SPECIAL NOTICE
D -- SOURCES SOUGHT MODELING AND SIMULATION SOFTWARE
- Notice Date
- 6/14/2018
- Notice Type
- Special Notice
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-18-SS-1192843
- Archive Date
- 7/6/2018
- Point of Contact
- Leroy Dawson, Phone: 3017964790
- E-Mail Address
-
Leroy.Dawson@fda.hhs.gov
(Leroy.Dawson@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A SOURCES SOUGHT NOTICE FOR INFORMATION AND ACQUISITION PLANNING PURPOSES ONLY. This is not a request for quote or proposal. This notice does not constitute a commitment by the Government to issue an RFP, RFQ, contract, or order. The Government will not pay for any effort expended or any material provided in response to this announcement. Requests for a solicitation will not receive a response. BACKGROUND: The U.S. Food and Drug Administration's (FDA's) supports the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. Industry trends are increasing the regulatory challenges in quality, manufacturing and drug product development. The complexity of manufacturing processes and controls is increasing, as is the complexity of products (i.e., drug substance, formulation and/or container and closure system). Clinical designs and development timelines are evolving and accelerating, respectively, which must be supported by more agile and flexible manufacturing technology platforms. A critical aspect of quality assessment is the development of process models and simulations to identify quality risk and for the implementation of model based control strategies to mitigate the identified risks. Continuous pharmaceutical manufacturing is an emerging technology that has the potential to improve the efficiency and quality assurance of the pharmaceutical sector. Continuous manufacturing processes are dynamic systems, unlike batch manufacturing processes. During the normal operation, a set of critical process parameters and/or quality attributes are kept close to the target values, rather than at a steady-state condition. Transient disturbances (deviations from these target values) may occur during normal operation. These are usually small enough to be controllable (i.e., being kept within a desired range). Larger changes in process parameters and quality attributes can happen when a process is in a transient state, such as during startup and shutdown, a change from one operating condition to another, or significant deviations such as those due to equipment failure or unexpected change in material attributes. Understanding of process dynamics as a function of input material attributes (e.g., material flow properties), process conditions (e.g., mass flow rates) or equipment design elements (e.g., blade types for a continuous blender) enables material traceability (the ability to preserve and access the identity and attribute of a material throughout the system) during and after production. This knowledge is essential for identification and mitigation of risks to product quality. Therefore, due to the dynamic nature of continuous processing, the risk assessment for a continuous manufacturing process may likely need to consider process understanding of the integrated system in addition to each unit operation. Continuous manufacturing also promotes the adoption of advanced control strategies where the FDA has limited experience. Therefore, specific modeling and simulation tools are needed to investigate the impact of process dynamics on product quality and the effectiveness of advanced control strategy approaches to mitigate the impact of disturbances to support FDA's quality assessment of the emerging technology continuous manufacturing. OBJECTIVE: The purpose of this proposed contract is to obtain the AspenOne Engineering platform and related support, Brand Name or Equal modeling and simulation software to study the dynamics of a continuous manufacturing process. REQUIREMENTS: The Contractor shall provide 36 tokens for the aspenOne Engineering platform and related support, brand name or equal. Tokens shall provide access to the products Aspen Plus, Aspen Plus Dynamics, Aspen Custom Modeler, and Aspen Properties This Sources Sought is being issued by the Food and Drug Administration (FDA) to seek companies capable of providing Engineering platform Commercial-Off-The-Shelf (COTS) software, AspenOne Licenses P/N V9; 36 Tokens each, and related support for 3 months or equivalent. AspenOne Engineering platform and related support, brand name or Equal modeling and simulation software. The Brand Name or Equal product's salient characteristics functionally is as follows: SALIENT CHARACTERISTICS: The salient characteristics required for the aspenONE Engineering (OR EQUAL) requirement are the following: aspenOne Engineering Platform (OR EQUAL), 1. Integrated ability to estimate material and thermodynamic properties of materials including access to NIST material property database. 2. Ability to model individual unit operations in steady state condition including plug flow reactor, continuous stirred tank reactor, crystallization, and separations 3. Ability to model multiple unit operations in steady state condition including plug flow reactor, continuous stirred tank reactor, crystallization, and separations 4. Ability to model continuous pharmaceutical processes including in the interaction of multiple units in steady state condition 5. Ability to model individual unit operations in dynamic mode including plug flow reactor, continuous stirred tank reactor, crystallization, and separations 6. Ability to model multiple unit operations in dynamic mode including plug flow reactor, continuous stirred tank reactor, crystallization, and separations 7. Ability to model system dynamics of a continuous pharmaceutical process modeling including the interaction of multiple units in dynamic mode 8. Ability to simulate and evaluate the impact of disturbances for a continuous pharmaceutical process 9. Ability to model various process control architecture for the process and evaluate control system performance 10. Ability to model and simulate model predictive control 11. Ability to simulate multiple case studies and conduct sensitivity analysis DELIVERABLE: OR EQUAL Product Description: aspenOne Engineering Part Number: V9 Quantity 36 tokens Period of Performance: 3 MONTHS ASPENONE ENGINEERING MAINTENANCE AND SUPPORT (OR EQUAL) The following are the salient maintenance and support characteristics for the Brand Name or Equal engineering platform: AspenTech Premier Plus Support, which consists of the following: - 24/7 customer care service - Access technical support via telephone, email, or web including case tracking via web - Access to online training modules - Access to online Knowledge Base including product documentation Assistance in resolving product usage issues and software installation issues The Contractor shall provide the download process, a link, and access to the download website (or EQUAL), to the COR, when patches are identified and/or when changes to links and processes occur Access to maintenance updates, patches, service packs, and hot fixes. Software updates and patches provided to the Contracting Officer's Representative (COR) by the Contractor as they become available on the Online Portal (or EQUAL The Contractor shall provide a list of Contractor points of contact to the COR upon contract award and an updated list when changes occur. IF PROPOSING EQUAL: Proposes an equal to product, Please provide an example where the "OR EQUAL" solution was successfully deployed in a similar Federal Government Agency and that the OR EQUAL solution did not cause any agency mission and work issues. IF PROPOSING THE BRAND NAME: AspenOne Engineering software licenses and maintenance support, please certify that you an authorized reseller for AspenOne Engineering as of the date of this submission, and that your company has the certification/specialization level required by AspenOne Engineering to support both the product sale and product pricing, in accordance with applicable AspenOne Engineering certification/specialization requirements. Unless otherwise specified, confirms to have sourced all AspenOne Engineering products submitted in this submittal from AspenOne Engineering or through AspenOne Engineering Authorized Channels only, in accordance with all applicable laws and AspenOne Engineering's current applicable policies at the time of purchase. •Does the proposed product meet the 508 standards below for new products and usability? Usability Standards • C203 Electronic Content • C202 Functional Performance Criteria • C205 Software • C206 Support Documentation and Service Standards for New Software: • E203 Access to Functionality • E204 Functional Performance Criteria • E205 Electronic Content 2. Interested companies shall provide the following Business Information for both the seller and manufacturer of the product (if different) (2 pages): • DUNS Number • Company Name • Company Address. • Company Point of Contact, phone number and email address • Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. • Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); • Current GSA Schedules appropriate to this Sources Sought • Current Government Wide Agency Contracts (GWACs) • Open Market • Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. • Any applicable Socio-Economical Classification(s): 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned and Small Disadvantaged Business. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Responses shall be limited to 10 pages. Responses must be received in writing, by no later than Monday, June 22, 2018, 1:30 PM, Eastern Time. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Leroy Dawson at leroy.dawson@fda.hhs.gov. The title of the email shall include the FBO Sources Sought Number, Project title, and Company Name_Capability Statement (for example: FDA-SS-18-1192843, PMSS Solution, and ABC Company Capability Statement).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-18-SS-1192843/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04955200-W 20180616/180614230710-b99433050d003134dfb97321c949ab33 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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