Attachment 1 - Minimum Specifications.pdf
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- Solicitation number
- 1232SA25Q0621
About this file
This document is an Attachment 1 - Minimum Specifications for a small-scale benchtop tangential flow filtration system for the USDA Biologics Development Module (BDM). The system must be a Sartoflow® Smart or equivalent, specifically designed for biopharmaceutical processing applications involving ultrafiltration and diafiltration of proteins/viruses. Key requirements include a system suitable for scaling studies with surface areas from 50 cm2 to 0.14m2, qualifiable for cGMP environments, equipped with a full-view touchscreen, low-shear four-piston membrane pump, 1L graduated recirculation vessel, pressure sensors, conductivity and temperature probes, and an electronic balance.
The specification mandates onsite installation, start-up, and software training, with verification through a customer site acceptance test. Documentation requirements include operation and software manuals, software installation procedures, component part confirmations, and calibration certifications. All packaging, shipping, and shipping-insurance costs must be included in the purchase price. The system is expected to support research, production, and laboratory environments with pre-defined sequences and programmable process recipes.
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| File | Type | Posted |
|---|---|---|
| Amd 0001 SF30 - 1232SA25Q0621.pdf | ||
| Terms and Conditions - 1232SA25Q0621.pdf |
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Attachment 1 - Minimum Specifications
Background and Scope The USDA Biologics Development Module (BDM) requires small-scale benchtop tangential flow filtration system for ultrafiltration and diafiltration applications that can easily fit our lab space.
Applicable Documents and Standards
Small-scale benchtop Tangential flow filtration system:
one (1) benchtop crossflow system Brand Name or equal to Sartoflow® Smart optimized for ultrafiltration and diafiltration.
Salient Characteristics:
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.
Government Furnished Property None
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.
Packaging and Shipping All packaging, shipping, and shipping-insurance costs must be included with purchase price.
File details come from the government source that posted it. Updated .