Welcome tonaphal.gr/datafiles/file/10-Tofflon presentation 2015.pdf · 80+% market share for FD...
Transcript of Welcome tonaphal.gr/datafiles/file/10-Tofflon presentation 2015.pdf · 80+% market share for FD...
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Welcome
to
Tofflon
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Tofflon has been working for Freeze Drying System
in the past 22 years
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Globally largest freeze drying system manufacturer
0.2 m2 - 50m2 Freeze
Dryers
400+ production size
Lyophilizers Annual
Output
5,000+ Installations
Since 1993 ( Include FD
>4,000 )
400+ Installations in
more than 30 countries
80+% market share for
FD System in China
Nearly 1,500 customers
base.
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- Four Manufacturing Plants :1. Freeze Dryer Facility –
35,000 sqm
2. R&D Center – 9,100 sqm
3. Freeze Drying System (Preparation,Loading,Barrier) – 45,000 sqm;
4. Pressure Vessel Land
( Chamber,Condenser,Shelf
– 66,000 sqm;
5. Tofflon-Dehui
The employees: 2,000 +
workers: 1,200+
engineers: 480+
QA: 100+
Sales: 68
Services: 150+
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Preparation System 2012
Tofflon Dehui
Shanghai KYOWAC
Tofflon TOP
Tofflon Aqua-Nova
Freeze Dryer
Joint Venture with Japan Kyowac in China 2003
Manufacturing Water System in Tofflon 2012
Clean Room System and AHU 2011
自动进出料事业部Tofflon Airex
Tofflon USA
Since 1993
Technical support and service in USA 2008
Barrier System, 2012
Tofflon developing partners
Design House Design equipment for FD system in Italy 2010
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CE Certificate (MD / LVD/ PED)
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USFDA 21 CFR PART 11 COMPLIANCE
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Steel certificate
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A Workshop with
Health, Safety and Environment Protection
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Harmony with Nature
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Lyophiliztion Lab
“Fastest Sublimation, Without Risk”
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Freeze Drying Microscope (UK)
(Lyophilized Drug Thermal Property Detection)
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Assembling and FAT
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Pressure Vessel Compliance:
Chinese GB150-1998/European PED/American ASME
Automatic machine to make Chamber; condenser; shelf
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Chamber; condenser; shelf all are made by Tofflon
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Modern manufacturing facilities and tools
Laser Cutting
Welding robotAuto-cutting Water knife
Electronic polishUltrasonic washing
CNC foldingCNC Punch
Auto-welding
CNCCentre
CNC gantry machining centers
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World-class, Reliable and High Quality Components
(USA, Europe and Japan)
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Use first class compressor and vacuum pump, storage for fast delivery
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Freeze Dryer Assembly Line
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5 x LYO-22 + 2 x LN2 Refrigeration System + 2 x
Automatic Loading and Unloading System
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Tofflon Global Team in Achema (Germany) in 2009
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Achema 2009 in Frankfurt, Germany
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Tofflon Booth in Achema 2012
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Tofflon Booth in Achema 2015
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Expoquimia 2011 in Barcelona, Spain
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CPhi Worldwide Madrid 2015
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Tofflon Global Team
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Tofflon Global Team
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Lyophilizer specialist in Tofflon USA
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Italian Design Centre
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5 x LYO-22 + 2 x LN2 Refrigeration System + 2 x
Automatic Loading and Unloading System
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RABS/c-RABS/Isolatore System
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Preparation System
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Project Management
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User Requirements (URS) or
Technical Specification
Design Specification
Design Qualification (DQ)
Equipment Build
Performance Qualification (PQ)
Operation Qualification (OQ)
Installation Qualification (IQ)
Equipment Qualification
Qualification Project
Plan (QPP)
Qualification
Functional Specification
Quality Plan
(QP)FAT
SAT
SOP
IQ2/OQ2/PQ2
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Inspection and Validation tools
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Alloy Analyzer
to test chamber materials
Indicator
showing
test result
QA
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Materials test result
can be stored and printed out with Excel Format
316
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Ultrasonic Thickness Inspector
to test shelves thickness
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Roughness Inspector
to test chamber door roughness
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Helium Leak Detector
For leakage test
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Temperature Uniformity Test
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Shelves Thermocouples Location
01
04
05
02
03
Inlet
Outlet
07
10
11
08
09
Inlet
Outlet
The First Shelf The Second Shelf
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Filter Integrity Test
(Water Intrusion Test)
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TIG Automatic Welding Machine
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Piping Welding
Process
Orbitally Welding
Pressure Keeping
Acid/Alkali Passivation
Blue Point Testing
Helium Leak Testing
<1x10-7Pa.m3/s
S.O.P/
Recording
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Boroscope Inspection
with Photos and Video Records
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100% Boroscope of all welds
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Documents
- User Requirement Specification (URS) or Technical
Specification
- Qualification Project Plan (QPP)
- Quality Plan (QP)
- Design Specification (DS)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Factory Acceptance Test (FAT)
- Site Acceptance Test (SAT)
- Performance Qualification (PQ)
- Traceability Matrix
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Other Documents of Equipment
Installation Instruction
Operation Instruction
Maintenance Manual
Main components List
Spare Parts List
Materials Certificate
Instruments Calibration Certificate
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Whole Life After-Sales Service
For many years, we have successfully established well-running after-sales service
mechanism and system which make us earn customers’ satisfaction and make us
stay ahead of the competition.
Prior Delivery
Complete documentations with full details of the equipment.
Supply of spare parts and accessories
Standard IQ and OQ documentation package, as
additional options to assist customers with equipment validation.
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Whole Life After-Sales Service
Post Delivery
Installation and start-up of new equipment
Site Acceptance Test
Product Training Courses
During Warranty
Locally-based after-sales service
As local assistance, there are also factory-trained technicians
.
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Whole Life After-Sales Service
Preventative maintenance / Corrective repairs
Remote problem solving (via telephone, internet, etc)
Lifetime Service
Modification of existing equipment to optimize its performance
Sales and supply of spare parts and accessories
Product training courses
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Total solution for pharmaceutical equipment
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Total solution for pharmaceutical facilities
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Looking forward to serve your project
Thank You for your time!