Auditing of Granulation Operation in Dry Production Area..... This topic comes under Audits and Regulatory Compliance.... This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II.... This Presentation Contain following... #Objectives #Fundamentals of Granulation #Reasons for Granulation #Methods of Granulation #Agglomeration #Fundamentals and Audit of Dry Granulation #Steps in Dry Granulation #Fundamentals and Audit of Fluid Bed Granulation #Scale-Up of Fluid bed Granulation #High share granulation-Fundamentals, Audit and Scale-Up #Overview and Comparison of Different Granulating Techniques #Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling #Conclusion #References Thanks For Help and Guidance of Mr. D.P.Mali Sir

1. Auditing of Granulation Operation in
Dry Production Area
Prepared By:
Mr. Pritam P. Kolge
M-Pharmacy, First Year (Sem II)
Department of Pharmaceutical Quality
Assurance,
Bharati Vidyapeeth College Of Pharmacy,
Kolhapur.
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Guided By:
Mr. D. P. Mali
Assistant Professor
Department of Pharmaceutical
Quality Assurance

2. CONTENTS
➢Objectives
➢Fundamentals & Audit of Granulation
➢Fundamentals & Audit of Dry Granulation
➢Fundamentals & Audit of Fluidbed-Granulation
➢Scale-Up of Fluidbed Granulation
➢High Shear Granulation: Fundamentals, Audit and Scale-Up
➢Overview and comparison of the different granulation techniques
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3. OBJECTIVES
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➢Auditing of granules is one side verification activity, such as inspection or
examination of a process or quality system, to ensure compliance to requirements.
➢An Audit can be continue forward after granulation.
➢An Audit might be specific to a function, process or production step.

4. Fundamentals of granulation –
➢ Reasons for granulation
➢ Overview of the different granulation processes
➢ Impact of the single processes on the granulate properties.
➢ Understanding the mechanisms of agglomeration
➢ Characterization of Granules
➢ Excipients for Granulation & their impact on Product properties
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5. Reasons of Granulation
➢To avoid powder segregation.
➢To enhance the flow of powder.
➢To produce uniform mixtures.
➢To produce dust free formulations.
➢To eliminate poor content uniformity.
➢To improve compaction characteristics of mix.
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Methods of Granulation
➢Dry Granulation
➢Wet Granulation
➢Compression Granulation

6. Agglomeration
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➢Drug is blended with diluents and
powder
➢A small amount of water (1-4%) is
sprayed
➢Agglomerate formation (size 150–
500μm)

7. Fundamentals & Audit of Dry Granulation :
Dry granulation is gaining more and popularity in the pharmaceutical industry as it may
offer advantages like fast development and Scale-Up, usability in continuous
manufacturing operations and improved process control.
➢ Design aspects of a modern roller compactor
➢ Impact of process parameters like compaction force,
➢ gap, roll speed, roll surface, roll width and side seal system on ribbon properties
➢ Principles of densification: solid fraction as critical
➢ material attribute
➢ Scale-Up
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8. ➢Compaction of powder
-SLUGGING
-ROLLER
COMPACTION
➢Milling
-CHILSONATER
-HAMMER MILL
➢Screening
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Steps in Dry Granulation

9. Fundamentals & Audit of Fluid bed-Granulation :
➢ Design aspects and working principle of a modern fluid bed dryer
➢ Basic principle and advantages of fluid bed granulation
➢ Impact of process parameters on product properties
➢ Process insights: how to run, control and design the process
Scale-Up of Fluid bed Granulation :
➢ Fundamentals of Fluid bed Granulation (process & technology)
➢ Which process parameter influences which product quality attribute
➢ How to scale-up?
➢ Consequences for the critical quality attributes
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11. High Shear Granulation: Fundamentals, Audit and Scale-Up :
➢ Plant geometry and design
➢ Process parameters (degree of filling, torque-speed, humidity, time)
➢ Methods of drying
➢ Special Case: Single-Pot-Granulation
➢ Scale-Up: influence of impeller speed, dosing speed
Overview and comparison of the different granulation techniques :
➢ How to choose the right one?
➢ Which technique for which kind of product: viewpoint of development
➢ Which technique for which product portfolio: viewpoint of production
➢ Comparison of direct and indirect cost: viewpoint of Management
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12. Rapid Mixer/High shear Granulator
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Mixing or Blending
• Mixing and Blending technique
• Mixing and blending speed
• Mixing and blending time
• Drug uniformity
• Excipient uniformity
• Euipment capacity/load
Wet granulation
• Binder adiition
• Binder concentration
• Amount of binder solution/granulating
solvent
• Binder solution/granulating solvent addition
• Mixing time
• Granulation end point
Wet milling
• Equipment size and capacity
• Screen size
• Mill speed
• Feed rate
Drying
• Inlet/Output
• Airflow
• Moisture uniformity
• Equipment capability/capacity
Milling
• Mill type
• Screen size
• Mill speed
• Feed rate
Audits of

14. Conclusion
➢Audits are carried out for rechecking of the processes and it helps in
building the quality of product and the processes of Granulation are very
important with respect to tablet dosage form.
➢Certain characteristics of both these processes are taken into consideration
when it comes to the audit of granulation.
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15. REFERENCES
➢ K. Pranitha, N. Vishal Gupta, Shanawaz Anis, T. M. Pramod Kumar, K.
Vaishnavi, Guide to Inspections of Tablet Manufacturing Facilities
including pre/post approval issues as per USFDA , International Journal
of Pharma-Tech Research, Jan.-Mar. 2012, Vol.4, No.1 : 49-55.
➢ Slideshare
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