SJNLMP UHPLC w Ultra High Field HR QQQ SOW.pdf

Statement of Work UHPLC with Ultra High-Field Triple Quadropole Mass Spectrometer for the San Juan Medical Products Laboratory

Background

The Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP) needs to add ultra-high field triple quadropole (UHF-QQQ) technology to analyze and quantitate samples. This instrument is needed for current projects b-lactam, nitrosamine, complex health fraud, and CRADA mass spectral data. The UHF-QQQ is capable of sensitive analyses of adulterants or contaminants in complex matrices. The ability to use Selected Reaction Monitoring (SRM) or Multiple Reaction Monitoring (MRM) provides exceptional sensitivity and selectivity by isolating specific ions and fragmenting them, making it ideal for quantifying a small number of known compounds in a complex mixture.

As a Medical Product Specialty Laboratory, the laboratory uses Mass Spectrometry technology to analyze a variety of drug samples. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025- 2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The system is used to analyze medical product samples using specific protocols and methods established by the FDA Laboratories, internal FDA programs, and the FCC program.

Objectives

To obtain a fully functional UHPLC with an Ultra High-Field Triple Quadropole Detector and comprehensive workstation/software.

Scope

The SJNLMP requires a comprehensive system that can perform targeted analysis with a high degree of sensitivity and specificity. Additionally, San Juan needs the ability to perform robust quantitative analyses with low detection limits in complex pharmaceutical analyses. The contractor shall provide all resources necessary to meet or exceed the requirements described in this Statement of Work (SOW).

Requirements

All the following system requirements are minimum requirements:

• The UHF-QQQ shall comply with the following quality requirements:

o ISO/IEC 17025-2017 https://www.iso.org/standard/39883.html, https://www.iso.org/standard/66912.html o ISO 9001:2008 https://www.iso.org/standard/46486.html o 21 CFR Part 11 Compliance Features Available https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm o USP, cGMP/cGLP https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flo gin

• The UHF-QQQ system shall include the following salient requirements:

https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/39883.html,%20https:/www.iso.org/standard/66912.html https://www.iso.org/standard/46486.html https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin https://login.usp.org/cas/login?service=http%3A%2F%2Fonline.uspnf.com%2Fcas%2Flogin o Ultra-High Performance Liquid Chromatograph that contains:

Binary Pump Min. Flow Rate 0.001 mL/min Max flow 8 mL/min Pressure Range 2 to 103 MPa (20 to 1034 bar, 290 to 15,000 psi) Autosampler Column Compartment

• Column Capacity 2 x max, 300 mm w/pre-heater or guard column, Max.

ID: 10 mm; 2 x max, 250 mm w/pre-heater and guard column, Max. ID:

10 mm

• Temperature Range 5 °C (max. 18 K below ambient) 120 °C o Diode Array Detector that contains:

Data Collection Rate Up to 250 Hz Detection Mode UV-vis Detection (Up to 10 Channels) Detector Type Single-Beam Type Diode Array Detector Drift < 1 mAU/hour at 254 nm Lamp Deuterium lamp, tungsten lamp Linearity < 5% at 2.2 AU (typically < 5% at 2.7 AU) Max. Cell Operating Pressure Standard biocompatible: 5 MPa (50 bar, 720 psi) Other flow cells: 12 MPa (120 bar, 1740 psi) Noise <± 6 μAU at 254 nm (standard flow cell, bandwidth: 4 nm, slit width: wide, time constant: 2 sec) No. of Channels 10 + 3D field PC Connection USB 2.0; 3-port HUB to connect further Photodiode Array 1024 element Spectral Bandwidth Pixel resolution: 0.6 nm (average) Temperature Range 5 to 35°C; 20 to 80% RH (non-condensing) Validation Functions Internal validation with holmium oxide filter Wavelength Accuracy ± 1 nm Wavelength Range 190-800 nm Wavelength Repeatability ± 0.1 nm Flow Cell, 2.5uL o Ultra-High Field Triple Quadropole

Highly sensitive full-scan MS Selected-ion monitoring (SIM) SRM with up to 30,000 SRMs definable and up to 600 SRMs/sec and timed SRMs High-resolution (0.2 Da FWHM) selected-reaction monitoring (H-SRM) Product ion scan Precursor ion scan Neutral-loss scan Reverse energy ramp MS/MS spectra (RER) MS/MS spectra for compound identification Polarity switching capabilities Quantitation-enhanced data-dependent (QED) MS/MS Mixed Mode Scan Function

Electrodynamic ion funnel RF lens Ion beam guide and neutral blocker

5.25 mm field radius Resolutions up to 0.2 Da FWHM Greater than six orders of dynamic range provide high confidence quantitation o Integrated Syringe Pump and Divert Valve Fully automated data system control of the divert valve and syringe pump with plug-and-play support.

Automated control of the divert valve enables switching of the solvent front, gradient end point, or any portion of the HPLC run to waste.

o Uninterruptible Power Supply (UPS)/Power Conditioner o Vacuum System Four-stage differentially pumped vacuum manifold Advanced triple-inlet turbomolecular pump integrated with the vacuum manifold Environmentally friendly dry pump system o Nitrogen Generator

Variable flow up to 35 LPM Variable pressure up to 116 psi Multi-Stage Purification producing analytical grade

Nitrogen gas up to 99.5% purity o Controller Software Package and Workstation PC Station and Monitor Win 11 One License for each Licensed software Capable of controlling and programming methods, sequences for the UHPLC and

UHF-QQQ

Data processing Capable of analyzing (spectral library) and reporting results (example:

TraceFinder™ software or equivalent, method development software) Database of compound names, SRM transitions, and collision energies 21 CFR Part 11 compliant USB Communication and Cables for all connections o The system shall include the current Instrument Controller Software

Instrument License Current Instrument Firmware

• Delivery, Installation and Service o Onsite installation of the entire system shall be included and inclusive of labor, delivery, and travel costs.

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

o Inside delivery, setup, and installation, cleanup (remove boxes and packing) of the area at the place of performance is required.

o The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

o Standard kits for operational qualification and performance verification (OQ/PV) shall be included.

o Installation of hardware and software shall be conducted by factory certified service personnel.

o 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:

The contractor shall demonstrate that all modules start up properly, are correctly installed and connected.

o Shall include Hardware IQ/OQ with Performance Verification.

o Shall include Software IQ/OQ and testing of basic functional specifications and Chapter

21 CFR part 11.

o The vendor shall provide IQ/OQ electronic documentation of Software and Hardware.

o The vendor shall include a minimum of one preventative maintenance visit for to ensure the instruments are functioning at peak performance.

• Warranty o The entire system shall be warranted for parts and labor for a minimum of 3-year limited warranty from date of formal government acceptance or 1-year from completed installation qualification.

o The warranty shall include unlimited telephone/e-mail support for questions regarding operation. On-site response time for repairs during the warranty period shall be no more than 72 hours, if needed.

o Warranty coverage shall include all non-consumable items and parts supplied ensuring proper functioning.

o As needed, factory-certified replacement parts, engineer labor and travel costs, software updates, notifications, and installation shall be included in the warranty plan to ensure maximum system operational readiness.

o The warranty plan shall include a minimum of one subsequent preventative maintenance visit to ensure the instruments are functioning at peak performance.

• Training o Onsite familiarization training for 3-5 user shall include basic system operation and routine maintenance.

Trade and Service Specs

• Equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.

• The Contractor shall provide a minimum of a three-year manufacturing warranty for all manufactured equipment and parts. The warranty shall be included with the equipment and not separately priced. The warranty shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an Original Equipment Manufacturer (OEM)-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

• Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

• The supplier shall provide training and validation of the equipment and software on site at the time of installation. Sufficient familiarization training for 3-5 users at onsite location will be provided, such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training.

• The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/operation qualification (IQ/OQ) certification. The qualification and verification report shall include the standard operating procedures and the allowed manufacturer limits for the instrument. A copy of the calibration report and the qualification and verification report(s) shall be reviewed and approved by an FDA representative before installation of the equipment and execution of protocols.

• Inside delivery, disposing pallets, boxes, and any associated garbage, and unpacking the equipment and inventory of parts with a lab representative.

Deliverables or Delivery Schedule

Deliverable Quantity Due Date Ultra-High-Performance Liquid Chromatograph System w/ DAD, Ultra-High Field Triple Quadropole, Software and Workstation

1 Within 6-8 weeks after date of award

Installation and Operation Qualification documentation 1 Within 6-8 weeks after date of award

Familiarization Training 3-5 users Within 6-8 weeks after date of award

Instrument and Software User Manuals 1 Within 6-8 weeks after date of award

Place of Performance

Food and Drug Administration San Juan Medical Products Laboratory 466 Fernandez Juncos Ave, San Juan, PR 00901-3223

POCs: To be identified at time of award.

Vendor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below between the hours of 8:00 a.m. and 4:00 p.m. in accordance with the delivery location time zone (Eastern Time, Central Time, or Pacific Time). The contractor shall provide at least a 2 week notice for installation, set-up, and training date(s). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Delivery must be inside the facility. Contractor staff must have photo ID to enter building. Unless otherwise specified, all reports or copies of service reports shall be delivered to the COR identified in each Order at time of service.

These reports shall detail services, locations of performance and dates performed.

Period of Performance

The Period of Performance begins the date of contract award execution and continues for three years (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance. Instrument to be delivered no later than 6-8 weeks after date of award.

Hours of Operation

The contractor is responsible for conducting business, between the hours of 8:00 AM – 4:00 PM Monday through Friday except Federal Holidays or when the Government facility is closed due to local or nation emergencies, administrative closings, increment weather, or similar Government directed facility closings.