GC / MS triple quadripôle

Trade Agreement: WTO-AGP / CPTPP
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:
Agilent Technologies Canada Inc.
6705 Millcreek
Unit 5
Mississauga Ontario
Canada
L5N5M4
Nature of Requirements:

Triple Quadrupole GC/MS

H4004-202262/A
Weaver, Tammy
Telephone No. - (613) 484-1809 ( )
Fax No. - (613) 545-8067 ( )

Due to the impacts from the COVID-19 pandemic, you cannot submit a statement of capability by mail or fax. Only email will be accepted.

Title: Gas chromatograph with tandem mass-selective detector (GC-MS/MS)

1. Advance Contract Award Notice (ACAN) Explanation
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.
2. Requirement
Health Canada requires the supply, delivery, installation, and qualification of a gas chromatograph with tandem mass-selective detector (GC-MS/MS) at Health Products Laboratory Toronto to expand its existing capacity for the identification and quantification of trace nitrosamine impurities in pharmaceutical drug products and active pharmaceutical ingredients. The system must be fully compatible with the current 7890A-GC/7010B-MSD such that methods can be shared between the two instruments without conversion, adjustment, or additional validation. The system must also be compatible with existing 59XX-MSD single quadrupole instruments. A system from Agilent Technologies that includes a model 8890 gas chromatograph and a model 7010B triple quadrupole mass-selective detector is identified to meet all mandatory requirements.
3. Criteria for Assessment of the Statement of Capabilities

3.1 Minimum Essential Requirements:

Any interested supplier must demonstrate by way of a statement of capabilities that it meets the following requirements:

General

1.1 GC-MS/MS system capabilities

1.1.1 The whole required system must include a gas chromatograph and a triple quadrupole mass spectrometer system. The GC-MS/MS system must allow users to perform MRM (multiple reaction monitoring) for quantification and identification in a single injection for the determination of compounds in the nitrosamine family in health product matrices including active pharmaceutical ingredients and finished pharmaceutical products. All of these must be achieved in electron ionization mode with fast (800 transitions/sec) data acquisition speed. The GC-MS/MS must support, deliver and enable MRM analysis with fast (0.5ms) dwell times to perform functions of differentiating isomers and separating analytes of interest from interferences.

1.1.2 The GC-MS/MS must have complete compatibility to run methods developed and validated for the existing 7890A-GC/7010B-MSD already in use at Health Products Laboratory Toronto without method translation, conversion, adjustment, or additional validation and while achieving the same sensitivity and dynamic range.

1.1.3 Methods developed and validated for the GC-MS/MS must be compatible to run on the existing 7890A-GC/7010B-MSD already in use at Health Products Laboratory Toronto without method translation, conversion, adjustment, or additional validation.

1.1.4 The GC-MS/MS must have complete compatibility to run methods developed for GC-MS (single quadrupole) instruments with 59XX-MSD series detectors that are already in use at Health Products Laboratory Toronto without method translation, conversion, or adjustment. This includes methods using selected ion monitoring (SIM) mode and methods using scan mode.

1.1.5 The software that comes with the GC-MS/MS must provide the functionality to directly access and analyse historic archived 7890A-GC/7010B-MSD, 7890A-GC/7000C-MSD, and GC/59XX-MSD raw data files at Health Products Laboratory Toronto.

1.2 Mass Spectrometer (MS) must meet all of the following mandatory technical requirements:

1.2.1 MS type must be Triple Quadrupole;

1.2.2 Mode of operation must be Electron Ionization (EI);

1.2.3 Must have dual filaments for EI;

1.2.4 Ion source must be non-coated and inert;

1.2.5 Ion source temperature range must be from 150 to 350 degrees C;

1.2.6 Electron energy range must be from 10 to 300 eV;

1.2.7 Must have two mass filters of monolithic hyperbolic gold-coated quadrupole;

1.2.8 Mass range must be m/z 10 to 1,050;

1.2.9 Mass axis stability must be 222, 100 msec dwell time;

1.2.22 For EI MRM must meet 600:1 RMS S/N or more for 1 uL of 2 fg/uL of OFN at transition m/z 272--> 222; and

1.2.23 Must be capable of automated in-situ method-controlled cleaning of the ion source using hydrogen flow, without venting the mass spectrometer, both concurrently with sample acquisition and as an independent cleaning action.

1.3. The automatic liquid autosampler and gas chromatograph must meet all of the following mandatory technical requirements:

1.3.1 The gas chromatograph must have electronic pneumatic controls that can control pressure to 0.001 psi and can correct for temperature with a specified temperature coefficient of 0.001 psi/degree C;

1.3.2 The gas chromatograph must have blackflush technology;

1.3.3 The gas chromatograph must have a multimode inlet; and

1.3.4 The autosampler must allow for 150 vial capacity and 16 sample turret.

1.4. Software

1.4.1 Software for data handling (quantitative and qualitative) and reporting of trace contaminants must be provided; and

1.4.2 The software licence must allow remote off-line manipulation of data on another workstation connected via the network.

1.5. Warranty

1.5.1 A minimum one (1) year full system (mass spectrometer, gas chromatograph, data system, etc.) warranty must be provided.

1.6. Qualification

1.6.1 Installation qualification and operational qualification service, demonstrating that the system fully meets its technical specifications after delivery and installation, must be provided.

1.7. Training

1.7.1 A minimum of four (4) days of full-time on-site familiarization training for five (5) Health Canada trainees must be provided.

4. Applicability of Trade Agreements
The requirement is subject to the following Trade Agreements:

Canadian Free Trade Agreement (CFTA),
World Trade Organization - Agreement on Government Procurement,
Canada-Europe Union Comprehensive Economic and trade Agreement (CETA),
Canada-Korea Free Trade Agreement (CKFTA)
Canada-Chile Free Trade Agreement
Canada-Columbia Free Trade Agreement
Canada-Panama Free Trade Agreement
Canada-Honduras Free Trade Agreement
Canada-Peru Free Trade Agreement
Canada-Ukraine Free Trade Agreement
Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)

5. Justification for the Pre-Identified
Supplier Agilent Technologies is the only supplier that can supply a system meeting all the technical requirements and has the exclusive rights for the 8890-GC/7010B-MSD.
6. Government Contracts Regulations Exception
The following exception to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) - "Only one person or firm is capable of performing the contract."
7. Exclusions and/or Limited Tendering Reasons
The following exclusion(s) and/or limited tendering reasons are excluded under the section of the trade agreement(s) specified:
World Trade Organization Agreement on Government Procurement (WTO-AGP) - Article XV, (1b) 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;
Canadian Free Trade Agreement (CFTA) - Article 513, 1b(iii) where the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist due to an absence of competition for technical reasons;
Canada-Korea Free Trade Agreement (CKFTA) - Article 16.10b (iii) the procurement can be carried out only by a particular supplier and a reasonable alternative or substitute does not exist because of the absence of competition for technical reasons;
Canada-Chile Free Trade Agreement - Article Kb-09 (1b), where, 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;
Canada-Colombia Free Trade Agreement - Article 1409 (b iii), Where the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist due to an absence of competition for technical reasons;
Canada-Panama Free Trade Agreement - Article 16.10 1b(iii) Provided that a procuring entity does not use this provision to avoid competition among suppliers, to protect domestic suppliers, or in a manner that discriminates against suppliers of the other Party, the procuring entity may contact a supplier of its choice and may choose not to apply Articles 16.06, 16.07, 16.08, 16.09 and 16.11 only under the following circumstances, if the procurement can be carried out only by a particular supplier and a reasonable alternative or substitute does not exist because of the absence of competition for technical reasons;
Canada-Honduras Free Trade Agreement - Article 17.11 2b(iii), the procuring entity may award a contract by limited tendering or other equivalent tendering procedures if a good or service being procured can be supplied only by a particular supplier and a reasonable alternative or substitute does not exist because there is an absence of competition for technical reasons;
Canada-Ukraine Free Trade Agreement - Article 10.13 1b(iii) if the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist for any of the following reasons: due to an absence of competition for technical reasons;
Comprehensive Economic and Trade Agreement (European Union) - Article 19.12 1b(iii), if the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist for any of the following reasons: due to an absence of competition for technical reasons;
Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) - Article 15.10b(iii), if the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute goods or services exist for any of the following reasons: due to an absence of competition for technical reasons.
8. Delivery Required
Delivery required: .31 March 2021

9. Cost estimate of the proposed is
$ 353,846.67 inclusive of GST/HST.

10. Name and Address of the Pre-Identified Supplier
Agilent Technologies Canada Inc.
6705 Millcreek Dr. Unit 5
Mississauga ON
L5N 5M4
Canada
11. Supplier’s right to submit a statement of capabilities
Suppliers who consider themselves fully qualified and available to provide the services and/or 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.
12. The closing date for a submission of a statement of capabilities:
The closing date and time for accepting statement of capabilities is 15 October 2020 at 2:00 p.m.
13. Inquiries and submission of statements of capabilities
Inquiries and statement of capabilities are to be directed to:
Tammy Weaver
Supply Specialist
Public Works and Government Services Canada
Acquisitions Branch

Telephone: 613-484-1809
E-mail:: T••••••••@••••••••.••.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.