Flowsheet Modeling And Simulation Software License Support And Maintenance Services - gProms or equal

Objective

The objective is to purchase a new license for gPROMS or equal to flowsheet modeling and simulation platform including model libraries for blending, granulation, milling, feeding, compression, tablet coating, oral absorption, crystallization, and drying.

Requirements

The Contractor shall provide a flowsheet modeling and simulation platform, gPROMS or equal, to study emerging pharmaceutical manufacturing technologies or equal to software license.  For a Vendor’s software to be deemed acceptable, the following salient characteristics shall be met:

Salient Characteristics – gPROMS or equal License

1. Flowsheet modeling environment for conventional pharmaceutical processes including a graphical interface with drag and drop functionality
2. Intelligent line routing and clearly differentiated stream types
3. Steady state and dynamic process models for all common process equipment including reactors, separators, flow transportation, heat exchangers, and process control
4. Steady-state and dynamic modeling of multiple process unit models connected together in a single flowsheet
5. Custom modeling capabilities to create user defined models
6. Dynamic flowsheet models that include elements of process control for studying the impact of process disturbances
7. Parameter estimation from experimental data to support model validation
8. Global sensitivity analysis to analyze the impact of inputs, and model parameters on process outputs
9. Ability to estimate physical properties of components and mixture for example using  Multiflash or Design Institute for Physical Properties (DIPPR) database
10. Ability to run steady-state optimization that are capable of handling many decision variables simultaneously
11. Multiple activities using the same model: steady-state and dynamic simulation, parameter estimation, steady-state and dynamic optimization
12. Modeling and solution power specifically designed to handle the simultaneous solution of large number of equations
13. Model initialization procedures for ensuring robust solution without user provided initial guesses
14. Mechanistic model libraries for synthesis and crystallization including well-mixed reactor, well mixed crystallizer, plug flow reactor, and plug flow crystallizer
15. Mechanistic model libraries for solids processing including roller compactor, twin granulation, two dimensional population balance granulation framework, fluid-bed drying, spray drying, continuous blenders, compression, and tablet coating
16. Mechanistic model libraries for product performance including oral adsorption, in-vitro dissolution, and pharmacokinetics
17. Integrated modelling and optimization platform for formulated product design and manufacture for Pharmaceuticals, Food & Consumer products
18. Custom modelling option for first principles model development for conventional pharmaceutical processes including a graphical interface with drag and drop functionality
19. Flowsheet Construction & Modification- Graphical definition and editing of process flowsheets, Intelligent line routing and clearly differentiated stream types, Custom modeling capabilities to create user defined models
20. Convection-dispersion models of horizontal and vertical blenders with adhesion to blender surfaces and fluctuating levels
21. Mill and screen (classifying) mill, accounting for breakage using one of several kernels
22. Fluid Bed creation of a wet granulate phase from fine powder particles by addition of liquid and evolution of granule liquid content due to drop nucleation and wetting mechanisms, granule growth via liquid-dependent layering and agglomeration
23. Dynamic high shear wet granulation with detailed models for creation of wet granulate phase, evolution of granule liquid content, granule growth and reduction in granule porosity
24. Dynamic dry granulation with detailed models for creation of compacted ribbon between rotating cylinders and accounting for side seal leakage, material compressibility and friction properties and spring back
25. Dynamic twin screw wet granulation compartmental model with configurable screw elements
26. Steady-state tablet compaction model and dynamic convection-dispersion model of the feed frame with adhesion to surfaces
27. Steady-state film coater model for predicting target operating conditions for optimization, scale-up and robustness studies
28. Prediction of oral absorption performance in the human gastrointestinal tract as a function of product formulation and drug substance properties, patient physiology and ingestion conditions
29. Generic in vitro dynamic vessel model for dissolution and precipitation (e.g. USP II and Amorphous Solid Dispersion (ASD)) as a function of the experimental system, operating procedure, product formulation and drug substance properties
30. Single, two and three compartment models characterizing the pharmacokinetics in the body of an externally administered drug substance) or equal
31. Steady-state and dynamic (including mixed-integer) optimization
32. Estimate model parameters from experimental data, with statistical analysis of significance
33. Utilize multiple processors for parallel execution where applicable
34. Multistage Continuous Mixed-Suspension, Mixed-Product Removal (MSMPR) crystallizer for batch and continuous operation and supersaturation generated by cooling, anti-solvent addition, reaction or evaporation
35. Psychrometric dryer, single droplet drying kinetics and fluid bed dryer) or equal
36. Spray dryer with evolution of droplet/particle size distribution, uniform vapor conditions, multi-component solvents
37. The transport and flow rate of material through a screw powder feeder

Maintenance and Technical Support: At minimum the contractor shall:

1. Delivery of software updates
2. One business-day response to all software defect inquiries
3. Availability of feature (level) upgrades

Training:

The Contractor shall provide:

• Access to one on-project training by the vendor

Instructions to Offers/Evaluation Criteria

Please read these instructions carefully. All items required to be included in the quotation as delineated in these instructions must be provided in Quoter’s quotations.

A. Instructions to Quoters:

• Quoters shall submit a complete pricing for all products listed in this RFQ. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award.
• Quoters should ensure that their initial submission represents their best pricing and that all information is provided to determine technical acceptability. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation.
• Quotations shall meet all the requirements of this solicitation in order to be considered technically acceptable.
• Quoters shall submit all assumptions in their quotation.
• Quoter shall be an Original Equipment Manufacturer, authorized reseller and/or servicing agent of the software manufacturer.
• Quotes shall meet all the salient characteristics of this solicitation. Quotes should contain all requirements outlined in Section 3 through Section 3.3 of this solicitation.
• Quoters shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits.
• Equal to Quotes must submit Technical volume with detailed point-by-point description of how the equal to product meets all the salient characteristics of this solicitation in Section 3 through Section 3.3 of this solicitation.
• Quoters submitting equal to products, shall submit Section 508 Product Accessibility Templates (PAT) in full text with their quotations.  For more information regarding PATs see:

• http://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/

• Questions and quotes shall be submitted electronically via email to Sephora Calderon at sephora.calderon@fda.hhs.gov.

Evaluation:

• All quotes will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis.
• All quotes will be evaluated on proposed products that meet or exceed all the salient characteristics, pricing, period of performance and quantity specified in Section 3, 3.1, 3.2 and 3.3 of this solicitation.
• Section 508 Product Accessibility

 BASIS FOR AWARD

All quotations will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. The award will be made to the lowest price Quoter that demonstrates they can meet all the requirements of this solicitation. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.