Ⅰ.Confirmation of Equipment Design ：
| 1 | Equipment | |
| 1.1 | Total volume
35L |
Use Fermentation tank Bioreactor |
| Working volume | 40-70% Quantity: 1 | |
| 1.2 | Liquid-adding container | Heat-resistant silica glass bottles
1L : 3pcs, 2L : 1pc, 10L 1pc, 20L : 1pc |
| 1.6 | Process piping | Enclosed installation
Open-shelves installation |
| 1.7 | Air pretreatment | Pressure-relief device No
Pre-filtration and pressure-relief devices No |
| 1.8 | Vapor pretreatment | Industrial steam filtration, hydrophobic and stress systems
No Pure steam filtration, hydrophobic and pressure relief systems required No |
| 1.9 | Cooling water pretreatment | First-level screen filter |
| 1.10 | Other | Air , Nitrogen, carbon dioxide, oxygen decompression device No |
| 1.11 | The buyer’s confirmation： | |
| 2 | Application | |
| 2.1 | Biological species | Bacteria（bacteria） Plant cells Mammlian Cells |
| 2.2 | Cultivating methods | Batch（Batch culture） Suspension culture
Microcarrier culture Fed batch（Batch supplement culture） |
| 2.3 | The buyer’s confirmation： | |
| 3 | Delivery date and installation site | |
| 3.1 | Equipment delivery date | 90-120 working days |
| 3.2 | The installation site | Customer will install the equipments by themselves |
| 3.3 | The buyer’s confirmation: | |
| 4 | Reactor/fermentation tank | |
| 4.1 | Tank | total volume： 35L Working volume Full volume
Working volume： 70% Diameter ratio： 1: 2.2-3 1: 1.5-1.8 ………. Design tank pressure： 0.3MPa …3…. barg Tank’s internal bile material： 316L 304 Test report of tank materials： 3（SGS）：Top cover, straight tube body, lower head No Internal polishing accuracy： Ra0.2 Ra0.4 Ra0.8 Internal electropolishing Internal pickling passivation External surface polishing treatment： Ra0.8 sand blasting Internal polishing test report： 3（SGS）：Top cover, straight tube body, lower head No Pressure vessel certificate： provide No Conform to GMP standard： Provide relevant documents No Viewing mirror： Side-view mirror Top-view mirror No floodlight： Side installation Top installation No Sterilization temperature： 100-130 °C，The sterilization time： 0-60min，The highest temperature： 135 °C Sterilization mode： In situ automatic sterilization (Can be sterilized separately for empty and full vessel) Manual operation Sampling valve： Denmarkkeofitt Bürkert No Sampling valve sterilization mode：Manual sterilization Tank bottom valve： Bürkert GEMÜ No Tank bottom valve sterilization mode：Automatic sterilization There are three optional filling liquid interfaces; A shallow aeration tube interface; A deep ventilation tube interface； A top flame inoculation interface；A side seed transfer interface Cleaning: high pressure cleaning interface is installed at the top； Tail gas condenser： yes No Exhaust gas incinerator： yes No |
| 4.2 | Jacket | Design pressure: 0.35Mpa
Jacket material: 304 stainless steel Temperature control jacket：Coverage ratio 80%，Internal optimization diversion structure Heat preservation jacket： yes No External surface treatment： buffing Ra0.8 matt |
| 4.3 | Top cover | Flat-topped tank cover, bolt – type compaction device；
Pneumatic open-cover mode Electrodynamic open-cover mode |
| 4.4 | The buyer’s confirmation: | |
| 5 | Mixing1 system | |
| 5.1 | Mixing type
Mechanical seal system |
The bottom double mechanical seal，Steam sterilization treatment
The top magnetic drive is not mechanical seal, the performance is better, the cost is high. |
| 5.2 | Mixing shaft type | Single axis, micro taper high speed type |
| 5.3 | Mixing speed | Speed range: 20-200rpm, stepless speed regulation |
| 5.4 | The mixing slurry | 2 grade elephant ear with 4-blade impeller or customer requirements |
| 5.5 | material | Internal tank and all contact with the material both are 316L |
| 5.6 | The buyer’s confirmation: | |
| 6 | Ventilation system | |
| 6.1 | Ventilation mode | bottom ventilation top ventilation The control interface can be selected in two modes
The bottom ring gas distributor The bottom l-shaped gas distributor |
| 6.2 | Filter | Air intake filter Exhaust filter
Automatic on-position sterilization Manual on-position sterilization on-position integrity testing off-position integrity testing None Brands：Sartorius Domnick Hunter |
| 6.3 | Gas species | air oxygen nitrogen carbon dioxide |
| 6.4 | Flow meter | Rotor flow meter + solenoid valve Gas mass flow meter + rotor flow meter
brands： Vogtlin Bürkert Cheng Feng |
| 6.5 | The buyer’s confirmation: | |
| 7 | Feeding System | |
| 7.1 | Feeding type | acid base antifoam Nutrient solution 1 + feeding material inoculation liquid
Note: usually, acid and alkali only use one peristaltic pump, the interface is optional, so the actual can only needs four peristaltic pumps. |
| 7.2 | Peristaltic pump | Intermittent type：Kolpalmer (Spirax Sarco) Watson-Marlow
Continous type：Kolpalmer (Spirax Sarco) Longerpump |
| 7.3 | The buyer’s confirmation: | |
| 8 | Inoculation and Seed transfer | |
| 8.1 | Inoculation | Inoculation approach：Flame inoculation Peristaltic pump + insert inoculation |
| 8.2 | subcultivation | Rigid tube seed transfer hose quick coupling seed transfer No |
| 8.3 | The buyer’s confirmation: | |
| 9 | Biological safety | |
| 9.1 | Exhaust disposition | High temperature sterilizer Chemical pool sterilization No |
| 9.2 | Sewage treatment | Dedicated pipe discharge mix emissions No |
| 9.3 | The buyer’s confirmation: | |
| 10 | Control function | |
| 10.1 | sterilization | Automatic sterilization of empty vessel or filled liquid vessel；Sterilization temperature: 100-130 ° C, sterilization time: 0-60 min；
Automatic sterilization of inlet and exhaust filters. Allowed tolerance of sterilization temperature：±0.1°C； Note: |
| 10.2 | Fermentation temperature | PID automatic control, plate heat exchanger for heating and cooling, cooling water for cooling, with circulating system;
Control range: cooling water temperature + 5-65 ° C, control precision: + / – 0.1 ° C, With real-time curve and historical curve, it can be tracked and controlled in sections. |
| 10.3 | pH | PID automatic control, peristaltic pump control, can choose one-way or two-way control;
Control range: 2-12ph, control accuracy: + 0.02 pH, resolution: 0.01pH It has a real time curve and a historical curve. |
| 10.4 | DO | PID automatic control, control air and O2 through mass flow meter;
It can be controlled in association with stirring speed and intake air flow, that is, the dissolved oxygen can be adjusted by changing the stirring speed and intake air flow; Control range: 0-100%, display range: 0-200%, resolution: 1% It has a real time curve and a historical curve. |
| 10.5 | Mixing speed | PID automatic control, stepless speed regulation control with governor;
Speed range: 20-200rpm; Control accuracy: plus or minus 0.5%, resolution: 1rpm It has a real time curve and a historical curve and can be tracked and controlled in section. |
| 10.6 | Tank pressure | PID automatic control, pneumatic control with proportional valve;
Control range 0-0.2 MPa, steady state precision: ±0.01MPa, resolution: 0.001 MPa It has a real time curve and a historical curve and can be tracked and controlled in section. |
| 10.7 | Ventilation flow | air 100L/min oxygen 3L/min nitrogen50L/min carbon dioxide 1L/min accuracy：±2%，resolution 0.1% |
| 10.8 | Material measurement | Yes None |
| 10.9 | Feeding control | Digital timing quantitative control, creep pump automatic replenishing； |
| 10.10 | antifoaming control | Yes None |
| 10.11 | Level control | Yes None |
| 10.12 | Exhaust gas sterilization | Yes None |
| 10.13 | Weighing system | Mettler weighing module |
