1. Topic:- Process Automation in Pharmaceutical Industry with
specific reference to Tablets & Coated products
Subject Name :- Pharmaceutical Manufacturing Technology
Subject Code:- MQA204T
Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
Presented by:-
Machhi Dhruvi A.
2nd sem M.Pharm.
2. CONTENTS
• Introduction
• Automation in pharmaceutical industry
• Classification of industrial & laboratory automation
• Advantages
• Disadvantages
• Process automation in tablet production
• Example of material handling improvement
• Processing step elimination or combination
• Rotary tablet press
• Tableting improvements
• Questions
• References
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3. INTRODUCTION
• Automation means the use of machine & equipment for performing physical &
system operations in a production process in place of human being.
Automation or labour-saving technology is the technology by which a process or
procedure is performed with minimal human assistance.
It is a system of doing work where material handling, production process & product
designs are integrated through mechanism of thoughts and efforts to achieve a set
regulating & controlling system.
It is a result of Industrialization, driven by the need to increase productivity as well
as to achieve consistent quality products.
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4. It can be done at various levels of manufacturing systems such as;
Handling of raw materials
Handling of Semi-finished goods or finished goods
During production process (uses efficient machinery)
In inspection and
Quality control operations.
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5. AUTOMATION IN PHARMACEUTICAL INDUSTRY
Basic purpose of Automation in Manufacturing industry is:
1. To increase Productivity
2. Improve quality of products & to reduce waste
3. To reduce the costs.
4. For safe handling of Hazardous substances.
5. To take heavy work from workers.
Regulation is a major consideration for Automation as it ensures compliance with
safety considerations & guidelines. For ex., cGMP, OSHA, EPA
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6. CLASSIFICATION OF INDUSTRIAL & LABORATORY
AUTOMATION
1. Process Automation:
• It deals mainly with handling of raw materials in forms such as liquids or powders.
• E.g., In oil refinery as well as in oil, gas & chemical industries
2. Discrete Automation:
• It essentially deals with assembly of parts requiring high level of mechanical motion
to produce consumer electronics products & products for the automotive industries.
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7. Pharmaceutical industry is hybrid of both, Process & Discrete manufacturing:
Process Automation system applies in the Primary manufacturing of API (Active
Pharmaceutical Ingredients)
Both Process & Discrete automation are applied in the secondary manufacturing of
formulation & packaging (i.e. in compounding, filling, washing & packing)
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8. ADVANTAGES
1. It provides better quality of goods & services.
2. It minimizes the total cost & labour cost.
3. It provides effective control in operation.
4. Greater accuracy
5. More output
6. Greater speed can be induced.
7. It can improve the working conditions.
8. Safety of workers is improved.
9. Reduce the wastage
10. The quality of product improves as human inputs are minimized.
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9. DISADVANTAGES
1. Huge capital investment is required.
2. The maintenance cost is very high because maintenance labour of high calibre is
required.
3. It can create unemployment.
4. Continuous power supply is required.
5. Large inventories are required.
6. Any breakdown, anywhere lead to the complete shutdown.
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10. PROCESS AUTOMATION IN TABLET PRODUCTION
Benefits of automation in Tablet production:
1. Improve material handling.
2. Improve specific unit operation.
3. Eliminate or combine processing steps.
4. Incorporate automated process control of unit operation & processes
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11. EXAMPLE OF MATERIAL HANDLING IMPROVEMENT
• Granulation & tableting sections of the computer controlled tablet manufacturing
process by Merck Sharp & Dohme (MSD) & Eli lily and company.
• There is virtually no human handling of materials during or between processing steps.
• The system is built in 3 story building which incorporate vertical drops to utilize
gravity whenever possible and uses pumps, vacuum, bucket, conveyors to move
material upward whenever necessary.
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13. PROCESSING STEP ELIMINATION
OR COMBINATION
• The design of a new production facility should attempt to
improve the old process by eliminating or combining certain
processing unit operations.
• This could take the form of simply eliminating tasks that are no
longer necessary or by the utilization of new pieces of equipment
that can perform more than one of the unit operations required
under the old processing system.
e.g., Dionsa mixer & Granulator: High Shear powder mixer &
processor
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14. Standard processing steps in the 1960s & before:
• Wet granulation was a highly labour-intensive & time-consuming process.
• Two separate mixing devices were used for the dry solids blending and for wet
massing, with a manual transfer step in between.
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Compression
Weighed
Ingredients
Load
mixer Mix, mass &
Agglomerate
ingredients
High shear mixer
Transfer
Drying
Fluidized bed dryer
Transfer
Lubricate Drum
(Store)
Transfer
Transfer
15. Standard processing steps in the 1980s:
• The number of transfer steps has been reduced to three or four,
• the manual handling of the batch material has been greatly reduced and
• the time of granulation manufacture has been cut from 2 days with an overnight
drying step as a few hours.
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Weigh
Ingredients
Load
processor Mix, mass,
Agglomerate,
dry & lubricate
Transfer
(store)
Compress
17. • New equipment is now being developed and gradually adapted by the pharmaceutical
industry which handles all of the steps in granulation preparation in one piece of
equipment.
• Not only handling of materials are reduced by the newer equipment used in the wet-
granulation operation, but the new process equipment is also capable of producing
granulation materials.
Continuous-batch Powder Mixing & Massing Equipment:
1. Littleford Lodige mixer
2. Diosna mixer & granulator
Granulators:
1. Fluid-Bed Spray Granulators
2. Double-Cone & Twin-Shell Blenders
3. Day-Nauta Mixer & Processor
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18. ROTARY TABLET PRESS
• It involves use of computer technology.
• Using a microprocessor, the pharma control units
corrects automatically weight variation, monitor the
mean & individual tablets values, control & discard
faulty tablets & may include a quick stop controls
that is put into operation when certain tolerances
arc exceeded .
• This system also
monitor optimal speed,
help to optimize tool use,
evaluating tableting data,
record errors and
conduct statistical evaluation during the run.
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19. TABLETING IMPROVEMENT
Thomas Tablet Sentinel (TTS):
• It is an automatically controlled tablet production unit with an online control &
monitoring of tablet weight.
• This unit utilizes commonly available strain gage technology.
• Strain gage placed on a tablet machine will monitor the strain that is incurred during
the compression step on the machine.
• The amount of pressure or compression force developed at each station is dependent
upon the amount of powder that was contained in each corresponding die.
• Measurement of this compression force is thus an indirect method of monitoring the
tablet weight.
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20. Latest monitoring system TTS II:
• The weight control system of TTS-Il is equipped with an audible signal to alert the
operator when a machine drift out of present limits, as well as automatic press
shutdown after a chosen number of rejected tablet have been observed by the system.
TTS III:
• have advanced sampling & microprocessor technology.
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21. QUESTIONS
• Write a short note on process automation in manufacturing of Tablets.
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22. REFERENCES
1. https://slideplayer.com/amp/13764974/
2. Lachman Leon and Schwartz B. Joseph, Pharmaceutical Dosage Forms:
Tablets, Vol 3, 2e, 1-74.
3. https://www.slideshare.net/souravmainan/300114-45188341
4. https://youtu.be/cMZSpc493KA
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