methods a. Direct Compression b. Granulation by compression 2. Wet methods a. Wet granulation b. Special procedures/related granulation processes 10/29/2024 24
  • 25. CHARACTERISTICS OF DI0SNA MIXER: ✓ The speed of mixing blades vary with the size of mixer. The tip speed is kept at 3-4/10 m/sec on low and 6-8/10 m/sec on high ✓ Chopper blade speed=1750- 3500 rpm, function as a lump and agglomerate reducer ✓The shape of particles produced by the diosna were more spherical ✓Complete mixing may be obtained in 30-60 sec. DIOSNA MIXER 10/29/2024 25
  • 26. CHARACTERISTICS OF GRAL MIXER/GRANULATOR: ➢Large scale mixing motion in the powder ➢Time control equipment ➢Explosion proof ➢Equipment available in 5 size ranges from 10-1200 lt. 10/29/2024 26 GRAL MIXER
  • 27. A no. of pharmaceutical manufacturers use this because: Drying efficiency high Easily cleaned Solvent vapors can be recovered Solvent vapor not discharged to the atmosphere DOUBLE CONE MIXER 27
  • 28. ADVANTAGE: Producing very uniform powder mixtures Not force to rely on vacuum for drying, but can use hot air. MODIFIED DAY – NAUTA MIXER: Effective way of producing drying with in the conical unit. DAY NAUTA MIXER 10/29/2024 28
  • 29. Tablet compression machines  Hopper for holding and feeding granulation to be compressed  Dies that define the size and shape of the tablet  Punches for compressing the granulation within the dies  Cam tracks for guiding the movement of the punches  Feeding mechanisms for moving granulation from the hopper into the dies 10/29/2024 29
  • 30. Single Punch Machine The compression is applied by the upper punch 10/29/2024 30
  • 31. Upper and Lower Collar Collar locker Single Punch Machine (Tablets) 10/29/2024 31
  • 34. Multi-station rotary presses  The head of the tablet machine that holds the upper punches, dies and lower punches in place rotates  As the head rotates, the punches are guided up and down by fixed cam tracks, which control the sequence of filling, compression and ejection.  The portions of the head that hold the upper and lower punches are called the upper an lower turrets 10/29/2024 34
  • 36.  The portion holding the dies is called the die table  The pull down cam (C) guides the lower punches to the bottom, allowing the dies to overfill  The punches then pass over a weight-control cam (E), which reduces the fill in the dies to the desired amount 10/29/2024 36
  • 37.  A swipe off blade (D) at the end of the feed frame removes the excess granulation and directs it around the turret and back into the front of the feed frame  The lower punches travel over the lower compression roll (F) while simultaneously the upper punches ride beneath the upper compression roll (G) 10/29/2024 37
  • 38.  The upper punches enter a fixed distance into the dies, while the lower punches are raised to squeeze and compact the granulation within the dies  After the moment of compression, the upper punches are withdrawn as they follow the upper punch raising cam (H)  The lower punches ride up the cam (I) which brings the tablets flush with or slightly above the surface of the dies 10/29/2024 38
  • 39.  The tablets strike a sweep off blade affixed to the front of the feed frame (A) and slide down a chute into a receptacle  At the same time, the lower punches re- enter the pull down cam (C) and the cycle is repeated 10/29/2024 39