2.presentazione Funaro Ima-basf Spain 402q49
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Bombos no perforados y perforados Tecnologías de recubrimiento IMA
CATERINA FUNARO - PROCESS LABORATORY MANAGER
SOLID DOSE SOLUTIONS
1
Introduction to coating process There was a time…
SOLID DOSE SOLUTIONS
2
Introduction to coating process There was a time…
SOLID DOSE SOLUTIONS
3
GS Solid Wall Pan
SOLID DOSE SOLUTIONS
4
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 SOLID DOSE SOLUTIONS
5
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
SOLID DOSE SOLUTIONS
6
GS solid wall pan
Film coating
Pellet film coating
Sugar coating
Powder layering SOLID DOSE SOLUTIONS
7
GS solid wall pan 11
9
IN
OUT
7
2
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 Heating unit Dust collector Outlet air fan Film spraying guns Air-exhausting paddle system Sliding system to move backwards SOLID DOSE SOLUTIONS
8
GS Pilot scale
GS 10 litres
GS 3 litres
GS 25 litres
SOLID DOSE SOLUTIONS
9
GS production scale
• • • • • • •
70 Litres 150 Litres 300 Litres 450 Litres 600 Litres 700 Litres 1200 Litres
PERFIMA 800
PERFIMA 500
PERFIMA 200 SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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 SOLID DOSE SOLUTIONS
12
IMA guns for film coating Nozzle control needle
Nozzle Regulator
SOLID DOSE SOLUTIONS
13
IMA guns for film coating
AIR CAP N° AIR CAP
GOCCE DROPS
VENTAGLIO ANGLE
44
11
7 7
SOLID DOSE SOLUTIONS
14
Schlick guns for film coating IMA installation ABC Schlick S45
PCA harm
SOLID DOSE SOLUTIONS
15
Ideal spray shape 2
1
?
3
SOLID DOSE SOLUTIONS
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
9
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
SOLID DOSE SOLUTIONS
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)
SOLID DOSE SOLUTIONS
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.
SOLID DOSE SOLUTIONS
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°.
SOLID DOSE SOLUTIONS
20
Sugar coating RECIRCULATION LINE
GUN & NOZZLE
SURGE CHAMBER
PUMP
PAN
RECIRCULATION VALVE
LIQUID CONTAINER
SOLID DOSE SOLUTIONS
21
Sugar coating pump & surge chamber
ATTENZIONE: ALTA PRESSIONE!
ATTENTION: HAUTE PRESSURE!
EN CAS DE ENGORGEMENT, AVANT D'INTERVENIR OUVRIR LA VALVE DE SÛRETE'
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, ÖFFNEN DIE SICHERHEITSVENTIL BEVOR INTERVENIEREN
out "OUT" "IN"
in
250 bar 0
CHIUSO
APERTO
drain
22
SOLID DOSE SOLUTIONS
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°)
SOLID DOSE SOLUTIONS
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°
°C
70-65-55-40
Core T° (END OF DRYING)
°C
38……34……30
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
25
Case history: Ibuprofen sugar coating FROM MANUAL TO AUTOMATIC PRODUCTION
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 SOLID DOSE SOLUTIONS
26
Case history: Valerian sugar coating FROM MANUAL TO AUTOMATIC PRODUCTION
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
SOLID DOSE SOLUTIONS
27
Case history: Valerian sugar coating FROM MANUAL TO AUTOMATIC PRODUCTION
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 SOLID DOSE SOLUTIONS
28
GS blowing paddles configuration FOR SUGAR SPHERES PRODUCTION, API LAYERING & FILM COATING OF PELLETS
SOLID DOSE SOLUTIONS
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 SOLID DOSE SOLUTIONS
30
GS Powder layering Typical sequence for powder layering:
1)
2)
4)
3)
5)
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
32
Powder layering: troubleshooting
ACTIONS : • Increase cores T° • Change binder concentration or type
STARS
SOLID DOSE SOLUTIONS
33
Powder layering: troubleshooting
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.
SOLID DOSE SOLUTIONS
34
Powder layering: troubleshooting
ACTIONS:
PELLETS with PORES
• Change type of binding agent or conc. • Decrease Core T° • Increase spray quantity
SOLID DOSE SOLUTIONS
35
Powder layering: troubleshooting
ACTIONS: • Decrease Cores T°
CRACKING
• Decrease powder quantity
SOLID DOSE SOLUTIONS
36
GS and Perfima loading & unloading Loading: manual or by gravity
Unloading: semi-automatic or automatic reversing the pan rotation.
SOLID DOSE SOLUTIONS
37
PERFIMA Perforated Pan
SOLID DOSE SOLUTIONS
38
Perfima general structure
Same mixing baffles geometry to guarantee mixing efficiency Coating Relative Standard Dev. < 6% for API liquid layering
SOLID DOSE SOLUTIONS
39
Perfima workable batches From 25% to 100% of the pan capacity
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
41
Perfima flexibility of workable batches
• Minimum batch - baffle height
SOLID DOSE SOLUTIONS
42
Perfima flexibility of workable batches
• Ratio maximum/minimum bed length ~ 1.7
SOLID DOSE SOLUTIONS
43
Perfima mixing concept
• Rotational mixing
Drum rotation
• Front-back mixing
Baffle effect
SOLID DOSE SOLUTIONS
44
Perfima mixing concept • Rotational mixing
SOLID DOSE SOLUTIONS
45
Mixing concept
• Front-back mixing
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
49
Perfima inlet air flow rate
• Suction angle ~ 45°
SOLID DOSE SOLUTIONS
50
Perfima inlet air flow rate
Suction area - drum length
SOLID DOSE SOLUTIONS
51
Perfima Clean In Place
Design scale-up: same nozzles locations, same sequence for all models
SOLID DOSE SOLUTIONS
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.
SOLID DOSE SOLUTIONS
53
Nozzles strategy and zones definition
SOLID DOSE SOLUTIONS
54
Pan filling sensor
Sensor under sealing level. Water quantity enough to cover mixing baffles. Draining sink on the bottom.
SOLID DOSE SOLUTIONS
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.
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
58
Perfima Lab
SOLID DOSE SOLUTIONS
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 - 42°C
40 - 42°C
Number of guns
1
4
Atom pressure (bar)
2
2
Pattern pressure (bar)
2
2
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)
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
61
Conclusions and questions
SOLID DOSE SOLUTIONS
62
CATERINA FUNARO - PROCESS LABORATORY MANAGER
SOLID DOSE SOLUTIONS
1
Introduction to coating process There was a time…
SOLID DOSE SOLUTIONS
2
Introduction to coating process There was a time…
SOLID DOSE SOLUTIONS
3
GS Solid Wall Pan
SOLID DOSE SOLUTIONS
4
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 SOLID DOSE SOLUTIONS
5
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
SOLID DOSE SOLUTIONS
6
GS solid wall pan
Film coating
Pellet film coating
Sugar coating
Powder layering SOLID DOSE SOLUTIONS
7
GS solid wall pan 11
9
IN
OUT
7
2
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 Heating unit Dust collector Outlet air fan Film spraying guns Air-exhausting paddle system Sliding system to move backwards SOLID DOSE SOLUTIONS
8
GS Pilot scale
GS 10 litres
GS 3 litres
GS 25 litres
SOLID DOSE SOLUTIONS
9
GS production scale
• • • • • • •
70 Litres 150 Litres 300 Litres 450 Litres 600 Litres 700 Litres 1200 Litres
PERFIMA 800
PERFIMA 500
PERFIMA 200 SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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 SOLID DOSE SOLUTIONS
12
IMA guns for film coating Nozzle control needle
Nozzle Regulator
SOLID DOSE SOLUTIONS
13
IMA guns for film coating
AIR CAP N° AIR CAP
GOCCE DROPS
VENTAGLIO ANGLE
44
11
7 7
SOLID DOSE SOLUTIONS
14
Schlick guns for film coating IMA installation ABC Schlick S45
PCA harm
SOLID DOSE SOLUTIONS
15
Ideal spray shape 2
1
?
3
SOLID DOSE SOLUTIONS
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
9
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
SOLID DOSE SOLUTIONS
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)
SOLID DOSE SOLUTIONS
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.
SOLID DOSE SOLUTIONS
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°.
SOLID DOSE SOLUTIONS
20
Sugar coating RECIRCULATION LINE
GUN & NOZZLE
SURGE CHAMBER
PUMP
PAN
RECIRCULATION VALVE
LIQUID CONTAINER
SOLID DOSE SOLUTIONS
21
Sugar coating pump & surge chamber
ATTENZIONE: ALTA PRESSIONE!
ATTENTION: HAUTE PRESSURE!
EN CAS DE ENGORGEMENT, AVANT D'INTERVENIR OUVRIR LA VALVE DE SÛRETE'
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, ÖFFNEN DIE SICHERHEITSVENTIL BEVOR INTERVENIEREN
out "OUT" "IN"
in
250 bar 0
CHIUSO
APERTO
drain
22
SOLID DOSE SOLUTIONS
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°)
SOLID DOSE SOLUTIONS
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°
°C
70-65-55-40
Core T° (END OF DRYING)
°C
38……34……30
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
25
Case history: Ibuprofen sugar coating FROM MANUAL TO AUTOMATIC PRODUCTION
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 SOLID DOSE SOLUTIONS
26
Case history: Valerian sugar coating FROM MANUAL TO AUTOMATIC PRODUCTION
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
SOLID DOSE SOLUTIONS
27
Case history: Valerian sugar coating FROM MANUAL TO AUTOMATIC PRODUCTION
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 SOLID DOSE SOLUTIONS
28
GS blowing paddles configuration FOR SUGAR SPHERES PRODUCTION, API LAYERING & FILM COATING OF PELLETS
SOLID DOSE SOLUTIONS
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 SOLID DOSE SOLUTIONS
30
GS Powder layering Typical sequence for powder layering:
1)
2)
4)
3)
5)
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
32
Powder layering: troubleshooting
ACTIONS : • Increase cores T° • Change binder concentration or type
STARS
SOLID DOSE SOLUTIONS
33
Powder layering: troubleshooting
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.
SOLID DOSE SOLUTIONS
34
Powder layering: troubleshooting
ACTIONS:
PELLETS with PORES
• Change type of binding agent or conc. • Decrease Core T° • Increase spray quantity
SOLID DOSE SOLUTIONS
35
Powder layering: troubleshooting
ACTIONS: • Decrease Cores T°
CRACKING
• Decrease powder quantity
SOLID DOSE SOLUTIONS
36
GS and Perfima loading & unloading Loading: manual or by gravity
Unloading: semi-automatic or automatic reversing the pan rotation.
SOLID DOSE SOLUTIONS
37
PERFIMA Perforated Pan
SOLID DOSE SOLUTIONS
38
Perfima general structure
Same mixing baffles geometry to guarantee mixing efficiency Coating Relative Standard Dev. < 6% for API liquid layering
SOLID DOSE SOLUTIONS
39
Perfima workable batches From 25% to 100% of the pan capacity
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
41
Perfima flexibility of workable batches
• Minimum batch - baffle height
SOLID DOSE SOLUTIONS
42
Perfima flexibility of workable batches
• Ratio maximum/minimum bed length ~ 1.7
SOLID DOSE SOLUTIONS
43
Perfima mixing concept
• Rotational mixing
Drum rotation
• Front-back mixing
Baffle effect
SOLID DOSE SOLUTIONS
44
Perfima mixing concept • Rotational mixing
SOLID DOSE SOLUTIONS
45
Mixing concept
• Front-back mixing
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
49
Perfima inlet air flow rate
• Suction angle ~ 45°
SOLID DOSE SOLUTIONS
50
Perfima inlet air flow rate
Suction area - drum length
SOLID DOSE SOLUTIONS
51
Perfima Clean In Place
Design scale-up: same nozzles locations, same sequence for all models
SOLID DOSE SOLUTIONS
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.
SOLID DOSE SOLUTIONS
53
Nozzles strategy and zones definition
SOLID DOSE SOLUTIONS
54
Pan filling sensor
Sensor under sealing level. Water quantity enough to cover mixing baffles. Draining sink on the bottom.
SOLID DOSE SOLUTIONS
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.
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
58
Perfima Lab
SOLID DOSE SOLUTIONS
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 - 42°C
40 - 42°C
Number of guns
1
4
Atom pressure (bar)
2
2
Pattern pressure (bar)
2
2
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)
SOLID DOSE SOLUTIONS
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
SOLID DOSE SOLUTIONS
61
Conclusions and questions
SOLID DOSE SOLUTIONS
62
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