2.presentazione Funaro IMA-BASF Spain

Bombos no perforados y perforados
Tecnologas de recubrimiento IMA
CATERINA FUNARO - PROCESS LABORATORY MANAGER
SOLID DOSE SOLUTIONS
Introduction to coating process

There was a time
Introduction to coating process

There was a time
GS Solid Wall Pan
Coating goals
NON FUNCTIONAL COATINGS
Coloring for better identification or
marketing
Taste or smell masking
Better compliance of patients
Decrease operators exposure to API dust
Better printing of tablets when required
Tablets smoothing, packaging improvement
Faster transit in the esophagus
FUNCTIONAL COATINGS:
Protection against moisture, humidity, oxidation
pH dependent release coatings
Time dependent release coatings
GS solid wall pan
THE DRUM:
Gentle mixing
No perforations
Smooth surface
6 welded mixing baffles
Powder coating is possible
Cores up to 0,5 mm can be worked
GS solid wall pan
Film coating
Pellet film coating
Sugar coating
Powder layering
GS solid wall pan

11
IN
OUT
1.
2.
3.
4.
5.
6.
7.
12 13
4
3
5
Product tank
Dosing unit
Sliding guns
Coating pan
Tablet temperature control
Inlet and outlet air device
Sugar coating spraying guns
6
14
8
8.
9.
10.
11.
12.
13.
14.
10
Electro pneumatic panel

Heating unit
Dust collector
Outlet air fan
Film spraying guns
Air-exhausting paddle system
Sliding system to move backwards
GS Pilot scale
GS 10 litres
GS 3 litres
GS 25 litres
GS production scale
70 Litres
150 Litres
300 Litres
450 Litres
600 Litres
700 Litres
1200 Litres
PERFIMA
800
PERFIMA
500
PERFIMA
200
10
GS solid wall pan

Paddles perforation always covered by the product during the process.
Standard paddles:
Up to 50% of maximum pan capacity
Special paddles with reduced perforated area:
Up to 30% of maximum pan capacity
11
GS solid wall pan

Case history - GS300 L / film coating:
Batch size:
80 kg = 100 L of tablets
Tablet density= 0,8 g/ml
Diameter 6,7 mm
Height 2,7 mm
2 Schlick guns
Inlet air: 1000 m3/h
Spray rate: 100-180 g/min
Pan speed 10 rpm
PT100 probe always immersed
Holes covered immediately after
spraying
12
IMA guns for film coating

Nozzle control needle
Nozzle
Regulator
13
IMA guns for film coating
AIRCAPN
AIR CAP
GOCCE
DROPS
VENTAGLIO
ANGLE
44
11
7
7
14
Schlick guns for film coating

IMA installation
ABC Schlick S45
PCA harm
15
Ideal spray shape

2
16
Schlick guns - ideal spray shape

PRODUCTION NOZZLE Mod. 930 S 35
Spray rate
(gr/min)
Nozzle
(mm)
AA
(bar)
PA
(bar)
Bed distance
(cm)
Spray width
(cm)
50
1,2
1,5
1,5
20
14
100
1,2
2,0
1,5
20
17
150
1,5
2,0
1,5
20
18
LABCOAT NOZZLE Mod. 970 S 75

Spray rate
(gr/min)
Nozzle
(mm)
AA
(bar)
PA
(bar)
Bed distance
(cm)
Spray width
(cm)
10
1,0
0,7
1,0
10
10
30
1,2
1,5
1,5
10
30
1,2
1,5
1,5
20
11
50
1,2
2,0
2,0
10
11
50
1,2
2,0
2,0
20
15
17
Schlick guns - ideal spray shape
Schlick Gun production S35 and

Labcoat S75
Nozzle diameter:
1,2 mm and 1,5 mm
AA = atomisation air (bar)
PA = pattern air (bar)
18
Spray guns position
Spray angle > 90 and oriented in

the mixing zone to spray on the
cores without disturbing their
movement and guarantee
uniformity of coating distribution.
19
In line spray control
Via Flowmeter
Via Scale
From the HMI it is possible to

READ the spray in g/min or
CONTROL the % of the total
spray in each phase.
In the recipe the spray can be set
as a range (MIN-MAX) and the
system automatically adjust the
spray depending on tablets T.
20
Sugar coating
RECIRCULATION
LINE
GUN & NOZZLE
SURGE CHAMBER
PUMP
PAN
RECIRCULATION
VALVE
LIQUID
CONTAINER
21
Sugar coating pump & surge chamber
ATTENZIONE: ALTA PRESSIONE!
ATTENTION: HAUTE PRESSURE!
EN CAS DE ENGORGEMENT, AVANT D'INTERVENIR OUVRIR LA VALVE DE SRETE'
WARNING: HIGH PRESSURE!
IN CASE OF CLOGGING, OPEN THE SAFETY VALVE BEFORE INTERVENTION
IN CASO DI INTASAMENTO, APRIRE LA VALVOLA DI SICUREZZA PRIMA DI INTERVENIRE
safety
ACHTUNG: HOCHDRUCK!
IN VERSTOPFUNGSFALL, FFNEN DIE SICHERHEITSVENTIL BEVOR INTERVENIEREN
out
"OUT"
"IN"
in
250
bar
0
CHIUSO
APERTO
drain
22
Sugar coating gun and nozzle

Example of nozzle code
standard
nozzle
163 . 835
Nozzle diameter
(0.035 x 25.4=0.89 mm)
fan opening angle 80

(max 90)
23
Factors influencing the sugar dosing

Spray time
Surge chamber pressure
Spray pressure
Recirculation valve sealing efficiency
Nozzle diameter
Syrup concentration and temperature
COATING PARAMETERS (150 kg batch)
m.u.
Value
Inlet air T
70-65-55-40
Core T (END OF DRYING)
383430
m3/ h
1500 1300
Pa
-20
Pan speed
rpm
4 10 - 12
Spray time
sec
10 - 30 - 45
Pause time
min
2-3
Drying time
min
2- 5
Spray pressure / recycle pressure
bar
2 / 1,3
163 . 832
Inlet air quantity

Pan neg. pressure
Nozzle
24
Case history: Ibuprofen sugar coating

FROM MANUAL TO AUTOMATIC PRODUCTION
Isolation:
film with Shellac organic solution 15 ml per kg of cores
Sub coating: sugar acacia suspension

Build up:
very thick sugar suspension
Smoothing:
traditional Sugar Syrup
Coloring:
traditional Sugar Syrup + Color
Polishing:
carnauba wax in powder
25
Case history: Ibuprofen sugar coating

TOTAL WEIGHT GAIN
+ 60%
STARTING BATCH SIZE
kg 120
FROM 28 HOURS..TO 7 HOURS

including all suspensions preparation
ALL STEPS IN ONE PAN WITHOUT INTERMEDIATE CLEANING
26
Case history: Valerian sugar coating

Isolation:
Film with Shellac organic solution
Build up:
Sugar very thick suspension (acacia and filler together)
Smoothing:
Traditional Sugar Syrup (AVOIDED TO REDUCE TIME!)
Coloring:
Traditional Sugar Syrup + Color
Polishing:
Capol wax in powder
27
Case history: Valerian sugar coating

TOTAL WEIGHT GAIN
+ 70%
STARTING BATCH SIZE
kg 110
FROM 3 SHIFTS..TO 6 HOURS

including all suspensions preparation
ALL STEPS IN ONE PAN WITHOUT INTERMEDIATE CLEANING
28
GS blowing paddles configuration

FOR SUGAR SPHERES PRODUCTION, API LAYERING & FILM COATING OF PELLETS
29
GS Blowing paddles configuration

SUGAR SPHERES PRODUCTION BY LIQUID LAYERING
SYRUP FORMULATION
SUGAR
53
WATER
25
STARCH
22
Starting Batch: 100 kg of sugar crystals

7 hours to apply 150 kg of syrup
30
GS Powder layering
Typical sequence for powder layering:
1)
2)
4)
3)
5)
31
Powder layering troubleshooting
ACTIONS :
STICKING
Reduce spray
Increase cores T
Increase Pan speed
Add glidant in formula
Increase gun distance
Increase powder quantity
Increase Spray pressure if possible
Change binder concentration or type
32
Powder layering: troubleshooting
ACTIONS :
Increase cores T
Change binder concentration or type
STARS
33
ACTIONS:
Change binding agent
Decrease Gun distance
DUSTY PELLETS
Decrease powder quantity

Decrease cores T to improve powder
adhesion
Powder particle diameter too large
respect to cores.
34
ACTIONS:
PELLETS with PORES
Change type of binding agent or conc.

Decrease Core T
Increase spray quantity
35
ACTIONS:
Decrease Cores T
CRACKING
Decrease powder quantity
36
GS and Perfima loading & unloading

Loading:
manual or by gravity
Unloading:
semi-automatic or automatic
reversing the pan rotation.
37
PERFIMA
Perforated Pan
38
Perfima general structure
Same mixing baffles geometry to guarantee mixing efficiency

Coating Relative Standard Dev. < 6% for API liquid layering
39
Perfima workable batches

From 25% to 100% of the pan capacity
40
Perfima flexibility of workable batches

Flexibility of workable batches means scale up in the same equipment.
Tablets quantity is calculated

to be enough to cover
mixing baffles.
Maximum
Ratio maximum/minimum
bed height ~ 2.3
Minimum
41
Minimum batch - baffle

height
42
Ratio maximum/minimum
bed length ~ 1.7
43
Perfima mixing concept
Rotational mixing
Drum rotation
Front-back mixing
Baffle effect
44
Perfima mixing concept

Rotational mixing
45
Mixing concept
Front-back mixing
46
Perfima drum holes

On IMA Perfima the pan holes are mechanically and electrolytically
polished to guarantee 100% product removal during the cleaning cycle.
Tablets side
TARGET: holes of perforated area easy to clean

Round shape on tablets side
Semi-conical hole type
Hole low roughness internal surface
Holes manufacturing:
Drilling
Electropolishing
47
Perfima range of capacity
PERFIMA800
800
PERFIMA
PERFIMA 500
PERFIMA 500
PERFIMA
200
PERFIMA
PERFIMALAB
200
0
50
100
150
200
250
300
350
400
450
500
550
600
650
700
750
800
850
900
LITRES
48
Perfima inlet air flow rate
Duct diameter
Duct diameter (mm)

Flow rate (m3/h)
LAB (15-60)
200
500
800
150
300
400
450
1,100
3,500
6,000
8,000
49
Suction angle ~ 45
50
Suction area - drum length
51
Perfima Clean In Place
Design scale-up:
same nozzles locations,
same sequence for all
models
52
Perfima Clean In Place

Cleaning nozzles
Inlet air duct detail
IMA Perforated Pan

can be fitted with a
completely automatic
Cleaning In Place
system. The machine
is equipped with
cleaning nozzles and
spray balls that cover
all machine areas to
be cleaned.
53
Nozzles strategy and zones definition
54
Pan filling sensor
Sensor under sealing level.

Water quantity enough to
cover mixing baffles.
Draining sink on the bottom.
55
Inspection
Once opened the doors

fitted on each side of the
pan, the machine is fully
accessible and can be
easily and quickly
inspected.
56
CIP validation cleaning recipe

Pre-washing
to wash out from the machine surfaces most of the residues
Washing with detergent
to remove all soluble and insoluble materials
Rinsing
To rinse the detergent form the pan surface
Drying
To dry the machine completely
CIP RECIPE
Total time (minute)
Total water consumption (litres)
PERFIMA 200
PERFIMA 500
90
105
1700
3600
57
Perfima Lab
Perfima Lab is a perforated pan for
laboratory applications and small
production batches. Thanks to its
interchangeable drums (three drums
available) it is possible to work a wide
range of capacities:
3-10 litres
8-30 litres
15-60 litres
58
Perfima Lab
59
Perfima working parameters

PARAMETER for Kollicoat IR at
25% in water
Perfima Lab
30 litres
Perfima
200 litres
25
160
10-14
7-10
Inlet air quantity (m3/h)
600
3500
Pan neg pressure (Pa)
- 10
- 10
60 -65
60 -65
40 - 42C
40 - 42C
Number of guns
Atom pressure (bar)
Pattern pressure (bar)
1,2
1,2
80 - 120
300 - 450
Batch size (kg)

Pan speed (rpm)
Inlet air T (C)

Cores T (C)
Nozzle
Spray rate (g/min)
60
IMA Laboratory in Bologna
EQUIPMENT AVAILABLE FOR COATING:
GS 25 liters
GS 30 liters
GS 300 liters
PERFIMA LAB 15 -30 -60 liters
PERFIMA 200 liters
2 pharmacists and 1 qualified engineer

More than 2800 trials filed
61
Conclusions and questions
62

2.presentazione Funaro IMA-BASF Spain

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

2.presentazione Funaro IMA-BASF Spain

Uploaded by

Copyright:

Available Formats

Bombos no perforados y perforados

Tecnologas de recubrimiento IMA

CATERINA FUNARO - PROCESS LABORATORY MANAGER

SOLID DOSE SOLUTIONS

Introduction to coating process

SOLID DOSE SOLUTIONS

Introduction to coating process

SOLID DOSE SOLUTIONS

GS Solid Wall Pan

SOLID DOSE SOLUTIONS

GS solid wall pan

SOLID DOSE SOLUTIONS

GS solid wall pan

Pellet film coating

GS solid wall pan

Electro pneumatic panel

SOLID DOSE SOLUTIONS

GS solid wall pan

SOLID DOSE SOLUTIONS

GS solid wall pan

IMA guns for film coating

SOLID DOSE SOLUTIONS

IMA guns for film coating

SOLID DOSE SOLUTIONS

Schlick guns for film coating

SOLID DOSE SOLUTIONS

Ideal spray shape

SOLID DOSE SOLUTIONS

Schlick guns - ideal spray shape

LABCOAT NOZZLE Mod. 970 S 75

SOLID DOSE SOLUTIONS

Schlick guns - ideal spray shape

Schlick Gun production S35 and

SOLID DOSE SOLUTIONS

Spray guns position

Spray angle > 90 and oriented in

SOLID DOSE SOLUTIONS

In line spray control

From the HMI it is possible to

SOLID DOSE SOLUTIONS

GUN & NOZZLE

SOLID DOSE SOLUTIONS

Sugar coating pump & surge chamber

ATTENZIONE: ALTA PRESSIONE!

ATTENTION: HAUTE PRESSURE!

EN CAS DE ENGORGEMENT, AVANT D'INTERVENIR OUVRIR LA VALVE DE SRETE'

WARNING: HIGH PRESSURE!

IN CASE OF CLOGGING, OPEN THE SAFETY VALVE BEFORE INTERVENTION

IN CASO DI INTASAMENTO, APRIRE LA VALVOLA DI SICUREZZA PRIMA DI INTERVENIRE

IN VERSTOPFUNGSFALL, FFNEN DIE SICHERHEITSVENTIL BEVOR INTERVENIEREN

SOLID DOSE SOLUTIONS

Sugar coating gun and nozzle

fan opening angle 80

SOLID DOSE SOLUTIONS

Factors influencing the sugar dosing

Surge chamber pressure

Recirculation valve sealing efficiency

Syrup concentration and temperature

COATING PARAMETERS (150 kg batch)

Core T (END OF DRYING)

Spray pressure / recycle pressure

Inlet air quantity

SOLID DOSE SOLUTIONS