“Brand Name or Equal” Milliflex Oasis Filtration Pump with option year periods of Post-Warranty Preventive Maintenance and Repair Services

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC), in order to determine if there are existing small business sources capable of providing a closed filtration device. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov.

Background:

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation and Testing laboratory and an ISO 17025 accredited testing laboratory of CBER. DBSQC is responsible for confirmatory lot release testing of biologicals and in-support testing required for licensing. Currently the DBSQC performs sterility tests with a Milliflex Rapid System, including Milliflex filtration pump manufactured by Millipore Sigma. The Milliflex pumps used for Milliflex sterility and Growth Promotion Qualification testing to support the use of Milliflex media have been discontinued; their service will be discontinued after 2025. DBSQC intends to replace the current pumps with a Brand Name or Equal Milliflex Oasis Filtration Pump in order to minimize variability in the lot release results in accordance with the 21 Code of Federal Regulations 601.12. The testing shall be consistent with sterility and Growth Promotion Qualification testing, which was performed for licensing and lot release testing by CBER. This instrument is critical for the conduct of official testing by DBSQC.

The instrument requires a yearly maintenance contract to ensure reliability for the support of ongoing research. This request is also for 4 option year periods of Post-Warranty Preventive Maintenance and Repair Services.

This is a Brand Name or Equal requirement. Products other than the specified Milliflex Oasis Filtration Pump are acceptable but shall meet all of the salient characteristics contained in the Minimum Technical Requirements below.

Minimum Technical Requirements (Salient Characteristics):

1. The pump frame shall be compatible with standard UV sterilization.
2. Shall have two filtration heads per pump.
3. Stainless steel, silicone, rubber gaskets shall withstand autoclaving at 121 C for up to 15 minutes or at 134 C for 5 minutes.
4. Filtration support height shall be 70 mm.
5. Funnel support and lid material compatible with standard UV and heat sterilization.
6. Pump height shall allow for easy access in a Class II Biosafety cabinet.
7. Shall have a user interface screen.
8. Shall have two pressure detection modes.
9. Shall allow splitting of the liquid sample.
10. Shall have an adjustable bottle holder height and tiltable display.
11. Shall have a pump rotation speed up to 240 rpm.
12. Shall have a timer range of 0.5 to 999.
13. The pump canister style shall be compatible with all EMDMillipore Steritest models.
14. The pumps shall be compatible with Millipore catalog #: MMHAWG124 filtration funnel to allow seamless compatibility with, 1) Milliflex Autospray Station, model #: MXRPSPRKT; 2) Detection Tower, model #: C6445-03; and 3) Image Processor, model #: M4476-17.

Installation, Training and Additional System Requirements:

1. The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration.
2. Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need.
3. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.
4. The contractor shall provide Onsite Qualification (IQ/OQ)
   1. Provide qualification protocol for FDA review and address any comments / suggestions.
   2. Execute qualification by manufacturer trained technicians and reagents based on an approved protocol.
   3. Use calibrators with current NIST and/or other national traceable calibration.
   4. Address any non-conformances.
   5. Provide qualification report for FDA review and address any comments / suggestions.
5. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format.
6. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The contractor shall demonstrate upon installation that the item meets or exceeds all performance specifications. Upon acceptance of the system, the contractor shall provide on-site operator training/familiarization. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.
7. Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year.

Post-Warranty Preventive Maintenance and Repair Services Minimum Performance Requirements:

1. 1. The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visits (including parts) per year.
   2. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 2 business days of call for service where problems cannot be resolved remotely after 2 business days.
   3. The Maintenance and Repair activities shall be performed by the service engineers who are trained and certified by the Original Equipment Manufacturer (OEM). The service provider should follow the OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.
   4. The service plan shall include access to OEM technical developments, repair procedure bulletins, and unlimited software, firmware, and application updates.
   5. The Contractor shall provide factory-certified replacement parts.
   6. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and troubleshooting with any equipment issues, Monday through Friday (excluding Federal Holidays).
   7. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, consumables, etc. for the system.

Deliverables: Service Records and Reports: the Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Place of Performance:

FOB Point Destination. All items shall include shipping, handling and inside delivery and installation to the destination identified herein.

FDA CBER

Building 52/72

10903 New Hampshire Avenue

Silver Spring, MD 20993

Period of Performance:

Delivery, installation, onsite qualification, and training shall occur within 30 calendar days from date of award.

4 - (1-year Post-Warranty Maintenance and Repair Option periods):

Option Year 1: 12 consecutive months commencing upon expiration of initial warranty;

Option Year 2: 12 consecutive months commencing upon expiration of Option Year 1;

Option Year 3: 12 consecutive months commencing upon expiration of Option Year 2;

Option Year 4: 12 consecutive months commencing upon expiration of Option Year 3;

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, unique entity identification (UEI) 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 again if responding to provide a service offered by another firm.
• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client 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 UEI number and size status) if not the respondent.
• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.
• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered items/services meet the technical requirements identified above.
• 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.
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.
• If a large business, provide whether subcontracting opportunities 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.
• Informational pricing is desired.
• The Government is not responsible for locating or securing any information, not identified in the response.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before May 2, 2025 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN-128757.

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.

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 and Proprietary Information:

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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.