Ultra-High Performance Liquid Chromatography QTRAP 6500+ System and Ion Mobility Spectrometry (UHPLC

Trade Agreement: WTO-AGP/NAFTA/AIT/Canada FTAs with Peru/Colombia/Panama
Tendering Procedures: Generally only one firm has been invited to bid
Non-Competitive Procurement Strategy: Exclusive Rights
Comprehensive Land Claim Agreement: No
Vendor Name and Address: 
AB Sciex LP
71 Four Valley Dr
Concord Ontario
Canada
L4K4V8
Nature of Requirements: 

Ultra-High Performance Liquid Chromatography QTRAP 6500+ System and Ion Mobility Spectrometry (UHPLC

39903-170344/A
Chubey, Karen
Telephone No. - (204) 291-5928
Fax No. - (204) 983-7796 
Email: karen.chubey@pwgsc-tpsgc.gc.ca

Public Works and Government Services Canada (PWGSC) on behalf of the Canada Food Inspection Agency intends to negotiate with AB Sciex LP. for the supply of one ultra-high performance liquid chromatography QTRAP 6500+and ion mobility spectrometry (UHPLC-QTRAP/IMS) which has the capabilities of quantifying and identifying a large number of pesticides and other chemical contaminants, differentiating isomers, and increasing selectivity to reduce interferences from samples in a single analysis. 

The required system includes an ultra-high performance liquid chromatography, hybrid triple quadrupole/linear ion trap and ion mobility spectrometry (UHPLC-QTRAP/IMS). The system must have capabilities of accurately quantifying and unambiguously identifying a large number of pesticides and other chemical contaminants, differentiating isomers, and increasing selectivity to reduce interferences at low parts-per-billion concentration levels in both positive and negative modes with fast data acquisition speed and polarity switching in a single analysis. A system from AB Sciex that includes EXION AD UHPLC, Sciex QTRAP 6500+, and SelexION+ Ion Mobility Spectrometry is identified to meet all mandatory requirements.

Criteria for assessment of the Statement of Capabilities 

MinimumEssential Requirements Any interested supplier must demonstrate by way of a statement of capabilities that its product meets the following requirements:

Minimum Mandatory Capabilities/Technical/Performance Criteria/Specifications

1.1. UHPLC-QTRAP/IMS System Capabilities
1.1.1. The whole required system must include an ultra-high performance liquid chromatography, a hybrid triple quadrupole/linear ion trap, and an ion mobility spectrometry (UHPLC-QTRAP/IMS). The UHPLC-QTRAP/IMS system must have capabilities of performing MRM (multiple reaction monitoring) for quantification, carrying on enhanced product-ion spectral scan for identification, and providing an orthogonal separation by IMS for differentiating isomers in a single injection for the determination of pesticides and other chemical contaminants in food. All these must be achieved at low parts-per-billion concentration levels in both positive and negative modes with fast data acquisition speed and polarity switching in a single analysis. The mass spectrometer must be able to perform MRM and enhanced product ion spectral scan simultaneously. As MRM transitions are positively detected, the data files (i.e. product ion spectra) can be directly searched against a mass spectral library to unambiguously confirm the eluted analytes by the product ion spectral scan - simultaneous to the quantification being reported in the same injection. The UHPLC-QTRAP must be able to be coupled with an ion mobility spectrometry device, which is amenable to MRM analysis with fast dwell times, in methods with polarity switching, to perform functions of differentiating isomers and separating analytes of interest from interferences in complex sample matrices. The ion mobility device must be able to be installedand removed under 5 mins to toggle between modes quickly without venting the system. 

1.1.2. The UHPLC-QTRAP must have complete capability and compatibility to import and run the existing validated API 5000 LC/MS/MS methods and compound libraries of a large number of pesticides, i.e. ~ 450, already in use in the Quality System at the Calgary Laboratory. As a part of mandatory requirements, all current UHPLC/ESI-MS/MS methods of up to 450 pesticides and libraries are required to transfer from the API5000 LC/MS/MS to UHPLC-QTRAP in less than 5 mins without retuning instrument parameters for individual pesticides while achieving the sensitivity and a dynamic range specified below.

1.1.3. UHPLC-QTRAP must deliver an increase in sensitivity of = 5 times in S/N on UHPLC/MS/MS methods already optimized on the API 5000 LC/MS/MS System for 90% of the 450 pesticides with an extended dynamic quantification range of = 3 orders of magnitude. It must provide the capability of combining positive and negativemode analysis into a single injection method with a 1 ms pause time, 1 ms dwell time and 5 ms polarity switches for a fast data acquisition to increase the method capacity. The software that comes with UHPLC-QTRAP must enable to directly access and analyse historic archived API 5000 LC/MS/MS data in the Quality System at the Calgary Laboratory.

1.2. Mass Spectrometer
1.2.1. MS type: hybrid triple quadrupole/linear ion trap LC/MS/MS mass spectrometer.

1.2.2. Supplied with electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI). The instrument ionization source housing must have a source housing hosting interchangeable APCI (Atmospheric Pressure Chemical Ionization) probe and ESI probes. Each probe will be coded for automatic identification by the software/firmware of the host system.

1.2.3. The source must have flow rates compatibility from 5 to 3000 µL/min, without flow splitting for ESI and 200 to 3000 µL /min for APCI.

1.2.4. Sensitivity MRM mode -positive: Reserpine 1 pg on column S/N > 510,000.

1.2.5. Sensitivity MRM mode -negative: Chloramphenicol 1 pg on column S/N > 180,000.

1.2.6. Triple quad scan speed: 12,000 Da/sec.

1.2.7. Linear ion trap scan speed: 20,000 Da/sec.

1.2.8. Polarity switching time: 5 msec, in MRM and Scheduled MRM (sMRM) modes.

1.2.9. Minimum MRM dwell time: 1 msec.

1.2.10. Triple quad mass range: (m/z) 5-2000.

1.2.11. Linear ion trap mass range: (m/z) 50-2000.

1.2.12. Triple quadrupole mass stability: 0.1 Da over 24 hours.

1.2.13. Scan types: Full scan MS and selected ion for both Q1 and Q3, product ion scan, multiple reaction monitoring (MRM), Scheduled MRM (sMRM), enhanced MS scan, enhanced product ion scan, enhanced resolution scan, MS3 scan, MRM3 scan,and TripleTrap scan modes.

1.2.14. Sensitivity EPI (enhanced product ion scan) mode: Reserpine 50 fg on column 1000 µL/min, 150-650 Da at 10,000 Da/sec, sum of product ions 195 and 174, S/N > 200 and C.V. < 5%.

1.2.15. Sensitivity MRM3 mode: Reserpine 50 fg on column 1000 µL/min, MRM3 of 609.3/397/365 with 200 msec cycle time, S/N >150 and C.V. < 5%.

1.2.16. Dynamic range: 6 orders of magnitude from LOD.

1.2.17. Software: Analyst Software v1.6.3 contains technical support for 21 CFR Part 11compliance; includes Scheduled MRM Pro Algorithm.

1.3. Ultra-high Performance Liquid Chromatograph
The system must be configured with the following specifications.
1.3.1. LC pump
1.3.1.1. Pump type: Micro volume double plunger pump (approx.. 10 µL/stroke).

1.3.1.2. Flow rate range: 0.0001 to 3 mL /min (10-1300 bar).

1.3.1.3. Flow rate accuracy: ±1% or ±2 µL, whichever is greater (0.01 to 3 mL /min).

1.3.1.4. Flow rate precision: ±0.06%RSD or 0.02 min. SD, whichever is larger

1.3.1.5.High pressure gradient system: Accommodate at least 2 solvents during a gradient run of step and linear gradient at multiple levels.

1.3.1.6. Pressure setting range: 10-1300 bar (1 bar steps)

1.3.1.7. Pressure accuracy: ±10% or 15 bar, whichever is greater 

1.3.1.8. High pressure gradient system: Mix ratio setting range, 0-100% (in 0.1% steps); Concentration accuracy, ±0.5% (at 0.5-3 mL/min); Flow rates possible, 0.0001 to 5 mL /min. 

1.3.2. Autosampler
1.3.2.1. Injection method: Variable injection volume flow through design.

1.3.2.2. Injection volume setting range: 0.1 to 50 µL ( 0.1 to 0.9 µL in 0.1 µL increments, 1 to 50 µL in 1 µL increments )

1.3.2.3. Sample capacity: 105 vials with 1.5 mL each. 

1.3.2.4. Injection volume precision: RSD = 0.25% (at 5 µL injection)

1.3.2.5. Injection volume accuracy: ±1% (50 µL, n = 10) max

1.3.2.6. Carryover: 0.0015% max (under specified conditions)

1.3.2.7. Sample aspiration rate: 0.1 to 15 µL /sec (0.1 µL /sec increments)

1.3.2.8. Rinse aspiration rate Variable: 1 to 35 µL/sec, (0.1 µL /sec increments)

1.3.2.9. Maximum allowable pressure: 1300 bar

1.3.2.10. Injection cycle time: 14 seconds minimum (under specified conditions)

1.3.2.11. Sample cooling system: Direct cooling system (environment conditions: room temperature below 30°C or lower and humidity 70% or less with cooler set to 4°C), dehumidification function included

1.3.2.12. Cooling range settings: 4 to 40°C (under specified conditions)

1.3.2.13. Temperature accuracy: ±3°C.

1.3.3. Column oven
1.3.3.1. Heating method: Block heating system

1.3.3.2. Temperature control range: ( Room temperature +5°C ) to 150°C

1.3.3.3. Temperature setting range: 4°C to 150°C ( in steps of 1°C )

1.3.3.4. Temperature control precision: ±0.05°C

1.3.3.5. Ambient temperature range: 4°C to 35°C

1.3.4. Column switch: 2 column or 6 position 7 port valve, 1300 bar pressure max.

1.3.5. Any other items, including hardware and software not explicitly stated, required for the system to be qualified as per protocols stipulated by the contractor and accompanying documentation thereof.

1.4. Ion Mobility Spectrometry
1.4.1. Ion mobility spectrometry device must be included in system - field upgrade enabled.

1.4.2. Must be installed and removed without breaking vacuum.

1.4.3. Must enable the introduction of chemical modifier in gas form that adds a new dimension to selectivity and dramatically increases separation capacity.

1.4.4. Must have a software controlled transparent mode which provides the capability to create a queue of multiple methods where the ion mobility is active and inactive within the same batch.

1.5. Computer or Data System (DS)
Contractor must supply a complete data system (hardware and software) meeting the requirements listed below:
1.5.1. Operating environment: OptiPlex XE2 Computer with WIN 7 for Embedded Systems with Image Software and a data processing station with a total of three 27 inch monitors.

1.5.2. Software licence: software licence to allow for remote off-line manipulation of data on another workstation connected via the network.

1.6 Minimum one (1) year full system (mass spectrometer, liquid chromatograph, data system, etc.) warranty

Justification for the Pre-Identified Supplier 
AB Sciex LP is the only known supplier that can supply equipment meeting all the technical requirements.

Government Contracts Regulations Exception(s) 

The following exception(s) to the Government Contracts Regulations is (are) invoked for this procurement under subsection 6(d) - "only one person is capable of performing the work". 
Exclusions and/or Limited Tendering Reasons 

The following exclusion(s) and/or limited tendering reasons are invoked: 
•  Agreement on Internal Trade (AIT) - Article 506-12(b) there is an absence of competition for technical reasons and the goods or services can be supplied only by a particular supplier and no alternative or substitute exists, respectively.
•  North American FreeTrade Agreement (NAFTA) - Article(s) 1016.2(b) for works of art, or for reasons connected with the protection of patents, copyrights or other exclusive rights, or proprietary information or where there is an absence of competition for technical reasons,the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists.
•  World Trade Organization Agreement on Government Procurement (WTO-AGP), Article XV(b) when, for works of art or for reasons connected with protection of exclusive rights, such as patents or copyrights, or in the absence of competition for technical reasons, the products or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists;

Period of the proposed contract or delivery date   Delivery is requested by November 30 2016.

The estimated value of the contract, including option(s), is $585,000 - $595,000 (GST/HST included). 

Name and address of the pre-identified supplier 
AB Sciex LP.
71 Four Valley Drive
Concord, ON   L4K 4V8

Suppliers' right to submit a statement of capabilities 

Suppliers who consider themselves fully qualified and available to provide the goods, services or construction services described in the ACAN may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

Closing date for a submission of a statement of capabilities 

The closing date and time for accepting statements of capabilities is September 21, 2016 at 2:00 p.m. CDT. 

Inquiries and statements of capabilities are to be directed to: 

Karen Chubey
Procurement Specialist 
Telephone: 204-291-5928
Facsimile:   204-983-7796
E-mail: karen.chubey@pwgsc-tpsgc.gc.ca


Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award.  However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.