NOI_FDA-SS-117299.pdf

NOTICE OF INTENT TO SOLE SOURCE

Date: May 8, 2023 Subject: Ambr15 analysis module equipped with BioPAT Spectro hardware and flow cell

FDA ID: NOI_FDA-SS-117299

This is a notice that the U.S. Food & Drug Administration (FDA) intends to issue a purchase order to Sartorius Stedim North America Inc., located at 565 Johnson Avenue, Bohemia, NY 11716. The Government intends to issue a sole source award in accordance with FAR 13.501(a)(1)(ii).

The NAICS Code is: 334516- Analytical Laboratory Instrument Manufacturing.

TECHNICAL MODULE REQUIREMENTS:

1. Shall include the following:

A. BioPAT Spectro hardware that includes a flow-cell that allows integration of 3rd party

Raman spectroscopy probes and data flows, specifically with the Tornado SpectroPort Raman Probe 785 and Tornado Spectral software.

B. All software updates to the existing ambr15 software that is necessary to confer operational compatibility and instrument recognition of the Analysis Module, the BioPAT Spectro, and the most recent version of Tornado Spectral, the operating and data collection software of the Tornado Hyperflux PRO Plus Raman spectrometer. Raman, FLEX2 and Ambr process data should be automatically collated in the Ambr software.

C. Automated, at-line pH measurement and Raman Spectroscopy for Ambr15 bioreactors.

D. Tracking of pH electrode performance over time.

E. Automated accurate pH sensor recalibration.

F. Optimized pH measurement modes for normal and high cell density cultures.

G. For the ambr15, sample volumes of 60 µL for pH samples and 110 to 200 µL for BioPAT

Spectro samples.

H. A cycle time of 160 s per reading for pH samples I. A cycle time of 5 to 15 min per reading for BioPAT Spectro samples.

J. User replaceable pH sensors, Raman flow cells, and reagent kits.

K. Reagent kits including calibration solutions, cleaning solutions and a waste container.

L. Shipping, handling, and onsite installation by an OEM trained technician to perform initial checks, ensure optimal device performance, and document results in a final installation service report.

o Installation must be coordinated with Pro the provider and servicer of the Tornado

Hyperflux PRO Plus Raman spectrometer.

M. Onsite training for six (6) End User(s) that includes at least basic operation and routine maintenance. Training should be performed by either qualified person(s) employed by the OEM or by individuals who have proof-of-training certification provided by the OEM that was acquired within 1 year of the instrument delivery date.

N. Include a one-year warranty provided by the OEM that begins upon equipment delivery.

o Warranty should cover all parts, labor, and service visits for at least 1 year. All replacements must be genuine OEM parts.

O. Include a four (one) year service and support plans provided by the OEM that begins after the end of the warranty period that includes unlimited remote phone technical and application support, unlimited field service calls, at least one preventative maintenance (PM) visit, and all software updates. Pricing of this plan shall be wholly inclusive of labor, travel, replacement parts, components, subassemblies, etc. Remote support should be available 24/7, 365 days a year. Maintenance and repairs must be performed by OEM factory certified engineers to perform maintenance. All replacements must be genuine OEM parts.

This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Sartorius Stedim North America Inc, within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: May 18, 2023, by 9:00AM (EDT). Please email responses to Nicole Craig at nicole.craig@fda.hhs.gov. No phone calls will be accepted.

mailto:nicole.craig@fda.hhs.gov