ESBD_394760_1739199866910_RFP 25-23 Large Scale Bioreactors Attachments A-E.pdf
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- Attached to
- RFP 25 23 Large Scale Bioreactors
- Solicitation number
- RFP_25-23_Large_Scale_Bioreactors
- Issued by
- Texas
About this file
This document contains technical specifications and requirements for RFP 25-23 Large Scale Bioreactors Attachments A-E, detailing requirements for multiple bioreactor systems. The RFP covers five different bioreactor systems: Cytiva Xcellerex XDR 50L to 200L, Cytiva Xcellerex X-platform 50L to 200L, Thermofisher HyPerforma DynaDrive S.U.B 50L to 250L, Eppendorf BioFlow 610, and Sartorius Biostat STR Generation 3 50L to 200L. Each system has specific required components including basic units with housing and control towers, control software for DO/pH control, air/O2 spargers, feed pumps, anti-foam control, mixing capabilities, liquid management systems, sensors, and necessary accessories.
All systems require installation and start-up assistance, operating manuals, spare parts kits, and appropriate tubing/connectors. Installation Qualification/Operational Qualification (IQ/OQ) is specifically noted as not needed for all systems. The specifications include both single-use technology systems (Cytiva and Sartorius models) and traditional stainless steel systems (Eppendorf BioFlow 610). Each system includes requirements for control software, hardware interfaces, and specific operational components like pH/DO sensors, mixing systems, and gas management capabilities. Pricing information for optional extras is requested for all systems.
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RFP 25-23 Large Scale Bioreactors Attachments A- E
Attachment A:
Cytiva Xcellerex XDR 50L to 200L Single-use technology and stirred-tank design for varied requirements of biotechnology training and development.
Required:
1. Scope without optional functions Basic unit-Full system with housing, control tower and appropriate size TCU
2. Control Software. System must provide software and hardware for:
DO control, pH control Air Overlay & Sparger O2 Sparger Feed pump Anti-Foam Control Mixing
3. Liquid Management IO cabinet with appropriate number of variable speed peristaltic pumps
4. Power Cord
5. Reusable pH Sensor
6. Reusable DO sensor
7. Spare parts Kit
8. Operating and Maintenance Manual
9. Installation and Start-up Assistance as required
10. All appropriate tubing, clamps and connectors for operation
Optional:
11. Pricing and availability for frequently requested optional extras for system
12. Installation Qualification / Operational Qualification (IQ/OQ) Not needed
Attachment B:
Cytiva Xcellerex X-platform 50L to 200L Single-Use cell culture bioreactor, with low-shear mixing, application ready bags for easier process optimization. These units consist of three separately housed components: the bioreactor vessel, a cabinet assembly, and the human machine interface (HMI).
Required:
1. Scope without optional functions Basic unit-Full system with housing, control tower and appropriate size TCU
2. Control Software. System must provide software and hardware for:
DO control, pH control Air Overlay & Sparger O2 Sparger Feed pump Anti-Foam Control Mixing
3. Liquid Management IO cabinet with appropriate number of variable speed peristaltic pumps
4. Power Cord
5. Reusable pH Sensor
6. Reusable DO Sensor
7. Operating and Maintenance Manual
8. Spare Parts kit
9. Installation and Start-up Assistance as required
10. All appropriate tubing, clamps and connectors for operation
Optional:
11. Pricing and availability for frequently requested optional extras for system
12. Installation Qualification / Operational Qualification (IQ/OQ) Not needed
Attachment C:
Thermofisher HyPerforma DynaDrive S.U.B 50L to 250L
Unit consists of the bioreactor tank and the Thermo Scientific HyPerforma DynaDrive BioProcess container. Stirred-tank design with unique drive train with multiple impellers.
Required:
1. Scope without optional functions Basic unit-Full system with housing, control tower and appropriate size TCU
2. Control Software. System must provide software and hardware for:
DO control, pH control Air Overlay & Sparger O2 Sparger Feed pump Anti-Foam Control Mixing
3. Power Cord
4. Spare parts kit
5. Operating and Maintenance Manual
6. Installation and Start-up Assistance as required
7. All appropriate tubing, clamps and connectors for operation
Optional:
8. Pricing and availability for frequently requested optional extras for system
9. Installation Qualification / Operational Qualification (IQ/OQ) Not needed
Attachment D:
Eppendorf BioFlow 610
Stainless Steel bioreactor designed for pilot production system, the BioFlow 610 offers a modular system with off-the-shelf options. Built on a mobile skid
Required:
1. Scope with below listed optional components
a. Basic unit-full system with housing, control software and tower, and appropriate TCU sized unit
2. Gas flow control for Two gas system
3. 2 TMFC Gas flow unit
4. Powercord
5. Rushton-type Impeller
6. Redundant pH/DO Sensor
7. Foam/Level sensor
8. (1) re-sterilizable sampling valve
9. (1) re-sterilizable addition valve
10. Sprayballs for clean-in place of vessel
11. External variable speed pump
12. Spare parts kit
13. Operating and Maintenance Manual
14. All appropriate tubing, clamps and connectors for operation
15. Installation and Start-up Assistance as required
Optional:
16. Installation Qualification / Operational Qualification (IQ/OQ) Not needed
Attachment E:
Sartorius Biostat STR Generation 3 50L to 200L
Stainless Steel bioreactor bag holder supporting the single-use Flexsafe STR bags.
Designed for pilot production system, full jacket for optimal temperature control, with integrated cell and gas supply.
Required:
1. Scope with below listed optional components
a. Basic unit-full system with housing, control software and tower, and appropriate TCU sized unit
2. Vessel level control
3. (2) gravimetric feeds
4. Local data archive, historical trends and batch reporting
5. Control Software. System must provide software and hardware for:
a. DO control, pH control
b. Air Overlay & Sparger
c. O2 Sparger
d. Feed pump
e. Anti-Foam Control
f. Mixing
6. Power Cord
7. 1 bag with standard cell culture spargers and impeller
8. 1 bag with standard fermentation spargers and impeller
9. Spare parts kit
10. Operating and Maintenance Manual
11. All appropriate tubing, clamps and connectors for operation
12. Installation and Start-up Assistance as required
Optional:
13. Pricing and availability for frequently requested optional extras for system
14. Installation Qualification / Operational Qualification (IQ/OQ) Not needed
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