Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The NAICS for this requirement is: 334516. The government is not obligated to make an award. The Government is not obligated to pay costs incurred by the Contractor during quote preparation and quote submission.
Background: This request is for the Division of Color Certification and Technology (DCCT), within the Office of Cosmetics and Colors, to acquire a new inductively coupled plasma mass spectrometer (ICP-MS). This system will replace an existing Agilent 7800 ICP-MS, which was purchased in May 2016 and will reach the end of its guaranteed support in October 2028. Timely replacement is necessary to ensure continuous service and to prevent any interruption in color certification activities.
DCCT needs an instrument capable of determining element concentrations and accurate element ratios at low concentrations. In contrast to conventional quadrupole-based instruments, an instrument equipped with a kinetic energy discrimination-capable collision/reaction cell will provide the agency with the capability for achieving lower detection limits and higher accuracy in determining element concentrations in complex color additive and other matrices.
Minimum Performance Requirements/Salient Characteristics:
All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the DCCT prior to purchase.
- General
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- The system shall be of a compact bench-top design to fit the space constraints of the laboratory and shall have an open architecture sample introduction area with external rotary pump(s) configured to fit under or behind the laboratory bench. The footprint for both the ICP-MS and the autosampler shall be smaller than height x width x dept: 35" x 45'' x 35”.
- The components and/or equipment shall be new, not used or refurbished, or previously used for demonstration.
- The system shall be a turn-key solution—the contractor shall be responsible for providing all hardware, components, instruments, and software that are otherwise required to meet these salient characteristics.
- The contractor shall provide the entire system including all necessary supplies and accessories and fittings required for immediate start-up and installation on-site at the designated laboratory delivery location.
- Instrument software must be able to control all components of the ICP-MS system (including autosampler, advanced diluting system, reaction system, plasma, mass analyzer, chiller, pump) with a single software program/package.
- The ICP-MS software shall demonstrate exceptional consistency and operational simplicity through advanced system setup and comprehensive auto-tuning of plasma operating parameters, torch alignment, collision cell conditions, ion optics (lenses), mass analyzer settings, detector parameters, and percent abundance factors — all in one single step
- All solutions, standards, and/or consumables required to perform initial instrument qualification are the responsibility of the offeror.
- Single hyperbolic quadrupole for mass analysis, Agilent 7850 (G8422AA) or equal.
- Sample Introduction system, Agilent SPS4 (G8415A) or equal.
- Advanced dilution system, Agilent ADS 2 (M5172A) or equal.
- Operating software and shall be Microsoft Windows based software
- Microsoft Office modules needed for data analysis and interpretation shall be included.
- Color laser printer.
- Heat exchanger/chiller for cooling the interface. The cooling water supply to the ICP-MS mainframe shall be supplied by a non-refrigerated heat exchanger to reduce maintenance cost.
- Roughing pump with noise reduction (quiet) cover.
- Gas regulator(s).
- Perfluoroalkoxy alkanes inert sample introduction kit with 2.5 mm sapphire injector PFA concentric nebulizer.
- The instrument installation and user familiarization training shall be included in price.
- 3-day on-site application consulting, routine operation and operator maintenance training
- A comprehensive spares kit, including nickel sample and skimmer cones, shall be supplied. An extra set of nickel sample and skimmer cones shall also be included.
- Spectrometer must be covered under warranty for a period of 1 year after installation. The warranty shall include unlimited on-site visits for problem resolution.
- The price proposal shall include optional service agreements for three additional years, covering all parts and labor for repairs or defects. This shall not obligate the FDA to purchase the service agreements. Optional service agreements shall not be exercised until expiration of the standard manufacturer's warranty.
- Sample Introduction, Agilent SPS4 (G8415A) or equal
- An integrated, computer-controlled, high-precision peristaltic pump (pump speed 0.1 to 0.5 rps) with a minimum of three channels and ten rollers shall be provided for independent pumping of the sample, internal standard, and spray chamber drain.
- The quartz spray chamber shall be thermoelectrically controlled and shall be fitted with a concentric micro-mist nebulizer.
- Temperature controlled spray chamber (-5 to 20 °C)
- Ultra-high matrix introduction capability shall be included, enabling reliable analysis of samples containing ≥5% total dissolved solids (TDS).
- A high throughput autosampler is required with a minimum capacity of at least 42 50-mL and 120-15 mL sample vials as well as positions for tune and rinse bottles.
- The autosampler shall come with a cover to prevent dust from entering sample containers during analysis.
- Autosampler capable of automated monitoring of signal washout using computer software.
- User selectable intelligent-automated monitoring of washout to the baseline and pre-emptive rinse routines for increased productivity.
- It shall have pumped drain kit.
- The sample introduction system shall be automatically tuned via the integrated software.
- Advanced dilution system, Agilent ADS 2 (M5172A) or equal
- Capable of automatically preparing calibration standards from a single stock standard.
- Preform fixed or predefined dilutions to cut down on manual pre-analysis dilutions, consumable usage, and laboratory waste.
- Performs reactive dilution when a measured signal is over range, reducing the need for repeat analyses.
- Gas flow controllers
- Instrument shall have computer-controlled gas flow controllers that precisely regulate the flow of gas in the instrument’s plasma and interface systems (plasma, torch, nebulizer).
- One collision/reaction cell gas line shall be included as standard. The system shall be upgradable to three cell gas lines in total, to cover all possible applications. It is not acceptable to use an external gas manifold for the additional cell gas lines because it increases the dead volume and changeover cannot be automated within run.
- Vacuum and Cooling system
- The instrument vacuum system shall consist of a single floor mounted external rotary pump, and single turbomolecular pump.
- Plasma and ion optics
- Torch
- One piece quartz torch with injector diameter of 2.5 mm for fast, easy replacement and high matrix tolerance. Demountable torches that use O-ring seals or require alignment of the separate concentric tubes are not acceptable, as they increase maintenance time and possibly introduce sample contamination.
- Torch position shall be fully computer controlled and fully auto tunable via the software in all three axes (horizontal and vertical position and sampling depth). The movement in each axis shall be independent of the other two. Torch position and reproducibility should be 0.1mm in all three axes. Computer readout of torch position is required for method and data audit purposes.
- Solid state electronics in both plasma and quadrupole RF generators.
- RF generator
- For tolerance of changes in sample matrix, the system shall include a high power-transfer efficiency and maintenance-free solid state digital drive 27 MHz RF generator with variable-frequency impedance matching.
- Minimum RF Power Range from 1000 W to 1600 W
- The RF generator shall be able to tolerate change from volatile organic solvents to aqueous samples without affecting plasma stability.
- Interface
- Shielded torch interface for precise ion energy control
- Shall come standard with nickel sampling (0.1mm) and skimmer (0.45mm) cones with option for use of platinum cones
- Ion optics
- Conical extraction and off-axis focus lens for uniform mass response curve.
- The main ion-lens assembly shall be located before the gate valve to reject neutrals and matrix components before they can enter the main high vacuum chamber.
- The main ion-lens assembly shall ensure that only ions enter the high vacuum region.
- An ion lens that incorporates a 90° ion deflection shall be the method of protecting the detector from stray photons and high-energy neutrals which would cause a raised background. However, due to the potential for ion energy, space charge and mass bias effects caused by high angles of deflection of the primary ion beam, the 90° deflection shall occur after mass separation—i.e., the deflection shall occur between the quadrupole mass analyzer and the detector.
- The main ion-lens assembly shall be located outside the main vacuum system and allow for removal, cleaning and replacement without opening the main vacuum system.
- Collision/reaction system
- To enable fast, stable and consistent interference removal, the cell shall be thermally-stabilized and operated with fixed RF amplitude for the full mass range.
- The cell shall switch between gas modes and between gas and no gas mode in 3 seconds or less.
- The ICP-MS shall be able to be used for semi-quantitative analysis in cell mode using helium cell gas. The cell shall operate effectively in collision mode using pure helium.
- The instrument shall be able to be used for the multi-element analysis of unknown samples containing chloride (Cl), sulfate (SO4), and organic content, without the need for polyatomic interference correction equations.
- Quadrupole mass analyzer
- The system shall use a true hyperbolic quadrupole, operating at high (3 MHz) frequency with a mass range of 2 - 260 amu
- The system shall have mass scan speed >3000 amu/sec and variable mass resolution
<0.3 u to >1.0 u.
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- The system shall have mass stability of ≤0.05 u per day ≤0.1 u per six months
- The system shall be capable of a linear dynamic range of at least 9 orders of magnitude without the need to use increased resolution at the highest concentration point.
- The detector dead time shall meet industry standard timing and be identical in both pulse and analog modes.
- The sensitivity for low mass (>10), mid-range mass (59-115), and high mass range (205-238) shall be at least 50 Mcps/ppm when operating under normal (no cell gas) instrumental conditions.
- The background at m/z 9 shall be less than 2 cps when operating under normal (no cell gas) instrumental conditions
- Oxide ratios measured using CeO+/Ce+ <2% when operating under normal (no cell gas) instrumental conditions.
- Double charged ratios measured using Ce2+/Ce+ <3% when operating under normal (no cell gas) instrumental conditions.
- Short-term signal precision measured under normal (no cell gas) instrumental conditions shall be <3% relative standard deviation over 20 minutes.
- Long-term signal precision measured under normal (no cell gas) instrumental conditions shall be <4% relative standard deviation over two hours.
- The detector shall offer a minimum dwell time of 3 msec in all modes (TRA and spectrum).
- The system shall include a collision/reaction cell to eliminate or significantly reduce interferences from molecular species and allow for accurate multi-element analysis of elements such as chromium, arsenic, selenium, thallium, cadmium, lead, antimony, and mercury under the same experimental conditions.
- The systems shall have the option of adding a 2nd and 3rd cell gas line to cover all possible applications, both current and future.
- The instrument shall be capable of eliminating interference at different masses, without the use of interference equations to correct for polyatomic interferences, in accurate determination of variable high matrix samples.
- The collision/reaction cell shall be able to reduce polyatomic interferences in collision mode using pure helium, hydrogen, or oxygen.
- Data system:
- The instrument shall include software for data acquisition, processing and reporting.
- The instrument shall include one-click plasma setting for simpler, more reproducible plasma optimization.
- The instrument shall include the capability for remote monitoring of instrument status and run progress and support remote control of instrument and run processes using the ICP-MS vendor's software utility running on a smartphone or tablet.
- The ICP-MS system shall include tutorial and standard operating procedures in electronic format for ease of operating and implementing software.
- The instrument control software shall offer an automated method setup wizard to users to build a fully functional method by simply asking a few questions.
Place of Performance:
Attn: Nebebech Belai, HFS-106
U.S. Food and Drug Administration, CPK2
Office of Cosmetics and Colors, Room 1059
4300 River Road
College Park, MD 20740
Period of Performance:
Performance begins on the date of formal government acceptance and continues through the end of the manufacturer's warranty period.
Quotes are due by email on or before September 23, 2025, by 4:00 P.M. (Eastern Standard Time) and should be sent to brandon.rafus@fda.hhs.gov
