SOW GC-MS mobile labs DRAFT.pdf

Statement of Work

Gas Chromatograph/Mass Spectrometer and Accessories with Hydrogen Generators

1. Scope:

The U.S. Customs and Border Protection Savannah Laboratory seeks to operate mobile laboratories and Forward Operating Laboratories (FOLs) along national ports of entry. The requirement is for thirteen (13) efficient and reliable gas chromatograph/mass spectrometry

(GC/MS) systems with accessories and seventeen (17) hydrogen generators for the mobile laboratories and FOLs will allow suspected controlled substances to be analyzed more efficiently at ports of entry almost in real time.

2. Requirements:

The LSSD Savannah Laboratory wishes to perform a technical review of all vendors being considered for the bid process to determine if they meet the requirements outlined below.

All equipment, parts, and accessories must be new. Used, refurbished or demonstrator items are not acceptable and will not be considered.

Install base for instrumentation – The vendor will demonstrate market establishment by having at least 10 instruments from the current family of instrumentation (not necessarily the exact model, but the same generation) within a 300-mile radius of the Savannah Laboratory (satellite laboratory). This proven track record of reliability is essential for the large casework demands of the laboratory. No prototypes, one-of-a-kind, or two-of-a-kind systems will be considered.

Local service and/or technical support personnel – The chosen instrument vendor will have service and/or technical support personnel, trained and deemed qualified to work on the current instrument model, within a 300-mile radius of the Savannah Laboratory (satellite laboratory).

This will allow for quick turnaround times and reduce service travel charges when the instrument requires service from the vendor. If the vendor is unable to meet this requirement, they may agree, in writing, to waive their travel charges in lieu of this requirement for any service that is necessary on the instrumentation. On-site repair and maintenance by the qualified personnel will be available within 5 business days of the service call and all required parts will be available within 5 business days and not made to order. Qualified technical representatives shall be available by phone for free. The warranty period shall be for a minimum of one year as of the date of successful install, whereby the instrument has been accepted and passes all requirements provided in this SOW, and shall include travel costs, parts costs and labor costs.

On-site training – The chosen instrument vendor shall provide on-site familiarization and installation at the various delivery addresses. The training will cover all aspects of the software, including: instrument startup and shutdown, instrument operation, method creation and running sequences of samples, qualitative analysis using the available detectors, and report generation.

At the end of the training, analysts should be able to independently create a new method, run a sequence of samples, interpret their results, and produce custom-made reports. They should also be familiar with all hardware parts of the instrument, for ease of later troubleshooting, and to be comfortable performing the preventative maintenance required for the instrumentation.

Equipment/Instrumentation Requirements

Must meet or exceed the following specifications (GC/MS systems):

1. Chromatographic Performance

a. Retention time repeatability< 0.008% or better

b. Area repeatability < 1%RSD or better

2. Gas Chromatograph

a. Autosampler tray mode for minimum of 150 2-ml glass vials, solvent wash, and waste dispensers.

b. Shall have the capability for column change without MS venting

c. Oven temperature: minimum range +10 degrees C – 450 degrees C or better

d. Shall be able to supports 20 oven ramps or more, including negative ramps.

e. Oven cool down (22 °C ambient) 450 to 50 °C in 3.0 min or less.

f. 100psi minimum split/splitless inlet or better

g. Electronic pneumatic control for split/splitness, and septum purge

h. Constant pressure and flow modes, pressure and flow must be programmable.

i. Pneumatic splitter for effluent splitting, backflushing, and column switching

j. Shall provide pressure units in psi, kPa, or bar.

k. Shall have carrier and makeup gas settings selectable for He, H, N2

l. Minimum detectable level (for tridecane) < 1.8 pg C/s or better

m. Designed for Capillary 0.2-0.5 um columns or better

3. Mass Selective Detector

a. Electron Impact (EI). Triple-Axis Detector.

b. Turbo-molecular pump

c. EI Ion source: Noncoated inert EI source or equivalent

d. Mass Filter Quadrupole or equivalent

e. Minimum Mass 1.6u or less

f. Maximun Mass: 1050u or more

g. IDP3 Oil Free Scroll Pump

4. Computer/Software

a. GC/MS MassHunter Acquisition with both MassHunter and classic

ChemStation Data Analysis

b. Must have built-in LAN communication

c. Must provide for automatic tuning

d. Must provide synchronous SIM/Scan and AutoSIM to convert any full scan method to a high sensitivity SIM or SIM/Scan method and to enable to acquire both SIM and Scan data in a single run.

e. Must allow for semiquant estimates of concentration of uncalibrated compounds that may be of potential importance.

f. Must allow data reprocessing while new data are being collected

g. Must provide enhanced data analysis and tools for qualitative analysis capabilities

h. Latest NIST MS Library Bundle includes 243k spectra with names, chemical structures, and retention indices. NIST search and AMDIS programs.

i. Compatible with Agilent Chemstation software in order to exchange methods and libraries with existing GC/FID and GC/MS equipment.

5. Other:

a. Laser Printer or better

b. Computer with Windows and flat monitor

c. Installation qualification

d. Output Qualification

e. Performance Validation

f. Ship-to Country: United states

g. On-site familiarization training at Installation

h. 1 Year warranty Gas Chromatograph

6. Hydrogen Generator:

a. 3PP Green Path: PEAK Precision H2 Trace 500cc (100-230v)

In addition to the above, the following specifications shall also be met:

The appropriate software and new instrument capabilities for sequencing must allow methods to be transferred from one similar system to another, and

EI SIM IDL

(Helium carrier gas with Auto

Liquid Sampler)

Demonstrated at

Install with

Autosampler

1.5 fg or less for Inert Extractor

EI source, Turbo Pump

8 sequential 1 μL injections of

100 fg/μL OFN standard solution at nominal 272 u ion.

Demonstrated at install when sold with a Liquid Autosampler

Sensitivity is critical to meeting and/or exceeding analysis requirements especially for low detection level. SIM using Auto Liquid

Sampler is commonly used for Target analysis in wider

GC/MSD application.

Unlike the Signal-to-noise of single injection, Instrument

Detection Limit (IDL) calculated from sequential 8 injections using Auto

Liquid Sampler (ALS) represents the performance of detection of the entire ALS-GC/MSD system.

High sensitivity allows for streamlining workflow operations, injecting less sample and obtaining comparable results to previous systems, while also increase consumables life, decreasing maintenance cost and preparing less sample.

Mass and Spectral

Accuracy (With optional Accurate

Mass Package)

Mass Accuracy – 1 µL injection of

100 pg/µL OFN, scanning from

50 to 300 u, will give its monoisotope at m/z 272.987 ±

0.005

Spectral Accuracy - 1 µL injection of 100 pg/µL OFN, scanning from 50 – 300 u, spectral accuracy will be 99.0%

Nominal mass data may sometimes be inadequate to identify or confirm a compound, necessitating a measurement with increased mass and spectral accuracy.

MassWorks Accurate

Mass software takes advantage of the ultra-high precision and stability of

Agilent 5977A’s proprietary and uniquely designed gold plated, monolithic, hyperbolic quartz quadrupole to calibrate the MSD to achieve the required level of accuracy and stability.

Detector Type The Mass Spectrometer’s detector shall be a Series II

Triple-Axis HED-EM, which places the HED-EM doubly off-axis from the axis of the transmission quadrupole.

This design increases sensitivity because it allows ion collection to be maximized

(increased signal) and neutral noise to be reduced below off-axis detector designs.

Gain

Normalization

Autotune

The Mass Spectrometer must have a Gain Normalized

Autotune which optimizes the

EM’s gain to ensures the optimal balance between ion count, linearity and EM life expectancy.

Gain Normalization provides consistent sensitivity during the aging of the EM and consistent ion counts between multiple

GC/MSD systems

Inert ion source The mass spectrometer must use an ion source where the metallic parts are constructed from inert material. Ion Source temp controllable from 100 – 350 degrees C. Stainless steel is NOT acceptable nor is coating the metallic parts with an inert material.

An inert ion source requires less cleaning and provides greater spectral integrity by eliminating surface activity reactions. An inert ion source more effectively resists active compounds sticking to the source.

Because abrasive cleaning will be periodically required a solid inert source will not have its inert surface worn away as can happen with a coated surface.

Directly heated and bakable monolithic quartz structure, hyperbolic form quadrupole

Mass Spectrometer must utilize a

Quadrupole Mass Filter consisting of a monolithic quartz structure.

A quadrupole consisting of 4 separate rods is NOT acceptable.

The rods must have a true hyperbolic shape in keeping with quadrupole theory. The

Quadrupole is to be is independently heated and its temperature is to be user-selectable from 100 – 200˚C.

The quadrupole mass filter is the heart of the instrument. The monolithic structure is important because individual rods can become mis-aligned and are less reliable data. Quartz provides excellent thermal stability and reduces thermal expansion to maintain excellent performance. True hyperbolic shaped quadrupole rods ensure lower field errors and provide the best possible ion transmission while maintaining resolution across the full mass range.

Heating of the quadrupole by independent temperature control keeps the system clean and stable, and reduces thermal variation of the quadrupole.

Heating to 200C allows robust operation and bake out.

Gold and titanium multilayer metalized hyperbolic electrode surfaces.

The quadrupole is to have its electrode surfaces covered by titanium composite and gold thin and thick films.

Gold conductors have excellent electrical conductivity without the undesirable oxidation typical of metal quadrupole rods. These properties reduce the need for cleaning.

Retention Time-

Locking software

The mass spectrometer data system must have an integrated retention time-locking module for analyzing target compounds in complex matrices. The software module must provide the creation of custom compound databases as well as the utilization of vendor provided databases. Vendor databases include: pesticides and endocrine disruptors, PCB’s, VOC’s, Fatty

Acid Methyl Esters, Drugs of

Abuse, and Flavors and

Fragrances.

Retention Time-

Locking allows analyst to get the same retention times from day to day and from instrument to instrument in any location regardless of operator, detector type or column maintenance.

Sequence actions Tuning MS, Sleep/Wake etc.. are available as the actions of

Sequence.

Availability of these actions ensure the data quality by calibrating MS with tuning, power saving by Sleep and so on for more productivity.

Sleep/Wake mode

(GC and MSD)

The Gas Chromatograph must have clock time programmability to allow a user to have the instrument come on at a specified time, and be at operating temperature and stable when use is required. This will also allow the user to program automated shutdown

Clock time programming will allow power and gas savings by automatically putting the instrument in a

“sleep” mode, which uses minimal power and gas flow rates. It times. An example of using this feature: Friday – 6:45 p.m. shut down system, Monday 6:30 a.m.

bring system back on line.

Sleep/Wake mode should also be available on MSD for power saving. When GC goes to Sleep

Mode, MSD is also goes to power saving mode for reduction of electric power consumption.

will also save operator time by having the instrument at full readiness when the user arrives for work in the morning.

Retention Time Performance, Peak Area Performance

GC must have a specification published for retention time repeatability of <0.008 % or <0.0008 minutes*

GC must have a specification published for area repeatability of

<0.5% RSD*

* 2 ng Tetradecane, using 8890 GC, Splitless inlet, ALS injector, and Agilent Data System

Precise retention time and area reproducibility are the basis for all qualitative and quantitative chromatographic measurements

EPC microchannel design

All GC pneumatics for inlets, detectors and auxiliary modules must have a pneumatics design based on microchannels that serves as a restrictor for pneumatic control instead of using a frit.

This microchannel-based design protects against gas contaminants such as particulates, water, and oils, and provides significant improvements in reliability and longevity over earlier generation GC designs using frits for restrictors from Agilent or other GC manufacturers.

Touchscreen User Interface on GC

Touchscreen user interface must utilize capacitive touchscreen technology with glass interface/overlay

Capacitive touchscreen technology provides superior responsiveness and finer resolution than resistive touchscreen technology. Glass overlay offers superior resistance to laboratory environment impact

Touchscreen User Interface on GC

GC must never require a stylus to perform touchscreen functions

Additional user interface components may hinder timely access if lost or misplaced.

Diagnostics

GC must be able to perform no less than 5 inlet diagnostic procedures without a need to cap-off septum purge or split vent lines:

- Leak and Restriction Test

- Pressure Decay Test

- Split Vent Restriction Test

- Gas Supply Pressure Check

- Septum Purge Flow Test

The ability to perform inlet diagnostics tests “hands-free” without needing to cap-off lines makes it easy to diagnose leaks to help avoid retention time variability, changing detector response, high background and bad peak shape.

Diagnostics

GC must be able to perform the following diagnostic procedures without a need to cap-off septum purge or split vent lines, as well as be able to autonomously configure these tests into method, sequence or instrument settings:

- Pre-run flow test to verify the total flow against the calculated column flow

- Periodic split vent restriction test to execute a split vent restriction test after every 100 runs

- Pre Sequence Tank Pressure Check to determine, via a browser, the maximum inlet pressure required to execute the sequence

The ability to perform diagnostic tests autonomously ensures that the GC system is ready to run and reduces the possibility that you’ll lose data because of empty tanks or clogged split vent traps.

This helps avoid retention time variability, changing detector response, high background and bad peak shape.

Automated Self- Testing

GC must perform, automated self-monitoring of over 20 GC and ALS parameters. If failure occurs, GC must provide an indication to user and record in the appropriate log

Automated self-monitoring alerts of a wide range of parameters that alerts the user to internal system failures to speed diagnoses to minimize downtime

Early Maintenance Feedback (EMF) Counters

For EMF counters, must be able to differentiate between injections on front and back inlets, and only increment counters associated with the configured injection flow path

Counting injections specific to flowpath maximizes effectiveness of EMFs by eliminating unnecessary consumable replacements.

Early Maintenance Feedback (EMF) Counters

For EMF counters, must be able to differentiate between injections onto columns for configured flowpath vs.

overall oven cycle

Distinguishing between actual injections onto columns vs the number of oven cycle runs provides more accurate column usage/lifetime information

Early Maintenance Feedback (EMF) Counters

For EMF counters, must have over 45 total counters available for tracking various inlet, detector and ALS parameters and consumables usage

Tracking inlet and detector components and consumables usage can help users plan to change these items before they fail and cause unplanned downtime or poor operating results

Designs for Use of Hydrogen Carrier Gas

GC firmware must be able to determine that if a hydrogen carrier gas set point is not attained within a specific period of time, then the GC will alert the user via an audible alarm. The alarm will intermittently sound for a short period of time. If the set point is still not reached, then the GC will shut down the EPC module, shut off the zone heaters and shut off the oven heater.

Not achieving carrier gas setpoints may be the symptom of a leak in the system. EPC shut down prevents loss or buildup of carrier gas.

Designs for Use of Hydrogen Carrier Gas

GC firmware must be able to determine that if a hydrogen carrier gas set point is not attained within a specific period of time, then the GC will alert the user via an audible alarm. The alarm will intermittently sound for a short period of time. If the set point is still not reached, then the GC will shut down the EPC module, shut off the zone heaters and shut off the oven heater.

Not achieving carrier gas setpoints may be the symptom of a leak in the system. EPC shut down prevents loss or buildup of carrier gas.

Designs for Use of Hydrogen Carrier Gas

The GC will be designed such that, if there is an explosion in the oven for any reason, the GC oven door to buckle under the explosive pressure and other GC components are designed to not come off instrument and strike a user.

Assists in safely releasing the oven pressure from the oven cavity.

Ambient temperature and pressure compensation

The Gas Chromatograph must have ambient temperature and pressure compensation for all pneumatics for all inlets, detectors and auxiliary pneumatics.

This compensation ensures stable retention times, area reproducibility and detector baselines regardless of changing ambient conditions

SSL/EPC Pressure Programming Rate

SSL EPC inlet is capable to program either up or down at a rate of up to 1034 kpa/min or 150 psig/min and no additional accessory is needed.

A fast programming rate enables fast changes from one pressure setpoint to another

Inlet maintenance

SSL

Inlet sealing system is built in standard with each S/SL inlet for quick, easy, injector liner changes in under 30 seconds.

Fast, easy inlet maintenance helps minimize instrument downtime

Factory programmed column information keys

The GC must be able to read and provide information of up to six GC columns that have an optional associated key programmed at the factory contains GC column information and will track items including:

- Part and serial numbers

- # Injections/runs

- Time at/above temperature limits

- Production date

- Date initially installed

- Temperature limits of GC columns

- Serial number of last GC installed in

A column key can:

- Reduce possible errors of manual input of method parameters

- Optimized maintenance schedules with usage tracking

- Better data quality as the system is aware of the configuration, Ease-of use

- Ability to better plan preventive maintenance before issues occur

3. Deliverables and Delivery Schedule:

Deliverables shall be delivered to the following addresses in the number listed:

Savannah Laboratory - Qty 5 GC/MS with accessories and Qty 7 Hydrogen Generators

U.S. Customs and Border Protection

1425 Chatham Parkway

Savannah, GA 31405

Springfield Laboratory - Qty 3 GC/MS with accessories and Qty 3 Hydrogen Generators

7501 Boston Blvd

Springfield, VA 22153

Houston Laboratory - Qty 4 GC/MS with accessories and Qty 4 Hydrogen Generators

4150 Interwood South Parkway

Houston, TX 77032

San Francisco Laboratory - Qty 1 GC/MS with accessories and Qty 3 Hydrogen

Generators

U.S. Customs and Border Protection

630 Sansome Street, Room 1450

San Francisco, CA 94111

The delivery of the instruments shall include inside delivery with lift gate as necessary to the addresses listed above.

4. Government-Furnished Equipment and Information:

Each specific delivery location will furnish the gases, cylinder regulators, power, and bench top requirements for installation. The vendor will provide a list of all installation requirements at the time the order is placed.

5. Vendor-Furnished Items and Responsibilities:

The vendor shall provide all necessary parts and tools to complete the installation of the GC/MS systems. The vendor shall install the instrumentation in such a way that all of the components listed in this Statement of Work function together as a turnkey system. This means there will be no hardware or software modifications required by the analyst for complete functionality of the individual components.

6. Period of Performance:

Installation and training will take place within 90 days after delivery is completed at each location. The Delivery Locations will evaluate the instrumentation over the first 30 days, after the completion of installation and training, to determine that it is capable of meeting all of the requirements outlined in this Statement of Work. If it is not, the vendor will fix the deficiencies within the next 30 days, or the instrumentation will be returned for a full refund.

7. Security;

Performance under this SOW does not require a security clearance. However, during the course of the service, the Vendor shall not use, disclose, or reproduce any data other than as required in the performance of this order.