INTEGRATED SOLUTION PROVIDER

for Bio-Process Engineering

Except for independent R&D, Tofflon integrates global resources to provide integrated solution for client.
Tofflon can provide the whole bio-process equipments and integrated system from media preparation,
cell/microbial cultivation, harvesting, DF/ UF, purification, buffer preparation to fill & finish.

Formulation
Integrated Solution

Key System & Technology

Fermentor & Bioreactor

Chromatography Systems & Column, Ultrafiltration

Systems, Dilution In-line Systems

Bio-Solution Preparation Systems

Pharmaceutical & Envioroment Protection

Project Management

Good Engineering Practice

Qualification

Manufacturing
Fermentor

Bioreactor

Chromatography Systems

Ultra Filtration Systems

Bio-solution Preparation Systems

Continuous Inactivation

Monoclonal Antibody

Vaccine Products

Insulin

Genetic Engineering Products

Protein Products

Blood Products

Customized Product & Service

Professional Technical Support

Integrated Solution

Complete Qualification Documentation

3D Design
Veterinary Vaccine
CLIENTS
FMDV, Suspension Cultivation,
Science & technology, China

Media preparation system for cell cultiva-

tion and virus cultivation.
Antigen treatment unit .

Veterinary Vaccine

CLIENTS
PRRSV (Porcine reproductive and respirato-
ry syndrom vaccine), Micro-carrier Cultivation
PCV (Porcine circovirus vaccine), Suspension
Cultivation, China

Bioreactor.
Trypsinization system+Media preparation.
Human Vaccine

CLIENTS
Pneumovax
Dysentry Bacillus Vaccine,
bio-pharma Industry, China

Media preparation system for cell cultiva-

tion and virus cultivation.
Antigen treatment unit .

Human Vaccine
CLIENTS
Rabies Vaccine,
Biotechnology co., Ltd., China

Integrated Solution
Media(cultivation & virus media ) preparation ,stor-
age and distribution
Buffer preparation ,storage and distribution
CIP distribution for toxic & non-toxic area.
Virus particles harvest system
 Chromatography System

DF/VF/UF Media Distribution System

Monoclone Anti-body

CLIENTS
Biotechnology company , Russia

Integrated Solution
Single use bioreactor
Media &buffer distribution system
DF/VF/UF
Chromatography system

Single Use Bioreactor

Blood Products

CLIENTS
Cogulation Factor Ⅷ
Biotechnology Company , China

Integrated Solution
Primary Purification Unit
Suspension System
Supernatant System
SD Inactivation System

Secondary Purification Unit

Ultrafiltration System
Equilibrium, Dilution, Buffer Preparation
System
Centrifuge Unit
Immunomodulator

CLIENTS
Large Modular pharma Industry, Russia

Integrated Solution
Reactor modular (include depth filtration)
Ultrafiltration modular
Products sterile accept modular
Fermentor & Bioreactor
The microbes, insect cells, plant cells, batch
/fed-batch/ continuous perfusion culture of
animal cells.

Process R&D, pilot scale, commercial scale

production.

The product is applied to the macromolecular

biological products such as vaccine, monoclo-
nal antibody, insulin, antibiotics, genetic engi-
neering products, recombinant protein prod-
ucts & etc.
Separation & Purification
Provide the integreted solution from membrane filtration,chromatography media screering,chromatography
equipment & its process. The chromatography systems & column,UF/DF and in-line dilution systems are all
involved in.

Tangential Flow Filtration Systems

Tangential Flow Filtration systems are applied in the

concentration for the bio-pharma production such as
monoclonal antibody, recombination protein, vaccine,
blood products etc.

Type Flow Accuracy

TFF-150 1-150 L/h ，0.017-3 L/min ±0.5%

TFF-600 6-600 L/h ，0.1-10 L/min ±1%

TFF-1200 10-1200 L/h ，0.17-20 L/min ±1%/0.5 L/h

TFF-1500 10-1500 L/h ，0.17-25 L/min ±1%/1.5 L/h

TFF-4400 60-4400 L/h ，1-70 L/min ±1%/3 L/h

Separation & Purification

Chromatography system & Colomn

Chromatography system is conceptually designed in accordance withcGMP and FDA requirements for
downstream bioprocessing of bio－pharmaceuticals.It is fully automated, available from pilot to industrial
scale. The fineengineering and product quality guarantees process stability, control andreproducibility. A
piping & instrumentation design (P&ID) diagram is first drafted stating number of pumps, valves, inlets and
outlets, bubble trap,and flow meters based on user requirement specifications (URS). All componentsfrom
inlets to outlets in the LPLC system are certified to meet regulatory requirements and traceable, and have
CIP features. The process control softwareis user-friendly .

HI Process 3L HI Process 10L HI Process 20L HI Process 30L

Flow Range 4-180 6-600 60-1200 150-1800

Maximum Pressure 6 Bar

Conductivity Range 0.001-500 mS / cm, ± 50 µS / cm
pH 0-14 ①， ± 0.1
Purple Outer Variable four wavelength / single wavelength
Tube Road PP / ss316l
Operation Temperature 4-40 @ PP / 4-80 @ SS316L ②

System Size 1800 / 800 / 1650 ( L / W / H )

Bio-Solution Preparation Systems

Bio-Solution Preparation Systems provide the process auxiliary

facilities for main process such as fermentation, purification inacti-
vation and emulsion(vaccine) process. Together with the main
process equipment ,a process chain is constituted, which links to
the whole biopharmaceutical process.

Media preparation system

Harvest system
Buffer preparation and storage system
Purification system
CIP / SIP station
Continuous Inactivation Systems
Project Management
These are three major factors that determine the success of a project. Our organizational model has been continu-
ously updated and improved in order to allow you fully reach these objectives. By dealing with us you can minimize
your direct resources neede to manage the project for the selection, purchase, installation, start-up and validation
of new production equipment.

Reliable Quality Shorter Time Focus on Costs

Good Engineering Practice

Product Knowledge

Process Knowledge
Operation &
Requirement Description & Design Verification Accept & Release Continuous
Regulation Requirement Improvement

Quality Requirement

Risk Management

Design Verification

Change Control
Qualification
PQ Detection
User Requirements Performance
Statement (URS) Qualification (PQ)

OQ Detection
Functional Design Operatrion
(FDS) Factory Acceptance
Qualification (OQ)
Test

Design and Development

IQ Detection
Design Qualification Installation
(DQ) Qualification (IQ)
Factory Inspection

Risk Assessment

Implementation and
Implementation
Manufacturing
Manufacturing Scale Qualifications
6 modern manufacturing facilities ( about 300,000 square meter ) GB150 CE
Global biggest pharm equipment manufacturing centre ASME GOST-R
sheet-metal center, CNC machining center PED FDA 21CFR
6S site management ISO 9001 PART 11
...... ......

Production and Processing

High-end machining center to ensure production delicately.

More than thousands processing equipments

International advanced level, exquisite process
More than 20 years experience, Good manufacturing practice and quality
management system, which ensure the good production quality.

PED ISO9000
Model G Instruction Management System

ASME Pressure Vessel

U Steel Seal qualification Manufacturing Licence