Cerulean SM410-CV Smoking Instrument
Added: Jan 31, 2016 8:23 pm The Centers for Disease Control and Prevention (CDC), National Center for Environmental Health, Division of Laboratory Sciences intends to award a sole source firm-fixed price equipment purchase contract to Cerulean Corporation 1470 East Parham Road Richmond, VA 23228. This contract will be for 90 days from time of award.The statutory authority for this sole source acquisition is 10 U.S.C. 2304 (c) (1) in accordance with FAR Part 6.302-1- only one responsible source and no other supplies or services will satisfy the agency requirement.The Cerulean SM410- CV (Cigar) smoking instrument is the only currently commercially available smoking machine designed specifically for smoking cigars which have been used in CORESTA collaborative studies. Whereas competitive 10-port smoking machines are all designed for cigarettes and require conversion kits that are of yet unproven in CORESTA collaborative studies on cigars. The Cerulean SM410-CV has a bespoke software dedicated to smoking cigars that enables the smoking machine to automatically determine the puff volume based on the cigar diameters as per the CORESTA method#64. The Tobacco Volatiles Laboratory has this specific operational platform (Cerulean SM41O\SM450) used across different programs within the laboratory providing the robustness, sensitivity and repeatability needed for the analysis requirements. Changing to another platform can induce differences or bias in the data of ongoing projects impacting possible interpretation of the results.No other vendor's produce 10 port cigar smoking instrument with the required specifications. In particular, TVB is an A2LA ISO Accredited Laboratory. With that status, smoking instrumentation purchased has to have a GxP Compliance Package. This package demonstrates that the manufacturer has meet the Design, Installation and Operational Qualifications designed to comply with ISO 3308 and with FDA 21 CFR part 11 requirements. The acquisition of instruments which many of our CDC Scientists are trained on with methods developed for is crucial or a key factor to meeting the time constraints for the deliverables of our CDC/FDA Cooperative agreement. Purchasing other smoking instrumentation not only would fail to meet the required specifications but would also require repeating method development activities due to other vendors not having the proper certification for the validity of their instruments.No solicitation will be posted to FedBizOpps. We will only issue a solicitation to Cerulean Corporation . Cerulean Corporation is the only source available to provide this service that meets mission critical requirements. This notice of intent is not a request for proposal. A determination to compete this procurement based on response to this notice is solely within the discretion of the Contracting Officer.Interested parties who believe they possess the capability to satisfy this requirement should submit a capability statement demonstrating their ability to meet this requirement. All responses must be sent in writing to Ms. Genesika Carter via email to fkn7@cdc.gov using solicitation number 2016-Q-64649 in the subject line, no later than 12:00pm Eastern Time, February 15, 2016.Place of Contract Performance:Centers for Disease Control and PreventionNational Centers for Environmental HealthDivision of Laboratory Sciences4770 Buford HighwayChamblee, GA 30341 2016-Q-64683 Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services
1/31/16, 8:23 PM