Micro Balance

Trade Agreement: Canadian Free Trade Agreement (CFTA) Tendering Procedures: Generally only one firm has been invited to bid Competitive Procurement Strategy: Lowest/Lower Bid Comprehensive Land Claim Agreement: No Nature of Requirements:

Micro Balance

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 The Department of Health Canada has a requirement for the supply of 1 ultra-microbalance to be delivered and installed at the Health Products Laboratory Toronto (HPLT). The ultra-microbalance must be in accordance with international standards including USP General Chapter Balances (United States Pharmacopeia) and GEON guideline PA/PH/OMCL (12) 77 R11 Qualification of Equipment Annex 8: Qualification of Balance (General European Official Medicines Control Laboratories Network). The ultra-microbalance will be installed on a marble slab for stability and must have a small footprint as limited space is available. Any increase in the balance’s size will have a direct negative impact on the usability by the laboratory. The ultra-microbalance will also be required to be used in a Class II or Class III biosafety cabinet in the future and a small footprint is crucial.

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 ultra-microbalance meets the following requirements:

1.1 The Contractor must supply and install the ultra-microbalance at the Health Products Laboratory Toronto. 1.2 The Contractor must conduct installation qualification / operational qualification (IQ/OQ) to demonstrate that the equipment as installed complies fully with the requirements of United States Pharmacopeia Balances. 1.3 The Contractor must provide calibration certificates that comply with ISO/IEC 17025:2017 and United States Pharmacopeia Balances. 1.4 Trained technical personnel must be available for technical assistance services in English. 1.5 The Contractor must provide a two (2) year service plan including repairs as needed and full annual on-site preventative maintenance and calibration (with calibration certificates that comply with ISO/IEC 17025:2017 and United States Pharmacopeia Balances). 1.7 The Contractor must provide a minimum one (1) year warranty covering all components of the equipment. 1.8 The equipment offered, including all internal components, must be new. No old instrument, demonstrator model, or refurbished parts will be accepted.

Operational Parameters 2.1 The balance must have a readability of 0.0001 mg or less. 2.2 The balance must have a maximum weighing capacity of 2.1g or greater. 2.3 The balance must have a repeatability of 0.00015mg or less. 2.4 The balance must have a minimum weight of 0.3 mg or less, determined as per USP requirements at 5% load and with a tolerance of 0.1%. 2.5 The balance must have a stabilization time of 10 seconds or less.

Dimensions 3.1 The balance, including power supply, must have the following maximum dimensions: Height 180 mm, Width 123 mm, Depth 356 mm. 3.2 The weighing pan must be at least 16 mm in diameter.

Features 4.1 The balance must support hands-free operation, including automatic opening of the draft shields, without the installation of further accessories. 4.2 The balance must have the ability to check and adjust its calibration automatically using a built-in weight. 4.3 The balance must have the ability to program a schedule for automatic calibration checks. 4.4 The balance must have a visual indicator that tells the user when it is leveled and ready for weighing. 4.5 The balance’s draft doors must be removable to allow for cleaning. 4.6 The balance’s built-in user interface must support customizable profiles that allow tolerances and other operating parameters to be configured and selected for different applications. 4.7 The balance must give a visual warning when the weight of the sample exceeds the balance’s capacity, in order to prevent possible damage. 4.8 The balance must give a visual warning when the weight of the sample is below the minimum weight, in order to ensure that results are in compliance with USP requirements. 4.9 The balance must allow users to reposition the control panel according to weighing needs, including the option to place the control panel outside when the balance is installed within a biosafety cabinet in order to prevent cross-contamination. 4.10 The balance must have a tray to catch spilled sample material, and the tray must be removable for cleaning.

4. Applicability of the trade agreement(s) to the procurement This procurement is subject to the following trade agreement o Canadian Free Trade Agreement (CFTA)

5. Justification for the Pre-Identified Supplier Mettler-Toledo been identified as the only company capable of delivering an ultra-microbalance that meets the operational requirements of the USP standards within the size constraints of the laboratory.

6. 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.

7. Exclusions and/or Limited Tendering Reasons The following exclusion(s) and/or limited tendering reasons are invoked under the Canadian Free Trade Agreement (CFTA) - Article(s) 513 (b)(iii)

8. Ownership of Intellectual Property Ownership of any Foreground Intellectual Property arising out of the proposed contract will vest in the Contractor.

9. Period of the proposed contract or delivery date The ultra-microbalance must be delivered and installed before March 31, 2022.

10. Cost estimate of the proposed contract The estimated value of the contract, including option(s), is $56,809.79 (GST/HST included).

11. Name and address of the pre-identified supplier Mettler-Toledo Inc. 2915 Argentia Road, Unit 6 Mississauga, ON L5N 8G6

12. 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.

13. Closing date for a submission of a statement of capabilities The closing date and time for accepting statements of capabilities is 2:00 PM EST on January 28, 2022.

14. Inquiries and submission of statements of capabilities Inquiries and statements of capabilities are to be directed to:

Stanley Chui - Senior Supply Officer 4900 Yonge Street 10th floor Toronto, Ontario M2N 6A6 Telephone: 416-949-5388 E-mail: stanley.chui@pwgsc-tpsgc.gc.ca

Delivery Date: Above-mentioned

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

Documents may be submitted in either official language of Canada.