GLOBAL HEMP SOLUTIONS · [email protected] (740) 444 -HEMP GLOBAL HEMP SOLUTIONS 4.2.0) Analytical HPLC system:10ml/min 4.2.1)Solid Phases for the method development

[email protected] (740) 444 -HEMP

GLOBAL HEMPSOLUTIONS

Continuous Liquid Chromatography Downstream Processing Design

（The Exact Drawings are referring to the DQ after PO）



INDEX

1. General………………………………………………………….….…...............…..03

2. Purpose of Chromatography Downstream Processing....................................................03

3. Budgetary Offer Description.....................................................................................................04

4. Scope of Supply...............................................................................................................................05

5. Scope of Engineering....................................................................................................................07

6. Lab Scale Process Method Development for the separations of CBDs by SF-SMB.08

7. Lab Scale SF-SMB Complete Process Main Execution Plan&Schedule........................09

8. Prices Summary...............................................................................................................................09

9. Equipment Test/Acceptance Document Description.........................................................10

10. Company Profile..............................................................................................................................13



1. General

With the development of Industrial Hemp and CBD, The technical Chromatography

Isolation and Purification process is very necessary, Especially the Thc removal or to control

the percentages. So We designed the whole process by using the Preparative and Industrial

Chromatography isolation and purification technologies. It has already been used in some of

Industrial Hemp client’s factory. Please be aware of that Without any approval from us,

Dissemination is not allowed.

2. Purpose of Chromatography Downstream Processing

1. According to the principles of environmental protection, high energy, high efficiency and

optimal technology, We make the process plan and design; Any Clients who have the interest,

Please send the manufacturing certificates from your local government to us first.

2. The purity of CBD extracted from the leaves and flowers of the industrial hemp plant is

more than 99%;

3. The THC is controlled below 0.1% or no detection, Closed destruction mode (by enhancing

carbonization) or collect it in a tank legally.

4. The specific process needs to be customized according to customers' raw materials andspecific requirements.

5. The downstream processing technologies is the key in the whole process, especially the Thccontrol or removal. Based on the strongest separation and purification experiences, We havedifferent technologies can be used for the downstream process, Like ATEX Prep HPLCChromatography or Continuous Simulated Moving Bed Chromatography. This proposal wemade is the references by using the Continuous SFC-Simulated Moving Bed Chromatography.



3. Budgetary Offer Description

3.1)Process description

The present budgetary offer is the supply of services as specified in this budgetary offer.Theproprietary chromatographic system that is commonly seen in separation. Due to its characterof continuous feeding, the system is deemed as a highly efficient separation method compare totraditional batch chromatography process.

The required pre-treated feeding material is delivered into the system, as well as the solvent.After a period of time, the entries of the feed and solvent will switch to the next columnsimultaneously to simulate the countercurrent flow of solid and mobile phases. After a fewround of the switch, the entire manufacturing process will be stabilized and will be ready forcontinuous production.

3.2)Project Quality Control

In the project implementation process, the supply and demand sides will form a quality controland the validation team to confirm the design qualification (DQ), (FAT) factory acceptancebefore delivery, installation qualification (IQ) and operational qualification (OQ).

3.3)Purpose and Scope

The design is strictly manufactured based on customer requirements (URS), and its technicalspecifications meet or partly exceed the requirements of URS. This will be one of the finaldesign documents of the equipment scheme. The document requires customer confirmation,after the confirmation, the document will be the basis for system design, production andverification, as DQ, FAT, IQ, OQ reference standards. All the production scale manufacturingprocess has to develop the lab scale SMB process by using the lab scale continuous SF-SMBchromatography system .



4.Scope of supplyDue to the lab scale method development, So we supply the following lab scale SFC-SMBequipment to identify the parameters in order to do the scale-up.

4.1)BASIC UNIT EQUIPMENT

4.1.1) PumpsA) Liquid Pump: Quantity: 2A-1) Flow rate: 50L/hrA-2) Max operating pressure: 20 MPaB) Feeding Pump: Quantity: 1

B-1)Flow rate: 6 L/hrB-2)Max operating pressure: 20 MPa4.1.2) Column

Quantity: 6Column type: Dynamic - Axial ColumnColumn diameter: 80 mmMax bed length: 450 mmMax packing pressure: 15 MPa4.1.3) ValvesPneumatic valves mainly from Swagelok are used.4.1.4) Piping

Complete stainless steel piping system including high pressure armatures, instrumentation,gaskets and fitting, typical brands used.4.1.5) Control system

The operator interface is a PLC with touched panel. All system temperatures and pressure aredisplayed on these screens. Graphic display screens of the complete system including some softpush buttons for operation.4.1.6)InstrumentationThe type and amount of instrumentation will mainly include the following components:Pressure sensor Mass Flow meter Controller4.1.7)OPTIONAL SUPPLYA CO2 supply and circulation system is also available as an added option to the above SF-SMBunit at additional cost.4.1.8)Winterization Qty:1 -40 C, 100 kg-oil/day4.1.9)MD or Low pressure Chromatography Column: 10KG/H



4.2.0) Analytical HPLC system:10ml/min4.2.1)Solid Phases for the method development 4.2.2) Lab Scale Method Development by using SF-SMB4.2) BUYER'S SCOPE OF SUPPLYThe Buyer shall supply the following in time according to the overall time schedule. Complete units including instrumentation and piping for electrical power station.4.2.1)Service stationswith distribution, all cables, wiring and supports as well as pre-treatment facilities.

4.2.2)Civil construction: Incl. site preparation, furniture, laboratory, ventilation.4.2.3)Material preparation4.2.4)Mechanical construction

5.SCOPE OF ENGINEERING5.1 Process Engineering includingl Process Flow Diagramsl Process descriptionl Sizing of equipmentl Equipment data sheets and equipment listl Utility requirementsl Plant operating and safety manual including start up and shut-down procedures5.2 Piping Design includingl P & I Diagrams

l Plant lay outl Piping stress calculations as far as necessaryl Piping drawings (General arrangement drawings and in case of necessity Isometrics)l Line listl Line of piping material (material take off)

l List of insulation for piping and equipment5.3 Mechanical Engineering including

l Mechanical specification and description of equipment

l Equipment specification listl Operating and maintenance manuals for items of equipment

l Manufacturer's drawings control5.4 Electrical Engineering including



l Electrical load requirementsl Operating and maintenance manuals from items of equipment as far as supplied

l Manufacturer's drawings control5.5 Instrumentation and Control Design including

l Specification of instruments and devices for process control

l Instrumentation loop and installation drawings

l Control logicl List of all instruments and cables (material take-off) and consumables

5.6 Structural steel design includingl General lay-out

l Foundation locations and loads5.7 Procurement including

l Purchasing of all equipment and material

l Transportation and delivery of equipment and material (to be agreed)

5.8 Supervision on site (Optional Price)

l Supervision of erection (12 man-weeks)

l Supervision of commissioning and start-up (4 man-weeks)

l Training (2 men for 2 weeks)

6.Lab Scale Process Method Development Plan for the separation of CBDSby SF-SMB.



Notes: Once the SFC-SMB equipment and MD and analytical HPLC systems purchased and set up at theclient’s site, We will send our scientist to be there and start the above lab process and manufacturingtest.

7.Lab Scale SF-SMB complete process Execution Plan and Schedule

Project Item 1 2 3 4 5 6 7 8 9 10 11 12

Equipment Selection

Equipment LayoutDesigning/DQ/Manufacturing

Client’s Plant DrawingDesign,including Pipes,IQ/OQ,Confirmation and

Preparation

Equipment Installation/IQ/OQ/and Confirmation

Lab Scale Process TrialOperation/PQ/PV


Item Total(USD)

MD(If client wants, then client needs to provide) and Winterization (Client’s selectionbased on requirement)or Low pressure Chromatography Column ID800mm*1MSF-SMB ID80mm*6Nos Complete system units

Anlalytical HPLC system

Installation and DQ/IQ/OQ/PQ/FAT/SAT/GMP documentation, Including the client’splant process design drawings

Application Method Process and Validation

Solid Phase Packing Medias

Project Management at the site & 2 Years warranty from the delivery date

Notes: The Supplier will provide the trial operation to the client, But all jobs start should be based on theofficial legal licenses the client has already got from the government. If any legal problems during theprocess at the client’s country , The supplier will not be responsible for that.

10. Equipment Test/Acceptance Document Description:

10.1 The other requirements of system

NO. Requirements

1 All the measurement use metric system.

2 Supplier should provide a control platform with a stable system performance, andequip necessary communication interface.

3 Supplier should provide related software instruction files of program development,encoding procedure usage and so on.

4 Supplier should list the power supply which meet the usage of equipment and otherrequirements of utility system.

5 Equipment/system is scheduled to run for 10 years, 24 hours a day and 120 hoursper week

6 Equipment running noise is less than 60bd ( within three inch from equipment)

7 This equipments should be provided with the ability of anti-electromagnetic

8 Prices Summary


interference and radio wave interference. The release and electromagneticinterference should meet the requirements of CE certification.

8 All the material contact with products should meet requirements of current EUcGMP, FIDGMP, USP Class Ⅵ and Chinese GMP.

9 All the pipeline’s welding points which contact with products should meet therequirements of current ASME BPE specification.

10

The material of system pipeline is polypropylene or similar polymer system, thematerial of pipeline gasket/joint ring should be EPDM or PTFE.

11

Suppler should provide supporting documents and Compatibility list of material ofsystem.

12

The whole surface of system should meet the requirement of wipe disinfection andair sterilization.

13

All the assembly, control circuit, connecting line etc. should be marked and easy to beidentified.

10.2 Accompanying documents itemsNo. Name QTY

1 Design Qualification 1pcs

2 Quality Project Plan 1pcs

3 Functional Design Specification 1pcs

4 Hardware Design Specification 1pcs

5 Software Design Specification 1pcs

6 Impact Assessment 1pcs

7 Required Traceability Matrix 1pcs

8 Factory Acceptance Test 1pcs

9 Installation Qualification 1pcs

10 Operational Qualification 1pcs

11 Installation manual 1pcs



12 Operational Manual 1pcs

13 Standard Operating Procedure 1pcs

14 Drawings 1pcs

15 All Certificates (MOC, EU, etc) 1pcs

16 Software Backup CD’s 1pcs

12 Packing list 1pcs

13 Spare parts list 1pcs

10.3 After Sales Service Requirement:No. Requirements

1 Provides computer program CD backups 1pc

2 Provides computer and PLC data line 1pc for each

3 Provides Written equipment maintenance, maintenance plan

4 Provides record and control software maintenance plan

5 Provides the equipment maintenance tools 1set

6 Supply of equipment spare parts within the service life and provide preferentialsupply commitment.

7 To provide users with equipment excellent performance that meet the user'stechnical parameters

8 After Equipment is arrival, the internal connection of pipeline and control lineinstallation, public line connection.

9 If Equipment is failed, we shall respond upon receipt of notification within 24 hours

10 Provide users with equipment excellent performance that meet the user's technicalparameters

11 After Equipment is arrival, the internal connection of pipeline and control lineinstallation, public line connection.

12 Regular inspection on equipment, freely assist the equipment examination and basicmaintenance without additional cost.



13

Equipment supplier is responsible for user training, and the content includes:

--- HPLC basic principle; equipment basic composition；

--- Understanding of each component of the new technology；

--- Assembly and disassembly on ID 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 andspecifications/model.

11. Manufacturing



Products research, Methods development and Lab and Industrial Scale Prep HPLC system andID column production and relevant continuous chromatography equipment.

ATEX Prep600 HPLC system with diaphragm pump at customer’s site

ATEX Prep1200 HPLC system with diaphragm pump

Documents

GLOBAL HEMP SOLUTIONS · [email protected] (740) 444 -HEMP GLOBAL HEMP SOLUTIONS 4.2.0) Analytical HPLC system:10ml/min 4.2.1)Solid Phases for the method development