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)’s Division of Biological Standards and Quality Control (DBSQC) in order to determine if there are existing small business sources capable of providing a 50L Pilot Freeze Dryer to replace SP Industries, Vertis 35XL (35L) Lyophilizer, which is ~15 years old and has been discontinued by the manufacturer, so is being offered as a trade-in on the new instrument. 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. This requirement also includes four (4) option years of post-warranty maintenance. 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
[email protected]. Background: The Division of Biological Standards and Quality Control (DBSQC) is responsible for preparing Center for Biologics Evaluation and Research (CBER) Biological Reference Standards and Reagents. These standards and reagents are used to quantify the potency of biological drugs used by manufactures during product production and used by international regulatory agencies - and the FDA - for lot-release testing before these biological drugs are approved for release to the public. DBSQC produces a variety of CBER Standards and Reagents and distributes them in various sized glass-labeled vials in accordance with the Code of Federal Regulations 610.60 – 65 and 812.5. Minimum Technical Requirements: Existing clean room space configuration not to exceed dimensions: Width 64cm Depth 198cm Height 192cm Freeze Dryer specifications: Condenser maximum low temperature: -85°C Lowest shelf temperature: ≤ -67°C / -70°C Shelf temperature range: -70C to +65C Shelf temperature control range: -55°C to +65°C Shelf pull-down from 20°C to -40°C: ≤ 40 minutes Condenser pull-down from 20°C to -45°C: 35 minutes Shelf temperature uniformity: +/- 1°C Condenser capacity: 20 liters/24 hours, 50 liters maximum capacity Condenser surface area: 10 ft2 (.93 m2) Maximum Deposition rate: ≥ 0.83 L/hour Number of compressors: 2 Compressor: #1: 3.5 hp; #2: 1.5 hp Stoppering: Bottom-up hydraulic Defrost: Hot gas Refrigerant type: Non-CFC Vacuum time to 100 mTorr: ≤ 45 minutes Vacuum rate of rise: ≤ 30 mT/hour Volume-based leak rate: ≤ .0042 mbarL/sec Lowest system vacuum: ≤ 15 mT Power requirement: 208/230V @ 60Hz Shall contain ten (10) 316L stainless steel shelves. Contractor shall provide all clean room installation accessories necessary for a complete turn-key installation. Freeze dry shall accommodate two mL, three mL and five mL vials that use 13 and 20 mm wide lyophilization stoppers. Stoppering shelf configuration for freeze dryer: Shall have adjustable shelves. Shall provide for stoppering of vials under vacuum. Shall be able to backfill with inert gas to validated 3 mL and 5 mL vials capped with 13 mm and 20 mm lyophilization stoppers, respectively. Shall include a vacuum pump capable of operating at 343 - 378 LPM @ 60Hz Shall provide a range of 1-3% low residual moisture content formulation for packaging of lyophilized products. Shall have functional properties, such as self-sealing and resistance to coring, and stability of lyophilization closures during free-drying process. All components shall be compatible with steam sterilization. Shall have a fully automated control system meeting the following: Freeze drying phases: At least (12) Twelve thermal treatment (pre freeze) steps each with rate/hold capability Product freeze (Programmable freeze dry control system At least (17) drying steps each with rate/hold capability Storage (hold) phase until cycle end Automatic backfill capability with air or inert gas. Automatic stoppering via controls on stoppering units Shall include an automated function and leak rate testing. Shall incorporate conditional and emergency alarms to protect product and equipment. Controls instrumentation shall meet the following: At least eight (8) type T product thermocouples At least one (1) condenser temperature probe At least one (1) shelf temperature probe Convection vacuum transducer Capacitance Manometer PVG/CM differential process control software to automatically advance to the next drying step based on Manometer pressure comparison. Automated batch reports include the cycle recipe, an event log, tabulated numeric data in 10-minute increments, and a historical graph. Two UPS shall be included – one each for PC and PLC – to protect the data collection function in case of temporary power loss. Windows 10 computer workstation with printer Historical trending, with user customized trends Ability to export data to a spreadsheet Batch report with capability to print and save to a PDF. Shall include Barometric End Point Process Control Software Pressure Rise Test for product dryness. Automatically closes/opens isolation valve. Measures vapor pressure rise in product chamber. Contractor shall provide installation. Contractor shall provide Onsite Qualification (IQ/OQ) Shall provide equipment qualification protocol for FDA review and address any comments / suggestions. Shall execute equipment qualification based on FDA-approved protocol. Shall prepare qualification report with data and any deviations. Shall provide qualification report for FDA review. Qualification shall be performed within 60 days after the delivery and installation of the instrument. Installation, Training and Additional System Requirements The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. 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. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. 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. 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. 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. The Government is offering the following trade-in equipment which is offered in “as is” condition. Contractor shall assume all costs for packaging and shipping trade-in equipment. Supervision and technical assistance (either virtually or in-person) shall be provided for removal of existing system. The trade-in equipment shall be picked up from the building 52/72 Loading Dock at the FDA campus. SP Industries Vertis 35XL (35L) Lyophilizer, serial # 219568 Post-Warranty Preventive Maintenance and Repair Services Minimum Performance Requirements: The Contractor shall provide one (1) scheduled on-site planned preventive maintenance and National Institute of Standards and Technology (NIST) calibration 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 by 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. The Contractor shall include software and firmware updates required during on-site instrument repair and instrument’s performance check during preventive maintenance during the coverage period(s). The Contractor shall provide factory-certified replacement parts. 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) 8:00AM – 5:00PM Eastern Time. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, 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. Period of Performance: Delivery, installation, and training shall occur within 90 calendar days from date of award. Delivery Location: FDA/CBER Building 52/72, Room 5296 10903 New Hampshire Avenue Silver Spring, MD 20993. 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 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 March 5, 2024 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA | OO | OFBA | OAGS | DAP, Attn: Warren Dutter, email
[email protected]. Reference: FDA-SSN-121146. 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.