Attachment 1 - Specifications.docx
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- Attached to
- Protein Purification System Federal contract opportunity
- Solicitation number
- 12805B22Q0496
About this file
This document contains a solicitation for a protein purification system and related specifications. The USDA Agricultural Research Service Plains Area requires a modular protein purification system including a 25L AKTA Pure or equivalent chromatography skid, UniFlux or equivalent tangential flow filtration system with 60 LPM flow capacity, and AKTA Avant 25 or equivalent benchtop chromatography system. The systems must support various chromatography techniques and automation with data logging. Quotes are due by August 22, 2022 and will be evaluated based on technical acceptance, past performance, and price under the lowest price technically acceptable criteria. Award will be made to the responsible offeror providing the most advantageous quote.
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| File | Type | Posted |
|---|---|---|
| Solicitation_12805B22Q0496.pdf |
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Attachment 001 Protein Filtration & Purification System Manhattan KS Specifications
Background and Scope The USDA Biologics Development Module requires a modular, flexible system for purification of proteins, peptides, and nucleic acids, from microgram to gram levels. The system needs to be able to support the development of scalable protein purification methods from pilot to manufacturing scale and needs to include tangential flow filtration (TFF) and cross flow filtration.
Applicable Documents and Standards A. Contractor must warranty the proper function, parts, software, and workmanship of the bioreactor system for 1 year as part of the initial purchase price.
Protein Purification 25 L Specifications:
One (1) Each protein purification system Brand Name or Equal to AKTA Pure 25 L system Salient Characteristics:
1. Must be able to support affinity chromatography, size exclusion chromatography (SEC), ion exchange chromatography, hydrophobic interaction chromatography, and reversed phase chromatography (RPC).
2. Must have a buffer selection system that can support up to 14 inlets.
3. Must support a flow rate of 0.001 to 25 mL/min.
4. Must support multiple sample injection, up to 5 samples.
5. Must support multiple fixed wavelength detection.
6. Must comply with safety certifications (CE, ETL, UKCA, EAC, KC, RCM).
7. Must be able to accommodate solution viscosity range from 0.35 to 10.0 cP.
8. Must be able to monitor pH range from 0 to 14 and operate from pH 2 to 12.
Tangential Flow Filtration System Specifications:
One (1) Each TFF system Brand Name or Equal to Cytiva UniFlux system Salient Characteristics:
1. Must be able to support up to 60 Lpm flow rates.
2. Must support fully automated tangential flow filtration/cross filtration for clarification, concentration and diafiltration applications.
3. Must support both stainless steel and single-use recirculation tank systems.
4. Control software must support full automation with data logging capabilities.
5. Controller software must be fully compliant with 21 CFR Part 11.
Benchscale Chromatography system:
One (1) Each benchscale chromatography sytem Brand Name or Equal to AKTA Avant 25 system Salient Characteristics:
1. Must support affinity chromatography, gel filtration/SEC, ion exchange chromatograpy, and hydrophobic interaction chromatography applications.
2. Must support automatic buffer preparation.
3. Must have buffer selection system that can support up to 18 inlets.
4. Must support a flow rate of 0.001 to 25 mL/min.
5. Must support multiple sample injection, up to 7 samples.
6. Must support multiple wavelength detection, up to 3 wavelengths.
7. Must comply with safety certifications (2006/42/EC (MD), 2004/108/EC (EMC), 1995/5/EC (R&TTE)).
7. Must be able to accommodate solution viscosity range from 0.35 to 10.0 cP.
8. Must be able to monitor pH range from 0 to 14.
Testing and Verification Qualification via a customer site acceptance test will be the verification standard.
Government Furnished Property None
Data Requirements Required documentation must include operation manual, software manual, software installation procedures. Required software for operation must be included.
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 .