Sciex QTRAP 6500+ System

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: 

Sciex QTRAP 6500+ System

H5337-164141/A
Hooper, Marlyn
Telephone No. - (613) 219-8478 (    )
Fax No. - (819) 956-3814 (    )

1. Advance Contract Award Notice (ACAN)

An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier. 

2. Definition of the requirement

Health Canada (HC) requires the supply, delivery and installation of an ultra-high performance liquid chromatography, and a hybrid triple quadrupole/linear ion trap (UHPLC-QTRAP) system to the Pest Management Regulatory Agency (PMRA) Laboratory Services Section(LSS). This requirement include 2 days on-site training for up to five (5) users and software upgrade for five (5) years.

The system must have capabilities of accurately quantifying and unambiguously identifying over 350 different pesticides and otherchemical contaminants, as well as differentiating isomers as low as 100 parts-per-trillion (ppt) concentration levels in both positive and negative modes with fast (less than 5 ms) data acquisition speed and polarity switching in a single analysis.

3. Criteria for assessment of the Statement of Capabilities  

Minimum Essential 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 System Capabilities
1.1.1. The whole required system must include an ultra-high performance liquid chromatography and a hybrid triple quadrupole/linear ion trap (UHPLC-QTRAP). The UHPLC-QTRAP system must have capabilities of performing MRM (multiple reaction monitoring) for quantification, carrying on enhanced product-ion spectral scan for identification in a single injection for the determination of pesticides and other chemical contaminants in complex samples such as plant leaves and soil. All these must be achieved at 100 parts-per-Trillion (ppt) concentration levels in both positive and negative modes with fast (5 ms) 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 amenable to MRM analysis with fast (1 ms) dwell times, in methods with polarity switching, to perform functions of differentiating isomers and separating analytes of interest from interferences in complex vegetation sample matrices. 
1.1.2. The UHPLC-QTRAP must have complete capability and compatibility to import and run the existing validated 3200QTRAP LC/MS/MS methods and compound libraries of a large number of pesticides, i.e. ~ 350, already in use in the Quality System at the PMRA Laboratory. As a part of mandatory requirements, all current UHPLC/ESI-MS/MS methods of up to 350 pesticides and libraries are required to transfer from the 3200QTRAP 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 at least one hundred (100) times in S/N on UHPLC/MS/MS methods already optimized on the 3200QTRAP  LC/MS/MS System for 90% of the 350 pesticides with an extended dynamic quantification range of three (3) orders of magnitude. It must provide the capability of combining positive and negative mode 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 increasethe method capacity. The software that comes with UHPLC-QTRAP must enable to directly access and analyse historic archived 3200QTRAP LC/MS/MS data in the Quality System at the PMRA 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 > 200,000.
1.2.5. Sensitivity MRM mode negative: Chloramphenicol 1 pg on column S/N > 80,000.
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 11 compliance; 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. Computer or Data System (DS)
Contractor must supply a complete data system (hardware and software) meeting the requirements listed below:
1.4.1. Operating environment: OptiPlex XE2 Computer with WIN 7 for Embedded Systems with Image Software and a data processing station with a total of two 27 inch monitors.
1.4.2. Software licence: software licence to allow for remote off-line manipulation of data on another workstation connected via the network.
1.5 Minimum one (1) year full system (mass spectrometer, liquid chromatograph, data system, etc.) warranty.
1.6 The contract would include the possibility to acquire an additional of two (2) identical EXION AD UHPLC and Sciex QTRAP 6500+ instrument systems within the next three (3) years (until April 2020) depending on operational needs and budgetary allocation.

4. Applicability of the trade agreement(s) to the procurement

This procurement is subject to the following trade agreement(s): 

Agreement on Internal Trade (AIT)
World Trade Organization - Agreement on Government Procurement (WTO-AGP)
North American Free Trade Agreement (NAFTA)

5. Justification for thePre-Identified Supplier

AB Sciex LP is the only known supplier that can supply equipment meeting all the technical requirements and has the exclusive rights for the EXION AD UHPLC and Sciex QTRAP 6500+ technology.

6. Exclusions and/or Limited Tendering Reasons

The following exclusions and/or limited tendering reasons are invoked under the:

World Trade Organization - Agreement on Government Procurement (WTO-AGP) - Article XV (b)
Agreement on Internal Trade (AIT) - Article 506 12(b)
North American Free Trade Agreement (NAFTA) - Article 1016.2(b)
7. Period of the proposed contract or delivery date

The equipment must be delivered on or before March 31, 2017; and

The proposed contract is for a period of 5 years, from date of Contract award.

8. Name and address of the pre-identified supplier

AB Sciex LP
71 Four Valley Dr
Concord, Ontario
L4K4V8
Canada

9. Suppliers' right to submit a statement of capabilities

Suppliers who consider themselves fully qualified and available toprovide 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 mustclearly demonstrate how the supplier meets the advertised requirements.

10. Closing date for a submission of a statement of capabilities

The closing date and time for accepting statements of capabilities is January 23, 2017 at 2:00 p.m. EST.

11. Inquiries and submission of statements of capabilities

Inquiries and statements of capabilities are to be directed to:

Marlyn Hooper
Supply Specialist
Public Services and Procurement Canada (PSPC) 
Scientific, Medical and Photographic Division- PV 
Portage III - Floor: 6A2 - Room: 48  
11 Laurier Street  
Gatineau, Quebec 
Canada
K1A 0S5
 
Telephone:    613-219-8478
Facsimile:     819-956-3814
E-mail:  marlyn.hooper@pwgsc.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.