Liquid Particle counter

Trade Agreement: NAFTA/AIT/Canada-Peru FTA/Canada-Colombia FTA Tendering Procedures: Generally only one firm has been invited to bid Attachment: None Non-Competitive Procurement Strategy: Exclusive Rights Comprehensive Land Claim Agreement: No Vendor Name and Address: VIRO MART LTD PO Box 1455 Burlington Ontario Canada L7R4L9 Nature of Requirements: Liquid Particle counter HIAC 9703 +

Public Works and Government Services Canada intends to negociate with Viro-Mart Ltd. , located in Burlington on behalf of its client, Health Canada, for the purchase of a Liquid particule counter HIAC 9703 + with PharmSpec 3.X software.

Minimum requirements

- The laboratory has a need to be able to analyze very small as well as large quantities of particles in various dosage forms or in natural health products, in a very short term. The mandate of the laboratory is to respond to emergencies that may arise with various kinds of products. The device must be able to detect a wide range of particles (from 0.5 microns to 600 microns) that may be present in any health products subject to an investigation or a compliance verification.

The instrument is the only one that would allow us to reach these requirements as well as the ability to analyze products that could contain as much as 18,000 particles per ml of product.

- It must be designed to be installed in a laminar flow cabinet which is required in Health Canada methods.

- The instrument must have a software built to comply with the latest versions of pharmacopoeias and conforms to the 21CFR Part II Standard in terms of traceabilities. The software must provide documentation about the data collected in a report that can not be changed by the user and that has an audit trail.

- The instrument must be programmed to allow analysis compliant to international standard such as USP, EP, KP and JP pharmacopeias.

- The instrument must have a sensor that allows to meet the specifications of the USP which is specific to the analysis of particules in pharmaceutical products.

- The instrument must operate with a software including procedures for the volume accuracy test, for environmental controls such as glassware blank and for the analysis of small volume injections and large volume injection (SVI and LVI).

- The instrument must not allow any external particulate contamination into the product.

To the knowledge of Health Canada, Viro-Mart Ltd. is the only enterprise that provide a liquid particule counter with the required functionalities and specifications above.

Section 6 (d) of the Government Contracts Regulations applies in this case, because only one person or organization is capable of performing the contract. The article 1016.2(b) of NAFTA is applicable on the basis of limited tendering due to reasons 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.

The above reasons can also be found in Annex 4.4 in Articles 506.12(a) of AIT.

All the deliverables must be received on or before March 29, 2013.

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.