FDA Office of the Commissioner (OC) Preventative Maintenance Agreement for Agilent 1290 & 1260

Background
The Center for Tobacco Product (CTP) Tobacco Products Laboratory (TPL), located in Atlanta, Georgia, has a requirement for a preventative maintenance agreement and operational qualification for two Agilent 1200 HPLC/UHPLC instruments (1260 Infinity II, 1290 Infinity II, and 1260 System Enhanced).

These instruments are essential for the Food and Drug Administration (FDA) Office of Chief Scientist (OCS) to fulfill legislative requirements and manage sample workloads related to tobacco product analysis. The goal is to develop methods for identifying and quantifying analytes in tobacco products under FDA regulatory jurisdiction.

Work Details
The Contractor shall provide a Service Agreement for all specified systems to ensure uninterrupted performance within manufacturer’s specifications while complying with local quality assurance and ISO 17025 certification. The contract includes:
1. At least one preventative maintenance inspection (PMI) service visit during each 12-month period for each instrument, scheduled by the Technical Point of Contact (TPOC) at least seven business days in advance.
2. Preventative Maintenance Services must include all consumables, parts, labor, and travel for remedial repair.
3. All new parts required for repairs must meet original equipment manufacturer’s specifications at no additional cost to the Government.
4. Documentation of preventative maintenance duties performed must be provided by the Contractor.
5. Qualification Services after planned PM and any repairs must include Operation Qualification/Performance Verification (OQ/PV), with at least one annual OQ/PV verification performed by a qualified engineer.

Place of Performance
Atlanta, Georgia