Tofflon and Its Freeze Drying System

Date: Febaury 28, 2013

Since 1993 establishment, Tofflon dedicated itself into freeze dryer technology.
In the past nearly 20 years, Tofflon only studied and made one product Freeze
Dryer. Today and tomorrow we will continue our whole-life dedication to freeze
drying system technology for the pharma and biotech industry.
To assist you better understand Tofflon and its expertise and capability in freeze
drying system, we highlight the following facts for your evaluation.
1

Globally largest and fastest growing freeze dryer brand

Tofflon is the largest freeze dryer manufacturer in the world and also the
fastest growing freeze dryer brand in the world. It has the globally largest
freeze dryer installations (3,000 lyophilizers since 1993). Its annual freeze
dryer output (averagely 300 lyophilizers annually) is more than the total
freeze dryers output from all the European freeze dryer manufacturers.
Since 2004, it has supplied nearly 300 freeze dryers for international
pharmaceutical industry covering 30 countries and regions: Canada, USA,
UK, Germany, France,Italy, Spain, Switzerland, Greece, Poland, Turkey,
Russia, Belarus, Egypt, Nigeria, The United Arab Emirates, India, Pakistan,
Bangladeshi, Singapore, Korea, Taiwan, Indonesia, Malaysia, Thailand,
Vietnam, Mongolia, Cuba, Mexico, Argentina, etc.

More than 200 Freeze Drying Systems (Freeze Dryer + Auto Loading
Systems + Barrier Systems) Project Experience
Among our 3000 freeze dryers projects, Tofflon has been working for more
than 200 freeze drying system projects: Freeze Dryer + Auto Loading
Systems + Barrier Systems. Today more than 100 Tofflon engineers are
working for auto loading systems development, installation and validation
and service.

Multinational References
Recent years Tofflon has been visited and audited by continuous
multinational pharmaceutical companies and engineering companies like
Sanofi Aventis (France), GSK(Belgium), Merial(France), AstraZeneca
(Sweden), Teva (Israel), Technip (France), NNE Pharmplan (Sweden),
Bayer Technology (Germany), M+W Zander(Germany), JGC(Japan),
Lallemand (USA, France) etc.
And Tofflon has installed
- In Merial: 2 x LYO-15(Pass-Through and Two-floor) + Semi-auto
Loading Systems;

- In former GSK JV: 2 x LYO-30(SIP,CIP) + AGV;

- In Novatis JV: LYO-13(SIP,CIP) + LYO-20(SIP,CIP).
And Tofflon is the only Chinese process equipment supplier to be formally
invited to participate GSK (Belgium) 6 x LYO-30(SIP,CIP)(Two-floor and
Pass-Through) + Mixed Loading Systems projects in Belgium for its
biological vaccine in 2009.
4 cGMP Projects
These years Tofflon has successfully stepped into North America and
European markets.
(1) 10 freeze dryers for Canada and USA including
- LYO-10(SIP,CIP) and LYO-5(SIP,CIP) for Ambio Pharma Inc. (Atlanta)
- LYO-5(SIP,CIP) for Praxair Inc. (Chicago)
LYO-13 for Texas Vet Lab (Texas)
2 x LYO-30(CIP) for Lallemand (Milwaukee)
2 x LYO-30(SIP,CIP) for Lallemand (St-simon France)
- LYO-7.5 (SIP,CIP, LN2) for Therapure Biopharma (Canada)
- LYO-5 for Bio-K (Canada)
(2) 20 freeze dryers for European markets including:
- 2 x LYO-10, LYO-3 and LYO-30 for GES Genericos (Spain),
- LYO-3(SIP,CIP) for Grupo Praxis Pharmaceutical (Spain),
- LYO-2(SIP,CIP) for Inmunotek Madrid (Spain)
- 2 x LYO-5(SIP,CIP) for Symbiosis Pharma Services Ltd. (UK)
- 1 x LYO-20(SIP,CIP) + Auxiliary Track Trolley System for Dr. Suwelack
Skin & Health Care AG (Germany)
- 1 x LYO-40(SIP,CIP) for Sacco S.r.l (Italy)
- 2 x LYO-25(SIP,CIP) for MN Pharmaceuticals (Turkey) (The first Turkish
pharma company which has been granted an USFDA approval and EU GMP
certificate from Germany).
- LYO-15(SIP,CIP) and LYO-30(SIP,CIP) for Kocak Farma (Turkey)
- LYO-15(SIP,CIP) for Idol Llac San A.S. (Turkey)
- LYO-13(SIP,CIP) and LYO-20(SIP,CIP) for Anfarm Hellas S.A.
Pharmaceuticals (Greece)
- LYO-20(SIP,CIP) for Strides Arcolab Polska Sp.z.o.o (Poland)
(3) US FDA approval and UK MHRA Compliant Projects in Emerging
Markets
- Strides Arcolab Ltd (India) 2 x LYO-8.6(SIP,CIP),
- Qilu Pharma (China) 7 x LYO-40(SIP,CIP) + API Auto Loading Systems,
12 x LYO-40(SIP,CIP) + 4 x API Auto Loading Systems
- Intas Pharma (India) LYO-25(SIP,CIP) + Row-by-Row
(Note: Intas Pharma is Indias first Biopharma company to receive EU GMP
certification.
5 Cooperation with World-class Filling/Capping Line Brands

Recent years in many freeze drying system projects, Tofflon works with
world-class filling/capping line brands:
a) In Intas project, Tofflon LYO-25 + Row-by-Row work with Bausch +
Stroebel filling line.
b) In a confidential project, Tofflon 4 x LYO-30 + Mixed Loading Systems
work with Bausch + Stroebel capping line.
c) In Merial project, Tofflon 2 x LYO-15 + Semi-auto Loading Systems work
with Bosch filling/capping lines.
d) In SBPC project, Tofflon 5 x LYO-22 + 2 x AGV + LN2 refrigeration +
RABS work with Bosch filling/capping lines.
e) In Yuheng project, Tofflon 4 x LYO-20 + Auto Loading Systems work
with Bosch filling/capping lines.
f) In Lvye project, Tofflon 3 x LYO-25 + AGV work with Bosch filling
/capping lines.
g) In a confidential project, Tofflon 4 x LYO-30 + Mixed Loading Systems
work with IMA filling line.
h) In Biomab (Indian Cipla JV) project, Tofflon LYO-5 + LYO-10 +
Semi-auto Loading Systems work with Inova filling/capping line.
6 International Certificates
Tofflon has been accredited and granted with:
- German TUV ISO 9001 Quality Assurance System
- European PED pressure vessel
- American ASME pressure vessel
- European CE and American UL Compliance
- Control System compliant with cGAMP and USD FDA 21 CFR Part
11 Guidelines
Tofflon Engineers with ISPE Membership, PDA Membership and ISL-FD
Membership.
7 International Standards
Tofflon freeze dryers are manufactured according to cGMP guidelines and
US FDA recommendations as per the following applicable standards:
- FDA 2004 Sterile Drug Products Produced by Aseptic Processing - cGMP
- EU GMP 2008 Guideline for Medicinal Products, Annex 1
- PIC/S 014-2 Isolators Used for Aseptic Processing and Sterility Testing
- ISO13408-3 Aseptic Processing of Health Care Product - Part3:Freeze dryer
- ISO13408-6 Aseptic Processing of Health Care Product-Part6:Isolator
systems
- ASME BPE 2009 Bioprocessing Equipment Standard
- CE Marking EEC 93/68 / Low voltage EEC 73/23 / PED 97/23/CE
- FDA 21 CFR PART 11 Electronic Records, Electronic Signature
- GAMP5 Good Automated Manufacturing Practice, etc.

8 World-class Critical Components

Since 1996, Tofflon freeze drying system has adopted world-class brands for
its critical components. Part of major components are listed as below:
Component
Brand
Freeze Dryer
Chamber/Condenser
China GB 150 Compliance for Asia
European PED Compliance for
Europe
American ASME Compliance for
America
Machinery and Electrical
European CE (MD, LVD) Compliance
USA UL Compliance
Canada CUL Compliance
Compressor
Copeland Piston (Germany)
Bitzer Piston (Germany)
Kobelco Screw (Japan)
Mycom Screw (Japan)
LN2 Refrigeration
Joint technology with Praxair (USA)
Vacuum Pump and Booster Pump Edwards (Britain)
Circulation Pump
Grundfos (Denmark)
Wilo (Germany)
Hermetic low temperature pump
(Germany)
Sundyne magnetic pump (USA)
Plate Heat Exchanger
Alfa Laval (Sweden)
Liquid-ring Pump
Nash-Elmo (Germany)
Hydraulic motor and units
Hydr-App (Italy)
Pneumatic Units
Festo
Venting filter
Pall (USA)
Millipore (USA)
Diaphragm / Membrane Valve
Burkert (Germany)
Temperature Sensor
Jumo (Germany)
PLC
Siemens (Germany)
Touch Screen
Siemens (Germany)
Charter Recorder
Yokogawa (Japan)
Electrical elements
ABB (Sweden)
Row-by-Row Autoloader
Servo motor and driver
Siemens (Germany)
Positioning system
BAHR (Germany)
Reducer
Neugart (Germany)
Coupling
KTR (Germany)
Displacement sensor
Novotechnik (Germany)
Position sensor
Turk (Germany)

PLC and HMI

RABS
Hypalon Gloves
Air supply filters
PLC and Touch Screen

Siemens (Germany)
North (USA)
Camfil (Sweden)
Siemens (Germany)

9 cGMP Documentation and Validation

cGMP Documentation:
- 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
Validation
- Shelves Temperature Uniformity Test
- CIP Validation (Riboflavin (vitamin B2) + Ultraviolet light)
- SIP Temperature Distribution Test
- Filer Integrity Test by Water Intrusion Test
- Software Qualification (SQ)
- Filter leakage test (Dop Testing)
- Airflow velocity test
- Air flow
- Particle Count and Air sampling test
- Noise test
- Light test
- Glove leak test
9

Strong Lyophilization process Support

What Tofflon offers is not only an equipment, but also lyophilization
solution. Tofflon is well renowned in the market for its lyophilization support.
We have built professional lyophilization lab and introduced world-class
scientific instruments like freeze drying microscope from Britain to help you
detecting your product thermal property, optimizing lyophilization cycle,
analyzing and solving product defects. With our assistance, what you get is
not only freeze drying system equipments, but also our know-how and
support in lyophilization process to save your money and control your
risk.

10 Locally-based and Whole-life Service

We offer locally-based and whole-life service for Tofflon freeze drying system,
including:
i.
We take responsibility for FAT, door-to-door transportation and SAT.
ii.
During warranty period, Tofflon warrants all the defects in materials
and workmanship at Tofflons expenses for Tofflon freeze drying
system.
iii.
Our international service centre guarantees service response
within 24 hours upon receipt your service requests via emails or
phone call.
iv.
During warranty period, we offer preventative Maintenance
Program (twice a year, free of labour costs) to ensure
equipments working in good conditions and any hidden defect to be
well solved in advance. Meanwhile through Preventative
Maintenance Program, we assist you to decide proper backup
spare parts in your warehouse so as to avoid the risk of long
waiting customized spare parts during production.
v.
For control system support, we offer remote access functions in
our control system to quickly diagnose and maintain any software
questions through remote access.
vi.
After warranty period, we offer annual maintenance contract (AMC)
to continue our service support.
vii.
We are also seriously establishing local service team and
mechanism to guarantee our responsibility in local service
support.
In the past years, Tofflon has been well recognized as the fastest growing
freeze dryer brand in the world, and had become the worlds largest freeze
dryer manufacturer. In the future Tofflon will grow up from equipment supplier
to solution provider and from China Tofflon to Global Tofflon in the freeze
drying system field. We are confident that Tofflon can serve your success,
because Tofflon is a Good Company with Good Machine and Good
People.
Thank you for your attention and regards,
Daniel Chau
zcg@tofflon.com
Shanghai Tofflon Science and Technology Co., Ltd.
(Has been listed on the Shenzhen Stock Exchange since Feb. 1, 2011).

Add: 1509, Duhui Road, Shanghai China, 201108

Tel : 0086 21 6490 8890
Fax : 0086 21 6490 5148
Email: info@tofflon.com
Web : www.tofflon.com