Port Linear Smoking Machine

The U.S. Food and Drug Administration (FDA) is requesting quotes for a service agreement and a qualification service for the CERULEAN SM450i Linear Cigarette Smoking Machine at TPL. This instrument is an integral component that support the Food and Drug Administration (FDA) Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. This instrument is needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products. Service Agreement and Qualification Service CERULEAN SM450i Linear Cigarette Smoking Machine Background The Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL) located in Atlanta, Georgia has a requirement for a service and qualification agreement for one of its Cerulean SM450i Linear Cigarette Smoking Machines. This instrument is an integral component that supports the Food and Drug Administration (FDA) Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL) to meet the legislative requirements and the sample workload that are an integral part of the Agency response to the legislation. This instrument is needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under the Food and Drug Administration (FDA) regulatory jurisdiction and to establish expertise in the analyses of tobacco products. Salient Characteristics The Contractor shall be capable of providing both the Service Agreement and Qualification Service for all systems specified in the Statement of Work Brand Name or Equal to that provided in a Cerulean service contract to ensure uninterrupted performance within manufacturer s specification as well as complying with local qualification assurance and ISO 17025 certification. All the following are minimum requirements. Preventative Maintenance Maintenance of the Linear Cigarette Smoking machine shall include a one (1) year full manufacturer s warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum of 72 hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications. The contractor shall perform one (1) preventative maintenance inspection (PMI) for the SM450i Linear Cigarette Smoking Machine during each one (1) year period of performance. The contractor shall perform one (1) operation qualification/performance verification (OQ/PV) for the SM450i Linear Cigarette Smoking Machine during each one (1) year period of performance. The OQ/PV must include all supplies needed to perform that service. The contractor under the service agreement shall repair or replace any part or parts which prove to be defective at no additional charge to the government. The contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon timeframe. The contractor shall be responsible to obtain all new parts required for all repairs and maintenance. The Contractor Officer Representative (COR) or Point of Contact (POC) shall contact the Contractor to schedule a mutually acceptable date and time for the preventive maintenance visit. All visits must be scheduled in advance with the COR or POC. Documentation of preventative maintenance duties performed must be provided. The PM service shall be performed by a Cerulean trained and certified engineer and must provide documentation that the instrument is functioning according to the manufacturer s specifications.…