Systèmes d'exposition cellulaire à l'interface air-liquide

Trade Agreement: CFTA / FTAs with Peru / Colombia / Panama / Korea
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:
MedTec Biolab Inc.
600 Meadowlands Drive
Hillsborough North Carolina
United States
27278
Nature of Requirements:

Title :

Air-liquid interface cell exposure systems

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 requires three (3) air-liquid interface cell exposure systems that enable the controlled exposure of human cells to airborne contaminants that meet all the minimum essential technical requirements as specified below.

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 all of the following requirements:

-The system must establish, maintain, and monitor conditions that ensure optimal cell viability (i.e. no change in typical cell viability indicators compared to incubator controls) for extended exposures (4-6 hours) to air;
-The system must enable efficient delivery of both gases (including ozone) and particles to cells, including the potential for enhanced deposition of particles through electrostatic precipitation;
-The system must include surfaces that, where in contact with the atmosphere, are non-reactive to ozone (e.g. stainless steel, Teflon);
-The system must include onboard temperature control and onboard humidity control that does not dilute the test atmosphere;
-The system must be housed within a temperature-controlled enclosure to prevent condensation issues;
-The system must have the capacity to reduce humidity post-exposure of cells such that exhaust is at non-condensing humidity at room temperature to protect downstream equipment;
-The system must offer a horizontal flow design that facilitates independent (in-house) setup and dismantling for exposures to various test agents both in the laboratory and in the field without the intervention of the manufacturer or vendor;
-The system must be easy to clean: exposure system can be restored to as-bought level of cleaninless with less than two (2) hours of down-time, including dissasembly and re-assembly; re-commisioning must not require assistance from manufacturer or vendor and must not require replacement of routine parts during each cleaning; between exposures to the same atmosphere, no need to routinely dispose of components, tubing, etc;
-The system must have a short flowpath: test atmosphere travel distance from inlet of dry test atmosphere, through humidification and to wells less than two (2) meters; smooth bends consistent with minimal particle loss, given manufacturer’s recommended test atmosphere flowrate; internal diameter (ID) not smaller than ¼? throughout; deadspace (volume exposed to test atmosphere) less than one (1) litre;
-The system must have few non-reusable components: while test atmosphere remains the same, all components should be re-usable (barring accidental damage) for a minimum of six (6) months assuming daily exposures. When changing test atmosphere, if some components must be replaced to avoid cross-contamination, these should represent a minor investment of time (less than one (1) person-hour. If some components are altered/damaged during regular use as per manufacturer’s instructions, replacement/repair should represent only a minor investment of time (less than one (1) person-hour);
-The system must allow two (2) entire multi-well plates to be placed inside for exposure of cells simultaneously without (1st plate) and with (2nd plate) electrostatic precipitation:

• accommodates reusable, autoclavable multi-well plates, including but not limited to Snapwell (12-well format) and Millicell-CM (6-well format) inserts;
• accommodates disposable multi-well plates for standard hanging inserts (e.g. Transwells) in 6, 12, and 24 multi-well formats;
• accommodates disposable multi-well plates for the miniaturised AMES assay in 6, 12, and 24 multi-well formats;
• Plate use should eliminate handling of individual inserts when placing in system.

-The system must allow for quick change of test atmosphere: exposure system can be re-purposed (dismantled, cleaned, re-assembled) to change test atmosphere (e.g. from wet aerosol to reactive gas; from clean air to particle aerosol) with less than three (3) hours of down-time, including dissasembly and re-assembly; re-commisioning must not require assistance from manufacturer or vendor;
-The system must allow for easy change of location and operation in the field: exposure system can be re-located (dismantled, cleaned, packaged, moved to a new location via ground/air transport, re-assembled) by one(1) person in one (1) person-day; can be re-commisioned within an hour; all packages should fit inside an average-sized automobile; re-usable packaging materials supplied by the manufacturer or vendor ensure protection of components during re-location; re-location does not require special permissions, certifications or waivers (eg transportation of dangerous goods, heavy lifting, etc);
-The system must allow for temperature measurement at the well;
-The system must include real-time measurement and data acquisition of post-well relative humidity (RH) and temperature;
-The system must include RH generation and control at optimal level for cells without diluting the test atmosphere;
-The system must generate and maintain steady optimal temperature (minimum temp of 35 Celsius, maximum temp of 37.5 Celsius) and relative humidity (>75% RH) at the well throughout the exposure;
-The system must fit inside a standard 4-foot fumehood;
-The system must operate under a slight vacuum, protecting the user;
-The system must have whetted surfaces (e.g.: stainless steel, teflon, etc) appropriate for reactive gases such as ozone;
-The system must provide for particle deposition enhancement via electrostatics with unipolar charging source;
-The sytem must include means to verify test atmosphere flowrate experienced by cells;
-Exposure conditions of the system must :

• Offer exposure stability for 4 to 6 hours; any test atmosphere losses (e.g. reactivity, deposition, etc.) should be predictable/documented by the manufacturer or vendor; post-conditioning, test atmosphere must be stable during exposure;
• Not expose cells to jets;

-The system must include post-well dryer (to prevent condensation in downstream equipment);
-The system must be compatible with Labview for data acquisition, notably of temp/RH readings.

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

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

• Canadian Free Trade Agreement (CFTA)
• Canada-Chile Free Trade Agreement
• Canada-Colombia Free Trade Agreement
• Canada-Honduras Free Trade Agreement
• Canada-Korea Free Trade Agreement
• Canada-Panama Free Trade Agreement

5.Justification for the Pre-Identified Supplier

The only known supplier of air-liquid interface cell exposure that meets all the above requirements is MedTec Biolab Inc. of 600 Meadowlands Drive, Hillsborough, NC, USA. For this reason, it is proposed to negotiate this requirement with MedTec Biolab Inc.

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 following:

• Canadian Free Trade Agreement (CFTA) -Article 513.1(b) (iii)
• Canada-Chile Free Trade Agreement (CCFTA) -Article Kbis-09, para 1 (b)
• Canada-Colombia Free Trade Agreement -Article 1409 para 1 (b) (iii)
• Canada-Honduras Free Trade Agreement -Article 17.11 para 2 (b) (iii)
• Canada-Korea Free Trade Agreement -which defers to WTO-AGP Article XIII, para 1 (b) (iii)
• Canada-Panama Free Trade Agreement -Article 16.10 para 1 (b) (iii)

8.Period of the proposed contract or delivery date

The air-liquid interface cell exposure system must be delivered no later than six (6) weeks following the contract award.

9.Name and address of the pre-identified supplier

MedTec Biolab Inc.
600 Meadowlands Drive
Hillsborough, NC
27278 USA

10.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.

11.Inquiries and submission of statements of capabilities

Inquiries and statements of capabilities are to be directed to:

Name : Marie-Claire Fortin
Title : Supply Specialist
Public Services and Procurement Canada
Commercial Consumer Products Directorate
Address : 140 O’Connor Street, 7th floor
L’Esplanade Laurier (LEL), East Tower
Ottawa, Ontario K1A 0R5
Telephone : 418-571-7258
E-mail : M••••••••@••••••••.••.ca

This PWGSC office provides procurement services to the public in both official languages.
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.