fluid bed granulation fluid bed dryer · fbd-30 11 0 30 18 12925 25 0 fbd-60 215 60 36 25850 4 0 10...
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FLUID BED DRYER
The “PAAN PHARMATECH ENGINEERS PVT.LTD.”
Fluid Bed Dryer has adopted new concept of GMP
Regulation with improved performance.
Ideal for drying wet granules.
The product container is lifted by externally mounted
pneumatic cylinders.
Safety features like Earth Circuit Relay, Solid flow
monitor and explosion vent for excess pressure.
AC frequency controller for the blower to control
fluidization.
Electro Pneumatic Control Panel -Complete
automation with PLC to control the full drying cycle.
Capacity 5kg – 500kg of dried product having initial
moisture content of 20 –25 %.
Optional provision of built in Raker ( slow speed
agitator) in the FBD bowl, externally driven to ensure
uniform drying of granules without slopping in the drying
process, thereby reducing the total processing time and
eliminating contamination by human touch.
The Inlet air plenum is dome safe and equipped with
drain. It is positioned above the floor to prevent the
accumulation of contaminants/bacteria underneath and
to facilitate cleaning.
The entire exhaust air filters are easily removable for
cleaning. Provision of HEPA filters in inlet air system.
DESCRIPTIONS (FEATURES)
FLUID BED GRANULATION
It is important to verify that the filter bag is also appropriate
for the product to be scaled up. Failure to use the proper
bag may result in product loss (if the openings are too
large) or unnecessarily restricted air flows (if the openings
are too small).
DIFFERENCES IN THE MOC IN FILTER BAGS
It is also very important to select proper screen to avoid
clogging of the bottom screen as this could result in slower
drying time extended well beyond predicted time.
DIFFERENCES IN BOWL SCREENS
It is more important to select the right pump type during
scale up and ignore small differences in the spray rates.
DIFFERENCES IN SOLUTION DELIVERY SYSTEMS
While using untreated air, the moisture content of the inlet
air varies according to the seasonal and weather changes
of the ambience (sunny, dry, wet, heavy rains humid
summer etc). For products having a narrow LOD limit (say
between 2-2.5%), weather variations can be problematic
while predicting the end point.
TREATED AIR V/S UNTREATED AIR(HUMIDITY CONTROL)
It is best to agree on a single formulation at the feasibility
level. Allow for changes like quantity of granulating
solutions and for variations in lubrication levels within
acceptable range. Increase in fines may require one to
increase the lubrication.
FORMULATION CONSIDERATION
Do not change the ancillary equipment throughout the
scale up process to minimize variations.
ANCILLARY EQUIPMENT
The unit operation:
All these cycle have common parameters
such as Fluidization air volume, inlet and outlet air
temperatures and filter bag shaking cycles. All three
operations must be understood and controlled to get the
optimum results.
The Premixing Cycle, Spray Cycle
and Dry Cycle.
MAJOR PROCESS PARAMETERS DURINGSCALE UP
This serves the purposes of both mixing the components
as well as preheating prior to the spray cycle. It is not
required to use a very high air volume at this stage, in fact,
that can lead to de-mixing due to the micro fined
component getting more trapped in the filter bags and the
coarser particles remaining in the bowl. Many equipment
today has built in safety interlocks that will prevent start of
the spray cycle before the premix is over and the required
temperature is achieved. Mixing Cycle for 45kg to 500kg -
3 or less components 1 to 2 mins and for 3 or more
components 3 to 5 mins
THE PREMIXING CYCLE
ltr/min using a multi headed nozzle.Spray rates ml/min -
45kg (150 to 350), 120kg (500 to 2000), 300kg (2000 to
3000), 500kg (3000 to 6500).
Generally 35-40 deg.C for organic and 60-70 deg.C for
water based product are useful at starting for the spray
cycle to begin.
The general rule is that there are dampers on both the inlet
and outlet sides. The inlet side is kept 100 % open and the
control is exercised on the outlet damper. The aim is to lift
the powder with maximum exposure to the spray zone.
INLET TEMPERATURE SET POINT:
DAMPER SETTINGS:
THE BAG SHAKING CYCLES :
Bag shaking duration:
The bag shaking cycle should be set as per the conditions
present during the cycle. Larger equipment may have
multiple settings for airflow during the drying cycle.
Granules are heaviest after the spray cycle and will
require maximum fluidization air. As the moisture is
driven off, the bed lightens and less fluidizing air is needed
to sustain particle flow. Therefore varying levels of air is
required throughout. Thus the bag shaking frequency will
increase during the whole process. Magnehelic gauges
provided as a useful tool to decide bag shaking frequency.
By tracking the time/pressure relationship, it is possible to
optimize the bag shaking cycles. It is a critical factor to
obtain the shortest possible drying cycle.
In a Spraying Cycle 15 to 45sec
and in Drying Cycle 20 to 120sec.
NOZZLE SELECTION AND HEIGHT:
ATOMIZING AIR:
SPRAY RATE:
Up to 100 kg batch sizes a single nozzle is used. Beyond
this multi headed nozzle is common. The nozzle height is
a vital. It depends upon the type of the product, the type of
operation (granulation, agglomeration, particle coating
etc.), and the amount of atomising air used.
The atomizing air pressure varies from about 2 bar to 4
bar. This will however depend upon the kind of binder
used its viscosity and its evaporation rate.
Spray rate varies as the bowl charge increases. 100kg to
300 kg, it is normally safe to use spray rates of around 2-3
THE SPRAY CYCLE
INLET AIR TEMPERATURE
SET POINT :
The inlet set point for the
drying varies between 80-95
deg.C for water based and
50-60 deg.C for solvent
g r a n u l a t i o n s . F o r
t empera tu re sens i t i ve
product drying the highest
allowable as a guideline.
Damper settings begin with
full open at both ends to
gradual closing of outlet
dampers to almost be equal
to the setting at the end of the
spray cycle
THE DRY CYCLE
TECHNICAL SPECIFICATION
MODEL - KgFBC / FBG
Top SprayWorking Volume Ltr.
Wurster Design Ltr./ Size
Steam Consumption @ 3 kg / hr
0Temperature C
Exhaust Fan kw
Elec. Heating kw
5
22
6 (7”)
12
35
100
7.5
15
45
18
48
100
7.5
30
110
24
70
100
7.5
60
220
36
140
100
18.5
450
-
210
100
18.5
670
-
280
100
30
1020
-
380
100
45
120 200 300
14 (9”)
38 (12”)
14 (9”)
38 (12”)
102 (18”)
38 (12”)
102 (18”)
102 (18”)
170 (24”)
417(32”)
170 (24”)
417(32”)
417(32”)
820(46”)
820(46”)
AHU:
3Air Volume m / hr 750 1000 1500 3000 4500 6000 8000
Top Spray
3Atomizing Air m /hr
Wurster Spray
25 25 30 110 110 110 110
25 90 90 270 270 540 540
25 25 2 x 25 2 x 25 4 x 25 - -
Off.: Plot-36, Shramsafalya, RSC -11, Veer Savarkar Nagar, Thane (W) – 400606 Maharashtra (INDIA).
Tel.: 91- 22 – 2582 8524, 0250-6454728/29 Telefax: 91 – 22 -2583 3896
Website: Email: [email protected]
Pharmatech Engineers Pvt. Ltd.PAAN
Pharmatech Engineers Pvt. Ltd.PAAN
'Fluidisation' is a process in which a bed of small solid
particles is suspended and agitated by a stream of air, Fluid
Bed technology has found enhanced use in
pharmaceuticals for drying, granulation, palletizing and
coating.
DESCRIPTION
FLUID BED PROCESSOR
Innovations in technology area, emerged more versatile,
automation and validation, in the Fluid Bed Processors
and the Rapid Mixing & Granulator. But The future will
witness the use of FBP with its feature like automation,
validation, closed and 'Single Pot Technology'
benefits, in wet granulation and particle coating.
SPRAY GRANULATION &PARTICLE COATING
It has two different geometry and this can effect the granulation
quality. Top spray granulator (FBE Granulator-Fig.2) in which a spray
nozzle introduced through the cylindrical expansion zone. In other
version, the nozzle introduced through conical expansion zone
(Fig.1) to allow higher fluidization. This results in lesser filter clogging
as against cylindrical expansion zone (due to uniform velocity).
TOP SPRAY MODE
THE EFFECT OF SPRAY MODEAND CHAMBER GEOMETRY
BOTTOM SPRAY (WURSTER) MODE
In wurster mode a cylindrical partition is placed slightly above the
bottom in the product container. The spray nozzle sprays the solution
through this partition onto the particles. The design of the air distribution
plate allows more air to pass through the partition than in the area
surrounding the partition. The fluidized particle moves through the
centre, meets the spray and travels upwards and then due to velocity
reduction falls back outside the partition.
FLOW PATTERN OF WURSTER COATING
MULTIPROCESSOR (TOP SPRAY & WURSTAR DESIGN)
It is observed that F.B.G. (spray granulation), often
results in granules with low bulk densities when
compared with granules made from wet mixed and dried
process methods.
Pharma experts found that, at the start of the spraying
process, a droplet of the spray solution is hit by the dry
air as it leaves the spray nozzle.Although each
individual droplet is small, the overall surface area
exposed to the dry air from a stream of droplet is so large
that instantaneous surface evaporation of the solvent is
great.As water/solvent evaporates, thus the rise in
viscosity is also great and the stickiness increases.
This results in “Case Hardening”. The skin of the spray
droplet becomes thick preventing further evaporation
and the inside of the droplet remains wet. Migration of
the inner wetness is limited due to the case hardened
situation.
Binder does not migrate from the spray droplet into the
powder particle, so does not penetrate to particle space
for the resultant densification during drying. The
enveloping of the spray droplets with powder and other
particles isolates it from the incoming air stream like
insulation and in combination with the case hardening
effect, retards the ability to dry the older spray droplets.
This favours the evaporation of further spray droplets, to
a case hardened state.
The solution as prescribed by experts is to humidify
the incoming air in an energy efficient manner by
creating a loop of the circulating fluidizing air. When
the hot and humid exhaust air is re-circulated back
in to the process, normal fluidization could be
maintained without excessive drying. The high
humidity of the inlet air stream retards premature
surface drying of the spray droplets enabling the
binder droplets to remain thin enough for
penetration in to the powder particles. The
resultant granules are seen to be very dense and
spherical. It can also be assumed that by controlling
the proportion of the humid air, it will be possible to
achieve the required bulk density and flow
characteristics of the product.
FLUID BED DRYER (FOR R&D)
TECHNICAL SPECIFICATION
MODEL
Container Volume(Ltr.)
Batch Capacity
oDrying Temp in C
Steam Consume @2
3 kg/cm in Kcal/hr
BLOWER
Capacity M³/hr.
Elec. Motor HP
Electric Loadin KW
FBD-30
110
30
18
12925
2500
5
FBD-60
215
60
36
25850
4000
10
FBD-120
430
120
50-85
54
51700
6300
15
FBD-200
650
200
-
82720
8000
20
750
250
-
103400
10000
25
850
300
-
129250
12500
30
1500
500
-
196460
16500
25+25
FBD-250
FBD-300
FBD-500
(FIG.1)
(FIG.2)
FLUID BED GRANULATION
Scale ups occur generally at 50 kg, 100 kg and 300kg
levels. Both technical and non technical issues frequently
affect scale up progression decisions. Thus successful
scale up may very well depend upon factors.
PRACTICAL & TECHNICAL FACTORSOFTEN ENCOUNTERED SCALE UP: