Bioreactor Parts for BioStat B-DCU II with BioPAT Analytics System

Notice of Intent to Award a Sole Source Contract for Bioreactor Parts

The Food and Drug Administration intends to make a sole source award for replacement operational parts, instrument calibrations, and software updates for a BioStat® B-DCU II with BioPAT® Analytics System in the amount of $99,000. The award will be made to:

Sartorius Stedim North America Inc.
5 Orville Drive
Bohemia, NY 11716

In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

The FDA/CDER has a requirement for operational parts, instrument calibrations, and software updates for a BioStat® B-DCU II with BioPAT® Analytics System in place at a CDER laboratory. This system is currently used for multiple on-going research projects to understand the role of process analytical technology (PAT), continuous manufacturing and optimization of the manufacturing of biologics, while at the same time monitoring critical quality attributes.

In order to meet new research demands, replacement parts and recalibration of the oxygen controllers are required as well as software updates for integration of replacement pieces of equipment. The parts must be compatible with the BioStat® B-DCU II with BioPAT® Analytics System. Sartorius-Stedim is the Original Equipment Manufacturer (OEM) and is the only manufacturer to supply the required OEM parts and perform service by an authorized engineer. This is needed to ensure all equipment is installed and calibrated properly and that any adjustments/repairs do not void current service agreements.

The NAICS code for this action is 334516. This procurement is made under the authority of FAR 6.302- Only one responsible source and no other supplies or services will satisfy agency requirements.
This is a notice of intent to issue an award on a sole source basis. This notice of intent is not a solicitation for competitive proposals. Any other firms desiring consideration must fully identify their interest and capability to provide this item to:
Lisa Yaw
Contracts Specialist
Lisa.Yaw@fda.hhs.gov
240-402-4018

A determination by the government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is on or about June 30, 2017.