AccelacotaBrochure2006.pdf

accelacotaestablished coating technologyaccelacota 150

accelacota 350

accelacota 750

www.manesty.com automation technologies

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Pro_Accelacota_uk.qxd 12.05.2006 14:11 Uhr Seite 2

p ro d u c t s accelacota 150, 350, 750With several thousand installations worldwide, the accelacota pioneered the way tablets could

be coated. Using sided vented pan technology, coating times were slashed and quality became

reproducible. Today using the latest in spray gun design, mixing baffles and control systems, the

accelacota continues to take the science of coating to new heights.

02 p ro d u c t s

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proven technology


accelacota 150Suitable for medium scale production

Standard drum capacity 170 litres

Alternative drum capacity of 230 litres is available

Segmented drums available for pellet coating

accelacota 350Suitable for large scale production


Alternative drum capacities of 310 or 450 litres are available


m ac h i n e established coating technology accelacota 150, 350 and 750The accelacota is used as a model against which all other manufacturers units are compared.*

The accelacota range of coating equipment is the pharmaceutical industry's tablet coating

standard, benefiting from a proven global installed base of accelacota 150 and accelacota 350

and now joined by the new accelacota 750.

04 m ac h i n e

This high quality coating equipment,

designed to cover a wide range of pro-

duction batches from medium scale to

large scale, has an unbeatable combina-

tion of a very efficient coating process

coupled with a high rate of return on

investment.

Innovative science based develop-

ments in the four key areas of; tablet mix-

ing, spraying, drying efficiency and con-

trol system technology, guarantee that the

accelacota provides a very effective

solution to obtaining a highly controlled

process, ensuring the delivery of high

quality end product.

The coater can also be provided with an

optional validatable clean in place system

with strategically located cleaning nozzles,

controlled by m-tec control system

technology.

effective drying

The fully perforated side-vented coater

drum and cabinet design allows highly

effective drying capacity in the process

without the need to use high drying tem-

peratures eliminating lower process effi-

ciencies (spray drying) and detrimental

thermal stresses on the product.

* Pharmaceutical Coating Technology, Coley, Hogan and Aulton.

1

1 temperature distribution in the

coating chamber

coating pan comparisons manesty competitors products

Perforated Pan Partially Perforated Pan Solid Pan

Drying efficiency High Intermediate Low

Turbulence Low High Intermediate

Processing conditions Lower heat temperature Higher inlet temperature Highest inlet temperature

required due to high required due to lower as airflow is low

airflow air flow

Process efficiency Extremely high Low due to spray drying Intermediate, around 90%

(>98%) caused by turbulence and

high inlet temperature

Process time Short Intermediate Long


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internal cabinet view

accelacota 750Suitable for large scale production


Alternative drum capacity of 750 litres is available


key benefitsLow capital investment

Reduced cost of ownership

Unique mixing baffle designs

Anti-bearding spray system

M-tec Integrated control system

Globally installed, proven technology

Minimal coating process times

accelacota drum capacities

accelacota 750

accelacota 350

accelacota 150

nominal batch

size (litres)

number of

spray guns

8

0 50 100

150

200

250

300

350

400

450

500

550

600

650

700

750

800

5 to 6

3 to 4


t e c h n o lo g y established technology why you should choose the manesty accelacota with m-tectm The accelacota range offers a high rate of return on investment.

m-tec fully modular control system. You determine the level of automation.

0 6 t e c h n o lo g y

versatile

Offering the ability to cover a wide range

of batch sizes, process complexities and a

full range of optional equipment, meeting

all of your coating needs.

proven

A large global installed base of equip-

ment, successfully coating tablets for

many years.

manesty

Our unrivalled process knowledge, equip-

ment quality and after market support

ensures our customers are choosing the

number one supplier of coating equip-

ment packages in the world.

1

1 spray guns

accelacota 150

and accelacota 350


t e c h n o lo g y mixing efficiencymanesty determine the product movement in the coating pan to be a key

attribute in the coating process. Effective mixing will give the benefits of low

product losses, low coating weight variability, eliminate product damage

and therefore increase productivity.

07

unique designs

Due to the unique designs of mixing baf-

fles offered on the accelacota range,

controlled product movement and even

distribution of the coating solution is

achieved.

mixing times

Baffle designs have shown mixing times of

40 to 50 minutes. These times have been

determined using a Colourimeter to mea-

sure the colour build up on tablets during a

coating process.

key benefitsBaffle designs to cover all product forms

Increased productivity, reduced product variability

Reduction in material costs

Controlled product movement

ploughshare stealth tubluar

mixing

efficiency High High Highest

Applications High friable products Friable products Products with

Reduced batch sizes Products with friability

0 8 t e c h n o lo g y

t e c h n o lo g y new simulation technologies opti coattm spray scienceComputational Fluid Dynamics (cfd) simulation software has been utilised to gain an

understanding of the complex nature of the atomization process and has allowed engineers

to optimise the airflow characteristics of the microclimate, which occurs in the vicinity

of the spray gun nozzle and the form of internal liquid and air flow passageways.

3

In addition, manesty has considered how

the coater cabinet drying airflow is affect-

ed in the region of the spray guns and its

manifold assembly. This has led to a

reduced spray gun profile design which

also optimises the drying air passage to

the tablet bed surface, thereby achieving

ideal conditions for coating film forma-

tion. By utilising new simulation technolo-

gies manesty has adopted a science

based design approach, which has led to

the successful development of the Opti

Coat spray gun. Many factors influence

the quality of the final film coated prod-

uct, some key study areas are:

spray pattern analysis

The difference in spray gun designs

becomes more apparent when observing

the spray patterns produced. At corre-

sponding air pressures, a spray gun with

large air outlet orifices produces an air

pattern that is less favourable in terms of

distribution of the solution onto the tablet

bed. With competitor air cap designs spray

pattern air pressures have to be higher so

1 2

as to generate a desired elliptical spray

pattern. The Opti Coat spray gun air cap

design balances the need for anti-beard-

ing characteristics with the requirement to

generate effective spray patterns.

droplet measurement

From a process perspective the overall

droplet size and distribution (span) will

influence the occurrence of process relat-

ed problems such as spray drying and over

wetting. The greater the control on

droplet size the easier it will be to have a

repeatable high efficiency coating process.

By employing state of the art Laser

Diffraction Measurement technology,

manesty has produced the Opti Coat

spray gun to produce the narrowest

droplet size distribution.

Predictive capabilities manesty

Process Scientists have developed a com-

puter-generated matrix model providing

the ability to predict the influence of criti-

cal process parameters on droplet size and

span, as well as process scale up.

opti coat spray gun

The Opti CoatTM Spray Gun is the ultimate

choice for Pharmaceutical film coating.

air flow analyis

1 Mathematical model of spray gun and

manifold assembly.

2 Air velocity simulation over spray gun

and manifold.


key benefitsAnti-bearding system with superior spray pattern

Enhanced droplet performance

Tool free, gmp compliant design

Low profile shape with integral connections for reduced airflow turbulence

Retro-fit capability to upgrade existing coating equipment

Recirculation option

0 9

t e c h n o lo g y manestys opti coattm spray gunBy employing state of the art fluid flow simulation software and reviewing customer

requirements, manesty has developed the Optimum Coating spray gun, the Opti Coat.

The Opti Coat spray gun includes considerable enhancements over existing spray gun

technologies and ensures manesty maintains its strong position as a world leader

in the film coating process.

3 4 5

At the heart of the film coating process

the Opti Coat spray gun brings together

research from in-house Process Scientists

and Design expertise to deliver a spray

gun, which out performs the competition

in terms of performance and suitability for

customer requirements. Compliant in all

aspects of GMP (Good Manufacturing

Practice) and utilising materials accept-

able for use by the Global Pharmaceutical

Regulatory Authorities for sealing and

construction, the Opti Coat spray gun

is the ultimate choice for Pharmaceutical

tablet film coating.

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cfd images

3 Air cap mesh

4 Air plume pressure contours

5 Droplet simulation


10 co nt ro l

21

co nt ro l m-tec control system technologymanesty coater systems are equipped with the latest m-tec control system technology. This provides

complete control of the coating process including air handling and solution delivery, as well as subse-

quent clean in place requirements. The control system is common across the entire range of coating

machines available from manesty, including the laboratory xl lab, the premier and of course the

accelacota. m-tec systems are tailored, specific to customers requirements by building from a library

of generic modules. These packages can be upgraded later as user needs change or develop.

architecture and design

m-tec control system design takes

advantage of years of coating experience

and through in-house software develop-

ment, provides the most intuitive operator

interface. Primary design focus on process

functionality provides great alignment

with user requirements.

robust machine control. plc based

Machine Control to handle control devices

and safety systems.

operator hmi. pc based Operator

Interface withTouch Screen and stainless

steel keyboard (shown). Hazardous area

option also available.

flexible automation. Automated

sequences tailored to suit customers

process requirements.

data exchange. Integration to com-

pany networks and batch management

systems available using industry stan-

dards.

m-tec . Utilises Microsoft Technology

and opc communications. User Access

Control management. Designed to enable

regulatory compliance with cgmp, gamp

and fda 21 cfr part 11.

automation manager

Powerful configuration tools provided for

users to develop recipe driven automation

for both coating and cip operations.

Consistent with industry batch standards.

recipe management. Product recipes

can be created from pre-built recipe

method templates prior to release to pro-

duction.

recipe method editor. For develop-

ment of custom recipe method templates.

reporting tools

Range of Reporting and Trending pack-

ages to support manual operation and

flexible automation. Accurate data acqui-

sition and comprehensive production

records, suitable for use in 21 cfr part 11

compliant systems. Ensures High Level of

Traceability.


11

2 3

key benefitsCommon, scaleable, platform for r&d, Pilot Plant and Production

Standard Operation, Reporting and Automation

Improved Maintenance and Process support

Modular software to enable easy upgrade path

Enables regulatory compliance

In house software design ensures continuous support

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Manual Cleaning Functions

Maintenance level access allows direct

drive of equipment and control devices

3 automated operation

Recipe driven automation

of the coating process

Recipe driven automation

of the integrated clean in place system

Process Endpoint Determination

Flexible recipe methods, tailored

to customer requirements

1 advanced process control

Closed loop control of

all process critical parameters

Ancillary Equipment Control

Process Alarming

Secure Machine and

Process Interlock handling

Ensures high level of repeatability

2 manual operation

Manual production control and batch

record generation.

Easy and consistent operation using

automated coater and ancillary equip-

ment start up sequences


12 o p t i o n s

o p t i 0 n s flexible coating capability from manestyAs you would expect from a worldwide supplier of coating systems, a range of optional equipment

and services are available to suit budget, process, regulatory and climatic requirements. As a

major innovator in side vented pan technology for over 30 years, use our proven design and

process support personnel to optimise the design and implementation of your coating requirements.

ply and installation, positioning of equip-

ment, utility connections, commissioning,

validation and training take advantage of

manesty s One Stop Solution.

inlet air handling

As we supply our accelacota Coaters

worldwide, different climatic conditions

require a custom made solution for the

delivery of process air at the correct vol-

ume, temperature and humidity. Our

modular and flexible air-handling units

condition the incoming air to meet the

required process conditions. Options

include preheating, humidity control, and

filtration. The units can also be flexibly

installed as single horizontal line or in a

dual deck format to optimise the use of

available space.

design expertise

Take advantage of our knowledge to

ensure ductwork specifications and rout-

ings meet process requirements at the

coater and exhaust air is safely taken away.

We can save you time by calculating all

the important hvac requirements to allow

the coating process to be the most effi-

cient possible.

turnkey installation

Increasingly, customers are looking for a

complete solution not only for their

equipment needs but also for its safe and

rapid installation and its associated servic-

es and utilities. This ensures that a single

main contractor takes responsibility for

the complete line, guaranteeing smooth

transition to full operational status. From

design, health and safety, ductwork sup-

k e y

1 Exhaust Filter Unit

2 Exhaust Air Duct

3 Inlet Air Duct

4 Air Handling Unit

5 Supervisor Station

6 Operator Interface

7 Coater

8 Spray System

9 Solution Vessel


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solution delivery systems

The new Opti Coat spray gun is sup-

ported by an efficient peristaltic pump

delivery system. This ensures excellent

control of solution delivery as the pump

speed is controlled by the m-tec control

system. By simply switching tubing a

range of aqueous and organic solvents can

be successfully used. Individual monitoring

of the performance of each solution line is

also available. Other delivery systems are

available to enable the coating of tablets

with sugar suspensions or more difficult

organic solvents if required.

loading and unloading solutions

Typically, tablets are delivered into the

drum via a loading chute or a material

handling system via the door of the coater.

100% of tablets will be discharged

through the front of the coater by using

our reverse unloading package. This valu-

able option quickly and safely removes

tablets from the drum and delivers them

into your container.

post delivery support

Following delivery to your site our com-

missioning personnel will ensure per-

formance to SAT requirements. Fully

comprehensive validation documentation

will ensure that your new accelacota

Coating System fully supports the appro-

priate regulatory requirements that you

need to comply with. The IQ and OQ ele-

ments of this documentation can also be

implemented by manesty personnel (in

support of your own staff) to allow the

start of PQ testing in the shortest possible

time.

exhaust air handling

Once again a range of options are avail-

able to remove the air from the accela-

cota Coater. From a simple Mechanical

Shake System to Full Safe Change capa-

bility to handle potent compounds, we

can provide the appropriate solution for

you. To ensure there is no water damage

to the filters during the Clean in Place

process a bypass system is fitted as stan-

dard.

clean in place (cip)

In conjunction with our m-tec control

system we can provide a fully validatable

clean in place option to remove all con-

taminates. This avoids the need to under-

take further manual work which is often

the case at the end of a wash in place sys-

tem. From the initial rinse through to

compressed air cleaning of solution tubes,

The accelacota incorporates a proven

CIP design. Our package will ensure you

will be coating your next batch of tablets

in the minimum possible time.

Control functionality depends on optional package purchased.


t e c h n i c a l data specifications

accelacota 150

accelacota 350

2050

1631

1795

2398

2295

2581 1275

2621

14 t e c h n i c a l data

2062

2327

1962

1665

1474

1309

12002196


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accelacota 750

3100 1900

2595

2295 2

700

2050

2398

2414


manesty | Kitling Road . Knowsley . Merseyside . England . United Kingdom . L34 9JS t +44 151 547 8000 . f +44 151 547 8001 . www.manesty.com

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Worldwide addresses and contacts.

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a + f automation undfrdertechnik gmbhIndustriestrae 11-1332278 Kirchlengern . Germanyp +49 5223 8791 0f +49 5223 8791 [email protected]

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Production companies Distribution companies

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Documents

AccelacotaBrochure2006.pdf