Opportunity

SAM #75F40126Q00408

FDA Solicits Service and Qualification Agreement for Cerulean SM450i Linear Cigarette Smoking Machine

Buyer

FDA Office of the Associate General Counsel for Administrative Law

Posted

September 17, 2026

Respond By

September 23, 2026

Identifier

75F40126Q00408

NAICS

811219, 541990

The U.S. Food and Drug Administration (FDA) Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL), Tobacco Products Laboratory (TPL) in Atlanta, Georgia, is seeking a service and qualification agreement for a Cerulean SM450i Linear Cigarette Smoking Machine. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL) - Tobacco Products Laboratory (TPL) - OEM Highlight: - Cerulean is the Original Equipment Manufacturer (OEM) for the SM450i Linear Cigarette Smoking Machine - Products/Services Requested: - Service and qualification agreement for Cerulean SM450i Linear Cigarette Smoking Machine (S/N: 0618-221795-1454) - Preventative maintenance, operation qualification/performance verification (OQ/PV), repairs, and technical support - One-year full manufacturer's warranty, unlimited on-site service visits, factory-certified replacement parts, software updates - All services performed by Cerulean-trained and certified engineers - Quantities and Line Items: - 1 Cerulean SM450i Linear Cigarette Smoking Machine (existing equipment) - 5 years of maintenance and qualification services (base year plus four option years) - Each year includes 1 maintenance agreement and 1 qualification service - Unique/Notable Requirements: - Compliance with ISO 17025 certification for all services - Documentation of maintenance, calibrations, and instrument performance - All repairs must use factory new Cerulean parts - On-site service at FDA facility during standard business hours - Period of Performance: - Base year plus four one-year option periods (total of five years) - Services performed Monday through Friday, excluding federal holidays, between 8:00 a.m. and 4:30 p.m. EST

Description

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 supports the Food and Drug Administration (FDA) Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL) to meet legislative requirements and handle the sample workload that are an essential part of the Agency's response to legislation. This instrument is needed to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under FDA regulatory jurisdiction and to establish expertise in tobacco product analyses.

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, requires a service and qualification agreement for one of its Cerulean SM450i Linear Cigarette Smoking Machines.

This instrument supports the FDA Office of the Chief Scientist/Office of Analytical and Regulatory Laboratories (OCS/OARL) in meeting legislative requirements and managing the sample workload. It is essential for developing methods to identify and quantify analytes in tobacco products under FDA jurisdiction and for establishing expertise in tobacco analysis.

Salient Characteristics

The Contractor shall provide both the Service Agreement and Qualification Service for all systems specified in the Statement of Work, labeled as “Brand Name or Equal”, matching the specifications of a Cerulean service contract to ensure uninterrupted performance within manufacturer’s specifications and compliance with local qualification assurance and ISO 17025 certification.

All the following are minimum requirements:

Preventative Maintenance

Maintenance shall include a one-year full manufacturer’s warranty on all parts, travel, and labor, including software and hardware. Coverage includes all non-consumable items and parts supplied, such as the base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum response time of 72 hours, factory-certified replacement parts, engineer labor and travel costs, software updates, and notifications. The contractor shall perform one preventative maintenance inspection (PMI) annually for the SM450i Linear Cigarette Smoking Machine. The contractor shall perform one operation qualification/performance verification (OQ/PV) annually, including all necessary supplies.

The contractor shall repair or replace any defective parts at no additional charge. Arrangements for the fastest delivery shall be made, with work resuming within 72 business hours or a mutually agreed timeframe upon receipt of parts.

The contractor shall procure all parts required for repairs and maintenance. The Contracting Officer Representative (COR) or Point of Contact (POC) shall schedule maintenance visits in advance. Documentation of maintenance performed must be provided. The maintenance shall be performed by a Cerulean-trained and certified engineer, with documentation confirming the instrument functions according to manufacturer’s specifications.

Service Calls

The contractor shall respond within 2 business days of a service call. Unlimited telephone and email technical support shall be available Monday–Friday, 9 a.m. to 5 p.m. EST. All repairs shall meet manufacturer specifications and use factory new replacement parts. Parts removed for replacement shall become the property of the contractor unless otherwise agreed. The contractor shall handle shipping and return logistics, including providing shipping instructions and return authorization, at their cost within 3 days after service completion. A diagnostic test or narrative summary demonstrating compliance with manufacturer’s specifications shall be performed and documented.

Qualification Service

The qualification service for each system shall include OQ/IPV after preventive maintenance or critical repairs, and shall include:

Documentation for calibrations and performance runs. Performed by a Cerulean-trained and certified engineer, with documentation of proper functioning. Removal of packaging materials is the contractor’s responsibility.

Service Conditions

Service shall be performed on-site at the FDA to the maximum extent practicable.

Off-site repairs shall include all packaging, shipping, and transportation costs, with liability for shipments. The contractor shall provide a Return Authorization Number or similar, and shipping account details for return shipments, at their expense.

The contractor shall only use tools, parts, instruments, and methodologies approved by the manufacturer.

Instruments for Preventative Maintenance and Qualification Service

Description/Serial Numbers

SM450i Linear Cigarette Smoking Machine

(S/N: 0618-221795-1454)

Warranty

All labor, replacement parts, and components (excluding consumables) shall be warrantied.

Records and Reports

The contractor shall provide the end-user with a copy of a field service report/ticket after each service call, including equipment details, reason for service, work performed, instruments used, technician information, on-site hours, and parts replaced.

Deliverables

0001 Base Year - Maintenance Agreement for: