RFP Document.pdf

#32 Primary Research Bioreactors

USER REQUIREMENT SPECIFICATIONS

Dakota Bioproducts Innovation Institute

Operating as “Dakota BioWorx”

2405 Research Park Way

Brookings, SD, 57006

South Dakota State University

Box 2201, SAD 200

1015 Campanile Ave

Brookings, SD 57007

U.S. DEPARTMENT OF COMMERCE

Economic Development Administration (EDA)

Award Number: 05-79-06192

Revision No.: 0

APPROVED

User Requirement Specification

Primary Research Bioreactor System

Effective Date: 03-07-23

1 TABLE OF CONTENTS

1 TABLE OF CONTENTS

2 SCOPE

3 BACKGROUND

4 PROCESS DESCRIPTION

5 BASIS OF DESIGN

5.1 CAPACITIES

5.2 SYSTEM CONSTRUCTION

5.3 HEALTH, SAFETY AND ENVIRONMENT (HSE)

5.4 OPERATION, PERSONNEL AND AUTOMATION

5.5 MATERIALS OF CONSTRUCTION

5.6 RELIABILITY & MAINTENANCE

6 ABBREVIATIONS, ACRONYMS & DEFINITIONS

7 USER REQUIREMENT SPECIFICATIONS

8 SELECTION CRITERIA

9 RETURN BIDS TO

10 OTHER PROVISIONS

2 SCOPE

The project will include a primary research sterile bioreactor system for screening process conditions, in addition to assisting in workforce development. This document defines the requirements and deliverables for five of these systems. It describes overall requirements that must be met to produce the specific equipment requested.

This document covers the procurement, delivery, and install of the systems.

This URS is the input document for the:

• Equipment procurement purposes

• Equipment sizing

• Functional and technical specifications

3 BACKGROUND

Dakota Bioworx is a research facility for the development of high-quality bioproducts.

Primary research bioreactors will be installed to enable customers to scale up their processes and assist in workforce development. These bioreactors will not be used as seed vessels; all use will focus on screening operating conditions at small scale and training workforce on proper bioreactor practices.

4 PROCESS DESCRIPTION

A single unit, consisting of four bioreactors, will be installed. Each bioreactor will have independent agitation, pH, temperature, and aeration controls but be operated from a single control unit. Bioreactors will be appropriately sterilized via autoclave. These systems will be commercial grade that are easily configurable to handle a wide variety of process requirements. This document specifically covers systems with reactor volumes of 1L or less.

5 BASIS OF DESIGN

5.1 Capacities

One unit shall consist of four bioreactors with a working volume of approximately 1L or less.

5.2 System Construction

The unit will have four vessels monitored by a single control tower.

5.3 Health, Safety and Environment (HSE)

The unit will satisfy appropriate conformity assessment procedures and the controls shall carry the UL marking. Systems shall be constructed to adhere to proper aseptic technique.

5.4 Operation, personnel and automation

The unit will be fully automated such that operations personnel will not need to attend to them once they are started and operating.

5.5 Materials of Construction

All materials of construction must be resilient to typical chemical cleaning agents such as phosphoric acid, potassium hydroxide, and sodium hydroxide up to 3%.

5.6 Reliability & maintenance

The fermentation systems will be designed to operate routinely during 24 / 7 / 365 operations. All wear parts shall be easily accessible and replaced on a regular maintenance schedule. Wear parts like gaskets shall be stock items that can be ordered and delivered in a timely manner.

6 ABBREVIATIONS, ACRONYMS & DEFINITIONS

Acronyms Description

ASME BPE

American Society of Mechanical Engineers Bio- Processing Equipment

Acronyms Description

HMI Human Machine Interface

NEMA National Electrical Manufacturers Association

OPT Optional Attribute

P&ID Piping & Instrumentation Diagram

PLC Programable Logic Controller

REQ Required Attribute

SCADA Supervisory Control and Data Acquisition

UL Underwriters Laboratories

URS User Requirements Specification

7 USER REQUIREMENT SPECIFICATIONS

URS TABLE – Primary Research Bioreactor System Designation Description Type URS-F1 Each vessel shall have a working volume of 1L or less. REQ URS-F2 Aspect ratio for the fermenters shall be approximately 3:1 (height:width). REQ

URS-F3

Tank baffles shall be removable and made of 316L stainless steel or similar quality material.

REQ

URS-F4

Relevant interior surface finishes shall be mechanically polished to 20 Ra.

REQ

URS-F5 Vessels and their jackets shall both have design temperatures of 300° F. REQ

URS-F6 Connections shall be sanitary. REQ

URS-F7

Vessel temperature control will be accomplished automatically via jacket or blanket and shall be able to control temperature in the vessel from at least 10 °C to 50° C.

REQ

URS-F8 Power shall be provided via a single point 120V. REQ

URS-F9

The operator interface shall be via HMI and offer password protection with operator, supervisor, and administrator levels of access.

REQ

URS-F10

The operator interface shall include a recipe function to save, load, or delete process recipes.

REQ

URS-F11

Full system documentation shall be provided, including instruction and maintenance manuals, safety instructions, P&ID, and dimensional drawings.

REQ

URS-F12

Control system documentation shall be provided, including specifications, wiring overview, circuit diagram, arrangement drawing, terminal connection diagram, REQ

URS-F13

System validation documentation (SAT, IQ, OQ) must be provided by manufacturer.

REQ

URS-F14

Manufacturer must offer US-based factory trained service engineers to assist with installation and training as needed.

REQ

URS-F15 Manufacturer must maintain US-based storage location for spare parts. REQ

URS-F16 Single exhaust filter and condenser. REQ

URS-F17 At least one MFC per vessel. REQ

URS-F18 Sterile sampling system. REQ

URS-F19 Pump box, including at least two peristaltic pumps per vessel. REQ

URS-F20 Startup assistance REQ

URS-F21 Sterile sampling kit REQ

URS-F22

Provisions for Mettler pH and DO probes in each vessel and control loops based on these parameters.

REQ

URS-F23 High & high-high foam sensor OPT

URS-F24 SCADA package OPT

URS-F25 Aux 20 mA outputs OPT

URS-F26 Water prefilter/regulator kit OPT

URS-F27 Preventative Maintenance Kit OPT

URS TABLE – Primary Research Bioreactor System Designation Description Type URS-F28 Spare parts Kit OPT

END OF SPECIFICATION

8 SELECTION CRITERIA

Vendors will be evaluated based on the following criteria:

Evaluation Criteria Description Ranking Weight

Mandatory Technical Requirements A review of your proposal to determine adherence with the REQ specifications and technical requirements.

1-10 30%

Proposal Pricing Review of your proposal in relation to the services offered in the proposal. Proposals will be evaluated against competing proposals for cost effectiveness. Proposals will be evaluated to be reasonable and appropriate.

1-10 20%

Technical Response The technical response in your proposal portrays knowledge, experience, and professionalism. Relevant product features and/or specifications are available with your equipment other than those mandatory specifications allotted above.

1-10 10%

Lead Time A review of your product’s lead time to meet business objectives.

1-10 15%

Product Warranty The available warranty, in scope, duration, and value, proposed with your product.

1-10 5%

Experience and Demonstrated Results Our evaluation will include a review of your history, your experience as it relates to the requirements within this RFP, evidence of past performance, quality and relevance of past work, references, and related items.

1-10 20%

9 RETURN BIDS TO

Craig Arnold Craig@dakotabioworx.org

Greg Opdahl Greg@dakotabioworx.org

Bobby Markham Bobby.Markham@sdstate.edu

10 OTHER PROVISIONS

Must meet 200 CFR buy America Provision• Title 49 Subtitle B Chapter VI Part 661

Federal Participation Disclosure – “This project will be partially funded with Federal funds from the United States Department of Commerce, Economic Development Administration and therefore is subject to the

Federal laws and regulations associated with that program.”

Must meet Federal Contract provision 200 CFR Title 2 subtitle A Chapter II Part 200

1.1 CERTIFICATION RELATING TO PROHIBITED ENTITY

For contractors, vendors, suppliers, or subcontractors who enter into a contract with the State of South Dakota by submitting a response to this solicitation or agreeing to contract with the State, the bidder or offeror certifies and agrees that the following information is correct:

The bidder or offeror, in preparing its response or offer or in considering proposals submitted from qualified, potential vendors, suppliers, and subcontractors, or in the solicitation, selection, or commercial treatment of any vendor, supplier, or subcontractor, is not an entity, regardless of its principal place of business, that is ultimately owned or controlled, directly or indirectly, by a foreign national, a foreign parent entity, or foreign government from China, Iran, North Korea, Russia, Cuba, or Venezuela, as defined by SDCL 5-18A. It is understood and agreed that, if this certification is false, such false certification will constitute grounds for the State to reject the bid or response submitted by the bidder or offeror on this project and terminate any contract awarded based on the bid or response. The successful bidder or offeror further agrees to provide immediate written notice to the contracting executive branch agency if during the term of the contract it no longer complies with this certification and agrees such noncompliance may be grounds for contract termination.

1.2 RESTRICTION OF BOYCOTT OF ISRAEL

mailto:Craig@dakotabioworx.org mailto:Greg@dakotabioworx.org mailto:Bobby.Markham@sdstate.edu https://www.ecfr.gov/current/title-49/subtitle-B/chapter-VI/part-661?toc=1 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/appendix-Appendix%20II%20to%20Part%20200

For contractors, vendors, suppliers, or subcontractors with five (5) or more employees who enter into a contract with the State of South Dakota that involves the expenditure of one hundred thousand dollars ($100,000) or more, by submitting a response to this solicitation or agreeing to contract with the State, the bidder or offeror certifies and agrees that the following information is correct:

The bidder or offeror, in preparing its response or offer or in considering proposals submitted from qualified, potential vendors, suppliers, and subcontractors, or in the solicitation, selection, or commercial treatment of any vendor, supplier, or subcontractor, has not refused to transact business activities, has not terminated business activities, and has not taken other similar actions intended to limit its commercial relations, related to the subject matter of the bid or offer, with a person or entity on the basis of Israeli national origin, or residence or incorporation in Israel or its territories, with the specific intent to accomplish a boycott or divestment of Israel in a discriminatory manner. It is understood and agreed that, if this certification is false, such false certification will constitute grounds for the State to reject the bid or response submitted by the bidder or offeror on this project and terminate any contract awarded based on the bid or response. The successful bidder or offeror further agrees to provide immediate written notice to the contracting executive branch agency if during the term of the contract it no longer complies with this certification and agrees such noncompliance may be grounds for contract termination.

1.3 CERTIFICATION OF NO STATE LEGISLATOR INTEREST

Offeror (i) understands neither a state legislator nor a business in which a state legislator has an ownership interest may be directly or indirectly interested in any contract with the State that was authorized by any law passed during the term for which that legislator was elected, or within one year thereafter, and (ii) has read South Dakota Constitution Article 3, Section 12 and has had the opportunity to seek independent legal advice on the applicability of that provision to any Agreement entered into as a result of this RFP. By signing an Agreement pursuant to this RFP, Offeror hereby certifies that the Agreement is not made in violation of the South Dakota Constitution Article 3, Section 12.