Sources Sought 133944 cap and labeler machine.docx

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER), requirement for Automated Vial Capper Machine and Labeler system.

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is- 333993 - Packaging Machinery Manufacturing; the applicable Small Business Size Standard is 600 employees.

Statement of Work (SOW)

Purchase of Automated Vial Capper machine and Labeler system

Part I: General Information

A. Objective

Procurement of Automated Vial Capper machine and Labeler system including installation, onsite qualification, training and optional annual onsite preventative maintenance service. This equipment is used for the preparation of Center for Biologics Evaluation and Research (CBER) Standards in support of vaccines and other biological products submitted for licensure and/or other regulatory decisions.

B. Background

Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation facility for CBER. This procurement is for the purchase of a replacement Capper and Labeler system to maintain critical production capabilities. These Standards are essential for quantifying the potency of biological drugs and are used by manufacturers during product development and production, as well as by international regulatory agencies and the FDA for mandatory lot-release testing prior to approving biological drugs for public distribution.

The Capper and Labeler system is intended to store CBER Reference Standards and Reagents, specifically for capping and labeling of various sized glass vials containing these critical biological products. The existing equipment has been discontinued by the manufacturer, making a replacement necessary to ensure uninterrupted production of these essential reference standards. Continued production is required to maintain compliance with Code of Federal Regulations 610.60-65 and 812.5. This acquisition supports critical mission of CBER under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act to safeguard the safety, efficacy, and quality of biological products that protect public health.

C. Scope

This procurement is for the purchase of Automated Vial Capper machine and Labeler system for Division of Biological Standards and Quality Control (DBSQC).

Part II: Work Requirements

See technical specifications for automated Vial capping and labeling system.

A.

· Maximum Footprint for Capper Machine and Labeler System: 16 x 5 feet.

The system should maintain high operational reliability and uptime during production periods. Variable speed control capability must be provided to match production requirements and workflow demands. The equipment must demonstrate consistent capping torque and labeling placement accuracy to ensure product quality and regulatory compliance. Container handling shall be designed for gentle operation to prevent container damage during processing. The system must operate effectively in a temperature-controlled laboratory environment with appropriate humidity levels.

1. Rotary Table

· Construction: Aluminum frame or equivalent durable frame material, with stainless steel external coverings or equivalent cleanable exterior surfaces

· Guide Rails: Stainless steel guide rails and center hub

· Support System: Anti-friction ball bearing supports with stainless steel pads

· Height Adjustment: Adjustable stainless steel threaded legs, or equivalent leveling mechanism, to support equipment leveling and integration with adjacent equipment; quoted configuration provides an adjustable height range of 33"–37".

· Cabinet: Integrated stainless-steel cabinet, or equivalent cleanable enclosure, with access panels for maintenance; cabinet shall fit within the overall 16 x 5 system footprint

· Base Frame: 30" with leveling feet

2. Utilities and Controls

· Power Requirements: Compatible with 115-volt, 60 hertz, 1-phase facility power, with adequate motor capacity to operate the integrated capper / labeler line at a minimum of 60 vials per minute for 3 mL and 5 mL vials using 13 mm and 20 mm aluminum crimp caps

· Drive System: Variable speed motor drive system capable of maintaining stable vial handling, capping, and labeling throughput at a minimum of 60 vials per minute, and supporting line start-up, stoppage, and changeover conditions.

· Air Supply: Requires clean compressed air utility, with minimum pressure of 30 psi or as specified by the manufacturer. CBER/FDA will provide clean compressed air at the installation site; the contractor/system manufacturer shall identify connection, pressure, and consumption requirements and connect/configure the equipment during installation.

· Control Panel: Capable of supporting labeler configuration with multiple conveyor drives as required by system design

· Interface: A minimum of 4.3" color touchscreen HMI with pushbuttons, or equivalent operator interface, providing clear visibility and manual control during production.

· HMI Mounting: HMI shall be mounted on the conveyor or system frame on the operator side of the equipment, in a location that provides clear visibility and safe, unobstructed access to controls during production; final location shall be confirmed during design or installation

· Production Rate: Minimum of 60 vials per minute

· Conveyor: Low friction chain conveyor with adjustable guide rails, minimum 3¼" wide or as required to accommodate specified containers

· Container Compatibility: Accommodates containers with outer diameter (OD) ranging from 5/8" to 4" and heights up to 6"

· Cap Sizes: Compatible with multiple closure sizes, including 13mm and 20mm

· Sealing Capability: Automated aluminum sealing for all supported cap sizes

· Components: Includes all necessary container handling and sealing components such as star wheel assemblies, cap seats, rollers, and delivery chutes

3. Wrap Labeling System

· Interface: Integrated system HMI/central touchscreen interface for labeling system control. If the labeler uses a separate HMI, it shall provide a 4.3" color touchscreen with push buttons, or equivalent color touchscreen/manual control capability, and be integrated with the overall line controls

· Safety Features: Alarms and warnings for label slippage detection (enhanced with optional alarm package)

· Maintenance Access: Open nip roller for quick correction of labeling problems

· Label Compatibility: Accommodate multiple label sizes including 0.75" x 1.75" and 1" x 2.625"

· Conveyor System: Chain conveyor, belt conveyor, or other functionally equivalent conveyor system with adjustable guide rails, sized to support stable vial flow, labeling accuracy, and integration with the capper / labeler line

· Application System: Multi-axis label application system with wrap belt assembly of sufficient dimensions to accommodate required label sizes and container configurations

· Labeling Head: Label applicator head configured for side-apply operation with dimensions appropriate to support required label sizes and production throughput

· Drive System: Belt rewind drive system of sufficient width and capacity to support continuous label feed and consistent application

· Peeler: Label peeler of sufficient size and configuration to ensure accurate and consistent label separation during operation

· Brake Unwind: Brake unwind mechanism of sufficient capacity to maintain controlled label tension and feed consistency throughout operation

· Wiper: wiper, 5"

· Applicator: Spring loaded secondary foam roller applicator

· Sensor: Polarized retroreflective sensor with conveyor mount

4. Automatic Tray Loader

· Integration: Seamless integration with the overall capping and labeling system

· Automation: Automatic tray loading capability to support continuous operation

· Flexibility: Downstream accumulation/handling system shall accommodate capped and labeled 3 mL and 5 mL vials after labeling and support manual removal or transfer for subsequent packaging operations

· Conveyor Integration: Compatible with the overall system conveyor design

· System Integration Components

· Conveyor System: Base frame with leveling feet of sufficient dimensions to support system operation and integration

· Guide Rail Assembly: Conveyor guide rail system of sufficient length to support container flow and system integration

· Labeling Head Mount: Multi-axis label head mounting system compatible with the conveyor height and configuration

· Top Hold Down Belt: Hold down belt of sufficient width and length to ensure stable container handling during operation

· Interface Spacer Wheel: Component interface spacer to ensure seamless integration between system elements

Place of Performance

Federal Research Center Building 52/72, Room 5296 (fifth floor) 10903 New Hampshire Avenue Silver Spring, MD 20993

Period of Performance Equipment delivery shall be completed within 60 days of contract award. Installation, Qualification and training completion shall be finalized within 90 days of contract award (30 days after delivery).

The four (4) optional years of post-warranty maintenance are estimated as:

Manufacturer’s Warranty Period: 12 consecutive months from installation and training (anticipated on/about 09/15/2026 – 09/14/2027)

The period of performance for the Option years in any resultant award will be estimated based on the date of award, required delivery of the system (inclusive of inside delivery, installation, and training), and the warranty offered. If/when Option Year 1 Post-Warranty Service/ maintenance is exercised, the periods of performance for all post-warranty Options will be firmed via unilateral modification.

Part III: Supporting Information

A. Security

The contractor Technicians / Customer Service Representatives are required to use White Oak campus parking lot and are required to follow government security procedures. Once the contractors enter the Security Desk at Bldg. WO75 Atrium or Bldg. 52/72 Loading Dock, FDA employees must escort the contractor Technicians and/or Customer Service Representatives during their presence in the building.

B. Packaging and Shipping Requirements

Advance notification at least 48 hours prior to delivery must be coordinated with FDA facility management. Deliveries to made between 9 AM – 3 PM. All shipping and delivery activities must comply with FDA security protocols. Installation is included with no separate shipping charges.

C. Installation and Setup Visual inspection for shipping damage and completeness shall be conducted upon delivery. Performance testing verification of all operational parameters is required. Government acceptance shall occur within 30 days of successful qualification.

The contractor should provide guidance and full support for any site preparation in collaboration with FDA counterparts.

D. Set-up and Configuration Complete system assembly and integration of all components shall be performed by the contractor. Software installation and configuration of control systems is required. Initial system optimization and performance verification must be completed.

E. Testing and Calibration procedures Factory Acceptance Testing (FAT) prior to shipment must be conducted to verify equipment performance and specifications at the manufacturer's facility before delivery.

Installation Qualification (IQ) and Operation Qualification protocols shall be provided by the contractor to FDA for review and approval. The contractor shall address any comments/suggestions from FDA staff. The contractor shall execute only approved protocols.

Installation Qualification (IQ) protocol determines the site preparation and installation of all equipment components according to manufacturer specifications to satisfy FDA requirements. Operational Qualification (OQ) performance verification must be conducted to demonstrate that the system operates as intended within specified parameters.

Performance Qualification (PQ) validation using actual production parameters and materials shall be performed to validate system performance under routine operating conditions.

Replicate analyses must be performed to verify consistency. Complete testing of all system functions is required. Testing design must be presented in the protocols. Verification of all safety systems and interlocks must be completed

Qualification (IQ/OQ):

1. Provide qualification protocol for FDA review and address any comments / suggestions

2. Execute qualification based on FDA approved protocol

3. Prepare qualification report with data and any deviations

4. Provide qualification report for FDA review and address any comments / suggestions.

F. Training and Manuals Comprehensive on-site training for FDA personnel should be provided. Operation, basic maintenance and troubleshooting training is required. Control system operation and parameter adjustment training must be included. Written training materials and certificates of completion shall be provided to all trained personnel.

Complete operation and maintenance manuals shall be provided (1 printed copies, 1 electronic). Software user guides and technical specifications must be included. Safety data sheets for all consumables and materials shall be provided.

G. Warranty and Maintenance

A minimum of twelve (12) months’ warranty from acceptance shall be provided. Complete coverage including parts, labor, travel and subsistence for all warranty repairs at no charge to the Government is required. The vendor shall provide response and repair services in accordance with their standard warranty terms and conditions. The vendor should provide one onsite preventative maintenance service and unlimited phone trouble shooting guidance.

Post-Warranty Service Agreement Option Periods

• The Contractor shall provide one (1) scheduled on-site (hardware and software) planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays).

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

k. Contractor Personnel Requirements The contractor’s technicians shall have a Real ID, or a USA government issued passport to enter the FDA laboratories. White Oak campus parking lot access is required for all contractor personnel. Compliance with security desk procedures at Building WO75 Atrium or Loading Dock at Building 52/72 is mandatory. FDA employee escorts are required during all contractor presence in the building. Adherence to all FDA security protocols is required without exception.

Anticipated Contract Type: Firm Fixed Price

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

· Business name, SAM Unique Entity ID number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);

· Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

· Three (3) years of past performance information, where the respondent has provided same or substantially similar product/service solutions on the same or near-same requirements. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include SAM Unique Entity ID number and size status) if not the respondent.

· If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

· If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

· Identification of AbilityOne Contracts available that can meet the requirement.

· Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC).

· Provide information if any of these specifications are too restrictive. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.

· If a large business, identify the subcontracting opportunities that would exist for small business concerns;

· Standard commercial warranty and payment terms;

· Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed place of performance; and

· Though this is not a request for quote, informational pricing is required

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before June 11, 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CBER-2026-133944.

Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).