Attachment 1 Specifications Document 12805B23Q0808.pdf
PDF 119 KB Posted
- Attached to
- BioReactor Bags 50L & 200L
- Solicitation number
- 12805B23Q0808
About this file
This specifications document outlines requirements for bioreactor bags to be used by the USDA Agricultural Research Service Biologics Development Module. The agency requires two each of 50L and 200L bioreactor bags compatible for use with Sartorius Biostat STR bioreactors. The bags must include single-use pH and dissolved oxygen sensors, arrive ready for use with all required filters installed, and be optimized for batch and fed-batch processes. Additional specifications include total and working volume ranges, diameter and height dimensions, and impeller sizes. Qualification will be determined via a customer site acceptance test. The government will provide the bag holders while required documentation and probe calibration certification must be included with the purchase.
The related federal contract opportunity is a solicitation posted by the Department of Agriculture Agricultural Research Service Field Research Implementation and Information Delivery Plains Area seeking bids for the bioreactor bags specified in the attached document.
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| File | Type | Posted |
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| Clauses and Provisions 12805B23Q0808.pdf |
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United States Department of Agriculture
Research, Education, and Economics
Agricultural Research Service
Specifications Document Bioreactor Bags
Background and Scope The USDA Biologics Development Module (BDM) requires bioreactor bags that are compatible for use with Sartorius Biostat STR bioreactors, 50L and 200L size.
Applicable Documents and Standards
Bioreactor bag 50 L and 200L Specifications:
Two (2) Each bioreactor bag Brand Name or Equal to Sartorius Flexsafe STR 50L bags Two (2) Each bioreactor bag Brand Name or Equal to Sartorius Flexsafe STR 200L bags Salient Characteristics:
1. 50L Bags must be compatible for use with Biostat STR 50L hardware. 200L bags must be compatible with Biostat STR 200L hardware.
2. Bags must come with single-use optical pH and dissolved oxygen (DO) sensors.
3. Bags must be delivered ready to use.
4. Bags must include all required gassing line filters.
5. Bags must be optimized for batch and fed-batch processes.
6. For 50L bags, must have total volume of 68L, with working volume of 12.5L to 50L. For 200L bags, must have total volume of 280L, with working volume of 50L to 200L.
7. 50L bags must have diameter of 370 mm and height of 666 mm. 200L bags must have diameter of 585 mm and height of 1,055 mm. Ratio of height/diameter must equal 1.8.
8. Bags must come with impellers installed. 50L bags must have impeller diameter of 143 mm. 200L bags must have impeller diameter of 225 mm.
Testing and Verification Qualification via a customer site acceptance test will be the verification standard.
Government Furnished Property BDM will provide bag holders of 50L and 200L size.
Data Requirements Required documentation must include confirmation of sterilization of bags, and certification of calibration for optical probes.
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 .