The document is a presentation on process automation in the pharmaceutical industry submitted for a Master's program. It discusses how automation technologies help enhance productivity in pharmaceutical development and manufacturing. The presentation covers various pharmaceutical manufacturing processes like mixing, milling, granulation and hot melt extrusion. It also describes common equipment used like fluid bed dryers and tablet compression machines. Benefits of automation include improved productivity and safety. A case study on automating a generic injectable drug manufacturing process is also summarized.

1. M. Pharm Sem -II Presentations
PROCESS AUTOMATION IN PHARMACEUTICAL INDUSTRY
SUBMITTED TO
SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF
MASTER OF PHARMACY
IN THE SUBJECT
Pharmaceutical Manufacturing Technology
IN THE FACULTY OF SCIENCE AND TECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year- 2021-22 1
Presented By-
Shalaka Shashikant Dhikale
( Roll No. 3)
Guided By-
Dr. S. P. Ahirrao

2. OBJECTIVE
 By streamlining the procedures, automation technologies aid
in enhancing the productivity of pharmaceutical development
and manufacture.
 Robots can easily complete repetitive operations like filling
and packing at a higher precision and speed than human
labor, which increases productivity.
 With automation in place, pharmacies can now spend less on
hiring and training employees while also reducing workplace
manual errors. Automated systems operate with a better level
of regulation and efficacy than people, whether it be when
labeling, distributing medication, or performing any other
daily task.
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3. INTRODUCTION
 What is automation ?
• Automation is the use of machines to complete the majority
of repeatable and significant tasks in the pharmaceutical
industry.
• There has been a faster rate of industry development, and the
pharmaceutical sectors are no exception.
• A process automation or automation system(PAS) is used to
autonomously control a process in places like chemical plants,
oil refineries, and industries that make paper and pulp.
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4. PHARMACEUTICAL MANUFACTURING
PROCESSES
 Pharmaceutical manufacturing, a component of the
pharmaceutical business, is the process of synthesizing
pharmaceutical medications on an industrial scale.
 A number of unit operations, including milling, granulation,
coating, tablet pressing, and others, can be used to breakdown the
drug production process into its component parts.
1) Development of formulations and pre-formulations
2) Feeding of powder during continuous production
3) Mixing of powders
4) Milling
5) Granulation
6) Hot melt extrusion
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5. 1) Development of
formulations and pre-
formulations
2) Feeding of powder during
continuous production
3) Mixing of powders
Pre-formulation studies are
a crucial step in the drug
development process
because they give the
formulation development
process a solid scientific
foundation.
 Since feeding is frequently
the first unit operation in a
process line for powder
based continuous processes,
it is essential to feed powders
consistently and properly
into succeeding unit
operations.
In order to achieve
performance dependability,
feed rate accuracy and
minimal disruptions, feeders
have been devised.
Overall process stability is
ensured by accurate and
reliable material delivery
made possible by feeders
with sound design.
The active pharmaceutical
component may be
combined with a variety of
excipients in the
pharmaceutical business to
produce the final blend that
is used to make the solid
dosage form.
To obtain the desired
product quality features, a
number of variables
presented by the variety of
components that may be
mixed (excipients, API) must
be taken into consideration.
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6. 4) Milling 5) Granulation 6) Hot melt extrusion
To decrease the average
particle size in a drug
powder, milling Is frequently
necessary during the
medication production
process.
This is due to a variety of
factors, such as improved
homogeneity and dosage
consistency, improved
bioavailability, and improved
solubility of the medicinal
ingredients.
 It is the method through
which smaller particles are
joined to create granules,
which are larger particles.
Granulation is employed for
several purposes.
Granulation enhances the
flow characteristics of
powders and the compaction
properties for tablet
formation by producing a
granule that contains all of
the components in the
mixture in the proper
proportions
It also prevents “demixing”
of the components in the
mixture. Wet and dry
granulation are the two
different types of
granulation.
In pharmaceutical solid oral
dosage manufacturing, hot
melt extrusion is used to
deliver medications with low
solubility and bioavailability.
Poorly soluble
pharmaceuticals can be
molecularly dispersed in a
polymer carrier, enhancing
the bioavailability and
dissolving rates.
Heat, pressure and agitation
are used in the procedure to
combine the components
and “extrude” them through
a die.
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7. PHARMACEUTICAL PROCESSING
EQUIPMENT
 Equipment for pharmaceutical processing and packaging is utilised
for a variety of tasks, including filling, counting and labeling as well
as processing tasks like blending, mixing, granulating, milling,
cleaning and sterilizing.
 Automation is the employment of tools and machinery in lieu of
people to carry out physical and mental tasks during the production
process.
 There are several different types of equipment for distinct unit
processes in pharmaceutical production, including;
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FLUID BED DRYERS HOT MELT EXTRUDER
PHARM. MILL ( CONICAL MILL) TABLET COMPRESSION MACHINE

9.  ADVANTAGES:
 Better productivity and higher production rates.
 Effective utilisation of resources.
 Better grade goods.
 Increased safety.
 Shorter labour week lengths.
 DISADVANTAGES:
 Large capital expenses.
 Higher standard of upkeep.
 Lower level of adaptability.
 Situations of workplace emotional stress.
 Relocation of workers in search of employment.
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10. PHARMACEUTICAL MANUFACTURING OF
STERILE SEMISOLIDS
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OINTMENT HYDROPHILIC OINTMENT CREAMS
GELS PASTES POULTICES

11. UNIT OPERATION OF SEMI SOLIDS SYSTEM
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Tank filled agitator for mixing of liquids
Tumble blender for mixing of solids and
semisolids
Hammer mill for milling and
size reduction of solid and
semisolids.

12. PARENTERAL DOSAGE FORM
 A sterile medication dosage that is appropriate for injection
administration is known as a parenteral dosage.
 A parenteral dosage type is typically administered
subcutaneously, intramuscularly, or intravenously.
 The most common parenteral dose forms are two:
 Small volume parenterals
 Large volume parenterals
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PARAMETERS SMALL VOLUME PARENTERALS LARGE VOLUME PARENTERALS
VOLUME 100 ml 101-1000 ml
ROUTE IV, IM, SC IV
DOSAGE UNIT Single/ Multiple Multiple
PRESERVATIVE Used Not used
BUFFER Used Not used
ISOTONICITY Not essential Must
PYROGENICITY Not essential Must
FORMULATION Solution, emulsion, suspension O/W Emulsion
USES As therapeutic agent, As
diagnostic agent
As nutrition, detoxification, aid
during surgery

14. CONTROL TESTS FOR SVPs & LVPs
 Clarity Test :
 The USP has set a limit of NMT 50 particles at 10µm and
NMT 5 particles at 25µm/ ml for LVPs.
 Limit for SVPs are NMT 10,000 particles of 10 µm & NMT
1000 of 25 µm.
 Additionally, visual evaluation is carried out in bright light
with a dark background.
 Pyrogen Test :
 After an intravenous injection of a sterile solution of the
substance under investigation, the body temperature of a rabbit
is measured as part of the test.
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15.  Sterility Test :
 The purpose of the sterility test is to find any live
microorganisms in pharmaceutical preparations that are
intended to be sterile.
 There are two approaches:
 Membrane filtration method
 Direct inoculation
 Bacterial Endotoxin Test :
 Lysate obtained from the hemolymph cells and ameobocytes
of the horseshoe crab, Limulus polyphemus, is used to quantify
the concentration of bacterial endotoxin that may be present in
the sample to which the test is applied. Turbidity, precipitation,
and gelation of the mixture are produced when endotoxin-
containing solution is added to the Lysate solution.
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16. CLEANING IN PLACE (CIP)
 CIP is automated cleaning technique that uses spray equipment
to apply cleaning solution to every surface of the process
vessel.
 In general, CIP is made to clean with aqueous cleaning agents.
The spray devices, CIP unit, and related piping to transport
cleaning solutions to and from the equipment to be cleaned are
the main components of a CIP unit.
 Following distribution throughout the vessel, the cleaning
solution cascades across the bottom of the process vessel and
down its sides.
 Discharge either goes to a holding tank or a waste
management facility immediately.
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17. CIP Cleaning system for pharmaceutical
industry
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18. CASE STUDY
 BACKGROUND
 A pharmaceutical company sought to complete the
manufacturing of a brand new generic medicinal medication.
 In order to control, record, and report on their world class
process, they intended to add a cutting edge, powerful,
extensible, and supportable automation system as part of their
endeavour.
 Malisko engineering has been tasked with helping them with
the stipulation, design, procurement, documentation,
programming, testing, commissioning, and validation of their
new system for process control, data and reporting.
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19.  OBJECTIVE
 Converting a modest, manual batch process used in research &
development for a generic injectable medicine into a massive, top-
notch automated process.
 CHALLENGES
 It was very challenging to concentrate on the specifics of the
automation system at first because the process design was still at
the “preliminary phase”, at best.
 Process, CIP, sequences must be kept consistent in order to preserve
sterility and the appropriate level of product quality.
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20.  RESULT
 Successfully completed and tested water batch trials
 Performing further water tests and enhancing CIP cycles
 Creating batches with inert chemicals and no active components to
duplicate the product in a testing setting (placebo batches)
 Monitoring across the control and process system has met client
requirements.
 Budget and schedule for the client’s project were met.
 The client is pleased with the project’s progress and level of
success.
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21. CONCLUSION
 Despite the fact that the business has historically been based
mostly on human processes, the pharmaceutical industry in India is
progressively adopting automated technologies.
 To be competitive in a linked world, it is now implementing new
automated operational technology (OT) and information
technology (IT).
 Automation would theoretically offer several benefits to the
pharmaceutical sectors, including increased productivity for
technologists, lower radiation exposure, and improved overall
image quality. The effectiveness of the QA department will
increase with the development of computer based QA algorithms
to identify and quantify QA defects, QA information extraction to
develop global QA norms, and organized databases.
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22. REFERENCE
 https://www.pharmaceutical-technology.com/buyers-
guide/pharmaceutical-packaging-equipment/
 Impact of Automation in Pharmaceutical Industry on Roles and
Responsibilities of Quality Assurance: A Review; Thomas George
Palamattathkuttiyil, Hemanth Kumar Somareddy, Shailesh
Thirumaleshwar, Mysore Prakash Gowrav; Department of
Pharmaceutics (Pharmaceutical Quality Assurance), JSS College of
Pharmacy, JSS Academy of Higher Education and Research, Sri
Shivarathreeshwara Nagara, Mysuru-570015, India
 https://en.wikipedia.org/wiki/Pharmaceutical_manufacturing
 https://www.leeind.com/industries/pharmaceutical-processing-
equipment
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23. REFERENCE
 Semi solid dosage forms manufacturing: tools, critical process
parameters, strategies, optimization and recent advances; Md.
Amman Maqbool*, Manoj Kumar Mishra, Supriya Pathak, Adarsh
Kesharwani, Anuradha Kesharwani; Indo American Journal of
Pharmaceutical Research, Vol 7, Issue 11, 2017.
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