Inactive

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capabil... This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: Process Analytical Technology (PAT) is a manufacturing methodology for high value chemicals and pharmaceuticals. PAT measures key quality and performance indicators in raw materials, in-process materials, and processes in real-time. A well-designed PAT-based process is stable, ensuring that the critical parameters and indicators remain within pre-described limits to ensure product quality and process safety. PAT is applicable to many standard operations performed in chemical processes, including reaction monitoring and crystallization procedures. Mettler Toledo is the world leader in in situ spectroscopy technology and PAT. EasyMax Workstation system is a major contributor in PAT development and widely used in pharmaceutical industries. Purpose and Objectives: The PAT system with selected probes can precisely control the reaction parameters such as temperature, pressure, airflow, pH, and provide the real time inline/online analytical results on the reaction transformation, particle size and in-situ imaging, and fundamentals of the thermochemistry and kinetics of a reaction. The reaction condition from the EasyMax system is robust and scalable and can be easily reproduced in the large-scale reactor (100L). With more projects coming from the APP program, the system will help us to accelerate process development work and identify the critical quality contributors for a process. The benefits of incorporating EasyMax Workstation with selected probes include improved product quality and uniformity, process cost reduction, enhanced process and product safety, eliminates/minimizes product re-work, speeds process cycle, facilitates regulatory acceptance and compliance, and overall creates a robust process that results in manufacturing of product that is right in first time. Project requirements: EasyMax 402 Advanced Synthesis Workstation with Easyviewer and ReactIR bundles. The unique features of EasyMax Workstation with selected probes include: Allows users to control a broad range of reaction parameters, such as temperature, pH, stirring speed or reagent addition with high precision; All experimental data is recorded automatically, and can be evaluated further and exported into other applications; An easy-to-use touchscreen, reaction parameters can be controlled, and data and trends displayed. A task sequence programmed on the touchscreen enables unattended operation. Anticipated Delivery: 30 days after receipt of award Other important considerations: Installation and first year warranty and service coverage and support on system, probes, and software are required. Option for 2nd and 3rd year maintenance plan on Easyviewer, ReactIR, and EasyMax 402 System. Capability statement /information sought. Small business concerns that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested small businesses are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist, Samson Shifaraw at samson.shifaraw@nih.gov. Facsimile responses are NOT accepted. The response must be received on or before 6/11/2022, 3:00 pm, Eastern Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).