Single Pot Processor

Single Pot Processor
Principle, benefits and Characteristics
Girish S Sonar
Cipla Ltd.,
Pharma R&D
Vikhroli (W), Mumbai
Date: 19.03.2013

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.

• What is ‘Single Pot Processor’?
• SPP Vs RMG
• Design features and Benefits
• Application
• Working Principle
• Case Study
• Post-approval changes
Outline

• RMG Vs SPP
• Application
• Case Study
Outline

• 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’

SPP = RMG + FBE + Mill
SPP = RMG FBE Mill
=

• SPP Vs RMG
• Application
• Case Study

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

• RMG Vs SPP
• Application
• Case Study

 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)

 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)

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

‘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

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

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.

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)

Schematic Diagram of Technical Area

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

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

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

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

Predetermined Targets:
 Control the reaction
 Max yield
 Efficient drying

33

Is it ‘scalable process’?
25L 600L/1200L

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

Thanks for attention !
Any Question ?
Girish S Sonar
Cipla Ltd.,
Pharma R&D
Vikhroli (W), Mumbai

Single Pot Processor

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