Fluid Bed Systems Hd/hdg/hdgc Drying, Granulating, Coating 362i2i

Fluid bed systems HD/HDG/HDGC Drying, Granulating, Coating Packaging Technology

2  |  Fluid bed systems

A lead on principle Present challenges facing the pharmaceutical industry

Fluid bed technology

include flexibility in production, processes that are optimized for the long term, and fast production procedures. Fluid bed technology from Hüttlin offers all of these features and helps you to gain a competitive lead. Diskjet

Three-component nozzle

Dynamic filter

NexStep software

Our Solutions have one thing in common – Quality Hüttlin fluid bed lines make it possible to carry out drying, granulating and coating/layering with just one product container. As a result, it is no longer necessary to exchange the container. A more efficient operation is ensured.

Making drying more efficient

Drying

The patented process gas distributor plate Diskjet ensures

ÑÑ Process times significantly reduced

fast and uniform mixing. Regardless of the drying conditions,

ÑÑ No dead zones in the product container

it allows for uniform fluidization of the entire batch.

ÑÑ Reduced filter load

The high exit speed of process air prevents sticking and

ÑÑ Processing of materials with different

clogging of the product on the bed resulting in a product with uniform residual moisture and improved reproducibility of processes.

densities is possible

Fluid bed systems  |  3

Granulation better than ever

Granulating

Depending on product characteristics and used binder,

ÑÑ Process times significantly reduced

the particle size of granulate can be controlled and

ÑÑ Very homogenous granulate

reproduced by selecting specific parameters. The uniformity

ÑÑ No size calibration needed

of the granulates and their homogeneous size distribution

ÑÑ Excipients (lubricants) can be added

produce excellent flow and pelletizing characteristics.

ÑÑ High output on tablet press

The efficiency of the system prevents large agglomerates from forming in most products rendering classification in a sieving mill unnecessary. Coating and layering in a quality that has never been

Coating and layering

seen before

ÑÑ Maximum reduction of process times

Combined with the Diskjet, the three-compo-nent nozzle

ÑÑ Homogeneous coating of particles

delivers spray fluid straight into the fluidized product.

ÑÑ Minimum spray losses

The fluid is coated at the site where the speed of the

ÑÑ Microtablets and fine particles can

product is highest ensuring even distribution of the spray

also be coated

medium. The thin layer on the surface dries fast, with virtually no agglomerates forming. In addition, the evaporation energy above the Diskjet prevents thermal load near the bottom from developing.

From left to right: Drying, granulating, coating and layering

4  |  Fluid bed systems

Product overview/dimensions Fluid bed technology Dryer

Granulator

Coater

Standard systems

UltraClean

HD 100

HDG 100

HDGC 100

HD 200

HDG 200

HDGC 200

HD 300

HDG 300

HDGC 300

HD 400

HDG 400

HDGC 400

HD 600

HDG 600

HDGC 600

HD 800

HDG 800

HDGC 800

HD 1 200

HDG 1 200

HDGC 1 200

HD 2 000

HDG 2 000

HDGC 2 000

HD 100UltraClean

HDG 100UltraClean

HDGC 100UltraClean

HD

HDG

200UltraClean

HDGC 200UltraClean

HD 300UltraClean

HDG 300UltraClean

HDGC 300UltraClean

HD

HDG

400UltraClean

HDGC 400UltraClean

HD 600UltraClean

HDG 600UltraClean

HDGC 600UltraClean

HD

HDG

800UltraClean

HDGC 800UltraClean

1 200UltraClean

HDGC 1 200UltraClean

HD

200UltraClean 400UltraClean 800UltraClean

1 200UltraClean

HDG

The right unit for the right purpose The modular design makes it easier to decide between dryers, granulators or coaters. The range of application can be extended with little additional capital investment.

HD Hüttlin Dryer

Application matrix

HDG Hüttlin Dryer-Granulator HDGC Hüttlin DryerGranulator-Coater

HD Mixing Drying Granulating Coating

HDG

HDGC

Fluid bed systems  |  5

Left: HDG spray nozzle Right: HDGC spray nozzle

Convinced by top-notch results Hüttlin fluid bed granulation technology does not involve any milling of the granulate for many products – a process that is still standard in traditional fluid bed lines. The uniformity of the granulate means that excipients (lubricants) can be added in the unit. Sieve analysis

Particle size distribution

0.00 mm

0.00 %

0.05 mm

0.65 %

Components (%)

Results from granulation

0.10 mm

5.20 %

0.16 mm

16.25 %

40

0.25 mm

39.65 %

30

0.32 mm

28.60 %

20

0.50 mm

8.45 %

0.80 mm

0.65 %

1.00 mm

0.65 %

1.25 mm

0.00 %

50

10 0

0

0.25

0.5

0.75 1.0

1.25

Particle size (mm)

6  |  Fluid bed systems

Tangential gas exit

Inspired to think ahead Any company laying claim to leadership in fluidized-bed technology must constantly tread new paths to open up new horizons. This results in technological feats such as the Diskjet gas distribution plate (patented), the dynamic filter system (patented) and the three-component spray nozzle spraying system.

Perfect mixing behaviour

energy. The tangential gas exit improves

The patented process gas bottom

the efficiency of the filter system. The

ensures fast and thorough mixing as well

high exit speed of process air prevents

as short drying periods. Independently

the product from settling on the bottom

of drying conditions, Diskjet produces

resulting in uniform residual humidity

even fluidization of the entire filling.

of the product and processes with

A homogeneous air stream provides

enhanced reproducibility.

optimum exchange of substance and

From left to right: Spraying system, Three-component nozzle, scheme Three-component nozzle, Dynamic filter

Fluid bed systems  |  7

Three-component nozzle

Dynamic filter

In addition to the spraying fluid and

The patented process filter system with

the atomizing air, the Hüttlin spray

its sequential-cleaning filter elements

nozzle also has a third component, the

meets even the most stringent

microclimate. The microclimate is

requirements. An internal cone in each

gas that protects the spray nozzle from

filter element serves to increase the

clogging. The spray direction of the

overall filter surface considerably and

nozzles is aligned with the exit of process

reduce the burden. When the filters

air from the Diskjet. The number of

close in the clean-off cycle, particles of

nozzles increases with the size of the

the product that are circulating or sticking

unit, making scale-up processes simpler

to the filter surface are returned to the

and ensuring consistent product quality.

process efficiently using compressed air. Whether fabric, Teflon or metal filters are used depending on the process.

Diskjet ▶ Homogeneous airflow ensures optimum exchange of substance and energy, the tangential air outlet puts less strain on the filter system ▶ Best product mixing results due to controlled and uniform process air distribution ▶ Process times can be significantly reduced Three-component nozzle ▶ Extremely low spraying losses due to the spray nozzle arrangement ▶ Homogeneous granulates, after-treatment with a sieve mill is no longer necessary ▶ Excellent coating quality and gentle handling of the product during coating ▶ Very short granulation and coating times Dynamic filter ▶ Continuous filter cleaning speedily re-routes the particles to the process ▶ Various filter materials can be selected to suit the respective processes NexStep ▶ Process development and optimization in the laboratory scale and reliably applied in the production scale via NexStep ▶ Scale-up without intermediate steps

Process air Compressed air

8  |  Fluid bed systems

Optimum combination of fluid bed lines Hüttlin fluid bed lines have a modular design. The base devices are designed as heavy-duty 10 bar or 12 bar pressure shock resistant and can be adjusted using various options.

Depending on the requirements, product

with different filter materials including

containers are available either without

a fully CIP-compatible metal filter.

spraying systems, with tangential spraying

Pneumatic/gravimetric filling and

systems for simple or underbed spraying

pneumatic discharging as a further option

systems for demanding applications.

offer significant advantages. As a result

The patented dynamic filter can be fitted

they are generally used as a standard.

Pneumatic discharging into two barrels

Fluid bed systems  |  9

Process filter

Product container

Spray systems

Diskjet

Cleaning systems

Precleaning 1. Low-pressure WIP

Main cleaning 1. Low-pressure WIP 2. Low-pressure WIP 3. High-pressure WIP

Main cleaning 1. Low-pressure WIP 2. Low-pressure WIP 3. High-pressure WIP

UltraClean Metal filter and jet cleaner

Filling/Discharging

Pneumatic filling (Vacuum) Cleaning: option

Gravimetric filling Cleaning: option

Pneumatic discharging (Vacuum) Cleaning: option

10  |  Fluid bed systems

UltraClean (pat. pend.) – CIP in action Hüttlin has made the CIP metal filter a viable solution. Metal filters with mycron meshed screens collect cleaning solution in the clean gas side. This can lead to long draining times in the cleaning cycle. Especially products prone to swelling amplify this problem. Hüttlin has come up with an ingenious solution: a metal filter that opens. An internal cone in the filter cartridge such as the one used in the proven dynamic filter is pushed downwards via a piston rod and the filter opens. This makes it possible to rinse away solids on the clean gas side of the filter quickly, thus reducing cleaning time significantly without compromising cleanliness.

Retractable jet cleaner

A retractable jet cleaner in the centre of the unit rounds off the UltraClean system. With three different positions, the 360°-rotating cleaning nozzle guarantees that the unit is cleaned completely. Thanks to computer-assisted calculation of the spray nozzle opening combined with the rotation speed of the jet cleaner it is possible to optimize the cleaning design towards the equipment requirements.

Fluid bed systems  |  11

5 Steps to perfect cleaning of the unit CIP can be this easy when UltraClean (pat. pend.) is used.

1. Preclean the product

2. Clean the metal filters

area and the metal filter

with the inside CIP nozzles.

from the outside with

This opens the metal filters.

the jet cleaner and blow clear the metal filters with compressed air.

3. Proceed with the main

4. Rinse the entire unit

cleaning of the unit using

and peripheral devices with

the jet cleaner and rotating

DI water as for the previous

spray nozzles in the

step. The filters can

peripheral devices. Various

alternately be cleaned from

cleaning agents can be

their inside and outside.

added to the warm water during this process.

5. Dry the unit with preheated process air while the filter cartridges alternate through an open and close cycle.

UltraClean filter system

Cleaning concept Cold water Hot water DI water

M

Jet cleaner

M

Detergent From highshear mixer

Exhaust air

M

A 1-5 B C D 1-2 E F G

Containment valve G

Pneumatic discharge system with UltraClean filter system

D1

B E

D2

Containment valve C

Recirculation (optional)

Quick action stop valve

A 1-5

Special wastewater treatment

Discharge container F

Supply air Quick action stop valve

12  |  Fluid bed systems

Inline process – overall perfection Inline process at Hüttlin means that the high-shear mixer granulator is physically attached to the fluid bed system using a product transfer line. The product is extracted from the high-shear mixer granulator using negative pressure and transported to the fluid bed with the process air. Regardless of whether a cone mill is interposed or whether the product is a difficult one, Hüttlin can rise to the challenge. Minimum transfer times combined with a maximum degree of emptying are proof of this. Closed product handling is proven technology at Hüttlin.

Fluid bed systems  |  13



High-shear mixer granulator Cone mill, wet mill Tranfer line Fluid bed device Discharge Discharge container Cone mill, wet mill Distributor cone Product barrels Lifting and swivelling column

14  |  Fluid bed systems

On the path to containment On an Hüttlin unit, filling and discharging is carried out without any vacuum conveyor systems. This eliminates the need for complicated additional installations. As is the case with the inline process, the unit is filled and discharged by means of conditioned process air. Competence in closed product handling is necessary for viable containment solutions.

Components of a fluid bed system

Supply air handling unit

Anti-freeze hatch Anti-freeze heater Prefilter F6/F9* Cooler (air dehumidification) Adsorption dryer Supply air humidity Steam heating with by* Humidization Aftercooler Hepa filter H13 Supply air quantity* Supply air temperature*

Air technology

Exhaust air unit

Dust concentration Exhaust air temperature* Shut-off flap Exhaust air filter F7/F9* Hepa filter H13 Shut-off flap by By Fresh make-up-air Gas concentration (LEL) Proccess air ventilator* Exhaust air humidity Silencer

* Standard Process unit

Ex-protective valve* Process air hatch* Discharge hatch* Product temperature* Discharge container Cone mill Discharge air filter* Discharge lifting column Discharge air hatch* Product transfer hatch Filling hatch Filling container Filling container Lifting column Process air hatch* Ex-protective valve*

Process unit

Fluid bed systems  |  15

Exhaust air unit

QA+ 3.42

TICR 3.41 QISA+ 3.41 F7

F9

MIR 3.41

H13

TI 1.01

TICR 3.04

MIR 3.02

FIC 3.01 H13

F9

F6

F6

Supply air handling unit

Fluid bed systems  |  16

Technical data (Standard unit) 100

200

300

400

600

800

1 200

2 000

3 000

256

527

749

937

1 315

1 880

3 266

5 029

10 553

Size HD/HDG/HDGC Product container volume (Liter)* Ventilator consumption (kW) Air flow (m3/h)* Differential pressure (Pa)

22

30

37

45

55

63

90

160

220

2 000

3 000

3 800

5 000

6 500

8 000

12 000

17 000

23 000 16 000

16 000

16 000

16 000

16 000

16 000

16 000

16 000

16 000

Heating power (kW)**

57

86

105

143

180

222

330

470

630

Steam consumption (kg/h)**

95

143

180

238

300

370

560

800

1 080

100

200

300

400

600

800

1 200

2 000

3 000

Granulator HDG

3

4

4

4

6

6

10

12

14

Granulator/Coater HDGC

6

6

6

12

12

12

18

24

36

12

12

18

18

18

30

36

48

Data* Spray nozzles (standard)

Spray nozzles (extended) Coater HDGC Compr. air cons. (Nm3/h)*** Dryer HD

100

100

100

100

100

100

100

100

100

Granulator HDG

190

240

240

240

300

300

500

640

750

Coater HDGC

240

240

240

360

360

360

480

620

860

100

200

300

400

600

800

1 200

2 000

3 000

Weight HD/HDG/HDGC (kg)

2 500

3 000

3 500

3 700

4 500

5 000

5 600

6 500

7 900

Air handling unit (kg)

250

340

340

400

440

510

650

790

1 100

Ventilator (kg)

300

600

770

870

930

990

1 050

1 500

2 000

Control (kg)

700

900

900

950

950

1 100

1 100

1 200

1 200

100

200

300

400

600

W1 (mm)

1 080

1 280

1 430

1 530

1 600

W2 (mm)

1 500

1 700

1 850

1 950

2 900

2 900

3 100

3 600

Dimensions

D1

W3 (mm) H1

D1 (mm)

800

1 050

1 200

1 300

1 500

4 150

4 600

4 700

5 050

5 500

800

1200

2000

3000

W1 (mm)

1 800

2 200

2 550

3 150

W2 (mm)

3 100

4 020

3 460

4 060

W3 (mm)

3 975

4 725

5 350

6 450

D1 (mm)

1 700

2 100

2 400

3 000

H1 (mm/min)

6 150

6 950

7 450

8 500

H1 (mm/min)

Dimensions W1 W3

W2

ZERT

EU-Kennnummer: 0588

* Technical data subject to alterations ** For process air heating from 10 °C to 80 °C *** For standard applications

Fluid bed systems  |  17

Device control and process monitoring The variety in requirements on modern control systems means that it must be possible to adjust them flexibly. Hüttlin’s control systems were developed based on this premise. Their modular structure can be adapted very easily, from control of an individual machine to entire production lines and integration into ME-systems.

Based on a Siemens or Allan Bradley PLC,

In addition to monitoring conventional

the control system was consistently

indicators such as temperature, torque,

developed according to GAMP guidelines

pressure and flow rate for liquid binder

and is extended to include a PC above

and strip gas, Hüttlin provides monitoring

a certain scope. Provicon fulfills all

of product humidity and particle size

requirements of the FDA 21 CFR part 11.

distribution. A NIR (Near Infrared) sensor can be integrated for inline monitoring

PAT Integration

of the product quality, residual

Process monitoring is one of the most

humidity, mixing quality and particle

important measures for meeting and

size distribution.

reproducing the required quality.

Hüttlin GmbH A Bosch Packaging Technology Company

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