SOW QQQ-ICPMS with HPLC_IRVLMP SOW.pdf

Statement of Work

Triple Quadrupole Inductively Coupled Plasma Mass Spectrometer (ICP-MS) with high-performance liquid chromatography (HPLC) system

Background

The Food and Drug Administration’s Irvine Medical Products Laboratory (IRVLMP) requires a new Inductively Coupled Plasma Mass Spectrometer (ICP-MS) system to replace an aging unit used to detect trace levels of toxic elements within regulated commodities. The system must have the ability to perform speciation of specific elements, such as arsenic, thus a high-performance liquid chromatography (HPLC) system is also required.

This system will be used to perform methods within FDA’s publicly available Elemental Analysis Manual (EAM).

The Agency is also interested in reducing detection limits for some elements in specific commodities, thus a triple quadrupole ICP-MS system supports the evolving mission of the Agency, specifically the Closer to Zero Action Plan.

Purpose/Objective

The purchase of one (1) triple quadrupole inductively coupled plasma mass spectrometer with a high performance liquid chromatography system (HPLC-QQQ-ICP-MS) for the Irvine Medical Products Laboratory (IRVLMP) Irvine, CA is required to ensure the laboratory has sufficient instrumentation to detect trace levels of toxic elements and perform speciation of those elements when necessary.

Scope

IRVLMP requires one (1) triple quadrupole inductively coupled plasma mass spectrometer with a high performance liquid chromatography system (HPLC-QQQ-ICP-MS) that meets or exceeds the requirements below:

Requirements

I. The contractor shall provide an Agilent 8900 QQQ-ICP-MS or equivalent. The Triple Quadrupole Inductively Coupled Plasma Mass Spectrometer shall meet or exceed the following requirements:

• General Parameters:

o The system must be a compact, bench-top design with external rotary pump(s) configured to fit under or behind the laboratory https://www.fda.gov/food/laboratory-methods-food/elemental-analysis-manual-eam-food-and-related-products https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods bench. The offeror shall provide a full listing of facility requirements (electrical, exhaust, plumbing, etc.) with their response.

o 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.

o All solutions, standards, and/or consumable required to perform initial instrument qualification are the responsibility of the offeror.

o An additional quadrupole placed before the reaction cell that allows for the selection of ions prior the entering the reaction cell.

o A quadrupole after the reaction cell for the selection of ions after the reaction cell and before the detector.

o Standard nickel cones with option for use of platinum cones o Conical extraction and off-axis Omega lens located outside the high vacuum region.

o Octopole reaction system with a temperature-controlled collision/reaction cell capable of performing kinetic energy discrimination with helium gas with option to utilize other gases such as hydrogen or oxygen.

o Minimum RF Power Range from 1000 W to 1600 W o The RF generator shall be able to change from volatile organic solvents to aqueous samples without affecting plasma stability, even if highly volatile organic solvents are introduced.

o Comprehensive auto-tuning capabilities for plasma parameters, torch position, collision cell, lenses, mass analyzer, detector, detector pulse/analog factors in one single step o 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.

o The system must have the ability to connect to a HPLC system and perform fully automated HPLC-QQQ-ICP-MS analyses for the purpose of speciation.

• Includes all components for using the QQQ-ICP-MS System:

o Computer, monitor, mouse, keyboard, and operating software o Heat exchanger/chiller for cooling the interface o Roughing pump with noise reduction (quiet) cover o Software capable of coupling with HPLC for speciation analysis o Gas regulator(s)

• Benchtop design with the following approximate maximum dimensions:

o Height x Width x Depth: ~30 in x ~47 in x ~30 in o Weight: ~420 lb

• Sample Introduction:

o Temperature controlled spray chamber (-5 to 20 °C) o Ultra-high matrix sample introduction capabilities capable of analyzing dissolved solids of up to 1%, with an additional configuration option that can be set up to tolerate samples with up to 25% total dissolved solids (TDS).

o A ≥3-channel, computer-controlled peristaltic pump is required for pumping sample, internal standard, and draining the spray chamber.

o The cooling water supply to the ICP-MS mainframe shall be supplied by a non-refrigerated heat exchanger to reduce maintenance cost.

o A high throughput autosampler is required with a minimum capacity of 240 10-mL sample vial.

o The autosampler should come with a cover to prevent dust from entering sample containers during analysis.

o Autosampler capable of automated monitoring of signal washout using computer software.

• Analysis/Detection Performance:

o 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.

o The detector dead time shall meet industry standard timing and be identical in both pulse and analog modes.

o The system shall be capable of mass resolution of ≤0.5 atomic mass units in order to carryout half-mass correction by detecting doubly-charged odd-mass numbered isotopes (e.g. 145Nd++ at m/z 72.5).

o 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.

o The background at m/z 9 shall be less than 2 cps when operating under normal (no cell gas) instrumental conditions o Oxide ratios measured using CeO+/Ce+ <2% when operating under normal (no cell gas) instrumental conditions.

o Double charged ratios measured using Ce2+/Ce+ <3% when operating under normal (no cell gas) instrumental conditions.

o Short-term signal precision measured under normal (no cell gas) instrumental conditions shall be <3% relative standard deviation over 20 minutes.

o Long-term signal precision measured under normal (no cell gas) instrumental conditions shall be <4% relative standard deviation over two hours.

o 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.

o The system must have the option of adding a 2nd and 3rd cell gas line to cover all possible applications, both current and future.

o 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.

o The collision/reaction cell shall be able to reduce polyatomic interferences in collision mode using pure helium.

o The collision/reaction cell shall include a Four-channel cell gas control as standard o The ICP-MS shall enable semi-quantitative analysis in collision cell mode using He cell gas. Use of reactive gases such as CH4 and NH3 or reactive gas blends is not acceptable.

o The software must enable the scanning of all elements within the mass range of the detector during routine spectral analysis and provide automated semi-quantitative results for each element.

o The software must offer the ability to enter interference equations (for isotopic and doubly-charged interferences) pre- and post-acquisition.

• The QQQ-ICP-MS must be compatible with the high performance liquid chromatography system described in Part II.

II. The contract shall provide an Agilent 1260 Infinity III High Performance Liquid Chromatography (HPLC) or equivalent. The HPLC system shall meet or exceed the following requirements:

• The HPLC system shall consist of at least the four following components 1) quaternary pump, 2) autosampler, 3) degasser, and 4) column compartment. The components should be a benchtop design and all modules can be configured into one vertical stack.

• General Parameters:

o The offeror shall provide a full listing of facility requirements (electrical, exhaust, plumbing, etc.) with their response for installation of the HPLC.

o The contractor shall provide the entire system including all necessary supplies and accessories and fittings required for coupling with the QQQ-ICP-MS instrument for immediate start-up and installation on-site at the laboratory delivery location.

o All solutions, standards, and/or consumable required to perform initial instrument qualification shall be included.

o An appropriate strong cation exchange HPLC column shall be provided to be used for ion chromatography-ICPMS analysis as part of immediate start-up and installation.

• Pump:

o Quaternary pump that includes an active seal washing system and solvent selector valve that allows a mixture of a minimum of two solvents from a minimum of four independent solvent sources o Flow rates range of 0.01 to 5 mL/min or better, per channel o Flow rate precision 0.2% RSD o Flow rate accuracy ±2% o Maximum pressure of 5000 psi o At least two chambers capable of mixing at percentages between 0 and 100% o Recommended pH range of 1.0-12.5 o Recommended salt concentration tolerance up to 2M

• Autosampler:

o Metal-free sample flow path at 600 bar o Variable injection volumes from 1-100 µL o Injection precision <1% RSD for all volumes o Carry-over, <0.1% o Capable of sending remote start signal to corresponding QQQ-

ICP-MS system.

o Software capable of coupling with HPLC for speciation analysis o The ICP-MS shall be able to perform fully automated HPLC-QQQ-

ICP-MS runs (with the appropriate HPLC system).

o ICP-MS acquisition shall be enabled by a start signal from an HPLC system.

o The software shall enable real-time data calculation and operations, such as peak integration and concentration calculations, during the HPLC-QQQ-ICP-MS run.

• Degasser:

o At least 2 channels o pH range of 1-12.5 o maximum flow rate of 10mL/min per channel

• Column compartment:

o Capable of temperature control at minimum of 5-80 °C range.

o Temperature accuracy of <0.1 °C and Temperature precision of <0.1

°C.

• Integration with QQQ-ICP-MS o The system shall have the ability to integrate with QQQ-ICP-MS system in order to perform speciation.

o The HPLC system shall have the ability to integrate with Triple Quadrupole ICP-MS instrument in Part I in order to perform speciation. Any additional software required shall be included and utilize existing operational computers to create a turnkey system.

o The system shall include all parts, software, consumables, tubing, etc. to seamlessly connect to the proposed QQQ-ICP-MS system (Part I) o Vendor shall provide all consumable requires to perform arsenic speciation per EAM 4.10 and EAM 4.11. The turnkey system shall meet all sensitivity, performance, and quality requirements of the aforementioned methods.

Trade and Service Specifications

1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.

2. System installation shall occur no later than 90-days from the date of award.

https://www.fda.gov/food/laboratory-methods-food/elemental-analysis-manual-eam-food-and-related-products

3. The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance. The warranty must include unlimited telephone/e-mail support for questions regarding operation. On-site response time for repairs during the warranty period should be no more than 72 hours, if needed. Coverage shall include all non-consumable items and parts supplied including base instrument, computer, monitor, printer, auto-sampler, and water chiller/heat exchanger ensuring proper functioning for the entire warranty period. As needed, factory-certified replacement parts, engineer labor and travel costs, software updates, notifications, and installation shall be included to ensure maximum system operational readiness.

4. Offeror shall transfer all methods from an existing QQQ-ICP-MS Agilent 8800 system to their system and confirm that quality control and sensitivity parameters are met. Methods are listed on the FDA EAM webpage. This shall occur prior to installation acceptance.

5. Offeror shall develop equivalent reports to existing reports used to support the Agency’s mission prior to installation acceptance.

6. Offered system 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, the FDA’s stated need, and shall be fit for intended purpose.

The system shall be delivered with all necessary supplies and accessories required for installation and start-up. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used as evaluation criteria for award. The following shall be demonstrated at the time of installation:

a. The results of the sensitivity test should meet or exceed the values supplied in the contractor’s response. For example, if the contract states that their system should achieve a response for m/z 7 of at least 50 Mcps/ppm when operating under normal (no cell gas) instrumental conditions, this should be demonstrated after installation.

i. Additionally, the specifications regarding background, oxide ratios, double charged ratios, short-term signal precision, and long-term signal precision must be demonstrated after installation.

b. Performance for each of the reaction/collision modes (He, H2, and O2 for Part II) must be demonstrated after installation and the contractor shall demonstrate and document that the system is capable of performing triple quad experiments.

c. The flow rate accuracy, injection precision, and carryover listed in the contractor’s response must be demonstrated

d. The contractor shall provide certificates of analysis (COA) for all chemical standards used to verify sensitivity, as well as a standard operating procedure (SOP) describing how the tests will be performed.

https://www.fda.gov/food/laboratory-methods-food/elemental-analysis-manual-eam-food-and-related-products

7. Operator training for at least two operators at the delivery site location shall be provided at the time of installation or shortly thereafter.

8. Onsite installation of the entire system shall be included and inclusive of labor, delivery, and travel costs.

9. Onsite familiarization should include basic operations, routine maintenance, and familiarization for quantitative and qualitative analysis, and appropriate use of the HPLC system to perform speciation. Offeror shall provide these services for up to three Agency staff per system install.

10. Inside delivery, setup, installation, and clean-up of the area at the place of performance is required.

Deliverables or Delivery Schedule

One (1) triple quadrupole inductively coupled plasma mass spectrometer with a high performance liquid chromatography system (LC-ICP-MS) for IRVLMP, Irvine, CA. meeting or exceeding the requirements stated above will be delivered, inside delivery required, in accordance to the following:

Description of Deliverable Qty Due Date 1 One triple quadruple inductively coupled plasma mass spectrometer

1 Delivery within 90 days after award.

2 Installation and training 1 Date to be agreed upon with the technical POC at delivery location. No later than 30 days after instrument delivery.

3 Manufacturer’s warranty of equipment, parts and operational services.

1 Begins at the completion of installation and government acceptance through one year.

Delivery Location and Place of Performance

POC: To be identified at time of award

FDA/IRVLMP

19701 Fairchild Rd.

Irvine, CA 92612

Period of Performance

The period of performance begins the date of contract award. All requirements shall be completed no later than 120 days after contract award. The equipment will include a 12 calendar month warranty period beginning the date of formal government acceptance.

Delivery will be accepted during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM Pacific Time.