ATTACHMENT 2 - STATEMENT OF REQUIREMENT - 1232SA26Q1452.pdf
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- Solicitation number
- 1232SA26Q1452
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This is a Statement of Requirements for the procurement and delivery of a small-scale benchtop tangential flow filtration system for the USDA Biologics Development Module (BDM).
The government requires a Crossflow System brand name or equal to Sartoflow® Smart optimized for ultrafiltration and diafiltration applications in biopharmaceutical processing. The system must support a wide range of surface areas from 50 cm² to 0.14m² and be suitable for scaling studies, low-volume work, and production in cGMP environments. Key technical specifications include a low-shear four-piston membrane pump, a 1L graduated recirculation vessel made of transparent polysulfone with a self-sealing lid and magnetic stir bar, pressure sensors in the feed/retentate/permeate lines, conductivity and temperature probes in the recirculation tank, and an electronic balance. The system must feature a full-view touch screen with pre-defined sequences and recipe programming capabilities. The contractor must provide onsite installation, start-up, and software training, with verification through a customer site acceptance test. Documentation requirements include operation manuals, software manuals, installation procedures, component part confirmations, and calibration certifications. Equipment must be delivered within 90 days of award to USDA-ARS-NBAF, Warehouse Building, 1200 Kretschmer Drive, Manhattan, KS 66052. The evaluation factor is technical acceptability. Technical inquiries should be directed to Steven Witte at steven.witte@usda.gov or (785) 712-3861.
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| File | Type | Posted |
|---|---|---|
| TERMS AND CONDITIONS - 1232SA26Q1452.pdf | ||
| SF1149 - 1232SA26Q1452.pdf |
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ATTACHMENT 2 – STATEMENT OF REQUIREMENTS
Project: Crossflow System
GENERAL INFORMATION
1.0 Scope of Work: Purchase and delivery of a Crossflow System
2.0 Background: The USDA Biologics Development Module (BDM) requires small-scale benchtop tangential flow filtration system for ultrafiltration and diafiltration applications that can easily fit in the lab space.
CONTRACTOR REQUIREMENTS
3.0 The following minimum specifications are required:
Small-scale benchtop Tangential flow filtration system – Salient Characteristics:
Benchtop crossflow system Brand Name or equal to Sartoflow® Smart optimized for ultrafiltration and diafiltration. The Salient Characteristics are as follows:
1. Must be a system specific and ideal to applications within the biopharmaceutical processing that provides ultra-filtration/diafiltration of proteins/viruses, formulation process development, and clarification of cells.
2. The system must be suited for both scaling studies and low volume UF and DF work over a very wide range of surface areas from 50 cm2 to 0.14m2.
3. Must be qualifiable to be used in production and cGMP environments.
4. Must be easy-to-use in any research, production or lab environment with a full view touch screen and control of the critical process parameters.
5. Must be equipped with pre-defined sequences and programmable to set up to run a process to a predefined recipe.
6. The system must come with low-shear four-piston membrane pump.
7. The system must be accompanied by 1 L graduated recirculation vessel made of transparent polysulfone with a self-sealing lid, vortex breaker, and magnetic stir bar for effective mixing.
8. Must be equipped with pressure sensors, each in the feed, retentate and permeate line for operating the system at user-defined set points.
9. Must have conductivity and temperature probe in recirculation tank.
10. Must be equipped with electronic balance at the recirculation tank.
Testing and Verification
• Must have onsite installation, start-up and software training included.
• Qualification via a customer site acceptance test will be the verification standard.
Data Requirements
• The required documentation must include operation manual, software manual, software installation procedures.
• Required software for operation must be included.
• Documentation must also include confirmation of each component part, and certification of calibration for optical probes and other parts.
4.0 Government Furnished: Not applicable.
5.0 Deliverables/Schedule: The equipment must be delivered within 90 days from issuance of the award. If the lead time is longer, this must be noted on the quote. The following is the delivery information:
USDA-ARS-NBAF
Warehouse Building
1200 Kretschmer Drive
Manhattan, KS 66052
6.0 Evaluation Factors: Technically acceptable
7.0 Technical Point of Contact: Should there be technical questions, please contact
Steven Witte
Email: steven.witte@usda.gov
Phone: (785) 712-3861
File details come from the government source that posted it. Updated .