Pharmaceutical Division
AIR + STEAM MIXTURE STERILIZATION
AUTOCLAVES - SUPERHEATED WATER
STERILIZATION AUTOCLAVES
ICOS is presen on the international markets with a
wide range of Autoclaves using the air + steam or
the superheated water for the terminal sterilization of
injectable solutions.
The wide experience acquired at ICOS in about 30 years
of activity anables us to offer an extremely diversified
products capable of meeting the requirements of
the most varied applications and to satisfy the strictly
standards of pharmaceutical industry
(FDA, cGMP, GAMP 5, etc.).
These machines are identified as follows:
• AIR + STEAM MIXTURE AUTOCLAVE,
AMS SERIES
• SUPERHEATED WATER AUTOCLAVE,
ASS SERIES
FIELD OF APPLICATION
The autoclaves in this series are used
to sterilize liquids in sealed containers
suh as: bottles, bags, prefilled syringes,
pockets, etc.
LOADING SIDE - TYPE AMS 24/1920
AMS
ASS
Series
Pharmaceutical Division
MAIN FEATURES
AIR+STEAM MIXTURE STERILIZATION
DETAIL OF DOORS MOVEMENT
ENT ON WORLD MARKETS WITH
D
EXTENSIVE
RANGE
OF
AUTOCLAVES USING AN AIR +
URE OR SUPERHEATED WATER .
O C L AV E S A R E U S E D I N T H E
ICAL INDUSTRY AND IN THE
SING FIELD.
S” MODELS IDENTIFY THE
VES THAT USE AN
MIXTURE.
” MODELS IDENTIFY THE
VES
THAT
USE
ED WATER.
SENTE SUI MERCATI MONDIALI CON
ASTA GAMMA DI
A UTOCLAVI
DI
NE CHE UTILIZZANO LA MISCELA
L’ACQUA SURRISCALDATA; QUESTE
RE VENGONO UTILIZZATE IN VARI
COLARE NELL’INDUSTRIA FARMACEU-
ORE ALIMENTARE.
AMS” IDENTIFICANO LE AUTOCELA ARIA+VAPORE.
“ASS” IDENTIFICANO LE AUTOQUA SURRISCALDATA.
required for the validation tests.
• Possibility of applying an
automatic loading and unloading
device for the product holding
structures.
• La camera di sterilizzazione è
costruita a sezione tonda, all’interno
sono applicati tutti gli accessori per
l’utilizzo con miscela aria+vapore o
acqua surriscaldata.
• Il corpo macchina è coibentato con
materiale ceramico con rivestimento
di lamierino in acciaio inossidabile.
• Il corpo macchina è supportato da
un telaio realizzato per consentire
un’ adeguata distribuzione del carico
sul pavimento.
• Sulla parte bassa della camera vengono applicate le guide per lo scorrimento delle strutture.
• La movimentazione delle porte
viene eseguita mediante dispositivo
elettromeccanico.
• La macchina dispone di connessioni
necessarie per i test di validazione.
• Possibilità di applicare dispositivo
di carico e scarico automatico delle
strutture.
DETAIL OF AIR RECYCLING FAN
OF APPLICATION
DI APPLICAZIONE
ves in this series are used
e liquids contained in
such as bottles, pockets,
di macchine vengono utilizerilizzazione di liquidi conteienti quali flaconi, sacche,
HARACTERISTICS
• Sterilization chamber of round cross section, containing all the accessories for its use with an
air+steam mixture or superheated water
• Machine body insulated with an high density ceramic material and covered by AISI 304 stainless
steel sheet
• Machine body supported by a frame designed for a suitable load distribution on the floor
• Chamber bottom fittedSTERILIZATION
with guides for moving
the product
loading carts
AUTOCLAVES • SUPERHEATED-WATER
AUTOCLAVES
/ AUTOCLAVI
DI STERILIZZAZIONE
• Doors driven by an electromechanical system
STICS
CONSTRUCTION CHARACTER
•IProvision
of connections required for the validation tests
CARATTERISTICHE COSTRUTTIVE
• Possibility of applying an automatic loading and unloading device for the product loading carts
The machine body and associated
safety devices are manufactured and
tested in compliance with the
standards required in the country of
destination. Unless there is a specific
request, the machines and systems
are manufactured in compliance
with the CE Standards.
• Machine body of AISI 316L
stainless-steel construction.
• Support frame of AISI 304
stainless steel.
• External panelling made of AISI
304 stainless steel.
• All the machine components are
of sanitary type.
• In the standard version, the door
tightness is guaranteed by a
pneumatically pressurized silicone
gasket.
• On request, the door gasket can
be made of an automatic pressuresealing type. This system guarantees
the tightness of the door in any
condition of operation.
• The chamber inside surface, the
CONSTRUCTION FEATURES
The machine body and associated safety devices are manufactured and tested in compliance
with the standards required in the country of destination. Unless there is a specific request, the
machines and systems are manufactured in compliance with the european (PED) or american
(ASME) standards.
• Machine body of AISI 316L stainless-steel construction
• Support frame of AISI 304 stainless steel
• External panelling made of AISI 304 stainless steel
• All the machine components are of sanitary type
• In the standard version, the door tightness is guaranteed by a pneumatically pressurized silicone gasket
• On request, the door gasket can be made of an automatic pressuresealing type. This system guarantees the tightness of the door in any
condition of operation
• The chamber inside surface, the tubing and all parts in contact with
the product are polished to a degree of roughness ² 0,5 um
ISTICHE PRINCIPALI
ion chamber of round
on, containing all the
s for its use with an
m
mixture
or
ed water.
body insulated with
material and externally
sheet stainless steel.
body supported by a
signed for a suitable
bution on the floor.
r bottom fitted with
moving the product
ructures.
driven
by
an
chanical system.
on of connections
AUTOMATIC LOADING AND UNLOADING
LOADINZ & UNLOADING SIDE - LATO CARICO E PRELIEVO
MOD.: ASS 15 / 1500
LOADING AND UNLOADING SIDE - TYPE AMS 30/1920
If particular reasons require that loading and unloading be carried out
automatically, ICOS can propose a range of solutions compatible with
the requirements of the customer.
A MISC
tubazioni ed ogni altra parte a contatto
con il prodotto vengono lucidate con
grado di rugosità ≤ 0,5 µ.
AIR + STEAM MIXTURE STERILIZATION
AMS
AUTOCLAVES - SUPERHEATED WATER
ASS
PROCESS DATA
C O N T R O L S Y S T E M STERILIZATION AUTOCLAVES
AUTOMATIC LOADING ANDSeries
UNLOADING
DATI DI PROCESSO
CELA ARIA+VAPORE • AUTOCLAVI DI STERILIZZAZIONE AD ACQUA SURRISCALDATA
SISTEMA DI CONTROLLO
PROCESS DATA
CARICOSIDE
-SC
RIC
O AU
OMATICO
LOADINZ & UNLOADING
-A
LATO
CARICO
ET
PRELIEVO
The sterilization program using an
The sterilizers
an air+steam
air+steam
mixtureusing
is applied
for
mixture
andof
superheated
different
types
loads. It iswater
also are
provided
with
a
control
system
used in microbiological laboratories,
consisting
of asterilization
programmable
particularly
in the
of
controller,
and printer.
sealed
plasticcomputer
containers.
The
The
control
system
manages
process foresees the application of the
machine and its basic
counterpressure
to parameters,
avoid
such as
temperature, Fo and
permanent
deformations.
pressure; it allows an easy
The sterilization program using
interfacing with the operator and
superheated water is used mainly
makes it possible to customize the
for sterilizing large containers,
work
cycles
and
manual
although it can also be used for
operations. The system provides a
other types of loads. The product is
complete hard-copy process
treated in counterpressure, in order
documentation and assists in the
to avoid deforming or breaking the
convalidation procedures.
containers.
N.B.: A full description of the
control system is contained in the
Il programma di sterilizzazione con
relative booklet.
miscela aria+vapore trova applicazione
MOD.: AMS 10
1500
If /particular
reasons require that
loading and unloading be carried
out automatically, ICOS Impianti
can propose a range of solutions
compatible with the requirements
of the customer.
Quando particolari necessità richiedono l’automazione delle operazioni di
carico e scarico, la ICOS Impianti, può
proporre una serie di soluzioni, compatibili con le esigenze del cliente.
The sterilization program using an air+steam mixture is applied for different types of loads.
It is also used in microbiological laboratories, particularly in
the sterilization of sealed plastic containers.
The process foresees the application of counterpressure to
avoid permanent deformations.
The sterilization program using superheated
water
is used
OF THE MATERIALS
IN THE QUALITY
per diversi
tipi di carichi.
Esso vieneUSED,
laboratori
A Nutilizzato
D I N Tnei
R A C also
C U RmicrobioAT E F I N I S H ,
mainly for sterilizing large containers,anche
although
itH E Ican
logici,C OinNparticolare
nella sterilizzazione
STRUCTION
AND
PROCESS
be used for other types of loads.
di contenitori
chiusi
in
materiale
E ICOS
C H A R A C T E R I S T I C S , A L L T Hplastico, ilMACHINES
processo prevede
la contropressioARE IN COMPLIANCE
WITH THE
The product is treated in counterpressure,
in UPorder
to avoid
ne per
evitare
deformazioni
permanenti.
-TO
-DATE STANDARDS
.
MOST
Il
programma
di
sterilizzazione
ad
deforming or breaking the containers.
CONTROL SYSTEM
acqua
viene prevalenteLe surriscaldata
macchine di sterilizzazione
a miscela
mente
utilizzato per
contenitori
di gros-sono
aria+vapore
e acqua
surriscaldata
so volume,
toglie
possacostidotate diciòunnon
sistema
di che
controllo
essere
utilizzato
anche per carichi
divertuito
da controllore
programmabile
si. Il computer
trattamento
viene fatto in controe stampante.
pressione,
per
evitare
deformazioni
deimacIl sistema di controllo gestisce la
contenitori,
o eventuali
rotture.fondamentali,
china ed
i suoi parametri
temperature, Fo, pressioni; conLe machins of “AMS” ed “ASS” series arequali
provided
with a control
sente un facile interfacciamento con
l’operatore e permette
personalizzasystem made up of a programmable controller
(PLC), laoperating
zione di cicli e gli interventi manuali.
produce computer
una completa docupanel (OP) orInoltre
industrial
(PC)
mentazione di processo ed assiste alle
and printer. operazioni di convalida della macchina.
La descrizione completa del sisteThe control N.B.:
system
manages the
ma di controllo è riportata nell’apposito
machine andprospetto.
its basic parameters,
L E M A C C H I N E P R O D O T T E D A L L A ICOS
such as temperature,
and pressure;
IMPIANTI, PER LAF0,
QUALITÀ DEI MATERIALI UTILIZZATI, PER L’ELEVATO GRADO DI FINITURA, PER LE
it allows an easy
interfacing with the
CARATTERISTICHE COSTRUTTIVE E DI PROCESSO,
TUTTE CORRISPONDENTI
AGLI STANDARD
operator andSONO
makes
it possible
to
FARMACEUTICI PIÙ RECENTI.
customize the working cycles and
maintenance operations.
The system provides a complete hardcopy process documentation and
assists in the convalidation procedures.
FUNCTIONAL DIAGRAM - DIAGRAMMA FUNZIONALE
FUNCTIONAL
DIAGRAM
AIR + STEAM MIXTURE
AUTOCLAVE - AUTOCLAVE A MISCELA ARIA + VAPORE
AIR + STEAM MIXTURE AUTOCLAVE
Note: A full description of the control
system is contained in the relative
booklet.
In the quality of the materials used, and
in their accurate finish, construction
and process characteristics, all the icos
machines are in compliance with the
FUNCTIONAL DIAGRAM - DIAGRAMMA FUNZIONALE
most up-to-date
standards.
SUPERHEATED
WATER AUTOCLAVE - AUTOCLAVE AD ACQUA SURRISCALDATA
FUNCTIONAL DIAGRAM
SUPERHEATED WATER AUTOCLAVE
CONTROL BOARD
CONTROL BOARD
QUADRO DI CONTROLLO
www.icosimpianti.com
NORMS AND STANDARDS
The new ICOS autoclaves are in
compliance with the following
Norms and Directives:
Governing directive/standard for
pressure vessels:
• CE NE 97/23/EEC (PED)
• ASME code Sec. VIII Div. 1, 2001
Ed. + Add. 2003
Technical norms/standards:
• CE EN 285:2009 + A2:2009
• 2004/108/EC
• 2006/42/EC
• cGMP
• CE EN 61010-1
• CE EN 61010-2-040
• HTM 2010
• UL, NEMA 4X, OSHA
AMS SERIES - AIR + STEAM MIXTURE AUTOCLAVES
Type
AMS 13/1100
AMS 26/1100
AMS 39/1100
AMS 13/1500
AMS 26/1500
AMS 39/1500
AMS 52/1500
AMS 26/1920
AMS 39/1920
AMS 52/1920
AMS 62/1920
AMS 74/1920
AMS 84/1920
AMS 96/1920
AMS 108/1920
AMS 120/1920
Chamber dimensions (mm / inches)
Overall dimensions (mm / inches)
Diameter
Width
Height
Lenght
Width
Height
Lenght
1100 / 43
1100 / 43
1100 / 43
1500 / 59
1500 / 59
1500 / 59
1500 / 59
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
800 / 31.5
800 / 31.5
800 / 31.5
1000 / 39
1000 / 39
1000 / 39
1000 / 39
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
800 / 31.5
800 / 31.5
800 / 31.5
1000 / 39
1000 / 39
1000 / 39
1000 / 39
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1300 / 51
2600 / 102
3900 / 154.5
1300 / 51
2600 / 102
3900 / 154.5
5200 / 204.5
2600 / 102
3900 / 154.5
5200 / 204.5
6200 / 244
7400 / 191
8400 / 330.5
9600 / 378
10800 / 425
12000 / 472.5
2200 / 86.5
2200 / 86.5
2200 / 86.5
2800 / 110
2800 / 110
2800 / 110
2800 / 110
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
2380 / 93.5
2380 / 93.5
2380 / 93.5
2480 / 97.5
2480 / 97.5
2480 / 97.5
2480 / 97.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
1780 / 70
3080 / 121
4380 / 172.5
1780 / 70
3080 / 121
4380 / 172.5
5680 / 223.5
3080 / 121
4380 / 172.5
5680 / 223.5
6480 / 255
7880 / 310
8880 / 349.5
10080 / 397
11280 / 444
12480 / 491
ASS SERIES - SUPERHEATED WATER AUTOCLAVES
Type
ICOS RESERVES THE RIGHT TO MAKE
PRODUCT CHANGES WITHOUT PRIOR
NOTIFICATION
Useful
Capacity
(litres / cu. ft.)
830 / 29
1660 / 58.5
2490 / 88
1300 / 46
2600 / 92
3900 / 137.5
5200 / 183.5
4900 / 173
7370 / 260
9830 / 347
11720 / 414
13990 / 494
15880 / 560.5
18150 / 641
20420 / 721
22690 / 801
ASS 13/1100
ASS 26/1100
ASS 39/1100
ASS 13/1500
ASS 26/1500
ASS 39/1500
ASS 52/1500
ASS 26/1920
ASS 39/1920
ASS 52/1920
ASS 62/1920
ASS 74/1920
ASS 84/1920
ASS 96/1920
ASS 108/1920
ASS 120/1920
Useful
Capacity
(litres / cu. ft.)
830 / 29
1660 / 58.5
2490 / 88
1300 / 46
2600 / 92
3900 / 137.5
5200 / 183.5
4900 / 173
7370 / 260
9830 / 347
11720 / 414
13990 / 494
15880 / 560.5
18150 / 641
20420 / 721
22690 / 801
Chamber dimensions (mm / inches)
Overall dimensions (mm / inches)
Diameter
Width
Height
Lenght
Width
Height
Lenght
1100 / 43
1100 / 43
1100 / 43
1500 / 59
1500 / 59
1500 / 59
1500 / 59
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
1920 / 75.5
800 / 31.5
800 / 31.5
800 / 31.5
1000 / 39
1000 / 39
1000 / 39
1000 / 39
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
1220 / 48
800 / 31.5
800 / 31.5
800 / 31.5
1000 / 39
1000 / 39
1000 / 39
1000 / 39
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1550 / 61
1300 / 51
2600 / 102
3900 / 154.5
1300 / 51
2600 / 102
3900 / 154.5
5200 / 204.5
2600 / 102
3900 / 154.5
5200 / 204.5
6200 / 244
7400 / 191
8400 / 330.5
9600 / 378
10800 / 425
12000 / 472.5
2200 / 86.5
2200 / 86.5
2200 / 86.5
2800 / 110
2800 / 110
2800 / 110
2800 / 110
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
3500 / 137.5
2380 / 93.5
2380 / 93.5
2380 / 93.5
2480 / 97.5
2480 / 97.5
2480 / 97.5
2480 / 97.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
2580 / 101.5
1780 / 70
3080 / 121
4380 / 172.5
1780 / 70
3080 / 121
4380 / 172.5
5680 / 223.5
3080 / 121
4380 / 172.5
5680 / 223.5
6480 / 255
7880 / 310
8880 / 349.5
10080 / 397
11280 / 444
12480 / 491
ICOS IMPIANTI GROUP S.p.A. - Pharmaceutical Division
Via E. Ellero, 15 - Zona Industriale - 33080 Cusano di Zoppola (PN) - Italy - Phone +39 0434 979596 - Fax +39 0434 574080
e-mail: [email protected]