Sterilization solutions
Serving the pharma industry worldwide
“For the Environmentally conscious”
Infection control solutions for the global
Pharmaceutical Industry
Located in modern factories near Venice in Italy, Steelco Group is a major global supplier of
infection control equipment and solutions for the healthcare, laboratory and pharmaceutical
sectors. Steelco’s success is demonstrated by its strong growth, becoming the partner of choice
for many of the world’s leading pharmaceutical companies who appreciate the company’s:
Extensive product range
Experience and knowledge
With over 3000 installations worldwide, Steelco
offers a wide portfolio including:
•Innovative washing equipment, customizing
loading racks to customer needs.
•Diversified, steam and ETO sterilization range
•Innovative fully automated closure processing
equipment.
•Drying and depyrogenation ovens
•Automation systems to maximize productivity
and safety.
•Strong track record of establishing long term
global partnerships.
•Integrated in-house operations from incoming
raw materials to installation, validation and
technical support.
•Fully certified quality systems with knowledge
of pharmaceutical manufacturing standards
Flexible solutions
•Ability to meet the most challenging processing
needs.
•Only using best proven readily available control
systems and components.
Center of washing
systems production
2
Global footprint
•Global HQ in Italy with regional customer
support centres in North America and Asia.
•Network of factory trained agencies in over 100
countries worldwide.
Center of sterilizers
production
“Engineered for quality”
Quality engineering process
Steelco Group’s engineering experience encompasses knowledge
and understanding to be able to satisfy the most stringent
requests from clients.
Technical consulting, design, engineering, project management, as well as commissioning and
qualification services of our equipment is offered, with customers appreciating the cost effective
high performance solutions offered to resolve complex washing and sterilization challenges.
Our respected engineering experience in the medical, laboratory, pharmaceutical and biotech
fields allows us to develop a proven approach that prioritizes the pharma manufacturing process
and safety bearing in mind life cycle costs of the equipment.
Our methodical approach is to first develop an in-depth understanding of the project and the
product goals in order to offer the best equipment and solution for the application.
Customers are always welcome to visit Steelco factories to see design and manufacturing
methods and audit our processes.
Quality system certification
In addition to having a certified Quality System as per ISO 9001 (and ISO 13485 for Medical
Division), our products are subject to rigorous quality control systems and inspection. This
coupled with continuously training our technically specialized personnel ensures you receive best
in class product solutions and support.
We constantly strive to improve on our high standards to enable us
to deliver optimal solutions for our partners in the pharma industry.
3
3D project layouts
Steelco Group offers complete ‘turnkey” solutions for washing and
sterilization processes in the pharmaceutical sector, with the ability to
undertake all stages of a project from concept to delivering solutions
that exceed customer expectations.
Steelco’s extensive experience assists customers to increase process productivity and quality
with improved ergonomics whilst limiting costs.
Washing systems
Autoclaves
Depyrogenization oven
Bin washer
Washer and sterilizer rubber
stopper and aluminum capping
Automatic unloading
4
“Service that is second to none”
Extensive customer
support services
Steelco Group offers a comprehensive range of services to ensure the
success of projects at each important step including:
•
•
•
•
•
•
•
•
•
•
•
Process and workflow design
Process equipment design and manufacture
Automation and SCADA
Installation and commissioning
Training packages, from basic to in-depth
Validation and documentation:
cGMP compliance consultancy and assessment
Training and assistance if requested by pharmaceutical companies
as well as regulatory inspectors on GMP related topics
Spare parts supply and first line service training
Fully comprehensive and preventative maintenance contracts
Periodic validation and re-qualification as required.
For all previously installed equipment Steelco can offer a range of
customizable service packages. Customer service excellence is Steelco
Group’s commitment to our clients and a cornerstone of our success with
emergency service support if needed available, 24 hours, 7 days a week.
Academy
Subject matter expertise is shared by our trainers at the Steelco academy
near Venice, Italy or at locations convenient to customers, with training on
a wide range of topics that are focused on:
•
•
•
Standards and work practices
Equipment and its use
Technical service training
Design warranty
Thanks to the design and quality of equipment, as well as the reliability of
the components used, Steelco can offer extended warranties.
Standard warranty is 10 years on pressure vessels. Steelco warrants
all materials and workmanship to be free of defects for 18 months from
shipment date. Steelco’s pharma sterilizer door gasket design carries a 4
years warranty without any lubrication required.
Only the best available “Non-Proprietary” components such as valves are
sourced. Components are selected for their reliability and availability to
reduce running costs and down time.
Steelco can use customer preferred parts provided that these meet
performance and reliability requirements.
5
Control system
User friendly control systems developed according to the latest
GAMP and design for 21 CFR Part 11 available, sourced from the
best available suppliers avoiding customized electronics.
Steelco Group can provide software source codes, allowing its customers to become
owners of the control system of the machine (“open source architecture”).
System platforms available include Siemens and Allen-Bradley which are easily
integrated with those already installed by pharmaceutical companies. The software is
structured and commented in English to allow a better understanding of functionality.
Multi Language tool for development software is also available.
Software is developed in compliance with current coding rules and programming and
according to standard ISA 88, ISA 95, IEC 61131-3 standard & GAMP 5.
The structure is designed for straightforward validation by the end user.
Tools to simplify validation are also available (validation wizard).
Telemodem capabilities are available for all our controller solutions as well as remote
diagnostic capabilities.
OP
PLC
INTEGRATED
ARCHITECTURES
INTEGRATED
ARCHITECTURES
Siemens
Siemens
AB
Allen-Bradley
AB
AB
AB
iFix
Siemens
6
ISA 88
Standard addressing batch process control
ISA 95
Enterprise-Control System Integration
IEC 61131
Programmable controllers
SiemensAB
...
Siemens
SCADA
Siemens
International standards:
iFix SC
Siem
HMI
Siemens
AB
HMI
Siemens
Allen-Bradley
OP
PLC
INTEGRATED
ARCHITECTURES
OP
SCADA
HMI
PLC
Allen-Bradley
...
“Safe reliable communication”
Integrated architecture
Steelco can install new equipment into an existing automation
system through the adoption of a simple (HMI) or more sophisticated
(SCADA) man-machine interface.
Complete customization of access levels is available (local or domain users).
In compliance with the individual internal policies of each customer, Steelco Group offers
remote service access by using virtual private networks to ensure the confidentiality and
safety of all transferred data.
Safe remote access using UMTS/LTE/GPRS networks solutions are also available.
All Steelco machines share the same interface system: despite different functions of modes with a logical evolution based graphic to interface ensure easier training and use
by operators.
Our machines are level 1 and 2 of the standard ISA 95, with the
ability to connect and supply all the next levels.
Level
Level
Level
4
3
2
Level
1
Level
0
business
logistic
systems (erp)
business planning
manufacturing
operations
systems
Manufacturing
Operations Management
mes, batch, lims,
am, etc
& logistics
Plant Production Scheduling,
Operational Management, etc
Dispatching Production, Detailed
Production Scheduling, Reliability
Assurance...
Work flow / recipe control to produce the
desired end products, maintaining records
and optmizing the production process.
Time Frame: Days, Shifts, hours, minutes,
seconds
Manufacturing Control
Monitoring, supervisory control and
automated control of the production process.
Time Frame: Minutes, seconds
control
systems
plc, dcs, pac
intelligent
devices
flow, vision,
pressure, etc
Establishing the basic plant schedule production, material use, delivery, and
shipping. Determining inventory levels.
Time Frame: Months, weeks, days
Basic control, supervisory
control, process sensing, process
manipulation
Sensing the production process, manipulating
the production process.
Time Frame: Minutes, seconds, milliseconds
The actual production process.
Time Frame: Minutes, seconds, milliseconds
7
Validation documents
Your need is unique
User safety, product quality and data integrity are Steelco Group
core values.
Equipment is developed and validated according to the latest GAMP and cGMP
standards. Steelco “know-how” allows the client’s to benefit from optimal solutions for
their individual requirements, in order to perform effectively and reproducibility cleaning,
sterilization and validation of pharma production components.
A risk based approach to comply with regulatory requirements is fundamental in the
development of our validation documentation. An extensive package is available to
minimize on-site validation time.
Steelco Group documents include but are not limited to the following:
•
•
•
•
•
•
•
•
•
Hardware Design Specification
Functional Design Specification
Software Design Specification
P&ID (Piping and Instrumentation Diagram)
Component List
General Arrangement Drawing
Electrical Drawings
Quality and Project Plan
Traceability Matrix
Steelco Group is available to customize documentation packages according to customer
standard requirements and to produce specific documents upon request.
Pre-validation of Steelco Group equipment ensures minimal project risk, less time and
cost to qualify the units on site.
8
“Tested and validated solutions”
Acceptance Tests & on site activities
Our reliability is unique
Factory Acceptance Test and Site Acceptance Tests.
Steelco Group is available anytime to support customers during all acceptance on site
including process development and mapping.
All on site activities undertaken to pre-agreed written protocols according to GDP and
HSE requirements.
Steelco keeps records of the technical file of each machine to enable full access in case of
third party inspection to verify compliance with directives and regulations currently in force.
Expertise in Design Quality and Hazop is available to customers.
Installation qualification (IQ), operational qualification (OQ), and performance qualification
(PQ) are provided in standard version or customized according to the final scope
of supply.
V-Model for specification, installation, start up and qualifications
User Requirements
Specification
verifies
Functional
Specification
verifies
Design
verifies
Specification
Performance
Qualification
Operational
Qualification
Installation
qualification
System Build
Safety
Safety features and interlocks are mandatory requirements for a safe operating system
and to maintain required quality. Steelco’s ergonomically designed equipment includes
appropriate alarms and other personnel protective devices.
9
Compliance and guidelines
Steelco Group complies with latest International requirements and guidelines, as well as local standards as
applicable:
European Directives
2006/42/EC
Safety of machinery
2004/108/EC and
amendments
Electromagnetic compatibility
2006/95/EC and amendments Low-voltage devices
97/23/CE
Pressure Equipment Directive-PED
ATEX 94/9/CE
Electrical equipment for explosive atmospheres
European standards
EN 12100-1
Safety of machinery. Basic concepts, general principles for design.
Part 1: Basic terminology, methodology.
EN 12100-2
Safety of machinery. Basic concepts, general principles for design.
EN 13857
Safety of machinery. Safety distances to prevent hazard zones being reached by
upper and lower limbs.
EN 349
Safety of machinery. Minimum gaps to avoid crushing parts of the human body.
EN 61000-6-2
EN 61000-6-4
Electromagnetic compatibility (EMC). Generic standard. Part 6-2: Immunity for
industrial environment. Part 6-4: Emission Standard for industrial environments (IEC
61000-6-4,modified); German version EN 61000-6-4.
EN 55011
Industrial, scientific and medical (ISM) radio-frequency equipment.
EN 61000-4-2 (IEC 1000.4.2)
EN 61000-4-4 (IEC 1000.4.4)
Electromagnetic compatibility (EMC). Part 4: Testing and measurement techniques.
Section 2: Electrostatic discharge immunity test. Section 4: Electrical fast transient/
burst immunity test
AD 2000
Calculation code harmonized with Directive 97/23/EC
EN 60204-1 (IEC 204.1)
Safety of machinery. Electrical equipment of machines. Part 1: General requirement
EN ISO 11135
Specifies requirements for the development, validation and routine control of an
ethylene oxide sterilization process
EN 1422
Sterilizers For Medical Purposes. Ethylene Oxide Sterilizers. Requirements And Test
Methods.
North American Standards
Canadian Standards
OSHA
CSA
NFPA
CRN
when applicable:
Russian Standards
FDA
GOST
UL
ASME
10
China Regulation
SELO
LST/LT Series
CLOSURE PROCESSING
SYSTEMS
Completely integrated
all in one solution
LST/LT Series
Closure processing equipment
Sterile continuity is the vision
Steelco Group aims at reducing manual contact to
the minimum level. The LST/LT series is ideal for the
treatment of closures for containers normally used
in the pharmaceutical industry, where continuous
sterility has to be maintained between different
phases.
The LST Series offers washing, rinsing, siliconizing,
sterilizing, drying and cooling all in one solution and
is compatible with different loading/unloading systems,
with the ability to interface with vaporized hydrogen
peroxide isolator.
Steelco Group produces a “Closure washer” version
- LT series - which only provides washing, rinsing,
siliconizing, drying and cooling phases.
Patent pending
Thanks to an extended range of capabilities, Steelco
Group now offers innovative customized stopper
processor solutions for highly cost-effective projects.
Chamber volume
from 40 litres / 1.4 cu.ft
to 480 litres / 17 cu.ft
Field of application
Designed for the
complete treatment
of closure devices
for pharmaceutical
products such as:
rubber stoppers,
plastic stoppers,
droppers, pistons, aluminium caps and other similar
components.
Closures loading
options:
• manual
• automatic
12
Useful baskets volume
(litres / cu. ft.)
40 / 1.4
80 / 2.8
120 / 4.2
180 / 6.4
240 / 8.5
480 / 17
Technical data, utilities consumptions and
drawings are available upon request
Automatic unloading into:
• washing
• rinsing
• siliconizing
• sterlization
• drying
• cooling
•
•
•
•
wheeled tanks
containers
sterile bags
sterile bags through HPV
(hydrogen peroxide vapor )
isolator
LEL
ALARM LIMIT
ALARM
CONTROLLIMIT
LIMIT
CONTROL LIMIT
DRYING PROCESS
DRYING PROCESS
“Assured
productivity and sterility”
250
250
200
200
150
150
100
The process
consists of combined phases and actions
100
50
designed
to provide maximum process flexibility and
50
Advantages of Steelco technology
TEMPERATURE
TEMPERATURE
Sterilizing quality process
Physical separation of the load into different sub batches
(basket) with uniform capacity offers the following
advantages:
efficiency.
LTat the same time
�
LT
PROCESSING EQUIPMENTstoppers
LST
capable of processing different kinds of
washing
drain
drain
dripping
dripping
1st rinse
1st rinse
drain
drain
dripping
�
drain
drain
dripping
dripping
3rd rinse
3rd rinse
drain
drain
dripping
dripping
siliconizing
siliconizing
drain
drain
dripping
dripping
sterilization
sterilization
drying
drying
cooling
cooling
product discharge
product discharge
through prearranged system
rotation,
rotation water spraying
�
rotation
enhanced surface exposure to
process fluids
rotation,
rotation water spraying
rotation
�
3000 // 110
118
2800
LT 240
3000 / 118
Type
optimization of the washing process,
with
WASHING
- RINSE effective
- SILICONIZING endotoxin and particle
reduction
WASHING
rotation,
water spraying- RINSE - SILICONIZING
3000 // 110
118
2800
3200 // 118
126
3000
2600 // 102
102
2600
2800 // 102
110
2600
LST
LST 240
180
3400
3200 // 134
126
3000
2800 // 118
110
LST 240
3400 / 134
ICOS RESERVES THE RIGHT TO MAKE
PRODUCT CHANGES WITHOUT PRIOR
ICOS
RESERVES THE RIGHT TO MAKE
NOTIFICATION
PRODUCT CHANGES WITHOUT PRIOR
NOTIFICATION
3000 / 118
1550 // 52
61
1330
1700 // 61
67
1550
42
84
12
8
18
12
pulses
1930vacuum
/ 76
20
360
240//12.7
8.4
540//12.7
19
360
240 // 6.3
8.4
180
720
540//25.4
19
240 / 8.4
720 / 25.4
drying
andPROCESSOR
cooling phases.
CLOSURE
TYPE “LST”: the “LST”
CLOSURE
“LST”: therinsing,
“LST”
process, inPROCESSOR
addition toTYPE
the washing,
phases
alsocomplete
includes the
sterilizing
phase. The
process
makes it
phase. The
possible
to complete
eliminate process
needlessmakes it
Useful
Total baskets
(litres /baskets
cu. ft.) (litres
/ cu. ft.)
volume
volume
20 // 0.7
60 // 2.1
(litres
cu. ft.) (litres
cu. ft.)
40
/
1.4
120
4.2
20 / 0.7
60 //2.1
80
2.8
40 // 1.4
120
4.2
80 //2.8
180 // 4.2
6.3
120
possible
to eliminate
intermediate
handlingneedless
of the product
intermediate
handling
of the product
that
may cause
its contamination.
240
8.4
120 // 4.2
360
240//12.7
8.4
540//12.7
19
360
that may cause its contamination.
sterilization
240
720
180 // 8.4
6.3
540//25.4
19
drying
drying
240 / 8.4sterilization
720 / 25.4
�
TIME
2,5
ICOS Pharma S.p.A. - Pharmaceutical Division
2,5
ICOS
Pharma
- Pharmaceutical
Division
Via
E. Ellero,
15 - S.p.A.
Zona Industriale
- 33080 Cusano
di Zoppola
(PN) - Italy
more efficient cycle
through prearranged system
These machines are designed for
for
products
such as:
rubber stoppers,
thepharmaceutical
complete treatment
of closure
devices
plastic
stoppers, droppers,
pistons,
aluminium
caps and
for
pharmaceutical
products
such as:
rubber stoppers,
other similar
components.
plastic
stoppers,
droppers, pistons, aluminium caps and
other similar components.
The control system manages the machine and its basic
1
parameters,
such as temperatures, F0, vacuum/pressure,
1
times0 and level control, and other critical parameters.
0
-1
The control
system monitors, records, and controls the
-1
operation of the equipment.
PRESSURE STERILIZATION
STERILIZATION
ports
allow
the downloading
ofCO2
data to a local
EthernetPRESSURE
non
explosive
mixtures
10% EO 90%
non explosive mixtures 10% EO 90% CO2
computer or to a future plant data collection system.
3 Rinsing phases
PRESSURE
PRESSURE
(BAR)
(BAR)
Actions
Loading of material
FIELD OF APPLICATION
Phone
+39 0434
5772911
- Fax +39
0434 5772900
Via
E. Ellero,
15 - Zona
Industriale
- 33080
Cusano di- e-mail:
Zoppola
(PN) - Italy
2 sales@icospharma.com
Phone +39 0434 5772911 - Fax +39 0434 5772900 - e-mail:
2 sales@icospharma.com
Customized cycle according
to client requirements.
Phases
cooling
cooling
STERILIZATION - DRYING - COOLING
FIELD OF APPLICATION
These machines are designed for
STERILIZATION - DRYING - COOLING
the complete treatment of closure devices
TIME
optimization
of the CIP phase
in a clean
environment
by means of prearranged
sterile
air at
20 C
°
system
in a clean environment by means of prearranged
system
industry
(FDA,
cGMP, GAMP
5, etc.).
This range
of machines
is made
up of two main categories:
This rangeWASHER
of machines
is made
ofoperating
two main process
categories:
CLOSURE
TYPE “LT”:
theup
“LT”
CLOSURE
TYPE “LT”:
the “LT”
operating process
consists ofWASHER
the washing,
rinsing,
siliconizing,
consistsand
of the
washing,
rinsing, siliconizing,
drying
cooling
phases.
steam
at 121
°C 130 C°
sterile air
at max.
sterile
sterile air
air at
at max.
20 C
° 130 C°
This
newthat
range
of ICOS
shows
series
of innovative
features
satisfy
the equipment
strict standards
of athe
pharmaceutical
features that
strict5,standards
of the pharmaceutical
industry
(FDA,satisfy
cGMP,the
GAMP
etc.).
2
2
rotation,
rotation water spraying
�
Number of
baskets
2
vacuum
pulses
1930
20
1700 // 76
67
18
rotation, water spraying
rotation
steam at 121 °C
120
4.2
80 //2.8
180 // 4.2
6.3
120
ICOS has a long experience in the treatment of closures for
ICOS has a long
experience
thepharmaceutical
treatment of closures
containers
normally
used ininthe
industry.for
containers
normally
used
in the pharmaceutical
This
new range
of ICOS
equipment
shows a seriesindustry.
of innovative
process,
in addition
to the
washing, rinsing,
siliconizing,
drying and
cooling
WASHING - RINSE - SILICONIZING
siliconizing,
drying and
phases also includes
thecooling
sterilizing
baskets Total baskets
Number of Useful
WASHING
RINSE
SILICONIZING
volume
volume
baskets
LST
LST120
80
LST 120
180
LST
uniform silicone distribution on individual
stoppers and the entire batch
rotation
20
Overall dimensions
Width
Height(mm / inches)
Lenght
2400 / 94.5
2600 / 102
1020 / 40
Width
Height
Lenght
2600 // 94.5
102
2600
1160
2400
2600 // 102
102
1020//45.5
40
2800 // 102
110
2600 // 102
102
1330//45.5
52
2600
2600
1160
rotation
�
1930 / 76
Overall dimensions (mm / inches)
rotation,
rotation water spraying
rotation,
rotation water spraying
1700 / 67
3000 / 118
LST
LST 40
20
LST 40
80
LST
Type
LST 20
TEMPO
TEMPO
rotation, water spraying
3000 // 110
118
2800
18
12
20
18
3rd RINSE
3rd RINSE
LT 180
240
LT
1550 // 52
61
1330
30%
1700 // 61
67
1550
30%
1930 / 76
2600 // 102
102
2600
2800 // 102
110
2600
nd
2nd 2RINSE
RINSE
2600 // 102
102
2600
2800 // 102
110
2600
1st RINSE
1st RINSE
LT
LT120
80
LT 120
180
LT
42
84
12
8
Useful baskets Total baskets
volume
volume
Useful
Total baskets
(litres /baskets
cu. ft.) (litres
/ cu. ft.)
volume
volume
20 // 0.7
60 // 2.1
(litres
cu. ft.) (litres
cu. ft.)
40 // 0.7
1.4
120
4.2
20
60 //2.1
80 // 1.4
2.8
240 // 4.2
8.4
40
120
LST SERIES - WASHING, SILICONIZING, STERILIZING AND DRYING MACHINES FOR
PHARMACEUTICAL
CLOSURES
LST
SERIES - WASHING,
SILICONIZING, STERILIZING AND DRYING MACHINES FOR
PHARMACEUTICAL CLOSURES
rotation, water spraying
dripping
2nd rinse
2nd rinse
minimizing particle generation due
to mechanical stress and effective
endotoxin reduction
rotation, water spraying
Overall dimensions
Width
Height(mm / inches)
Lenght
2000
/ 78.5
2600
/ 102
1020
/ 40
Width
Height
Lenght
2200 // 78.5
86.5
2600 // 102
102
1160
2000
2600
1020//45.5
40
2600 // 86.5
102
2600
1330//45.5
52
2200
2600 // 102
102
1160
Number of
baskets
Number of
baskets
2
rev. 01/12
rev. 01/12
loading
washingof material
LAVAGGIO - RISCIACQUO - SILICONATURA
LAVAGGIO - RISCIACQUO - SILICONATURA
ACTIONS
Overall dimensions (mm / inches)
LT 20
40
LT
LT 40
80
LT
Type
LT 20
ACTIONS
through
prearranged system
WASHING
WASHING
Type
CHAMBER
CHAMBER
WATER
WATER
%%
100%
LT SERIES - WASHING, SILICONIZING AND DRYING MACHINES
FOR PHARMACEUTICAL CLOSURES
100%
LT SERIES - WASHING, SILICONIZING AND DRYING MACHINES
FOR PHARMACEUTICAL CLOSURES
SILICONIZING
SILICONIZING
Pharmaceutical Division
PRESSURE
PRESSURE
(BAR)
(BAR)
PHASES
PHASES
loading
of material
COOLING
COOLING
Pharmaceutical Division
succession make it possible to obtain the most appropriate cycle for
the characteristics
the material
to bethe
processed.
succession
make itofpossible
to obtain
most appropriate cycle for
the characteristics of the material to be processed.
ACQUA
ACQUA
IN CAMERA
IN CAMERA
AMENTO
AMENTO
�
STERILIZATION
STERILIZATION
CLOSURE
www.icospharma.com
www.icospharma.com
elimination of the excessive
PROCESS DATA
accumulation of material during
PROCESS DATA
The process consists of combined phases and actions designed to
treatment phases
The process consists of combined phases and actions designed to
CHAMBER
CHAMBER
WATER
WATER
(%)(%)
G
G
LST
Series
Series
PRESSURE
PRESSURE
(BAR)
(BAR)
PROCESSING EQUIPMENT
HEATING
HEATING
The choice of time and phase succession allows the user to
STERILIZATION PROCESS
STERILIZATION
PROCESScycle to match the characteristics
obtain the
most appropriate
CLOSURE
of the material to be processed.
0
0
-1
-1
rotation, fluid bed
Washing
rotation, fluid bed, detergent
overflow
rotation, water diffuser
drain
rotation, water spraying
Siliconizing
dripping
rotation
drain
Sterilization
steam at 121 °C
VACUUM STERILIZATION
rotation, water diffuser
Drying 90% EO 10% CO2sterile air with HEPA filters
VACUUM
explosive STERILIZATION
mixtures
rotation, water spraying
explosive mixtures 90% EO 10% CO2
Cooling
sterile air with HEPA filters
rotation
in a sterile environment by
rotation, fluid bed, silicone
Product discharge
means of prearranged system
rotation, water spraying
dripping
rotation
overflow
drain
dripping
13
LST/LT series
Constructions features
The machine body and jacket are completely made of AISI 316L stainless-steel. The machine
body is insulated with ceramic material and with an external cladding of stainless steel.
AISI 316L stainless steel piping is connected with ASME tri-clamp connections. The inner part
of the chamber, the tubings, the baskets and all parts in contact with the product are polished
to ≤ 0.5 μm / 20 µ/in.
All welds are continuous, ground and provided with a surface finish equal to the level of finish
of the adjacent surfaces joined by the weld according to ASME BPE requirements. Gaskets,
elastomers, sleeves, and other interior sealing components are FDA approved.
The stopper processor uses fluid bed washing
technology, powered by a water recirculation pump.
This sets the machine apart from other
manufacturers by providing:
• A gentler and more effective washing action.
• No use of compressed air during the washing
cycle.
• The recirculation pump also acts as an
emulsifier of the silicone oil injected and
precisely dosed into the recirculation pump
loop system, allowing for the use of much
lower levels of silicone oil per cycle than other
solutions, making the CIP WIP cycle much
more effective.
�
Highly effective drying system by air
pulses and a rotating chamber canister.
Sample points available
for analysis
14
�
Equipment is engineered and
manufactured to optimize running costs,
saving utility costs.
FIlters available for
recycling phase
Electrical Panel in
compliance with EU, UL and
local standards as needed
“Advanced multitasking process”
LST/LT series
Chamber features
Even distribution of load in separate baskets ensures better final results. Washing by a
simultaneous combination of basket rotation and fluid-bed action is achieved by a recirculation
pump and spray nozzles. It is designed for continuous effective operation without excessive
adjustment or replacement due to wear.
The possibility to visually check line clearance simplifies the verification that no stoppers are left in
the unit from previous cycles.
Suspended particles are skimmed off by side overflow drains. Appropriate sized relief valves are
provided as required for each pressurized component.
�
The chamber can be completely
inspected through a loading door.
The basket doors have automatic
opening and closure.
�
No presence of sharp edges
in order to prevent injuries
to equipment operators or
damaging of the closures.
�
Ten different loading and
unloading solutions are offered.
LST/LT series
Loading systems
Automatic loading is undertaken using a: stopper storage tank with
mixer, suction tube, measuring tank with sanitary valves and aspirator.
Manual loading is carried out using AISI 304 stainless-steel
containers of the same capacity as the machine baskets.
15
LST/LT Series
Unloading systems
Possibility to interface the unloading door with wheeled tanks,
containers, sterile transfer bags and HPV (hydrogen peroxide
vapor) isolator.
Unloading door equipped with a system for interfacing with clean area
(bio-seal frame with “FDA approved facilities”).
Chamber doors made in accordance with requirements for sterile
environments.
Semiautomatic unloading into containers (“standard” application)
Unloading is semi-automatic and undertaken in stainless steel containers
provided with a lid of the same capacity as the machine basket.
The unloading phase is protected by a sterile air flow originating from the
inside of the chamber.
Automatic unloading into wheeled containers with Alfa Beta valve
Unloading is completely automatic and it is achieved with hermetically
sealed wheeled containers of 100 liter capacity; the containers are built of
AISI 316L stainless steel and are internally sterilizable.
Semiautomatic unloading into Sterile bags
Unloading is semiautomatic and it is discharged through sterilized PVC
bags. The bags are treated at the stainless-steel station provided with a
heat-sealing system for sealing the PVC bags. The unloading phase is
protected by a sterile air laminar flow.
Automatic unloading into clean pre-sterilized bags
through HPV Isolator
Unloading is completely automatic and it is carried out through HPV
Isolator and transferring into alpha-beta sterilized bags.
The complete system includes:
• HPV isolator with alpha-beta port.
• HPV generator.
• Conveyor system from CPE port and alpha-beta port.
• Set of alpha-beta bags (each bag with the same capacity as each
basket of the CPE – 10 litters of stoppers).
• Transferring trolley for bags.
Automatic unloading into Sartorius Stedim Biotech clean & pre-sterilized
Biosafe® Bags through the Biosafe® Biosteam S Port
Unloading is completely automatic and is carried out through the Biosafe®
Biosteam S Port transferring the closure into gamma-irradiated Biosafe® Bags.
The complete system includes:
• Biosafe® Biosteam Port ducted to the closure processing equipment.
• Biosafe® 110 Monolever Port ducted to the isolator of the filling machine.
• Disposable Biosafe® Bags.
• Transferring trolley for Biosafe® Bags filled with closure.
Biosafe and Biosteam are registered trademarks of Sartorius Stedim Aseptics S.A.
16
Patent pending
Versatile cGMP Steam Sterilizers
AV Series
SATURATED STEAM
STERILIZATION
AV Series
Saturated steam sterilizers
Obtain the best results
In pharmaceutical production, the need to optimize
sterilization processes is important to increase safety
and productivity.
Steelco Group is able to offer an extremely diversified
product range capable of meeting the requirements
of the most varied applications and satisfy the strict
standards of the pharmaceutical industry.
Due to our investments in the research of innovative
solutions, Steelco sterilizers are high performing,
reliable and easy to use with excellent results.
Steelco Group offers a wide selection of saturated
steam sterilizers to exceed industry standards, available
in single or pass-through versions, with hinged (AVL
Series) or sliding doors (AVS Series).
Built to a very high standard, each unit is tailored to the
customer’s individual specifications.
Cart guides are welded into chamber floor.
Field of application
Chamber volume
Used for sterilizing steam safe
materials such as: vials, bottles,
glass items, fabric materials,
sealed or vented containers,
rubber parts, machine part and
filters, etc.
from 195 litres / 7 cu.ft
to 10.000 litres / 353 cu.ft
in several different dimensions with
configurable options
Technical data, utilities consumption and
drawings available upon request
Floor or pit mounted solutions
Flexible layout options
The AV Series offers flexibility configuration
and versatility.
The electrical panel can be integrated or
remotely installed.
18
right
left
technical area
technical area
shared
technical area
round or rectangular
chamber
“Sterility Assurance”
Sterilizing quality process
The sterilization cycle has been specifically designed to reduce time and
energy consumption, improving efficiency and throughput.
The preconditioning phase at the beginning of the cycle and the fractional
vacuum phase at the end have been developed to maximize performance
and minimize cycle time and energy use.
Each sterilizer can be equipped with any combination of cycles with
complete flexibility to customize each phase and its parameters. Cycles
are easily recalled from the HMI and are protected from unauthorized
changes by a multi-level password system.
The following cycles are available depending on machine specification:
The control system manages the
machine and its basic parameters,
such as temperature, F0 and
pressure; it enables easy interfacing
with the operator and makes the
customization of working cycles and
maintenance operations possible.
Service programs:
Vacuum leak test
Machine SIP
Bowie & Dick test
Automatic sterilization of machine and vacuum brake filter (SIP)
Predisposition for Automatic integrity test of vacuum brake filter (W.I.T.)
Working programs:
Fractioned vacuum
Software used by Steelco is
according to GAMP guidelines and
designed for 21 CFR Part 11 where
required.
SCADA system available for
complete integration.
Rapid cooling by shower and counterpressure
Gravity purge and counter-pressure
Rapid cooling by shower and counterpressure + seal test by vacuum crush
Cooling by water injection in the jacket and counter-pressure
Air + steam mixture and counter-pressure
Tyndalization
Pharmacy with natural cooling
Slow heating with drying by slow vacuum
Drying by hot air
pit mounted
or floor loaded
vertical sliding down
horizontal sliding
left or right
hinged door
left or right
19
AV Series
Construction features
In the standard version, the door seal is achieved by a pneumatically pressurized
silicone gasket; ensuring the integrity of the door in any phase of operation.
Sliding doors are driven by an electromechanical system made in compliance with the
requirements for clean areas and it is equipped with bio-seal or airtight separation.
Door seal system guaranteed for 4 years operational use without lubrication.
The sterilizing chamber is entirely covered by
a full jacket system of dimple welded type for
fast heat transfer and to optimize chamber
temperature distribution.
Single or twin air filters installed in parallel,
capable of being sterilized in place.
Air detector following EN 285 to detect the
presence of air or non-condensable gases within
pure steam.
All piping and ports in contact with the chamber
are made of AISI 316L, are sloped and self
draining. All components are of sanitary type
where appropriate, including clamp fittings.
The front loading side is fitted with connection
ports for validation testing.
Airtight or bio-seal separation.
Low maintenance with long life
proven components.
Optimised for energy savings & low wastage.
Drain cooling system available to cool down all
effluents prior to discharge into drains.
Safe applications
The unloading door can be interfaced with a HPV (hydrogen peroxide vapor)
generator and/or isolation technology or with dedicated systems according
to sterile requirements.
HPV generator
20
isolation technology
TERMINAL
STERILIZATION
AMS/ASW Series
Steam and mixture
& Superheated water autoclaves
AMS Series
Steam air mixture
sterilizers
ASW Series
Superheated water
sterilizers
Different options
for differing needs
Steelco’s range autoclaves using air + steam or
superheated water are for the terminal sterilization of
injectable solutions.
Both methods of sterilization avoid any damage of
the processed liquid material and their containers,
including heat sensitive materials.
Thanks to an effective recirculation of air or water,
uniform temperature is maintained in the sterilizing
chamber, during all process phases.
Required pressure balance is achieved by using
sterile compressed air in the chamber.
Field of application
Used to sterilize liquids in
sealed or heat-sensitive
containers such as:
bottles, ampoules, vials,
semi-open containers,
bags, blister packing,
pre-filled syringes,
pockets, contact lenses, LPV’s, etc, and also for the
pasteurization of products like blood plasma.
Air-Steam or Superheater Water Process?
Selection depends on the products thermal lability,
level of dryness to be reached, utilities available on
site and running costs.
Chamber volume
from 830 litres / 29 cu.ft
to 25.000 litres / 883 cu.ft
in several different chamber sizes,
configurations and accessories to tailor
each unit to exact requirements
Technical data, utilities consumption and
drawings available upon request
Floor or pit mounted solutions
Versatile loading/unloading systems
and automation
Steelco can provide a range of automated loading and unloading solutions including
integration with robotic systems.
22
“Sterility Assurance”
Sterilizing quality process
AMS Series
The sterilization program using an air+steam mixture is
appropriate for different types of loads.
It is also used in microbiological laboratories, particularly
in the sterilization of sealed plastic containers.
The process includes the application of counterpressure
to avoid permanent deformation of containers.
Sterile compressed air
Pure steam is used in the
chamber for heating liquids
and over-pressure filtered
air is injected into chamber
to compensate for the rising
temperature and pressure
inside products.
Internal fans ensure a
uniform temperature
distribution, between 110°C
to 135°C, and to avoid cold
spots across the chamber.
ASW Series
The sterilization program using superheated water is used mainly
for sterilizing large containers, although it can also be used for
other types of loads.
The product is treated in counterpressure, in order to avoid
deforming or breaking the containers
The ASW Series offers a rapid, safe and effective terminal
sterilization process for high product throughput.
High capacity pump
Rapid heating and cooling
are standard phases.
Products are completely dry
at the end of the cycle.
Water is continuously circulated
through the system and cascades
over the load using spray nozzles,
high capacity pump and large
diameter piping to ensure high
water flow rates. The recirculating
water is heated and cooled by
external heat exchangers.
Meticulous control of heating
and sterilization is achieved by
superheating the water using
modulated steam.
Compressed air at overpressure
is injected to compensate for
the rising temperature and
pressure that builds inside the
products when heated. The
cooling phase brings the product
down to ambient temperature
by continuously spraying the
recirculating water over the load.
To assist heat penetration
and when fluids are liable to
separation, the load can be
rotated during the complete cycle.
Chamber Seal
An automatic pressure sealing type door gasket is available upon request.
This system ensures the seal of the door in any condition of operation.
Steelco Group guarantees these door seals for it 4 years.
23
AMS/ASW Series
Construction features
The machine body and jacket are completely made of AISI 316L
stainless-steel.
The machine body is insulated with ceramic material and with
external cladding stainless steel.
Pipings in compliance with ASME BPE made of AISI 316L
stainless steel with tri-clamp fittings and all machine components
of sanitary type.
The inner part of the chamber, the tubings, the baskets and all
parts in contact with the product are polished to ≤0.5 μm.
The control system PLC is capable of storing and
executing preprogrammed cycles and performing all
self-diagnostics cycles.
Unique sealing of fan shaft for easy
inspection and maintenance
Uniformity of temperature guaranteed
by recirculation pump action
Flexible RTDs
Recircutlation system
Energy savings with recirculation water
cooling system
Equipment is provided with a grounding
lug for proper static grounding and
seismic compliance if required
The front loading side the machine is provided with the
connection ports required for the validation tests.
Useful combined solution
Steelco Group designs combined/modular systems sterilization,
where heating and sterilization phases are carried out with saturated
steam, like a normal sterilizer, or with a mixture of steam and air in
the same autoclave.
24
CHEMICAL
STERILIZATION
AGS/AGS-E Series
Ethylene oxide media
AGS/AGS-E Series
Ethylene oxide sterilization autoclave
Steelco’s latest range of sterilizing autoclaves using Ethylene
Oxide increases performance and versatility.
Manufactured in our factories in Italy after a long research
program and an extensive series of tests, the AGS/AGS-E
series is the best relationship between engineering, quality,
price, operating running costs and most important safety of
the system and operators.
Steelco’s range of ETO sterilizers use thermal combustion for
a complete breakdown of the sterilizing gas.
Field of application
Used for low temperature
sterilization of heat-sensitive
products according to the EN
1422 Standards for the medical
processing industry such as:
plastic syringes, perfusion sets,
dialysis cartridges, heat-sensitive
rubber products and special surgical instruments.
Productivity and energy saving
Chamber volume
The new range has been designed for best in class energy recovery in
order to optimize consumption.
The vacuum system is provided with a water ring pump, which is supplied
with water drawn from the separator by creating a closed circuit. The
temperature is maintained at optimum levels by a heat exchanger. The
pump outflow is directed to the separator, from where it is sent to the
neutralizing system.
from 1000 litres / 35 cu.ft
to 63.000 litres / 2.225 cu.ft
Available in a wide range of
chamber sizes and volume.
Technical data, utilities consumption
and drawings available upon
request
Following customer requests, dedicated chambers for separate processes can be supplied:
Sterilization chambers
Conditioning
chambers
26
Degassing
chambers
TEMPO
WASHING
rotation,
water spraying- RINSE - SILICONIZING
dripping
rotation
dripping
siliconizing
drain
CHAMBER WATER (%)
drain
drain
LT 240
3rd
rinse
3000 / 118
2600 / 102
2800 / 110
1160 / 45.5
2
4
20 / 0.7
40 / 1.4
60 / 2.1
ICOS RESERVES THE RIGHT TO MAKE
PRODUCT CHANGES WITHOUT PRIOR
NOTIFICATION
rotation, water spraying
rotation
8
80 / 2.8
240 / 8.4
1550 / 61
30%
12
120 / 4.2
360 / 12.7
1700 / 67
18
180 / 6.3
540 / 19
CLOSURE WASHER TYPE “LT”: the “LT” operating process
1930 / 76
20
240 / 8.4
720 / 25.4
consists of the washing, rinsing, siliconizing,
2600 / 102
2800 / 110
3000 / 118
2
20 / 0.7
4
40 / 1.4
60 / 2.1
120 / 4.2
120 / 4.2
2600 / 102
This new range of ICOS equipment shows
a series of innovative
LST 120
3000 / 118
2600 / 102
2800 / 110
3200 / 126
features that satisfy the strict standardsLSTof180
the pharmaceutical
industry (FDA, cGMP, GAMP 5, etc.).
LST 240
3400 / 134
540 / 19
720 / 25.4
consists of the washing, rinsing, siliconizing,
1930 / 76
20
240 / 8.4
240 / 8.4
This range of machines is made up of two main categories:
Useful baskets Total baskets
volume
volume
(litres / cu. ft.) (litres / cu. ft.)
Number of
baskets
2
20 / 0.7
60 / 2.1
1160 / 45.5
4
40 / 1.4
120 / 4.2
1330 / 52
8
80 / 2.8
240 / 8.4
2600 / 102
1550 / 61
12
120 / 4.2
360 / 12.7
2800 / 110
1700 / 67
18
180 / 6.3
540 / 19
3000 / 118
pulses
1930vacuum
/ 76
20
drying and cooling phases.
the “LST”
process, in addition to the washing, rinsing,
siliconizing, drying and cooling
WASHING - RINSE - SILICONIZING
Number of
baskets
Lenght
1020 / 40
sterilization
LST 40
2600 / 102
steam/ 102
at 121 °C 1160 / 45.5
2600
LST 80
drying
LST 120
cooling
LST
180
2800 / 110
2600 / 102
1330 / 52
sterile air at max. 130 C°
2600 / 102
1550 / 61
sterile/ 110
air at 20 C
° 1700 / 67
2800
2
20 / 0.7
60 / 2.1
4
40 / 1.4
120 / 4.2
80 / 2.8
240 / 8.4
12
120 / 4.2
360 / 12.7
18
180 / 6.3
540 / 19
intermediate handling of the product
steam at 121 °C
drying
sterile air at max. 130 C°
cooling
sterile air at 20 C
°
product discharge
in a clean environment by means of prearranged
system
phase. The complete process makes it
possible to eliminate needless
that may cause its contamination.
drying
cooling
These machines are designed for
the complete treatment of closure devices
for pharmaceutical products such as: rubber stoppers,
plastic stoppers, droppers, pistons, aluminium caps and
other similar components.
Vacuum sterilization program
2,5
cooling
ICOS Pharma
S.p.A. - Pharmaceutical Division
drying
phases also includes the sterilizing
FIELD OF APPLICATION
AGS-E series
possible to eliminate needless
in a clean
by means ofpulses
prearranged
3000
/ 118environment
1930vacuum
/ 76
20
240 / 8.4sterilization
720 / 25.4
system
process,
in addition to the washing, rinsing,
Series
STERILIZATION - DRYING - COOLING
phase. The complete process makes it
that may cause its contamination.
Pressure sterilization program
8
CLOSURE PROCESSOR TYPE “LST”: the “LST”
2
phases also includes the sterilizing
Useful baskets Total baskets
volume
volume
(litres / cu. ft.) (litres / cu. ft.)
AGS series
TIME
Height
rotation
2600 / 102
Via E. Ellero, 15 - Zona Industriale - 33080 Cusano di Zoppola (PN) - Italy
Phone +39 0434 5772911 - Fax +39 0434 5772900 - e-mail:
2 sales@icospharma.com
up 2to 10% of Ethylene Oxide, with
the remaining 90% made of inert gas
(normally Nitrogen)
up to 90% of Ethylene Oxide, with the
residual
10% made of inert gas (normally
1
Nitrogen)
0
FIELD OF APPLICATION
sterilization
LT
LST
drying and cooling phases.
intermediate handling of the product
240 / 8.4sterilization
720 / 25.4
Process under optimized conditions
ICOS RESERVES THE RIGHT TO MAKE
PROCESSOR TYPE “LST”:
PRODUCT CHANGES WITHOUTCLOSURE
PRIOR
NOTIFICATION
rotation, water spraying
industry (FDA, cGMP, GAMP 5, etc.).
This range of machines is made up of two main categories:
“Optimal cycles”
LST 40
2600 / 102
containers normally used in the pharmaceutical
industry.
LST 80
features that satisfy the strict standards of the pharmaceutical
siliconizing, drying and cooling
WASHING - RINSE - SILICONIZING
Lenght
1020 / 40
-1
STERILIZATION - DRYING - COOLING
rotation
SILICONIZING
1330 / 52
Height
2600 / 102
3000 / 118
rotation, water spraying
dripping
3rd RINSE
2nd RINSE
1st RINSE
WASHING
1160 / 45.5
Overall dimensions (mm / inches)
CLOSURE WASHER TYPE “LT”: the “LT” operating process
Overall dimensions
/ inches)
rotation,(mm
water
spraying
3200 / 126
Lenght
1020 / 40
2600 / 102
Width
LST 20 of closures
2400for
/ 94.5
ICOS has a long experience in the treatment
360 / 12.7
30%
Width
2400 / 94.5
3000 / 118
CHAMBER WATER %
3000 / 118
WASHING
2600
/ 102
1330 / -52RINSE - SILICONIZING
8
80 / 2.8
rotation,
water spraying
2600 / 102
1550 / 61
12
120 / 4.2
rotation
2800 / 110
1700 / 67
18
180 / 6.3
dripping
LST 20
LST 240
3400 / 134
product discharge
3rd RINSE
2600 / 102
2nd RINSE
Lenght
1020 / 40
SILICONIZING
2200 / 86.5
Height
2600 / 102
1st RINSE
Width
2000 / 78.5
TEMPO
Number
of Useful baskets Total baskets
volume
volume
baskets
(litres / cu. ft.) (litres / cu. ft.)
rotation
LST SERIES - WASHING, dripping
SILICONIZING, STERILIZING
AND DRYING MACHINES FOR
PHARMACEUTICAL CLOSURES
siliconizing
2nd rinse
3rd rinse
rotation(mm / inches)
Overall dimensions
2600 / 102
drain
Type
rotation
rotation
rotation, water spraying
LT 80
drain
LT 120
dripping
LT 180
drain
dripping
LT 240
This new range of ICOS equipment shows a series of innovative
Height
2600 / 102
Pharmaceutical
Division
PHARMACEUTICAL
CLOSURES
WASHING
PRESSURE (BAR)
LT 40
TIME
rotation, water spraying
rotation, water spraying
CHAMBER WATER %
drain
through prearranged system
drain
2800 / 110
ICOS has a long experience in the treatment of closures for
containers normally used in the pharmaceutical industry.
2600 / 102
LOADING SIDE - TYPE LST 20-40-80
These machines are designed for
the complete treatment of closure devices
for pharmaceutical products such as: rubber stoppers,
plastic stoppers, droppers, pistons, aluminium caps and
other similar components.
TIME
2,5
ICOS Pharma S.p.A. - Pharmaceutical Division
PRESSURE STERILIZATION
non explosive mixtures 10% EO 90% CO2
PRESSURE (BAR)
Via E. Ellero, 15 - Zona Industriale - 33080 Cusano di Zoppola (PN) - Italy
Phone +39 0434 5772911 - Fax +39 0434 5772900 - e-mail:
2 sales@icospharma.com
PRESSURE (BAR)
1st rinse
LT 180
Useful baskets Total baskets
volume
volume
(litres / cu. ft.) (litres / cu. ft.)
CLOSURE PROCESSING
EQUIPMENT
LST SERIES - WASHING, SILICONIZING, STERILIZING AND DRYING MACHINES FOR
100%
LT SERIES - WASHING, SILICONIZING AND DRYING MACHINES
FOR PHARMACEUTICAL CLOSURES
2nd rinse
LT 20
rotation
2600 / 102
rev. 01/12
dripping
LT 120
Type
dripping
Type
rotation, water spraying
2600 / 102
STERILIZATION PROCESS
PRESSURE (BAR)
drain
2200 / 86.5
Number of
baskets
rev. 01/12
1st rinse
LAVAGGIO - RISCIACQUO - SILICONATURA
ACQUA IN CAMERA
washing
drain
dripping
succession make it possible to obtain the most appropriate cycle for
the characteristics of the material to be processed.
loading of material
through prearranged system
Width
2000 / 78.5
LT 80
PRESSURE (BAR)
TIME
The process consists of combined phases and actions designed to
ACTIONS
loading of material
LT 20
COOLINGLT 40
PRESSURE (BAR)
www.icospharma.com
STERILIZATION - DRYING - COOLING
PHASES
ACTIONS
washing
TEMPO
PROCESS DATA
PHASES
Overall dimensions (mm / inches)
Type
HEATING
STERILIZATION
LAVAGGIO - RISCIACQUO - SILICONATURA
CHAMBER WATER (%)
Series
100%
LT SERIES - WASHING, SILICONIZING AND DRYING MACHINES
FOR PHARMACEUTICAL CLOSURES
succession make it possible to obtain the most appropriate cycle for
the characteristics of the material to be processed.
ACQUA IN CAMERA
CHAMBER WATER (%)
PRESSIONE
SSING EQUIPMENT
100
The process consists of combined phases
50 and actions designed to
STERILIZZAZIONE - ASCIUGATURA - RISCALDAMENTO
LT
LST
PROCESS DATA
TEMPE
WASHING - RINSE - SILICONIZING
1
0
-1
PRESSURE (BAR)
PRESSURE STERILIZATION
non explosive mixtures 10% EO 90% CO2
0
-1
VACUUM STERILIZATION
explosive mixtures 90% EO 10% CO2
0
-1
VACUUM STERILIZATION
explosivedata
mixtures 90% EO 10% CO2
Process
Effective and safe
abatement of Ethylene
Oxide at completion of
sterilization process by
thermal combustion
Phases
non explosive
mixtures
explosive
mixtures
Heating of load with hot water circulating in the
heating jacket and alternating vacuum phases followed
by the inflow of hot air
˜
˜
Humidification of load, with alternating phases of
vacuum and steam inflow at low pressure
˜
˜
Sterilization of load by pressurization of the chamber
with the gas mixture
˜
with preset steam
pressure
Gas discharge
˜
by vacuum pump
Inflow of inert gas
Load degassing with alternating vacuum and hot-air
inflow phases for a preset time
˜
˜
˜
Sterilization temperature up to a max. of 60°C with temperature distribution of ± 1° C.
The right sterilization temperature must be matched to the type of the material to be processed.
Quality details in every phase of the process
The ETO gas is heated through evaporators, before being introduced into the chamber. Load moistened through the inflow
of low-pressure clean steam supplied by a steam generator.
The air, which is supplied into the chamber in the degassing phase, is filtered through absolute filters to guarantee higher quality.
27
AGS/AGS-E Series
Manufactured with the highest
industrial standards
Steelco’s rectangular cross section sterilization chamber is
completely surrounded by a high efficiency heating jacket for
rapid and even heating of loads.
Machine body is completely made of AISI 304 stainless-steel,
insulated with high density ceramic material, and clad in stainless
steel sheet.
The chamber and the hydraulic system are completely built, and
clad stainless steel. Process piping is made tri-clamps and flange
connections.
Panels and sterilization chamber are satin finished.
Pneumatic control of the valves is fitted.
Compliance and solutions
Steelco has developed an automatic horizontal sliding door
system with a heated jacket, where the closure of the door is
assured by a pneumatically pressurized gasket with a 4 year of
warranty.
Dedicated to autoclaves that use a potentially explosive mixture,
Steelco has specifically designed a safe hermetic closure
guaranteed by a pressure-sealing device with automatic tie-rods.
All safety devices are in compliance with international standards
with parameters continuously monitored to avoid the risk of
explosion.
Machine provided with necessary connection ports for validation
tests.
Design pressure
The chamber is dimensioned taking into account the
following parameters: 1, 5 bar + vacuum working
pressure; 2,7 bar + vacuum design pressure.
Complete protection of the environment
Abatement of Ethylene Oxide at completion of sterilization process: increasingly
stringent parameters make it necessary to offer safe accepted abatement systems on
every Ethylene Oxide sterilizer.
Steelco Group follows the ATEX, US, OSHA, NFPA and FDA regulations and complies
with ISO 11135, EN 1422.
28
DRY HEAT
STERILIZER
SD/EG Series
Advanced solutions for
special applications
SD Series
Class 100 static air
depyrogenation sterilizers
Steelco Group designs and manufactures a wide range of Class
100 static depyrogenation sterilizers (ISO 14644-1 class 5) to
meet the most challenging pharmaceutical requirements.
The depyrogenation process is aimed at the reduction in the level
of pyrogens, with the use of hot air in temperature which range
from 250°C up to 300°C.
The high performance Class 100 oven solution ensures an even
distribution of hot air for the entire cycle including large loads,
with the installed HEPA filters preventing cross contamination.
Field of application
Used for the sterilization
and depyrogenation of heat
resistant materials such
as: bottles, vials, glass
containers, metal trays and
production equipments
such as stainless steel vessel
etc. Laboratory glassware
and instruments, materials sensitive to humidity,
thermostable basic pharmaceutical products and
chemical compounds, non aqueous liquid materials
such us oils, glycerines, etc.
Chamber volume
from 330 litres / 12 cu.ft to
10.000 litres / 353 cu.ft
A large range of chambers and
configurations are available.
Technical data, utilities consumption and
drawings available upon reques
Complete layout versatility
Available with a choice of three types of doors:
swing-out, horizontally sliding and vertically
sliding, with the goal to always guarantee the
door tightness, regardless of unit dimensions.
pit mounted
and floor loaded
30
vertical sliding down
horizontal sliding
left or right
hinged door
left or right
LEL
ALARM LIMIT
CONTROL LIMIT
“Drying without compromise”
DRYING PROCESS
Drying quality process
200
150
100
50
HEATING
STERILIZATION
COOLING
STERILIZATION PROCESS
heat transmission points.
Particular care is used to eliminate
LT
CLOSU
LST
www.icospharma.com
Specially designed filter retention
system
to minimise thermal
Series
stress.
through prearranged system
dripping
1st rinse
rotation, water spraying
Filtration of chamber
exhaust air
rotation, water spraying
dripping
rotation
3000 / 118
Type
LST 20
LST 40
TEMPO
LST 80
LST 120
2nd rinse
LST 180
LST 240
WASHING
rotation,
water spraying- RINSE - SILICONIZING
drain
dripping
3rd rinse
drain
rotation cooling system.
Water-based
An air cooled system can be
supplied
on request.
rotation, water spraying
dripping
siliconizing
drain
2600 / 102
2800 / 110
3000 / 118
SILICONIZING
3rd RINSE
2nd RINSE
1st RINSE
WASHING
1550 / 61
30%
12
120 / 4.2
1700 / 67
18
180 / 6.3
540 / 19
CLOSURE WASHER TYPE “LT”: the “LT” operating process
1930 / 76
20
240 / 8.4
720 / 25.4
consists of the washing, rinsing, siliconizing,
360 / 12.7
drying and cooling phases.
CLOSURE PROCESSOR TYPE “LST”: the “LST”
process, in addition to the washing, rinsing,
LST SERIES - WASHING, SILICONIZING, STERILIZING AND DRYING MACHINES FOR
PHARMACEUTICAL CLOSURES
rotation
drain
2800 / 110
LT 240
ICOS RESERVES THE RIGHT TO MAKE
PRODUCT CHANGES WITHOUT PRIOR
NOTIFICATION
rotation
siliconizing, drying and cooling
WASHING - RINSE - SILICONIZING
Filtration
ofalso includes the sterilizing
phases
Overall dimensions (mm / inches)
Number of Useful baskets Total baskets
volume
volume
baskets
air flow
phase. The complete
process makes it
(litres / cu. ft.) (litres / cu. ft.) pressurized
Width
Height
Lenght
2400 / 94.5
2600 / 102
1020 / 40
2
20 / 0.7
60 / 2.1
to eliminate
needless
throughpossible
HEPA
filters
2600 / 102
2600 / 102
1160 / 45.5
4
40 / 1.4
120 / 4.2
intermediate handling of the product
2800 / 110
2600 / 102
1330 / 52
8
80 / 2.8
240 / 8.4
of
99.99%
efficiency
that may cause its contamination.
3000 / 118
2600 / 102
1550 / 61
12
120 / 4.2
360 / 12.7
3200 / 126
2800 / 110
1700 / 67
18
180 / 6.3
540 / 19
(EU 13).
vacuum pulses
sterilization
drying
cooling
3400 / 134
3000 / 118
1930 / 76
20
240 / 8.4
720 / 25.4
2
Air heated through
steam or electric
heating elements.
rev. 01/12
drain
2600 / 102
LT 180
PRESSURE (BAR)
washing
LT 120
FIELD OF APPLICATION
rotation, water spraying
STERILIZATION - DRYING - COOLING
dripping
rotation
sterilization
steam at 121 °C
drying
sterile air at max. 130 C°
cooling
sterile air at 20 C
°
product discharge
in a clean environment by means of prearranged
system
These machines are designed for
the complete treatment of closure devices
for pharmaceutical products such as: rubber stoppers,
plastic stoppers, droppers, pistons, aluminium caps and
other similar components.
TIME
Filtration of air
recycling
2,5
ICOS Pharma S.p.A. - Pharmaceutical Division
Via E. Ellero, 15 - Zona Industriale - 33080 Cusano di Zoppola (PN) - Italy
Phone +39 0434 5772911 - Fax +39 0434 5772900 - e-mail:
2 sales@icospharma.com
PRESSURE (BAR)
ACQUA IN CAMERA
loading of material
CHAMBER WATER %
Pharmaceutical Division
Adjustable temperature ramp, sterilization
plateau,
cooling temperature, chamber pressure, cooling time
100%
LT SERIES - WASHING, SILICONIZING AND DRYING
MACHINES
FOR PHARMACEUTICAL CLOSURES
PROCESS
DATA
The
control
system manages the machine and its basic
ICOS has a long experience in the treatment of closures for
are
all
available.
containers normally used in the pharmaceutical industry.
The process consists of combined phases and actions designed to
Overall dimensions (mm / inches)
Number of Useful baskets Total baskets
parameters,
such as temperature, Ft, Fh and pressures.
Type
volume
volume
This new range of ICOS equipment shows a series of innovative
baskets
(litres / cu. ft.) (litres / cu. ft.)
Width
Height
Lenght
succession make it possible to obtain the most appropriate cycle for
features that satisfy the strict standards of the pharmaceutical
LT 20
2000 / 78.5
2600 / 102
1020 / 40
2
20 / 0.7
60 / 2.1
We
guarantee excellent PID control of temperature and
the characteristics of the material to be processed.
LT 40
2200 / 86.5
2600 / 102
1160 / 45.5
4
40 / 1.4
120 / 4.2
industry (FDA, cGMP, GAMP 5, etc.).
LT 80
2600 / 102
2600 / 102
1330 / 52
8
80 / 2.8
240 / 8.4
throughout
all
phases.
chamber
pressure
LAVAGGIO
- RISCIACQUO - SILICONATURA
This range of machines is made up of two main categories:
PHASES
ACTIONS
CHAMBER WATER (%)
RTD PT 100 for
temperature and
pressure control.
1
Set flexible for RTDs
in the chamber.
0
-1
PRESSURE STERILIZATION
non explosive mixtures 10% EO 90% CO2
Perfect compatibilty
The SD series features connection ports on the front loading side for
validation testing.
Machines equipped with special product holding trays and handling
trolleys, can be also interfaced with the isolation technology.
PRESSURE (BAR)
LDAMENTO
TEMPERATURE
The HEPA filters abate the level of particle contamination in
the chamber also during critical phases, such as heating and
cooling.
RE PROCESSING EQUIPMENT
IZING
250
Fully compatible with the strict standards of the pharmaceutical
industry, the SD Series is supplied with HEPA filters (99,99%
efficiency) for filtration of pressurized air flow (EU 13), air
recycling and exhaust chamber air (EU 12).
0
-1
VACUUM STERILIZATION
explosive
mixtures 90% EO 10% CO2
Inspection window
isolation technology
in the front loading side
31
SD Series
Construction features
Chamber, areaulic system, doors and other machine structural
components are made of AISI 316 stainless steel.
Chamber insulated with high density ceramic insulating material
and covered externally by AISI 316 stainless steel panel.
Uniform air distribution through differentially
perforated walls, particularly suitable for
varied loads.
Chamber with rounded internal angles and
TIG welded smooth seams.
Uniform automatic chamber pressure and
temperature control.
Inside of chamber polished to ≤ 0.5 μm.
Automatic pneumatic door locking mechanism.
Hermetically sealed doors with a special profile
silicone gasket with double sealing strip. Gasket
allows the formation of vacuum to guarantee
perfect door seal during every phase of the cycle.
System designed to minimize cross contamination
risk.
Chamber provided with a double bottom for even
temperature distribution.
Norms and standards
The SD Series is in compliance with the following latest
Norms and Directives:
cGMP; GAMP; FDA; EN 1822; ISO 14644/1/2; CFR’s
including 21 CFR parts, 201, 211 and part 11 available
32
as option; EUROVENT; Technical Reports “Parenteral
Drug Association”; 2004/108/CE, 2006/95/CE ; plus
other local and international standards as applicable.
“Drying without compromise”
EG Series
Tray drying ovens
for granulates
Static tray drying ovens manufactured by Steelco are
some of the most technically advanced machines in
existence.
Thanks to a long experience in hot air drying, these
machines are designed for optimizing process
parameters for effective, uniform and gentle drying.
A wide range machines, fully compatible with the strict
standards of the pharmaceutical industry (FDA, cGMP,
GAMP 5, etc.) are offered.
Provision of tray handling trolleys, customized to suit
end user requirements.
Chamber volume
from 330 litres / 11.5 cu.ft
to 10.000 litres / 308.5 cu.ft
Field of application
This range of machines is used for drying by hot air of
materials such as granulates, pellets, powders and porous
load in pharmaceutical industry processes.
Technical data, utilities
consumptions and drawings
available upon request.
TEMPERATURE
CONCENTRATION
Special application
LEL
For the treatment of granules with presence of solvents,
the dryer can be equipped to monitor flammability hazard
by controlling LEL.
ALARM LIMIT
CONTROL LIMIT
DRYING PROCESS
Main options
The hot air drying ovens can be supplied with a self washing
system in the chamber and a device for the removal and
insertion of tray support carts.
TEMPERATURE
250
200
Upon request
and for particular types of applications, the
150
electrical system
and components of the machine can
100
be supplied50to be compliant with flameproof type (ATEX
regulation).
HEATING
STERILIZATION
COOLING
STERILIZATION PROCESS
CLOSURE PROCESSING EQUIPMENT
TEMPO
LT
LST
Series
33
CLOSURE
PROC
EQUI
www.icospharma.com
Pharmaceutical Division
EG Series
Drying quality process
The EG Series has even hot air distribution
in the chamber. Special perforated walls and
temperature control, ensure the drying quality
process.
The mechanical construction of the machine
body is designed to resist temperatures of up
to 300 °C.
The unit is provided with filters for the inlet
and exhaust air flows in the chamber.
Steam and electric heated options are
available with a maximum temperature
of 120°C.
Construction features
The machine body and aeraulic system are
made of AISI 316 stainless steel.
The chamber has a rectangular cross section
and is fitted with a rectangular hatch.
External panelling is made of AISI 316
stainless steel with the chamber having a
polished finish.
Fast-closing swing out doors and gaskets are
made of silicone rubber.
Floor or pit mounted solutions.
Documentation/Validation
Comprehensive operating and maintenance manuals and IQ/OQ documentation is provided as standard.
Steelco helps you to minimize the time needed for validation, with decreased breakdowns, increased production and
operative lifetime achieved.
34
low impact, high results
washing and sterilization equipment
for the environmentally conscious
the future today
www.steelcospa.com
www.icospharma.com
Steelco Group is an active member of ISPE & ASME BPE Committee
and we present in the ISPE Sustainability Guidelines.
Steelco equipment is manufactured in modern factories and provide a
significant contribution to reducing utilities consumption and waste.
Washers, disinfectors and
automated systems
for animal cages, feeding
bottles and fish tanks
Laboratory glassware
washing systems
Headquaters and
Center of washing systems production
Center of sterilizers production
STEELCO S.p.A.
Via Balegante, 27 - 31039 Riese Pio X (TV) - Italy
Ph. +39 0423 7561 - Fax +39 0423 755528
e-mail: steelco@steelcospa.com
www.steelcospa.com
Washing systems
Serving the global pharma industry
All brand names, trademarks and registered trademarks mentioned in this catalog belong to their respective owners.
The products and technical specifications are subjected to change without prior notice. Please consult your Steelco dealer for the latest information.
Steam sterilizers VS L series
for pharma and research laboratories
ICOS Pharma S.p.A.
Via E. Ellero, 15 - 33080 Cusano di Zoppola (PN) - Italy
Phone +39 0434 5772911 - Fax +39 0434 5772900
e-mail: sales@icospharma.com
www.icospharma.com
HUNGARY
USA
ASIA
Temesvár u., 19-21
1116 Budapest - Hungary
Ph. +36 1 371 0257
Fax +36 1 371 0258
e-mail: steelco@t-online.hu
999 Stinson Way - Unit 307
West Palm Beach, FL 33411 USA
Ph. +1 561 791 8313
Fax +1 561 791 8213
e-mail: steelco-usa@steelcospa.com
6th floor, Suite 16, IOI Business Park
Persiaran Puchong Jaya Selatan - Bandar Puchong Jaya
47100 Puchong, Selangor - Malaysia
Ph +60 3 8064 4339 (Ext. 112) - Fax: +60 3 8064 4340
e-mail: steelco-asia@steelcospa.com
Worldwide agencies available for sales support.
DC-PD-02-PH ST EN Rev.01
Steelco Group Branches: