RFP Document.pdf

STERILE BIOREACTOR SYSTEMS SEEDS (4X7.5L)

USER REQUIREMENT SPECIFICATIONS

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

Sterile Fermentation Systems Seeds 7.5L

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 SKIDDED 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 several skid-mounted sterile bioreactor systems to perform as seed vessels for larger systems. This document defines the requirements and deliverables for four of these systems. It describes overall requirements that must be met to produce the specific equipment requested. This document covers the procurement and delivery of the systems, with no required installation.

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.

Several bioreactor systems of different sizes will be installed to enable customers to scale up their processes. These customers will be able to generate data and/or small volumes of fermentation broth and/or finished product.

4 PROCESS DESCRIPTION

Several separate sterile bioreactor systems will be installed, with plans to add capacity as required in the future. The bioreactor skids will be stand-alone or twin units equipped with their own dedicated control and monitoring systems. Each skid will include an agitation system, aeration system, exhaust system, and temperature and pressure control. Each will be SIP and CIP cleanable or be appropriately sterilized via autoclave. These systems will be commercial grade systems that are easily configurable to handle a wide variety of process requirements. This document specifically covers four systems with reactor volumes of approximately 7.5L.

5 BASIS OF DESIGN

5.1 Capacities

Four bioreactors shall have a working volume of approximately 5L.

5.2 Skidded Construction

Each system will be mounted on a skid. Piping for steam, air, and water will be located on the skid, as well as any and supporting equipment. The control system and associated wiring will also be mounted on the skid. These vessels may also be assembled in multi-vessel skids as twin units so long as the SCADA allows for individual unit control.

5.3 Health, Safety and Environment (HSE)

The bioreactors will satisfy appropriate conformity assessment procedures and the controls shall carry the UL marking. Selected unit shall be constructed per the current ASME BPE standard. The units will be designed to protect users from hot surfaces. Pressure relief safety valves or rupture disks shall be vented to a safe location.

5.4 Operation, personnel and automation

The fermentation systems will be fully automated as standalone units such that operations personnel will not need to attend to them once they are started and operating. An ethernet connection for SCADA interface for batch reporting shall be provided.

5.5 Materials of Construction

All materials of construction must be compatible with ambient and hot water for injection (WFI), and typical chemical cleanings agents such as phosphoric acid, potassium hydroxide, and sodium hydroxide up to 3%. Piping specifications, including all gasket and valve seat material must align with current ASME-BPE standards, where applicable.

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

CIP Clean In Place 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 SIP Sterilization In Place UL Underwriters Laboratories URS User Requirements Specification WFI Water for Injection

7 USER REQUIREMENT SPECIFICATIONS

URS TABLE – Sterile Fermentation Systems

Designation Description Type URS-F1 The four fermenter working volumes shall be approximately 5L with a total volume of approximately 7.5L. REQ

URS-F2 The four fermenters must be skid mounted and mobile as either individual units or two twin skids. REQ

URS-F3 Aspect ratio for the fermenters shall be approximately 3:1 (height:width). REQ URS-F4 ASME/CE certification is required. REQ URS-F5 The agitators shall be Rushton impellers. REQ

URS-F6 The system must be capable of an oxygen transfer rate of > 300 mmol O2/L/hr. REQ

URS-F7 Tank baffles shall be removable and made of 316L stainless steel or similar quality material. REQ

URS-F8 Interior surface finishes shall be mechanically polished to 20 Ra. REQ URS-F9 Vessel design pressure shall be 40 psig and full vacuum. REQ URS-F10 Vessel jacket design pressure shall be 50 psig and full vacuum. REQ URS-F11 Vessels and their jackets shall both have design temperatures of 300° F. REQ URS-F12 Connections shall be sanitary. REQ URS-F13 All electrical enclosures shall carry a NEMA 4 rating. REQ

URS-F14 Vessel temperature control will be accomplished automatically via tank jacket. REQ

URS-F15

Each fermentation system should be supplied mounted on a steel frame skid. The skid shall be an open, modular design that can facilitate the addition of standard options at any time.

REQ

URS-F16 Power shall be provided to the skid via a single point 220V or 480V, 3-phase/ 60Hz connection. REQ

URS-F17 The SCADA shall be accessible remotely over the institute network. REQ

URS-F18 The operator interface shall be via HMI and offer password protection with operator, supervisor, and administrator levels of access. REQ

URS-F19 The operator interface shall include a recipe function to save, load, or delete process recipes. REQ

URS-F20

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

REQ

URS-F21

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

URS-F22 The head plate removal system shall be motorized or spring assisted. REQ

URS-F23 System validation documentation (SAT, IQ, OQ) must be provided by manufacturer. REQ

URS-F24 Manufacturer must offer US-based factory trained service engineers to assist with installation and training as needed. REQ

URS TABLE – Sterile Fermentation Systems Designation Description Type URS-F25 Manufacturer must maintain US-based storage location for spare parts. REQ

URS-F26 The sanitary piping skid design and program must enable automated cleaning in conjunction with a 3rd party CIP system REQ

URS-F27 Auto pressure control, including pressure transmitter and pressure control valve, with ability to monitor pressure in SCADA OPT

URS-F28 Single inlet filter w/ temperature indicator OPT URS-F29 Single exhaust filter w/ temperature indicator OPT URS-F30 Exhaust condenser for SIP OPT URS-F31 Load cells for direct measurement of the vessel volume OPT URS-F32 Two gas mixing with a thermal mass flow meter OPT URS-F33 Auto flow control OPT URS-F34 Overlay valve OPT URS-F35 5 addition valves OPT URS-F36 SIP housing OPT URS-F37 Dual ph/DO ISM transmitter option OPT URS-F38 120 mm optical ISM DO option OPT URS-F39 120 mm ISM pH option OPT URS-F40 High & high-high foam sensor OPT URS-F41 Glycol cooling option via second heat exchanger OPT URS-F42 Sample valve OPT

URS-F43 Pump box, including four fixed speed peristaltic pumps with pulse width modulation OPT

URS-F44 Electropolish option to guarantee finish of 15 Ra or less OPT URS-F45 Low seal pressure switch for bottom-drive impeller OPT URS-F46 SCADA package OPT URS-F47 Startup assistance OPT URS-F48 Dual exhaust filter OPT URS-F49 Sterile sampling kit OPT URS-F50 Pro ext ethernet switch OPT URS-F51 Aux 4-20 mA outputs OPT URS-F52 3” sight glass on head plate OPT URS-F53 Water prefilter/regulator kit OPT URS-F54 Utility steam prefilter/regulator kit OPT URS-F55 Process steam prefilter/regulator kit OPT URS-F56 Instrument air prefilter/regulator kit OPT URS-F57 Preventative Maintenance Kit OPT URS-F58 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 mailto:Craig@dakotabioworx.org mailto:Greg@dakotabioworx.org mailto: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

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, 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 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.