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Single Pot Processor
1. Single Pot Processor
Principle, benefits and Characteristics
Girish S Sonar
Cipla Ltd.,
Pharma R&D
Vikhroli (W), Mumbai
Date: 19.03.2013
2. Disclaimer
All material on this presentation, including text and
images, is of presenter's opinion only and does not
represent that of any vendor or promoting any
machine/equipment nor employee's view.
3. • What is ‘Single Pot Processor’?
• SPP Vs RMG
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
Outline
4. • What is ‘Single Pot Processor’?
• RMG Vs SPP
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
Outline
5. • A high-shear-mixer-granulator-dryer, combining
the steps of mixing, granulation and drying in oral
solid dosage form production
• Thus, single pot processing (SPP) is the
production of pharmaceutical granules using a
wet granulation process in which dry mixing,
liquid addition, wet granulation, drying and sizing
of the granules is done in one machine.
What is ‘Single Pot Processor’
7. • What is ‘Single Pot Processor’?
• SPP Vs RMG
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
8. SPP Vs RMG
Features SPP RMG
Function Granulation + Drying +
Milling + Blending
Granulation
Jacket temp Specific control No specific
control available
Impeller position Top driven At Bottom
Alignment Tilt up to 70° Fix
Binder addition
mechanism
Pressure difference/
peristaltic pump
Peristaltic pump
Drying
mechanism
Combination of heating,
tilting the bowl, vacuum,
microwaves, Transflow
No drying
9. • What is ‘Single Pot Processor’?
• RMG Vs SPP
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
10. Flexibility:
Single Pot Processing: mixing, granulation and drying in
1 machine - number of material handling steps is
decreased
Drying technique : Vacuum-drying, microwaves,
Transflow and swinging bowl – improvement of the
granule characteristics and a reduction in drying time
Explosion proof design
Containment:
Perfect GMP-design, easy to clean, CIP system
Dust-free loading
Design features and Benefits (1)
11. Swinging Bowl: better granulate quality and faster drying
User friendly: operator-machine interaction (Video
monitoring)
Top driven mixer and chopper: easy cleaning, GMP
accepted
Process parameters are independent of atmospheric
conditions
High yield
Reduced use of cleaning liquids
Solvent recovery systems
Change over in less than 2 hours
Compact technology – reduce space requirement
Design features and Benefits (2)
12. • What is ‘Single Pot Processor’?
• RMG Vs SPP
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
13. 1. Wet granulation - Water based, solvent based
2. Vacuum drying
3. Effervescent products – to control fusion
reaction
4. Oncology drugs, hormonal products or highly
potent compounds- special care require to
avoid exposure of the operators
5. Hot melt granulation
6. Pelletizing
7. Coating
Application
14. • What is ‘Single Pot Processor’?
• RMG Vs SPP
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
15. ‘Top Driven’ advantage
Shaft seals are not in direct contact with the
product : No risk for cross contamination
Easy to clean and inspect : full accessibility
with open bowl
No need for hoist to remove the impeller
blade
17. Granulation endpoint determination
NIR and FBRM (Focused Beam Reflectance Measurement) :
Measurement of moisture content, homogeneity of the
mix and particle distribution
Visual observation through camera
Torque measurement of Impeller and Chopper
19. Vacuum Drying - Principle
• The boiling point of liquids is lower at lower pressures
• By applying vacuum in the bowl, the boiling point of the granulation
liquid used is significantly decreased.
20. Characteristics of Vacuum Drying System
• Highly efficient vacuum system (roots bower + Vacuum pump)
• Energy supply through heated jacket of lid and bowl
• Liquid recovery unit ( 1 or 2 condensers)
23. Microwave Drying - Advantage
• Energy supply independent from
vessel wall; wall temperature can
be controlled in order to avoid
caking
• No risk of wet lumps (drying inside
to outside)
• Significantly reduced drying time
• Scale up of drying time is linear
(linear to installed μ-wave power) ;
similar drying time small and large
batch size
27. SPP – Containment
Buck Valve/ Hicoflex technology for loading and discharging
Isolated boxes for higher toxic compounds
Contained sampling valve
Oxygen sensor provided to ensure the level is below the explosion
limits
Oxygen replaced by Nitrogen gas in a automatic cycle
Buck Valve Hicoflex Valve Oxygen Sensor Isolated Box
28. Cleaning system (1)
• Through the wall design, small
area to clean
• Numerous improvements to
avoid gaps and dead space
inside the bowl in order to
make WIP/CIP easier
• No permanent cabling and
piping around the machine
30. • What is ‘Single Pot Processor’?
• RMG Vs SPP
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
31. Case Study : Effervescent Product (1)
Ingredient Qty/batch (in Kg)
Active 45.00
Anhydrous Acid 115.50
Alkali 98.30
Binder 4.50
Sweetner 0.45
Purified water 1.60
C6H8O7 + 3 NaHCO3 Na3C6H5O7 + 3 H2O + 3 CO2 + Heat
Citric acid Sodium bicarbonate Sodium Citrate
35. • What is ‘Single Pot Processor’?
• RMG Vs SPP
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
36. Post approval changes (SUPAC):
Manufacturing Equipment Changes
Level Definition Existing process Changed
process
Filing
Documentation
I 1. Change from non automated or non
mechanical equipment to automated
or mechanical equipment to move
ingredients and
2. Change to alternative equipment of
the same design and operating
principles of the same or of a different
capacity.
Granulation:
RMG
Drying: Tray
dryer
Granulation:
SPP
Drying: SPP
Annual report
II Change in equipment to a different
design and different operating
principles.
Granulation:
RMG
Drying: FBE
Granulation:
SPP
Drying: SPP
Prior approval
supplement with
justification for
change
Ref: SUPAC-IR: Immediate Release Solid Oral Dosage Forms, November 1995
SUPAC-MR: Modified Release Solid Oral Dosage Forms, September 1997
http://www.gea-ps.com/npsportal/cmsdoc.nsf/WebDoc/webb8eta36
37. Thanks for attention !
Any Question ?
Girish S Sonar
Cipla Ltd.,
Pharma R&D
Vikhroli (W), Mumbai