134-202627-001 RFP - Biopharmaceutical Automated Fill Machine Isolator (10-20-26).pdf

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Biopharmaceutical Automated Fill Machine Isolator
Solicitation number
134-202627-001
Issued by
Watauga County, North Carolina

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Summary

This is a Request for Proposals (RFP) issued by Wilson Community College, a state agency in North Carolina, for the design, fabrication, delivery, installation, and commissioning of a Biopharmaceutical Automated Fill Machine Isolator. The equipment will be housed within the Biomanufacturing Education & Skills Training (BEST) Center expansion and will serve as a training device for manual aseptic processing and drug product manufacturing techniques, emphasizing educational value over high-throughput production capability. The isolator system must accommodate 2 ml and 25 ml injection vials with manual loading, automated filling at up to 40 units per minute with ±1% accuracy, mechanical stopper insertion, and integrated containment with glove ports and rapid transfer ports. The RFP was issued on October 20, 2026, with written questions due by October 27, 2026, state responses provided by November 3, 2026, and proposals due on November 10, 2026, at 2:00 PM ET at Wilson Community College in Wilson, North Carolina. The contract is anticipated to be awarded in December 2026, with an anticipated one-year performance period beginning after contract execution, including equipment design, fabrication, Factory Acceptance Testing (FAT), delivery, installation by or after August 11, 2027, startup, commissioning, acceptance testing, training, and final documentation delivery.

Pricing shall be submitted on a milestone-basis with costs allocated across ten deliverable phases: Project Initiation & Project Management, Engineering and Design, Equipment and Materials Procurement, Fabrication/Assembly/Integration/Programming, FAT & PreShipment Inspection, Packaging/Freight/Transportation/Delivery, Installation/Startup/Commissioning, Acceptance Testing & Final Inspection, Training & Knowledge Transfer, and Final Documentation/Certificates/Project Closeout. All costs must be included in the proposal price, including equipment, materials, engineering, fabrication, software, controls, FAT, packaging, freight, delivery, installation, startup, commissioning, training, and documentation. Vendors may propose temporary import tariff surcharges as a separate line item subject to negotiation and mutual agreement. The evaluation will be conducted using a Best Value methodology, with proposals ranked by Technical Approach, Vendor References, Vendor Experience, Financial Statements, and Cost, in that order of importance. Proposals will be evaluated on a one-step basis with potential negotiations authorized under North Carolina General Statutes. Vendors must be registered with the North Carolina Secretary of State and eVP (Electronic Vendor Portal), provide three customer references, demonstrate financial stability, and certify compliance with E-Verify requirements and fair employment practices.

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STATE OF NORTH CAROLINA

Wilson Community College

Request for Proposals #: 134-202627-001

Biopharmaceutical Automated Fill Machine Isolator

Date Issued: October 20, 2026

Proposal Opening Date: November 10, 2026

At 2:00 PM ET

Direct all inquiries concerning this RFP to:

Will Robl

Purchasing & Capital Improvements Manager

Email: wrobl@wilsoncc.edu

Phone: (252) 246-1240

Ver. 09/2026

Request for Proposals #

134-202627-001

For internal State agency processing, including tabulation of proposals, provide your company’s eVP (Electronic Vendor Portal) Number. Pursuant to G.S. 132-1.10(b) this identification number shall not be released to the public. This page will be removed and shredded, or otherwise kept confidential, before the procurement file is made available for public inspection.

This page shall be filled out and returned with your proposal.

Failure to do so may subject your proposal to rejection.

Vendor Name

Vendor eVP#

Note: For a contract to be awarded to you, your company (you) must be a North Carolina registered Vendor in good standing. You must enter the Vendor number assigned through eVP (Electronic Vendor

Portal). If you do not have a Vendor number, register at https://evp.nc.gov/Sign

Electronic responses ONLY will be accepted for this solicitation.

Ver: 09/2026 1

EXECUTION

In compliance with this Request for Proposals (RFP), and subject to all the conditions herein, the undersigned Vendor offers and agrees to furnish and deliver any or all items upon which prices are bid, at the prices set opposite each item within the time specified herein.

By executing this proposal, the undersigned Vendor understands that false certification is a Class I felony and certifies that:

this proposal is submitted competitively and without collusion (G.S. 143-54), that none of its officers, directors, or owners of an unincorporated business entity has been convicted of any violations of Chapter 78A of the General Statutes, the Securities Act of 1933, or the Securities Exchange Act of 1934 (G.S. 143-59.2), and it is not an ineligible Vendor as set forth in G.S. 143-59.1.

Furthermore, by executing this proposal, the undersigned certifies to the best of Vendor’s knowledge and belief, that:

it and its principals are not presently debarred, suspended, proposed for debarment, declared ineligible or voluntarily excluded from covered transactions by any Federal or State department or agency.

As required by G.S. 143-48.5, the undersigned Vendor certifies that it, and each of its sub-Contractors for any Contract awarded as a result of this RFP, complies with the requirements of Article 2 of Chapter 64 of the NC General Statutes, including the requirement for each employer with more than 25 employees in North Carolina to verify the work authorization of its employees through the federal E-Verify system.

As required by Executive Order 24 (2017), the undersigned Vendor certifies will comply with all Federal and State requirements concerning fair employment and that it does not and will not discriminate, harass, or retaliate against any employee in connection with performance of any Contract arising from this solicitation.

G.S. 133-32 and Executive Order 24 (2009) prohibit the offer to, or acceptance by, any State Employee associated with the preparing plans, specifications, estimates for public Contract; or awarding or administering public Contracts; or inspecting or supervising delivery of the public Contract of any gift from anyone with a Contract with the State, or from any person seeking to do business with the State. By execution of this response to the RFP, the undersigned certifies, for Vendor’s entire organization and its employees or agents, that Vendor are not aware that any such gift has been offered, accepted, or promised by any employees or agents of Vendor’s organization.

By executing this proposal, Vendor certifies that it has read and agreed to the INSTRUCTION TO VENDORS and the NORTH CAROLINA GENERAL TERMS AND CONDITIONS incorporated herein. These documents can be accessed from the NC eProcurement Sourcing Tool.

Failure to execute/sign proposal prior to submittal may render proposal invalid and it MAY BE REJECTED. Late proposals cannot be accepted.

COMPLETE/FORMAL NAME OF VENDOR:

STREET ADDRESS: P.O. BOX: ZIP:

CITY & STATE & ZIP: TELEPHONE NUMBER: TOLL FREE TEL. NO:

PRINCIPAL PLACE OF BUSINESS ADDRESS IF DIFFERENT FROM ABOVE (SEE INSTRUCTIONS TO VENDORS ITEM #21):

PRINT NAME & TITLE OF PERSON SIGNING ON BEHALF OF VENDOR:

Wilson Community College

Refer ALL Inquiries regarding this RFP to:

Will Robl, Purchasing & Capital Improvements Manager Email: wrobl@wilsoncc.edu Phone: (252) 246-1240

Request for Proposals # 134-202627-001 Proposals will be publicly opened: Tuesday, November 10, 2026 Wilson Community College, A-100 Board Room 902 Herring Avenue E Wilson, NC 27893

Using Agency: Wilson Community College Commodity No. and Description: 231518 Pharmaceutical industry machinery and equipment and supplies Requisition No.: TBD mailto:wrobl@wilsoncc.edu

Proposal Number: 134-202627-001 Vendor: ____________________________________

Ver: 09/2026 2

FOR STATE USE ONLY: Offer accepted and Contract awarded this ____ day of _______________, 20____, as indicated on the attached certification, by ______________________________________________________

VENDOR’S AUTHORIZED SIGNATURE: DATE: E-MAIL:

VALIDITY PERIOD

Offer shall be valid for at least one hundred and twenty (120) days from date of bid opening, unless otherwise stated here: ______ days, or if extended by mutual agreement of the parties in writing. Any withdrawal of this offer shall be made in writing, effective upon receipt by the agency issuing this RFP.

ACCEPTANCE OF PROPOSAL

If your proposal is accepted, all provisions of this RFP, along with the written results of any negotiations, shall constitute the written agreement between the parties (“Contract”). The NORTH CAROLINA GENERAL TERMS AND CONDITIONS are incorporated herein and shall apply. Depending upon the Goods or Services being offered, other terms and conditions may apply, as mutually agreed.

(Authorized Representative of Wilson Community College)

Ver: 09/2026 3

1.0 PURPOSE AND BACKGROUND

1.1 CONTRACT TERM

2.0 GENERAL INFORMATION

2.1 REQUEST FOR PROPOSALS DOCUMENT

2.2 ePROCUREMENT FEE

2.3 NOTICE TO VENDORS REGARDING RFP TERMS AND CONDITIONS

2.4 RFP SCHEDULE

2.5 PROPOSAL QUESTIONS

2.6 PROPOSAL SUBMITTAL

2.7 PROPOSAL CONTENTS

2.8 ALTERNATE PROPOSALS

2.9 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS

3.0 METHOD OF AWARD AND PROPOSAL EVALUATION PROCESS

3.1 METHOD OF AWARD

3.2 CONFIDENTIALITY AND PROHIBITED COMMUNICATIONS DURING EVALUATION

3.3 PROPOSAL EVALUATION PROCESS

3.4 EVALUATION CRITERIA

3.5 PERFORMANCE OUTSIDE THE UNITED STATES

3.6 INTERPRETATION OF TERMS AND PHRASES

4.0 REQUIREMENTS

4.1 PRICING

4.1.1 IMPORT TARIFF TEMPORARY SURCHARGE

4.2 TRANSPORTATION AND IDENTIFICATION

4.3 DELIVERY AND INSTALLATION

4.4 WARRANTY

4.5 MAINTENANCE OPTION

4.6 DESCRIPTIVE LITERATURE

4.7 VENDOR EXPERIENCE

4.8 REFERENCES

4.9 VENDOR’S REPRESENTATIONS

4.10 FINANCIAL STABILITY

4.11 SUBCONTRACTORS

4.12 SECRETARY OF STATE REGISTRATION

5.0 PRODUCT SPECIFICATIONS AND SCOPE OF WORK

GENERAL

SPECIFICATIONS

PROJECT SCHEDULE

5.4 TASKS/DELIVERABLES

5.5 TECHNICAL APPROACH

5.6 CERTIFICATION AND SAFETY LABELS

6.0 CONTRACT ADMINISTRATION

Ver: 09/2026 4

6.1 CONTRACT MANAGER AND CUSTOMER SERVICE

6.2 INVOICES

6.3 POST AWARD BUSINESS REVIEW MEETINGS

6.4 CONTINUOUS IMPROVEMENT

6.5 PERIODIC REPORTS

6.6 ACCEPTANCE OF WORK

6.6 DISPUTE RESOLUTION

6.8 PRODUCT RECALL

6.9 CONTRACT CHANGES

6.10 ATTACHMENTS

ATTACHMENT: PRICING

ATTACHMENT: INSTRUCTIONS TO VENDORS

ATTACHMENT: NORTH CAROLINA GENERAL TERMS AND CONDITIONS

ATTACHMENT: CUSTOMER REFERENCE TEMPLATE

ATTACHMENT: LOCATION OF WORKERS UTILIZED BY VENDOR

ATTACHMENT: CERTIFICATION OF FINANCIAL CONDITION

Ver: 09/2026 5

1.0 PURPOSE AND BACKGROUND

The Biomanufacturing Education & Skills Training (BEST) Center of Eastern North Carolina, operated by Wilson Community College, is expanding its current design to include simulated cleanrooms that will be utilized for training in drug product manufacturing. To provide a capstone experience for trainees, the expansion will feature an automated fill machine housed in an isolator that simulates a controlled environment. Wilson Community College is seeking proposals to build and install a unit that meets the user requirements listed within.

The design should facilitate advanced training on manual operations and aseptic techniques, with emphasis on educational value rather than high-throughput capability, operational flexibility, or additional premium features.

The contract will include multiple phases, including project kickoff and design review; equipment design, fabrication, assembly, integration, and programming; Factory Acceptance Testing (FAT); delivery and installation; startup and commissioning; functional and acceptance testing; training; delivery of required documentation; and final project acceptance. Interested vendors should provide a written proposal that describes their solution.

The intent of this solicitation is to award an Agency Specific Contract.

1.1 CONTRACT TERM

The term of the Contract shall begin on the date of final Contract execution (the “Effective Date”) and shall continue until completion and acceptance of all requirements within the scope of work as set forth in the SPECIFICATIONS AND SCOPE OF WORK Section below. Wilson Community College anticipates that the Project Scope of work will be completed within one (1) year of the Effective Date. The Vendor shall begin work under the Contract within ten (10) business days of the Effective Date. In addition, the State reserves the right to extend a contract term after the last active term.

Proposals shall be submitted in accordance with the terms and conditions of this RFP and any addenda issued hereto.

2.0 GENERAL INFORMATION

2.1 REQUEST FOR PROPOSALS DOCUMENT

The RFP is comprised of the base RFP document, any attachments, and any addenda released before Contract award, which are incorporated herein by reference.

2.2 ePROCUREMENT FEE

ATTENTION: This is an NC eProcurement solicitation facilitated by the Ariba Network. The eProcurement fee may apply to this solicitation. See paragraph entitled ELECTRONIC PROCUREMENT of the North Carolina General Terms and Conditions.

General information on the eProcurement Services can be found at: http://eprocurement.nc.gov/.

What is the Ariba Network?

The Ariba Network is a web-based platform that serves as a connection point for buyers and Vendors. Vendors can log in to the Ariba Network to view purchase orders, respond to electronic requests for quotes, participate in Sourcing Events, and collaborate with buyers on contract documents.

For training on how to use the Sourcing Tool to view solicitations, submit questions, develop responses, upload documents, and submit offers to the State, Vendors should go to the following site:

http://eprocurement.nc.gov/training/vendor-training.

2.3 NOTICE TO VENDORS REGARDING RFP TERMS AND CONDITIONS

It shall be the Vendor’s responsibility to read the Instructions to Vendors, the North Carolina General Terms and Conditions, all relevant exhibits and attachments, and any other components made a part of this RFP and comply with all requirements and specifications herein. Vendors also are responsible for obtaining and complying with all Addenda and other changes that may be issued in connection with this RFP.

http://eprocurement.nc.gov/

Ver: 09/2026 6

If Vendors have questions or issues regarding any component within this RFP, those must be submitted as questions in accordance with the instructions in the PROPOSAL QUESTIONS Section. If the State determines that any changes will be made as a result of the questions asked, then such decisions will be communicated in the form of an RFP addendum. The State may also elect to leave open the possibility for later negotiation of specific provisions of the Contract that have been addressed during the question-and-answer period, prior to contract award.

Other than through the process of negotiation under 01 NCAC 05B.0503, the State rejects and will not be required to evaluate or consider any additional or modified terms and conditions submitted with Vendor’s proposal. This applies to any language appearing in or attached to the document as part of the Vendor’s proposal that purports to vary any terms and conditions or Vendors’ instructions herein or to render the proposal non-binding or subject to further negotiation. Vendor’s proposal shall constitute a firm offer that shall be held open for the period required herein (“Validity Period” above).

The State may exercise its discretion to consider Vendor proposed modifications. By execution and delivery of this RFP Response, the Vendor agrees that any additional or modified terms and conditions, whether submitted purposely or inadvertently, shall have no force or effect, and will be disregarded unless expressly agreed upon during negotiations and incorporated by way of a Best and Final Offer (BAFO). Noncompliance with, or any attempt to alter or delete, this paragraph shall constitute sufficient grounds to reject Vendor’s proposal as nonresponsive.

2.4 RFP SCHEDULE

The table below shows the intended schedule for this RFP. The State will make every effort to adhere to this schedule.

Event Responsibility Date and Time

Issue RFP State October 20, 2026 Submit Written Questions Vendor October 27, 2026 Provide Responses to Questions State November 3, 2026 Submit Proposals Vendor November 10, 2026, by 2:00 pm Contract Award State TBD

2.5 PROPOSAL QUESTIONS

Upon review of the RFP documents, Vendors may have questions to clarify or interpret the RFP in order to submit the best proposal possible. To accommodate the Proposal Questions process, Vendors shall submit any such questions by the “Submit Written Questions” date and time provided in the RFP SCHEDULE Section above, unless modified by Addendum.

Questions related to the content of the solicitation, or the procurement process should be directed to the person on the title page of this document via email by the date and time specified in the RFP SCHEDULE Section of this RFP. Vendors will enter “RFP # 134- 202627-001 – Questions” as the subject of the message. Question submittals should include a reference to the applicable RFP section. This is the only manner in which questions will be received.

Questions or issues related to using the Sourcing Tool itself can be directed to the North Carolina eProcurement Help Desk at 888- 211-7440, Option 2. Help Desk representatives are available Monday through Friday from 7:30 AM ET to 5:00 PM ET.

Questions received prior to the submission deadline date, the State’s response, and any additional terms deemed necessary by the State will be posted in the Sourcing Tool in the form of an addendum and shall become an Addendum to this RFP. No information, instruction or advice provided orally or informally by any State personnel, whether made in response to a question or otherwise in connection with this RFP, shall be considered authoritative or binding. Vendors shall rely only on written material contained in an Addendum to this RFP.

2.6 PROPOSAL SUBMITTAL

IMPORTANT NOTE: This is an absolute requirement. Vendor shall bear the risk of late submission due to unintended or unanticipated delay. It is the Vendor’s sole responsibility to ensure its proposal has been received as described in this RFP by the specified time and date of opening. Failure to submit a proposal in strict accordance with instructions provided shall constitute sufficient cause to reject a Vendor’s proposal(s). Solicitation responses are subject to Sealed Bidding requirements.

Ver: 09/2026 7

Vendor’s proposals for this procurement must be submitted through the Sourcing Tool. For training on how to use the Sourcing Tool to view solicitations, submit questions, develop responses, upload documents, and submit offers to the State, Vendors should go to the following site: https://eprocurement.nc.gov/training/vendor-training

Questions or issues related to using the Sourcing Tool itself can be directed to the North Carolina eProcurement Help Desk at 888- 211-7440, Option 2. Help Desk representatives are available Monday through Friday from 7:30 AM EST to 5:00 PM EST.

Tips for Using the Sourcing Tool

1. Vendors should review available training and confirm that they are able to access the Sourcing Event, enter responses, and upload files well in advance of the date and time response are due to allow sufficient time to seek assistance from the North Carolina eProcurement Help Desk.

2. Vendors may submit their responses early to make sure there are no issues, and then submit a revised response any time prior to the response due date and time. The State will only review the most recent response.

3. Vendors should respond to all relevant sections of the Sourcing Event. Certain questions or items are required in order to submit a response and are denoted with an asterisk. The Sourcing Tool will not allow a response to be submitted unless all required items are completed. The Sourcing Tool will provide error messages to help identify any required information that is missing when response is submitted.

4. Simply saving your response in the Sourcing Tool is not the same as submitting your response to the State. Vendors should make sure they complete the submission process and receive a message that their response was successfully submitted.

5. Only Proposals submitted through the Content Section of the NC eProcurement Sourcing Event will be considered.

Proposals submitted through the Message Board will not be accepted or considered for award.

If confidential and proprietary information is included in the bid, also submit one (1) signed, REDACTED copy of the bid. Such information may include trade secrets defined by N.C. Gen. Stat. § 66-152 and other information exempted from the Public Records Act pursuant to N.C. Gen. Stat. §132- 1.2. Vendor may designate information, Products, Services, or appropriate portions of its response as confidential, consistent with and to the extent permitted under the statutes and rules set forth above. By so redacting any page, or portion of a page, the Vendor warrants that it has formed a good faith opinion, having received such necessary or proper review by counsel and other knowledgeable advisors, that the portions determined to be confidential and proprietary and redacted as such, meet the requirements of the Rules and Statutes set forth above. However, under no circumstances shall price information be designated as confidential.

If the Vendor does not provide a redacted version of the bid with its bid submission, the Department may release an unredacted version if a record request is received.

2.7 PROPOSAL CONTENTS

Vendors shall provide responses to all questions and complete all attachments for this RFP that require the Vendor to provide information and upload them to the Sourcing Event in the Sourcing Tool. Vendor may not be able to submit its response in the Sourcing Tool unless all required items are addressed. Vendors shall provide authorized signatures where requested. Failure to provide all required items, or Vendor’s submission of incomplete items, may result in the State rejecting Vendor’s proposal, in the State’s sole discretion.

Vendors shall upload the following items and attachments in the Sourcing Tool:

a) Cover Letter, which must include the following: (i) a statement that confirms that the Vendor has read the RFP in its entirety, including all links, and Addenda released in conjunction with the RFP; (ii) a statement that Vendor agrees to perform in accordance with the scope of work, requirements, and specifications contained herein; and (iii) Vendor’s agreement to comply with all instructions, terms and conditions, and attachments.

b) Title Page: Include the company name, address, phone number and authorized representative along with the Proposal Number.

https://eprocurement.nc.gov/training/vendor-training

Ver: 09/2026 8

c) Completed and signed version of EXECUTION PAGES, along with the body of the RFP.

d) Signed receipt pages of any addenda released in conjunction with this RFP, if required to be returned.

e) Vendor’s Proposal addressing all Specifications of this RFP.

f) Completed version of ATTACHMENT: PRICING

g) Completed and signed version of ATTACHMENT: CUSTOMER REFERENCE FORM

h) Completed and signed version of ATTACHMENT: LOCATION OF WORKERS UTILIZED BY VENDOR

i) Completed and signed version of ATTACHMENT: CERTIFICATION OF FINANCIAL CONDITION

2.8 ALTERNATE PROPOSALS

Unless provided otherwise in this RFP, Vendor may submit alternate proposals for comparable Goods, various methods, or levels of Service(s), or that propose different options. Alternate proposals must specifically identify the RFP requirements and advantage(s) addressed by the alternate proposal. Each proposal must be for a specific set of Goods and Services and must include specific pricing. Each proposal must be complete and independent of other proposals offered. If a Vendor chooses to respond with various offerings, Vendor shall follow the specific instructions for uploading Alternate Proposals in the Sourcing Tool.

2.9 DEFINITIONS, ACRONYMS, AND ABBREVIATIONS

Relevant definitions for this RFP are provided in 01 NCAC 05A .0112 and in the Instructions to Vendors referenced in the Sourcing Tool which are incorporated herein by this reference.

3.0 METHOD OF AWARD AND PROPOSAL EVALUATION PROCESS

3.1 METHOD OF AWARD

North Carolina G.S. 143-52 provides a general list of criteria the State shall use to award contracts, as supplemented by the additional criteria herein. The Goods or Services being procured shall dictate the application and order of criteria; however, all award decisions shall be in the State’s best interest. All qualified proposals will be evaluated, and awards will be made to the Vendor(s) meeting the specific RFP Specifications and achieving the highest and best final evaluation, based on the criteria described below.

While the intent of this RFP is to award a Contract(s) to a single Vendor for all line items, the State reserves the right to make separate awards to different Vendors for one or more line items, to not award one or more line items or to cancel this RFP in its entirety without awarding a Contract, if it is considered to be most advantageous to the State to do so.

If a Vendor selected for award is determined by the State to be a non-resident of North Carolina, all responsive proposals will be reviewed to determine if any of them were submitted by a North Carolina resident Vendor who requested an opportunity to match the price of the winning proposal, pursuant to Executive Order #50 and G.S. 143-59 (for more information, please refer to ATTACHMENT: VENDOR REQUEST FOR EXECUTIVE ORDER #50 PRICE MATCHING. If such proposals(s) are identified, the State will then determine whether any such proposal falls within the price-match range, and, if so, make a Contract award in accordance with the process that implements G.S. 143-59 and Executive Order #50.

The State reserves the right to waive any minor informality or technicality in proposals received.

3.2 CONFIDENTIALITY AND PROHIBITED COMMUNICATIONS DURING EVALUATION

While this RFP is under evaluation, the responding Vendor, including any subcontractors and suppliers, is prohibited from engaging in conversations intended to influence the outcome of the evaluation. See Paragraph 29 of the Instructions To Vendors entitled

COMMUNICATIONS BY VENDORS.

Ver: 09/2026 9

Each Vendor submitting a bid to this RFP, including its employees, agents, subcontractors, suppliers, subsidiaries and affiliates, is prohibited from having any communications with any person inside or outside the using agency; issuing agency; other government agency office or body (including the procurement lead named above, any department secretary, agency head, members of the General Assembly and Governor’s office); or private entity, if the communication refers to the content of Vendor’s proposal or qualifications, the content of another Vendor’s proposal, another Vendor’s qualifications or ability to perform a resulting contract, and/or the transmittal of any other communication of information that could be reasonably considered to have the effect of directly or indirectly influencing the evaluation of proposals, the award of a contract, or both.

Any Vendor not in compliance with this provision shall be disqualified from evaluation and award. A Vendor’s proposal may be disqualified if its subcontractor and/or supplier engage in any of the foregoing communications during the time that the procurement is active (i.e., the issuance date of the procurement until the date of contract award or cancellation of the procurement). Only those discussions, communications or transmittals of information authorized or initiated by the issuing agency for this RFP or inquiries directed to the procurement lead named in this RFP regarding requirements of the RFP (prior to proposal submission) or the status of the award (after submission) are excepted from this provision.

3.3 PROPOSAL EVALUATION PROCESS

Only responsive submissions will be evaluated.

The State will conduct a One-Step evaluation of Proposals:

Proposals will be received according to the method stated in the Proposal Submittal Section above.

All proposals must be received by the issuing agency not later than the date and time specified in the RFP SCHEDULE Section above, unless modified by Addendum. Vendors are cautioned that this is a request for offers, not an offer or request to contract, and the State reserves the unqualified right to reject any and all offers at any time if such rejection is deemed to be in the best interest of the State.

At the date and time provided in the RFP SCHEDULE Section above, unless modified by Addendum, the proposal from each responding Vendor will be opened publicly and all offers (except those that have been previously withdrawn, or voided bids) will be tabulated. The tabulation shall be made public at the time it is created. When negotiations after receipt of bids is authorized pursuant to G.S. 143-49 and 01 NCAC 05B.0503, only the names of offerors and the Goods and Services offered shall be tabulated at the time of opening. If negotiation is anticipated, cost and price shall become available for public inspection at the time of the award. . Interested parties are cautioned that these costs and their components are subject to further evaluation for completeness and correctness and therefore may not be an exact indicator of a Vendor’s pricing position.

At their option, the evaluators may request oral presentations or discussions with any or all Vendors for clarification or to amplify the materials presented in any part of the proposal. Vendors are cautioned, however, that the evaluators are not required to request presentations or other clarification—and often do not. Therefore, all proposals should be complete and reflect the most favorable terms available from the Vendor.

Upon completion of the evaluation process, the State will make award(s) based on the evaluation and post the award(s) to the electronic Vendor Portal (eVP), https://evp.nc.gov, under the RFP number for this solicitation. Award of a Contract to one Vendor does not mean that the other proposals lacked merit, but that, all factors considered, the selected proposal was deemed most advantageous and represented the best value to the State.

The State reserves the right to negotiate with one or more Vendors, or to reject all original offers and negotiate with one or more sources of supply that may be capable of satisfying the requirement, and in either case to require Vendor to submit a Best and Final Offer (BAFO) based on discussions and negotiations with the State.

https://evp.nc.gov/

Ver: 09/2026 10

3.4 EVALUATION CRITERIA

BEST VALUE: "Best Value" procurement methods are authorized by N.C.G.S. §§143-135.9 and 143B-1350(h). The award decision is made based on multiple factors, including: total cost of ownership, meaning the cost of acquiring, operating, maintaining, and supporting a product or service over its projected lifetime; the evaluated technical merit of the Vendor's offer; the Vendor's past performance; and the evaluated probability of performing the specifications stated in the solicitation on time, with high quality, and in a manner that accomplishes the stated business objectives and maintains industry standards compliance. The intent of "Best Value" procurement is to enable Vendors to offer and the Agency to select the most appropriate solution to meet the business objectives defined in the solicitation and to keep all parties focused on the desired outcome of a procurement.

A ranking method of source selection will be utilized in this procurement using evaluation criteria listed in order of importance in the Evaluation Criteria section below to allow the State to award this RFP to the Vendor(s) providing the Best Value and recognizing that Best Value may result in award other than the lowest price or highest technically qualified offer. By using this method, the overall ranking may be adjusted up or down when considered with, or traded-off against, other non-price factors.

EVALUTION METHOD: Narrative and by consensus of the evaluating committee, explaining the strengths and weaknesses of each proposal and why the recommended awardee(s) provide the best value to the State.

All qualified proposals will be evaluated, and award made based on considering the following criteria listed in descending order of importance, to result in an award most advantageous to the State:

1. Vendor Technical Approach (Section 5.5)

2. Vendor References (Section 4.8)

3. Vendor Experience (Section 4.7)

4. Financial Statements (Section 4.10)

5. Cost (Section 4.1 and Attachment: Pricing)

3.5 PERFORMANCE OUTSIDE THE UNITED STATES

Vendor shall complete ATTACHMENT: LOCATION OF WORKERS UTILIZED BY VENDOR. In addition to any other evaluation criteria identified in this RFP, the State may also consider, for purposes of evaluating proposed or actual contract performance outside of the United States, how that performance may affect the following factors to ensure that any award will be in the best interest of the State:

a) Total cost to the State

b) Level of quality provided by the Vendor

c) Process and performance capability across multiple jurisdictions

d) Protection of the State’s information and intellectual property

e) Availability of pertinent skills

f) Ability to understand the State’s business requirements and internal operational culture

g) Particular risk factors such as the security of the State’s information technology

h) Relations with citizens and employees

i) Contract enforcement jurisdictional issues

3.6 INTERPRETATION OF TERMS AND PHRASES

This RFP serves two functions: (1) to advise potential Vendors of the parameters of the solution being sought by the State; and (2) to provide (together with other specified documents) the terms of the Contract resulting from this procurement. The use of phrases such as “shall,” “must,” and “requirements” are intended to create enforceable contract conditions. In determining whether proposals should be evaluated or rejected, the State will take into consideration the degree to which Vendors have proposed or failed to propose solutions that will satisfy the State’s needs as described in the RFP. Except as specifically stated in the RFP, no one requirement shall automatically disqualify a Vendor from consideration. However, failure to comply with any single requirement may result in the State exercising its discretion to reject a proposal in its entirety.

Ver: 09/2026 11

4.0 REQUIREMENTS

This Section lists the requirements related to this RFP. By submitting a proposal, the Vendor agrees to meet all stated requirements in this Section, as well as any other specifications, requirements, and terms and conditions stated in this RFP. If a Vendor is unclear about a requirement or specification or believes a change in a requirement would allow for the State to receive a better proposal, the Vendor is encouraged to submit these items in the form of a question during the question-and-answer period in accordance with the Proposal Questions Section above.

4.1 PRICING

Proposal price shall constitute the total cost to the State for complete performance in accordance with the requirements and specifications herein, including equipment, materials, engineering and design, fabrication, system integration, software and controls, Factory Acceptance Testing (FAT), packaging, handling, freight and transportation, delivery, installation, startup and commissioning, acceptance testing, training, documentation, administrative costs, including travel, and other fees necessary to provide a complete and operational automated vial filling/isolator system. Complete ATTACHMENT: PRICING and upload in the Sourcing Tool. The pricing provided in ATTACHMENT: PRICING, or resulting from any negotiations, is incorporated herein and shall become part of any resulting Contract.

INVOICES MAY NOT BE PAID UNTIL AN INSPECTION HAS OCCURRED AND THE GOODS OR SERVICES ACCEPTED.

4.1.1 IMPORT TARIFF TEMPORARY SURCHARGE

Pricing shall be exclusive of any pending tariffs or temporary tariff surcharge. Vendor may request a temporary tariff surcharge in ATTACHMENT: PRICING SUBMITTAL WORKBOOK as a charge separate from the contract price. Any temporary tariff surcharge(s) associated with purchases shall be provided by way of a percentage tariff surcharge. All tariff surcharges proposed are intended to be temporary and based on current tariff implications specific to related commodities with evidence of submitted documentation of affected MSRP products. Vendor understands that the agency may request additional justification. Any temporary tariff surcharge percentage will be negotiated and mutually agreed upon. The state is not obligated to accept any proposed import tariff surcharge. Proposed tariff surcharges may be used as a factor for evaluation and award.

4.2 TRANSPORTATION AND IDENTIFICATION

The Vendor shall deliver Free-On-Board (FOB) Destination to any requested location within the State of North Carolina with all transportation costs and fees included in the total proposal price.

When an order is placed using a purchase order, the purchase order number shall be shown on all packages and shipping manifests to ensure proper identification and payment of invoices. If an order is placed without using a purchase order, such as via phone, the Buyer’s name shall be show on all packages. A complete packing list shall accompany each shipment. Vendors shall not ship any products until they have received an order.

4.3 DELIVERY AND INSTALLATION

The Vendor shall deliver Free-On-Board (FOB) Destination to the following location(s):

BEST Center of Eastern NC Wilson Community College 4101 NC Highway 58 S Wilson, NC 27893

Vendor shall perform and complete all deliveries in strict accordance with the final, approved project completion schedule.

Delivery shall not be considered to have occurred until installation has been completed. Upon completion of the installation, the Vendor shall remove and properly dispose of all waste and debris from the installation site. The Vendor shall be responsible for leaving the installation area clean and ready to use.

4.4 WARRANTY

Vendor warrants that all equipment furnished under this RFP will be newly manufactured, of good material and workmanship. The warranty will apply from date equipment is put into operation for a minimum period of twelve (12) months or the length of the

Ver: 09/2026 12 manufacturer’s warranty, whichever is longer. Such warranty shall cover the cost of all defective parts replacement, labor, freight, and technicians’ travel at no additional cost to the State, or as specified by the Procurement Entity herein. To the extent not superseded by the terms of this paragraph, manufacturer’s warranty terms shall apply. Vendor’s warranty shall be at least the level of coverage provided for its comparable customers.

The report of a problem does not presuppose that every call must result in an “on-site” visit for service/repair. The Vendor and/or service sub-contractor shall utilize best efforts to resolve problems in a timely fashion by using acceptable servicing methods to include, but not limited to, verbal problem analysis and remote diagnosis. The warranty requirement does not impose any additional duty on the State to make other than normal and good faith problem resolution efforts or expenditures of time. Vendor shall be responsible for compliance with warranty terms by any third-party service provider. Vendor shall provide contact information for warranty service provider, below.

Vendor is authorized by manufacturer to repair equipment offered during the warranty period? YES NO

Will the Vendor provide warranty service? YES NO, a manufacturer-authorized third party will perform warranty service.

Contact information for warranty service provider:

Company Name: _______________________________________________

Company Address: _____________________________________________

Contact Person (name): _________________________________________

Contact Person (phone number): __________________________________

Contact Person (email): _________________________________________

4.5 MAINTENANCE OPTION

Following expiration of the above warranty, Vendor, or its third-party service provider, shall maintain the system specifications and performance level in accordance with the manufacturer’s published specifications and those of this RFP. Maintenance shall include all parts, remedial maintenance labor, travel and living expenses incurred. Except as specifically provided for elsewhere herein, coverage shall be at least for 8:00 am ET to 5:00 pm ET, Monday through Friday, except State recognized holidays and shall include a minimum of two (2) preventive and safety maintenance inspections per year. The State shall have the option to accept the maintenance coverage in this paragraph at the price offered in ATTACHMENT: PRICING of this RFP, if applicable.

4.6 DESCRIPTIVE LITERATURE

DESCRIPTIVE LITERATURE/CERTIFICATION

Each proposal shall be accompanied by complete descriptive literature, specifications, certifications, and all other pertinent data necessary for thorough evaluation of the item(s) offered and sufficient to determine compliance of the item(s) with the specifications. Failure to include such information shall be a sufficient basis for rejection of the proposal, at the discretion of the State.

4.7 VENDOR EXPERIENCE

In its Proposal, Vendor shall demonstrate experience with public and/or private sector clients with similar or greater size and complexity to the State. Vendor shall provide information as to the qualifications and experience of all executive, managerial, legal, and professional personnel to be assigned to this project, including resumes citing experience with similar projects and the responsibilities to be assigned to each person.

4.8 REFERENCES

Vendor shall upload to the Sourcing Tool at least three (3) references, using ATTACHMENT: CUSTOMER REFERENCE FORM, for which it has provided Goods and/or Services of similar size and scope to those proposed herein. References shall not be from the same company or from the soliciting State entity. In addition, Vendor shall provide references for and identify other government

Ver: 09/2026 13 contracts it has received, for which your company has supplied the same or similar model of equipment offered. The State may contact these users to determine whether the Goods provided are substantially similar in scope to those proposed herein and whether Vendor’s performance has been satisfactory. The information obtained may be considered in the evaluation of the Proposal.

4.9 VENDOR’S REPRESENTATIONS

If Vendor’s proposal results in an award, Vendor agrees that it will not enter any agreement with a third party that may abridge any rights of the State under the Contract. If any Services, deliverables, functions, or responsibilities not specifically described in this solicitation are required for Vendor’s proper performance, provision and delivery of the Service and deliverables under a resulting Contract, or are an inherent part of or necessary sub-task included within such service, they will be deemed to be implied by and included within the scope of the contract to the same extent and in the same manner as if specifically described in the Contract. Unless otherwise expressly provided herein, Vendor will furnish all of its own necessary management, supervision, labor, facilities, furniture, computer and telecommunications equipment, software, supplies and materials necessary for the Vendor to provide and deliver the Services and/or other Deliverables.

4.10 FINANCIAL STABILITY

As a condition of contract award, the Vendor must certify that it has the financial capacity to perform and to continue to perform its obligations under the Contract; that Vendor has no constructive or actual knowledge of an actual or potential legal proceeding being brought against Vendor that could materially adversely affect performance of this Contract; and that entering into this Contract is not prohibited by any contract, or order by any court of competent jurisdiction

Each Vendor shall certify it is financially stable by completing the ATTACHMENT: CERTIFICATION OF FINANCIAL CONDITION. The State is requiring this certification to minimize potential performance issues from Contracting with a Vendor that is financially unstable. This Certification shall be deemed continuing, and from the date of the Certification to the expiration of the Contract, the Vendor shall notify the State within thirty (30) days of any occurrence or condition that materially alters the truth of any statement made in this Certification.

4.11 SUBCONTRACTORS

No portion of the work shall be subcontracted without prior written consent of the State. In the event that the Vendor desires to subcontract some part of the work specified herein, the Vendor shall furnish with their bid the names, qualifications, and experience of their proposed subcontractors. The Vendor shall, however, remain solely and fully liable and responsible for the work done by its subcontractor(s) and shall assure compliance with all the requirements and specifications of the contract.

4.12 SECRETARY OF STATE REGISTRATION

Prior to entering into a contract with the State, the awarded Vendor(s) must complete registration with the NC Secretary of State.

Upon notification of award, the selected Vendor(s) must furnish evidence of filing within 10 business days. Failure to provide this documentation may result in the disqualification of the Vendor(s) bid from further consideration for the award.

No purchase orders shall be issued prior to confirmation of completed registration with the Secretary of State.

A contract award under the above-referenced solicitation, and the resulting purchase orders, will produce repeated orders and transactions in North Carolina and will constitute “transacting business” in the State, which requires a certificate of authority from the North Carolina Secretary of State as provided in G.S. §55-15-01 (corporations) or §57D-7-01 (LLCs). Please go to: https://www.sosnc.gov/ to register.

Vendor has registered with the North Carolina Secretary of State: Yes☐ No ☐ https://www.sosnc.gov/

Ver: 09/2026 14

5.0 PRODUCT SPECIFICATIONS AND SCOPE OF WORK

GENERAL

WCC is seeking proposals to build and install an Automated Fill Machine Isolator unit. The primary objective is to provide a realistic training environment for manual aseptic processing. Therefore, the design should emphasize operator interaction and skill development rather than maximizing production throughput or automation. This unit will be installed in the BEST Center expansion currently in the design phase to include simulated cleanrooms that will be utilized for training in drug product manufacturing. To provide a capstone experience for trainees, the expansion will feature an automated fill machine housed in an isolator that simulates a controlled environment. Awarded vendor will work closely with architect O’Brien Atkins Associates and contractor Barnhill Building Group during the design and construction of the BEST Center.

The equipment will be installed in a GMP-simulated education and workforce training facility. Full GMP validation, including comprehensive IQ/OQ/PQ validation activities, is not required. The Vendor shall, however, provide sufficient installation, startup, commissioning, testing, and documentation to demonstrate that the system has been properly installed, is operational, and performs in accordance with the requirements and acceptance criteria established in this RFP.

SPECIFICATIONS

The specific items and any specifications that the Procurement Entity is seeking are listed below. Items offered by the Vendor must meet or exceed the listed Specifications to be considered for award.

A. FILL MACHINE

Containers to be filled:

Specifications

Vials A1. 2 ml injection vials (2R), ∅ 16.0mm x 35mm x 1.00mm, nested (will be un-nested for filling)

A2. 25 ml injection vials (25R), ∅ 30.0mm x 65mm x 1.20mm, nested (will be un-nested for filling)

A3. Other sizes optional, propose size(s)

Materials of Construction:

Specifications

Material Components A4. 304 Stainless Steel

Material Flows:

Specifications

Container Loading A6. Manual

Packaging Removal A7. Manual de-bagging

A8. No Laminar Air Flow unit to provide ISO 5/Grade A

A9. No e-beam

Vial Removal A10. Manual de-lidding/liner removal

A11. Automated de-nesting if required for filling

Container Unload A12. Trays of nests

Filling:

Specifications

Product A13. Liquid solution (water or growth media)

Ver: 09/2026 15

Product Supply A14. Plastic bag on hanger, with load cell

Batch Size A15. 1 - 20 L

Fill Orientation A16. Nested or in-line

Line Speed A17. Up to 40 units/min

Fill Volume A18. 0.1 - 25.0 ml

Fill Accuracy A19. +/- 1% or better

Stoppering:

Specifications

Stoppers A20. 13mm rubber serum stoppers

A21. 20mm rubber serum stoppers

Insertion A24. Mechanical

In-Process Control:

Specifications

Fill Level A25. Volume or weight, reject station, data logging

Stopper A26. Stopper placement, reject station, data logging

B. CONTAINMENT

Isolator:

Specifications

Air Handler B1. Integrated, uses air from surrounding cleanroom and returns without treatment (simulates ISO 5/Grade A)

Classification B2. Not required (simulates ISO 5/Grade A)

Metal Components B3. 304 Stainless Steel

Ports B4. Gloves for all manual operations and corrective actions

B5. Rapid Transfer Ports for container supply, stopper supply, product

Testing B6. Glove integrity

Environmental Monitoring

B7. Sampling and counting of nonviable particles

Decontamination B8. Sampling station for passive settling plates

C. FILL MACHINE & ISOLATOR

Utilities:

Specifications

Compressed Air C1. As needed to operate fill machine

Electricity C2. 480 VAC, 3 phase, 60 Hz (compatible in United States)

Water C3. No water

Clean Steam C4. No clean steam

Ver: 09/2026 16

Automation & Control:

Specifications

Control C5. PLC

C6. Optional: Delta V

Data C7. SCADA

C8. Optional: Delta V

Functions C9. Alarm management – filler and isolator

C10. Data logging – filler and isolator

Human-Machine Interface (HMI)

C11. User-friendly and external to isolator

Batch Records C12. MES provided by others

Documentation & Spare Parts:

Specifications

Documentation C13. Owner’s manual

C14. No validation reports

Spare Parts C15. Common, long lead-time

Testing, Shipping, Installation, Support:

Specifications

Pre-shipment Testing C16. FAT

Shipping C17. Shipping to BEST Center of Eastern NC, Wilson, NC

C18. Unloading Support

Installation and Testing

C19. Installation

C20. Commissioning

C21. SAT

Support C22. Start-up

C23. Training - operations and maintenance

PROJECT SCHEDULE

Vendors shall provide a detailed proposed project schedule identifying anticipated durations and major milestones from Contract execution through final acceptance. Project phases and corresponding major milestones are as follows:

A. Project Initiation

This includes kickoff and design review, aligning with the contract start and early planning requirements.

B. Engineering and Design

Covers engineering activities, design development, and design approval.

C. Equipment and Materials Procurement

Represents early purchasing of critical items that affect schedule.

Ver: 09/2026 17

D. Fabrication, Assembly, Integration and Programming

All manufacturing‐related activities grouped into a single unified phase — avoids duplication between “fabrication,” “assembly,” “integration,” and “programming.”

E. Factory Acceptance Testing (FAT) and Pre‑Shipment Inspection

Includes complete FAT performance, documentation, and any inspection prior to shipment.

F. Freight, Shipment and Delivery

Shipping, transportation, crating, and arrival at the installation site.

G. Installation, Startup and Commissioning

Covers installation of equipment, system startup, commissioning activities, and readiness validation.

H. Functional and Acceptance Testing

Acceptance testing once installed (distinct from FAT because it occurs onsite).

I. Training and Delivery of Required Documentation

Operator training, maintenance training, and delivery of manuals, drawings, and other required documentation.

J. Final Inspection and Final Acceptance

Final review, validation, and formal acceptance by the purchasing entity.

For planning purposes, the BEST Center anticipates approximately twelve (12) months for equipment design, fabrication, integration, and completion of FAT. This timeframe is an estimate and is not intended to prescribe the Vendor’s manufacturing schedule.

Installation of the equipment at the BEST Center is anticipated to occur after August 11, 2027. Vendors shall account for this anticipated installation timeframe in their proposed project schedule and shall identify any scheduling constraints, long-lead items, dependencies, or other factors that may affect the proposed delivery and installation dates.

The Contract shall be…

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