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 In addition to the spraying fluid and the atomizing air, the Hüttlin spray nozzle also has a third component, the microclimate. The microclimate is gas that protects the spray nozzle from clogging. The spray direction of the nozzles is aligned with the exit of process air from the Diskjet. The number of

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

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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.

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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

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

ZERT

EU-Kennnummer: 0588

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 Hohe-Flum-Straße 42 79650 Schopfheim Germany Phone +49 7622 6884-0 Fax +49 7622 6884-111 www.boschpackaging.com [email protected]