Handheld Raman spectrometer

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: Interchangeable Parts Comprehensive Land Claim Agreement: No Vendor Name and Address: Pegram Technologies Inc 47 Glendonwynne rd Toronto Ontario Canada M6P3E5 Nature of Requirements: Public Works and Government Service Canada (PWGSC) intends to negociate a contract with the supplier Pegram Technologies Inc for the procurement and delivery of the TruScan RM handheld Raman spectrometer, Thermo Scientific RM TruScan, Version 2.0.1 with discovery library, TruScan IQ/OQ document version 2.0.1 (electronic version) complete with chemical kit , attachment for sampling using standard vials and attachment for sampling tablets.

These items are to be delivered to Health Canada's laboratory located in Longueuil, Province of Quebec.

Sole source and no substitute justifications

The Longueuil Laboratory analyses routinely pharmaceuticals, natural health products, fraud samples and counterfeit samples. This device will be used in Health Canada's analysis program to confirm whether a product is counterfeit or not. The laboratory also collaborates in the evaluation program of reference standards distributed by the U.S. Pharmacopeia. Raman and FTIR spectrometry are complementary techniques, one being more sensitive to excipients while the other is more sensitive to the active ingredients. The laboratory is already equipped with an FTIR spectrometer, buying a Raman spectrometer will allow us to obtain more complete data in the anlaysis of counterfeit samples.

The spectrometer and the other listed items must be purchased from Thermo Scientific Company (the manufacturer) for the following reasons: 1. In addition to analyzing counterfeit pharmaceuticals, this device can also analyze dietary supplements (considered as natural health products in Canada), active pharmaceutical ingredients , liquids or unknown powders. All these forms of samples are routinely analyzed by Health Canada's laboratory. 2. The device can store additional information with the Raman spectrum, such as images or data on the size of the samples analyzed. This feature will allow Health Canada's laboratory to collect more comprehensive information to determine whether a product is counterfeit or not. 3. The device allows the creation of three different roles for users, allowing restricted access to data modification , preventing a user from inadvertently modifying methods stored in the device. This is necessary to ensure the consistency of the results obtained from the device. 4. The device has a software allowing for the creation of robust methods of analysis and comparison of existing data with a library containing spectra of over 4000 molecules. By getting this device, the Health Canada's laboratory avoids developing its own library for these molecules. We estimate that we will save a substantial amount of money in our operations costs if we purchase this feature. 5. The software uses statistical calculations to make a more accurate and selective comparison of the recorded spectra with the spectra available in library, thus avoiding false positives. Health Canada's laboratory must be able to give reliable results for compounds analyzed for which little or no data are available. 6.To meet the GMP standards , this device is completely sealed. This ensures the validity of the results, avoiding contamination that may originate from outside the device. In addition, this device includes documentation of stored data in PDF format and an audit trail capacity. Health Canada's laboratory is itself accredited ISO 17025 , it is essential that the instrument used meets this quality standards. 7. Health Canada's laboratory has been working for several years with international groups with a mandate similar to theirs. These collaborators share databases developed for authentic pharmaceutical samples. By getting a similar device, the laboratory avoids developing its own librairies from scratch. This is yet another economy in our operations costs. 8. Health Canada's laboratory works closely with United States Pharmacopeia (USP), which has selected this instrument in their initiative to provide libraries of Raman spectra that will be sold to pharmaceutical companies. The USP distributes about 3000 reference standard of active pharmaceutical ingredients. As the Health Canada's laboratory collaborates in the assessment program of reference standards distributed by the USP, analyses will have to be done on reference standards with this device. It is therefore essential that the laboratory choose the device that is approved by the USP.

For all the above reasons, this is the only known existing system that is capable of performing this requirement.

The purpose of this Advance Contract Award Notice (ACAN) is to signal the government's intention to award a contract for these goods to:

Pegram Technologies Inc 47 Glendonwynne road Toronto, Ontario M6P 3E5

Before awarding a contract, however, the government would like to provide other suppliers with the opportunity to demonstrate that they are capable of satisfying the requirements set out in this notice, by submitting a Statement of Capabilities during the 15 calendar day posting period.

If other potential suppliers submit a Statement of capabilities during the 15 calendar day posting period that meet the requirements set out in the ACAN, the gouvernment will proceed to a full tendering process on either ther government's electronic tendering service or through traditional means, in order to award the contract.

If no other supplier submits, on or before the closing date, a Statement of Capabilites, meeting the requirements set out in the ACAN, a contract will be awarded to the pre-selected supplier.

Quantity: 1 each Delivery date: on or before March 31, 2013

Any interested supplier must demonstrate by way of a Statement of Capabilities, that its product meets the above mentioned requirements.

Justification of the Pre-selected supplier: Pegram Technologies Inc is the only supplier capable of meeting Health Canada's requirements due to logistical and compability reasons, where the introduction of a non-standard unit and /or manufacturer would cause operating difficulties, compatibility issues, maintenance problems and additional manipulation and handling costs.

The closing date and time for accepting Statements of Capabilities is:

February 7, 2013 at 14h00 EST

Inquiries and Statements of Capabilities are to be directed to

Mary Paradis Contracting officer, PWGSC Telephone: 514-496-3874 Fax: 514-496-3822 E-mail: mary.paradis@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.