Pilot Scale SFC System SFC-DAC Column · [email protected] (7 40) 444 -HEMP GLOBAL...
Transcript of Pilot Scale SFC System SFC-DAC Column · [email protected] (7 40) 444 -HEMP GLOBAL...
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1. Quotation ..................................................................................................... 1
Quotation ............................................................................................. 1
2. System Configuration and Technical Specifications ............................... 2
Project Introduction ........................................................................... 2
General Appearance .......................................................................... 3
Introduction System Description ..................................................... 4
System PI&D Drawing ................................................................ 4
Product Features ........................................................................ 4
Main Components Configuration Tables ....................................... 5
Main Components Description.................................................... 6
DAC-HB50Dynamic Axial Compression Column Description ........ 9
Appearance Picture .................................................................... 9
Cylinder Components ............................................................... 10
Piston Components .................................................................. 10
Control System ......................................................................... 12
Hydraulic system PI&D Drawing ............................................... 12
Column Tube .................................................................................. 12
Control System Description............................................................ 14
The Configuration Tables of Control system ............................. 14
Key Parts of Control System ..................................................... 16
Control Software ............................................................................... 17
3. Other Project Requirements .................................................................... 18
System Other Requirements.............................................................. 18
Accompanying Documents Items ...................................................... 19
4. After-sales Requirements ........................................................................ 19
5. Company Profile ....................................................................................... 20
Table of Contents
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1.1Quotation
Equipment Name Configuration Unit QTY Total Price CS-Industrial SFC purification
system CS-SFC180 Set 1
Dynamic Axial Compression Column
DAC-SFC50 Set 1
Air Shipped and Installation in the USA
S&I-USA Set 1
TOTAL USD
Special Notes:
1. Shipping to US Port and Installation guidance are INCLUDED andcovered by manufacturer. Transit from US Port to client facility notincluded. Additional taxes, fees, tariffs are not included
2. Manufacturer will provide 2 years quality warranty.
1.Total Quotation
Included
Included
Included
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SOLUTIONS
Super-critical Fluid Chromatography (SFC) uses the super-critical fluid as
the mobile phase. The fluid not only has viscosity and high diffusion coefficient
close to the gas , but also has high density and strong dissolving ability close
to the liquid. So the SFC combines the advantages of both GC and HPLC. The
chromatographic stationary phase used for SFC is similar to liquid
chromatography. The mobile phase is typically a mixture of CO₂ and an
organic solvent (methanol, etc.). It not only can separate thermally unstable,
high molecular weight, strongly polar or non-volatile compounds which is
difficult to separate by GC, but also can separate high molecular weight
compounds which are difficult to separate by HPLC. Because of its unique
advantages and characteristics, SFC has been very extensive research and
application.
Based on the requirements of the Super-critical Fluid Chromatography
(SFC) system, this project completes its DDS, and finally designs
equipment that meets the needs of separation and purification of raw
materials for customers. The system includes:
Fluid delivery modules (including CO₂ pump and organic solvent pump)
Injection modules
High-pressure DAC modules
High-pressure UV detection modules
Back pressure control modules
CO₂ recovery modules
Control and data processing modules
2. System configuration and Technical Specifications
2.1 Project Introduction
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General Appearance
CS-Industrial ATEX SFC purification system (The specific dimension will be confirmed on DQ Design Documents)
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Infusion system unit description
2.3.1 System PI&D Drawing
Product Features
The supercritical fluid chromatography (SFC) system was developed based
on an industrial preparative HPLC. It can be used to separate chiral
compounds, any complex mixtures or natural extracts ranging from grams
to tens of kilograms.
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The efficiency of Supercritical fluid chromatography is usually 3 to 5 times
the traditional preparation of chromatography, which can speed up the
separation of compounds from grams to kilograms to meet the needs of
the medical chemistry to its clinical trials.
Performance:
From the selection of engineering components to final assembly and site
installation, we have complete control over the entire process of designing,
manufacturing and testing the system to provide you with the best
performance guarantee.
Reduce the influence of the environment.
The use of supercritical CO2 reduces the consumption of organic solventsby 5 to 20 times, and our unique CO2 recycling technology allows you todramatically reduce CO2 consumption up to 20 times, while reducingproduction costs and environmental impact.
Main components configuration tables
Item Specifications QTY Brand Origin
CO2 Pump Diaphragm pump,Wetted Material:316 SS steel/PTFE, Max flow : 120LPH , Max Pressure:30MPa
1pcs LEWA Germany
CO2Pump Flowmeter
Brand:E+H Promass Mass Flowmeter Accuracy:±0.15% 1pcs E+H Germany
CO2Pump Pressure sensor
Pressure setting range:0~30MPa,Accuracy:±0.15%,Signal Output:4...20 mA
1pcs E+H Germany
Injection Pump Piston Pump , Wetted Material : 316 SS Steel/PTFE, Max Flow : 30LPH , Max Pressure:30MPa
1pcs HAMBOM China
Modifier Pump Diaphragm pump, Wetted Material : 316 SS Steel/PTFE, Max flow : 60LPH , Max Pressure:30MPa
1pcs LEWA Germany
Modifier Pump Flowmeter
Brand:E+H Promass Mass Flowmeter Accuracy:±0.15% 1pcs E+H Germany
Modifier Pump Pressure Sensor
Pressure setting range:0~30MPa,Accuracy:±0.15%,Signal Output:4...20 mA
1pcs E+H Germany
Back Pressure Back Pressure setting range:0~40MPa 1pcs Masoneilan Germany
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Item Specifications QTY Brand Origin Valve
PLC Electrical Control System
PLC components, including PLC controller (Siemens, Germany), CPU modules, power modules, input and output modules, memory cards and other components
1pcs Siemens Germany
Electrical components system piping, fittings and other accessories, including: air switch, AC contactor (SCHNEIDER France), phase failure and phase sequence protection relays, fuse holders, switching power supply, etc.
1pcs SCHNEIDER
Germany
IPC, Core Duo E5300 / memory 2G / hard drive 160G / DVD drive
1pcs Avantech Taiwan
Electrical cabinet: Material: SUS304, matte finish
1pcs HAMBOM China
Others: Liquid crystal display (HP), buttons, lights, wires, etc. Protection level: IP65
1pcs HP USA
Chromatography Work Station
Second development based on GE platform Which is control and data processing integrated software, conforming to FDA and GMP requirements, with multi-level user permissions, manual control, alarm settings and other functions, detailed records of system operation log, real-time display of operating parameters, flow path status, Various detection curves, graphical user interface, data can be automatically recorded and stored, copy, process records and report print output, the original data can’t be changed
1pcs HAMBOM China
Main Components Description
2.3.4.1Infusion Pump
German LEWA diaphragm pump, Pressure resistance is up to 20Mpa, the
designed working temperature is not less than 60℃and the designed standard
satisfied with ATEX relevant requirements; The internal surface roughness
satisfied with SF4 level requirement, The materials that contact all liquid and
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medium is not less than 316L, Explosion-proof standards for design:
ExdIIBT4;
Characteristics: Maintenance costs are very low and maintenance interval
period is very long; Mechanical efficiency is very high; the security of
Resistance to overload is very high; Stroke adjustment doesn't need too much
energy; Stroke control linear is very good. When it is running, you can also
adjust the stroke. It can provide a variety of drive configuration and pipeline
connection scheme to you. It is equipped with high pressure protection valve.
When the pressure is over than the maximum working pressure (200bar or can
set by the operators), the system will stopped automatically and release the
over pressure by waster liquid outlets and protect the system. The check valve
material is SUS316L, PTFE.
Mass flow meter
E+H Promass Mass flow meter from Germany is a multivariate flow rate
measurement system and can be measured by liquid or gas. Explosion the
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authentication: ATE, FM, CSA, TIIS. Food industry Explosion
authentication/health requirements:3A,FDA; Multivariate measurement: It
can simultaneously measure the mass flow rate and density.
Accuracy: liquid±0.15%,Gas:±0.50%
Pressure Transmitter
Brand : E+H , Stroke : 0-10Mpa .E + H, one of the world's largest
professional manufacturer of pressure and temperature measurement
instruments and equipment.
Back Pressure Regulating Valve
Brand: MASONEILAN (Masoneilan).
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2.4 SFC-DAC-HB50 Dynamic Axial Compression
Column Description
2.4.1 Appearance Picture
SFC-DAC-ID50/80mm
Pneumatic flow regulating valve features:
(1) Erosion-resistant, flash-resistant.(2) Shut off tight, seal level can reach ANSI.
(3) High reliability: unbalanced spool and top guide stem design to
ensure that the valve can achieve maximum stability even in harsh conditions.
(4) High efficiency: 21000 series through the interior design, actuator
stability and closure of the integration to achieve the most appropriate control
performance. It also offers a completely efficient valve platform using a wide
range of materials, pressure ratings and valve end connections.
(5) A variety of different forms of internal options, such as noise
reduction, anti-cavitation.
(6) Simple structure, easy maintenance.
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The dynamic axial compression column consists of the following components:
1. Cylinder parts 2.Supporting parts 3. Piston parts 4.Tube parts 5. Frame parts 6.
Control system 7. End cap parts 8. Chain clamps part.
2.4.2 Cylinder parts
Hydraulic cylinder jacket material: 45#steel , Thermal refining : 25 ~
30HRC. Adopt the automatic welding, detection treatment; ensure no leakage
porosity and welding defects.
Piston rod : Hard chromium plating surface treatment, plating chromic
layer in the atmosphere and has stronger passivation ability, can keep the
metal luster, It can't produce the chemical reaction in a variety of acid
medium. Coating hardness will be reached to 1000 HV, excellent wear
resistance
Seal ring: the Parker precision O-rings and block circle, and to ensure the
hydraulic cylinder will not have the leakage under high pressure and longtime
wear-resisting performance.
The hydraulic cylinder surface: the primer is the anti-rusting paint, paint
processing outer lacquer.
The hydraulic cylinder strictly comply with JB/T 10205-1500 “The
inspection standard of hydraulic cylinder technology conditions". Under the
35MPa pressure, there is no external and internal leakage.
The hydraulic oil: the viscosity is 46 ~ 68 CST, anti-wear hydraulic oil.
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Piston Parts
Piston main parts: Seat Connection, orientation cycle, and active sealing rings,
bowl type seal ring, distributor, type of mesh filter board, O-rings, etc.
Piston parts material: SUS316L/PTFE/PEEK, all materials meet FDA, NSF
standards and the bolt connection between piston and cylinder, very easy to
dismounting and the floating piston design will eliminate the coaxial tolerance
between hydraulic cylinder and column tube.
The pistons used the three seals design, bowl type of seal ring and active
sealing ring and oriented ring, all these will ensure the column tube sealing
performance;
The piston distributor adopted H-Tree style, the end cap of column tube
design adopted the sector distribution methods, and to ensure the fluid will be
converged rapidly
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Control System Adopting imported gas, oil circuit component; improve the sealing performance of the entire system, no leakage, high reliability, while improving product life.
Hydraulic system PI&D Drawing
1、Air compressor 2、Filter 3、Air source Main Switch 4、Air Pressure Regulation Valve 5、Barometer 6、Pneumatic pump 7、Overflow valve 8、Barometer 9、Pneumatic four way valve 10、Hydraulic cylinder
Column Tube
It is using the most advanced domestic grinding technology, it can guarantee
that column wall roughness will be ≤ 0.02 mm, also greatly enhance the degree
of finish and reduce the column wall effect to improve the performance of
column.
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No. Name Specification/Material/Brand/Requirements QTY 01 Frame Material 304 SS Steel 1
02 Column Tube
Material 316 SS Steel
1
Column diameter 50mm,Design Pressure 30MPa,with heating jacket
Length 650mm Polishing degree Inner surface Ra≤0.2μm,extra surface Ra≤1.4μm
03 End cap
Material 316 SS Steel —— Seal ring Material: O-ring (FEP + SI) 2 Polishing degree
Inner surface Ra≤0.2μm,extra surface Ra≤1.6μm ——
Distributor 316 SS Steel Sector distribution methods, to ensure the fluid will be converged rapidly
1
Frit 316 SS Steel Pore size:2~3um
1
04 Piston
Material 316 SS Steel —— Distributor Material:316 SS 1
Frit 316 SS Steel Pore size:2~3um
1
Seal ring Material: O-ring (FEP + SI) 2
05 Compressio n System
Control Panel
304 SS Steel 1
Pressure Gauge
Brand:MAXIMATOR;Stroke:0-250BAR/PSI Accuracy:5BAR
1
Pneumatic Pump
Brand: MAXIMATOR 1pcs
Manual Brand:EAGLE The manual four-way valve controls 1pcs
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four-way valve
the direction of the hydraulic stem movement
Check valve Brand:EAGLE 1pcs Pressure retaining valve
Brand:EAGLE 1pcs
06 Pneumatic Module
General air source switch
Brand:Legris 1pcs
Pressure regulating valve/ Oil-water separator
Brand:SMC;Regulating the pressure of the air source
1pcs
No. Requirements
01 Column tube made of seamless steel tubes, the inner surface adopt quilting, grinding, elector-polishing, polishing method, to ensure no material off, no red rust, dark spots.
02 All welding parts are fully automatic welding, electric polishing or mechanical polishing, to ensure smooth surface, no burrs.
03 Connecting the end cap and column with chain clamp, connecting column and frame with claps, easy to disassemble, chain clamp material: 304 SS Steel, polished. Nut Material: 304 SS Steel
04 Pressure regulating valve adjust gas pressure and oil pressure to appropriate position, can be locked.
05 Pipe joints adopt quick change connector, easy to disassemble.
06 Liquid Drainage Line Material: PTFE metal hose, fixed with piston and column bottom through stainless steel head, easy to disassemble and no liquid leakage.
07 Equipped with a gas source connection pipeline, a set of solvent pipeline while packing column, pipeline material: PTFE metal hose.
Control System
The configuration tables of Control parts
No. Name Design, Manufacturing Standard
01 On-line control
It is combined by the keyboard of positive pressure explosion-proof and LCD screen. The operators can set up the flow rates and then start the Infusion pumps. If there is an abnormal problem, the pumps can be stopped by operation of keyboard and the display screen can display flow rates.
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02 Local Control
Valves Control
All kinds of valve switching will be controlled by the connection of Computer and PLC in order to realize all kinds of liquid selection and trend.
Pressure and flow control
PLC will read pressure transmitter, Mass flow meter current electricity output, display system pressure, control and display different solvent flow.
Emergency Brake Control
System has an emergency break switch which can rapidly stop the system if an emergency occurs. After the treatment of system problems, the system will be recovered to the previous process. It has the emergency stop button and can easily touch it and stop the system according to the requirements.
03 Software Configuration
Meet FDA CRF part II related requirements with historical records, all data has the traceability, It can keep record of all operation status.
04 Interfa ce
Overall Require ments
Including monitoring procedures, operating procedures and external equipment; User control system can ensure the safe, reliable and continuous; Automatic control system is safe, easy to operation, the structure is reasonable, Through the line or other way connection, can be in equipment remote operation and monitoring.
Monitori ng
interface
Display the running state of the equipment (such as: preparation, operation, stop, etc.), Display system running program process (such as: the stage operation, operation etc.), Display equipment real-time online detection data, including pressure, flow rates, UV detector;
Others It can set the alarm
05
Data Acquisi tion and store
Data acquisiti
on
Automatic record and storage Data can be preserved and kept record Process record printout The report printout Data is reliable Raw data cannot be changed
Data need to
be collecte d and
automa tic
recorde d.
Valves in and out position and switch status Column Position Pipeline flow direction Flow rates Pressure UV Absorption (preserve the chromatogram) Alarm information Operation and program operation record Gradient elution curve
Data preserva tion
Provide the system data storage medium capacity size requirements
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Key Parts of Control system 2.5.2.1
Industrial control computer
Advantech from Taiwan, China
19 "rugged 4 u mounted case, it is equipped with 14 passive back plane or
industrial motherboard, the resistant disk drive bays can support three 5.25"
and one 3.5 "disk drive, the front end is equipped with two USB or PS / 2
keyboard I/O interface, the system status LED indicator on the chassis front
panel can display power supply, hard disk, and the operation of the system
voltage, the blowing cooling fan can maintain positive air circulation within
the whole case. Due to these characteristics, it makes the system have the
stronger anti interference, dustproof, shockproof, anti-interference flowability.
PLC Control system
Siemens PLC controller: the maintenance workload is small, easy
maintenance, low failure rate, and can improve the diagnosis and display
function. PLC or external input device has failure with actuator, the operators
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can quickly find out the cause of the failure according to the light emitting
diode or PLC programmer information and use replacement modules can be
ruled out so quickly
Siemens Frequency Converter
Siemens MM4 series drives have a simple, modular design that allows
maximum flexibility in configuration, with three fully programmable, isolated
digital inputs, complete inverter and motor protection.
Control software
System software developed based on GE's software platform, the software
features as following
• Friendly graphical user interface, online real-time display of the various
parameters during operation, such as time, flow, flow rate;
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3. Other Project Requirements
3.1 System other requirements
• Good operation interface, easy to achieve a variety of functions
• Multi-mode operation can be selected, debug mode, manual mode and
automatic mode;
• Comprehensive data operation log to ensure that every step can be
traced back;
• GLP/FDA-21CFR Part II fully support GLP/FDA-21 CFR Part II• Strictly distinguish user's operation authority, in case operator's change
of production data;
• Multiple Tasks Hyper-Threading Data Processing System, fast system
response and fast processing;
• High precise data acquisition and processing to ensure the accuracy of
the chromatographic calculation results.
NO Requirements
01 All the measurement use metric system.
02 Supplier should provide a control platform with a stable system performance,
and equip necessary communication interface.
03 Supplier should provide related software instruction files of program development, encoding procedure usage and so on.
04 Supplier should list the power supply, which meet the usage of equipment and other requirements of utility system.
05 Equipment running noise is less than 100bd ( within three inch from
equipment)
06 This equipment should be provided with the ability of anti-electromagnetic
interference and radio wave interference. The release and electromagnetic
interference should meet the requirements of CE certification.
07 All the material contact with products should meet requirements of current EU
cGMP, FDA, cGMP, USP Class Ⅵ and Chinese GMP.
08 All the pipeline’s welding points which contact with products should meet the
requirements of current ASME BPE specification.
09 The material of system pipeline is polypropylene or similar polymer system,
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the material of pipeline gasket/joint ring should be EPDM or PTFE.
10 Suppler should provide supporting documents and Compatibility list of
material of system.
11 The whole surface of system should meet the requirement of wipe disinfection
and air sterilization.
12 All the assembly, control circuit, connecting line etc. should be marked and
easy to be identified.
No Names QTY 01 Qualification of equipment supplier and quality assurance files 1pcs 02 Qualification of relevant assembly supplier and supporting files. 1pcs 03 Material report 1pcs
04 DQ-Design Qualification (DQ) 1pcs
05 FAT-Factory acceptance test 1pcs
06 SAT-Customer site acceptance test 1pcs
07 Installation Qualification (IQ) 1pcs
08 Performance Qualification (PQ) 1pcs
09 Operational Qualification (OQ) 1pcs
10 Installation manual 1pcs
11 Operational Manual 1pcs
12 Packing list 1pcs
13 Spare parts list 1pcs
Other requirements
No. Requirements
14 DQ/FAT/SAT scheme should be provided to user and sign to confirm, then next step work can be conducted.
No. Requirements 01 Provides computer program CD backups 1pcs 02 Provides computer and PLC data line 1pc for each 03 Provides Written equipment maintenance, maintenance plan
04 Provides record and control software maintenance plan
05 Provides the equipment maintenance tools 1set
3.2 Accompanying documents items
4. After-Sales Service Requirement
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06 Supply of equipment spare parts within the service life and provide preferentialsupply commitment.
07 Provide one year of equipment warranty and lifetime maintenance services.
08 Free to provide assistance to debug, start support services, including
assistance in installation, operation and commissioning.
09 If Equipment is failed, we shall respond upon receipt of notification within 24
hours rushed to the site within 72 hours to solve the problem.
10 To provide users with equipment excellent performance that meet the user's
technical parameters
11 After Equipment is arrival, the internal connection of pipeline and control line installation, public line connection.
12 Regular inspection on equipment, freely assist the equipment examination and
basic maintenance without additional cost.
13
Equipment supplier is responsible for user training, and the content includes:
--- SFC basic principle; equipment basic composition
--- Understanding of each component of the new technology
--- Assembly and disassembly on DAC column and internal structure
--- The operation status under the running
--- Operating system interface and method of operation
--- Equipment daily maintenance;
--- Equipment failure analysis method and solving steps
14 Equipment supplier provides wearing parts, consumable list, the use of brand
and specifications/model
5、Company Introduction
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Manufacturer is located in China was established in 1998, which is a largest professional Preparative HPLC system and DAC/SAC column and SMB manufacturer in China. We are specially majoring in Products research, Methods development and Lab and Industrial Scale Prep HPLC system and DAC column production and relevant continuous chromatography equipment.
CS-Prep500 HPLC system with diaphragm pump at customer’s site
Production Scale SFC system with diaphragm pump
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The company includes more professional Labs for samples analysis, Preparative process scale-up, process optimization, QC and so on. It is focused on technology innovation and Prep Chromatography equipment construction. Our manufacturer has more than 200 employees who are engaged in Preparative Chromatography Industry. All these are very professional and technical.
In 2005, the first Chinese DAC column with our Chinese first intellectual property patent was developed by the Manufacturer. In 2006, the simulated moving bed chromatography equipment for sugar alcohol, chemical and pharmaceutical industries was successively developed by us with their patents.
The development of five separation projects for Chromatography Industry was listed on the "2006 Science & Technology Project" and also on the "2006 Innovative funds project" and other awards. Our manufacturing facility has more than 13 patents, 3 high tech products in china and 20 registration trademarks.
In 2009, they established the "Biological Process Control center" with the Chinese Academy of Sciences (CAS). All these are the first in china. At the same time, we are establishing the best long-term business relationship with many famous International Pharmaceutical companies in the world.
CS-Prep HPLC system with DAC-ID500mm Column
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5. Part of SFC customer list
No. Client Name SFC-Prep
HPLC SFC-DAC Size Qty(set)
1 Beijing Academy of Military Sciences
Prep DAC-150 1
2 Beijing 301 Hospital Prep DAC-50 1
3 Shenzhen Xinlitai Prep DAC-150 1
4 Nanjing Shenhe Pharmaceutical Prep DAC-100 1
5 Suzhou University Prep DAC-100 1
6 Hangzhou Huajinyunshang
Pharmaceutical Prep DAC-100 1
7 Shanghai Deyi Biology Prep DAC-150 2
8 Anygen from Korea Prep DAC-100/150(2)/
200 4
9 Sanofi from France Prep DAC-80/150 2
10 Teva from Hungary Prep DAC-150 2
11 Ambio peptide from USA Prep DAC-300 2
12 Lonza from Switzerland Prep DAC-300 1
13 Dr. Reddy Lab from India Prep DAC-150/600 2
14 Bachem from Switzerland Prep DAC-450 1
15 Hetero drugs from India Prep DAC-50/80 3
16 Cargoen from Switzerland Prep DAC-50/150 2
17 Evonik from Germany SMB DAC-80 1
18 Laurus Lab from India Prep DAC-50/100/200 3