process automation in pharmaceutical industry Small volume parentrals

1. MAHATMA GANDHI VIDYAMANDIR’S
PHARMACY COLLEGE, PANCHAVATI, NASHIK 422003
Sub:Pharmaceutical Manufacturing Technology
A PRESENTATION ON
Process Automation In Pharmaceutical
Industry (Small Volume Parentral)
Presented By:
Suryawanshi Kunal Anil

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VISION:
 To be a centre of professional excellence by contributing honestly to
the pharmacist moulding process.
MISSION:
 Impart high quality education to graduates
 Contribute to all spheres to professional activities
 Uphold human values and ethics
 Nature them into globally competent professional

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 Introduction:
 What is automation?
 Means the use of machines and equipment for performing
physical and mental operations in a production process in place of
human beings
 Automation is the use of machines to complete the majority of
repeatable and significant tasks in the pharmaceutical industry.

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 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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 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.

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 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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 ADVANTAGES:
 It provides better quality of goods and service.
 It minimizes the total cost in direct labor cost.
 Greater accuracy, more output and greater speed are induced.
 It can improve a better working conditions.
 Safety of workers is improved.
 Minimal Wastage in done.

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 DISADVANTAGES:
 Huge Capital investment is required.
 The maintenance cost is very high because maintenance labor
of high caliber is required.
 It can create unemployment.
 Continuous power supply is required.
 Large inventories are required.

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 PARENTERAL DOSAGE FORM:
 Parenteral dosage forms are sterile pyrogen free preparations
intended for administration by the injection under or through one
or more layers of skin or mucous membrane.
 There are mainly two types of parenteral dosage form:
A. Small Volume Parenterals (SVP):-
B. Large volume parenterals (LVP):-

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A) SMALL VOLUME PARENTERALS(SVP)
 These are usually ranges from 1 to 30 ml in volume i.e. Less than
100 ml in volume.
 Mostly given as multiple doses.
 Different types of small volume parenterals are
 E.g. Ampoules,
Vials, Dry powder, Prefilled syringes.

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B) LARGE VOLUME PARENTERALS (LVP)
 These are supplied for single dose having more than 100 ml.
 These are delivered through IV route.
 These generally provide electrolytes, nutrition to the body.
 E.g. Normal saline

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PROCESS AUTOMATION IN STERILE MANUFACTURING
1. Advanced Cleanroom Technology - Barrier Systems -
• Conventional Clean Room
• Restricted Access Barrier System
• Isolator
2. Robotic Systems
3. Ready to use Technology (RTU)

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 Conventional Clean Room
 Conventional Clean Room (CCR)
 ISO 5 (class A) surrounded by ISO 7 (class B) room
 Pressure difference (15 Pa) between the clean room classes
 Critical operations with open sensitive products are carried out
under Unidirectional Airflow (class A protection)
 Manipulations (i.e. trouble shooting, change of format parts) are
done directly by opening of the machine cladding

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 Operator gets directly in contact with critical surfaces (class A area)
 Gowning of the operator according to class B requirements
 Material transition to class B (autoclave, pass box, dry heat oven)
 Regular wipe sanitization
 Heavy routine viable monitoring
 Periodical room sanitization
 Machine parts pre-sterilized or disinfected in situ

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 Restricted Access Barrier System (RABS)
 Surrounding clean room class B for the filling operation
 Pressure difference (15 Pa) between the clean room classes
 All manipulations during production are done via gloves of the RABS
 Ergonomic designed system for the process inside (Mock-up studies)
 Transfer of format parts via Rapid Transfer Port (RTP)

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 Material transfer via Rapid Transfer Port (RTP) or material locks
 Gowning of the operator according class B requirements
 Conventional cleaning and disinfection
 Same viable monitoring as CCR
 Locked doors (barrier) during operation
 The system isolates the operator from the critical areas to increase
Sterility Assurance Level (SAL)

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 Isolators
 ISO 5 (class A) inside isolator
 Surrounding clean room ISO 8 (class D or C) for the filling
operation
 Positive pressure difference towards the filling room
 Ergonomic designed system for the process inside (Mock-up studies)
 Complete closed system with Vaporized Hydrogen Peroxide (VHP)
decontamination of all surfaces

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 Complete independent HVAC-unit
 All manipulations during production are done via gloves
 Gowning of the operator according class C or D requirements
 Material transfer via Rapid Transfer Port (RTP) or material locks
 Area to be monitored is very limited
 Very high SAL

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 Robot / Handling systems
 More and more "semi-automatic" systems, but human intervention
are still necessary or possible
 Robotic systems are necessary for Advanced Aseptic Systems
 Robots works better and more efficient
 Individual positive transport
 Avoidance of glass to glass contact
 Minimizing rejects and glass breakage rate and very flexible

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 References:
1) https://www.slideshare.net/DanishSayyad1/process-automation-
with-respect-to-sterile-products?next_slideshowtrue.
2) https://www.slideshare.net/ShalakaDhikale/process-automation-in-
pharmaceutical-industrypptx

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