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: m••••••••@•••••.••.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.