AKTA Ready 450 Liquid Chromatography System   2

Request for Information (RFI)

AKTA Ready 450 Liquid Chromatography System

General Information:

This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expense associated with responding to this RFI.

RFI Response and due date: 21 August 2023 10:00 AM EDT

Instructions to Responders:

Responses from all capable and qualified sources are encouraged to respond to this request.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats: Microsoft Word or Adobe PDF.

2. Cover Page (1page)
Title
Organization
Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)
Topic area(s) addressed
NAICS Code

3. Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI as detailed below. Please review the place of performance requirements. Please submit written responses via email in Microsoft Office 2000 or 2007 format. All responses should be complete: in 12-point font; and not to exceed 3 pages total, including graphics, tables, and appendices.

No hardcopies shall be accepted. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained. No inquiries regarding any potential future acquisition activities shall be entertained.

Potential offerors are requested to direct all questions via email to the Point of Contact listed below. Responses are due to the Point of Contact, Ms. Rebecca Wisner at email: rebecca.c.wisner.civ@health.mil no later than 10:00AM EDT, 21 August 2023

The AKTA Ready ady 450 Liquid chromatogry system meets the Pilot Production Facility (PBF) at the Walter Reed Institute of Reseach's requirement for a single use-chomatogry system.

WRAIR's requirement is of single-use chromatography system with following specifications:

AKTA Ready 450
Shall utilize single-use flow paths
Shall support flow rates of 5-450mL/min
Shall support flow rate accuracy of no more than +/-6% or +/-12mL/min (whichever is larger)
Shall be no larger than 64cm x 94cm x 55.8cm (WxHxD)
Shall have max operating pressure of 4bar
Shall support 8+4 inlets and 6 outlets
Shall support both isocratic and gradient chromatography
Shall measure UV wavelength at 3 wavelengths simultaneously
All product contact sensors shall be single-use and meet the following specifications:

Pressure: 0.1-4 bar ( 0.1 bar, or 5% of actual value)
- Temperature: 2 C-30 C ( 1 C)
- Conductivity: 1-200 mS/cm ( 5% of actual value)
- UV: 0-2 AU (linearity 2%)
- pH: 3-10 ( 0.3)

Shall utilize an integrated single use pH sensor
Shall support use of TriclampTM and AseptiQuickTM connectors
Shall have BioPhorum extractables protocol
Materials shall be compliant with USP<88> Class VI test for biocompatibility and animal free
Shall utilize UnicornTM 7 software and Windows 10 OS for HMI control
Software shall be 21 CFR Part 11 compliant
Shall utilize 120V electrical power supply
Enclosure shall be constructed of stainless steel, IP55 rated, and designed to meet cGMP requirements
Shall provide installation and operational qualification and documentation to meet cGMP requirements