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 <788> 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.