Project Title

Refrigerated Centrifuge unit in support of the chemotherapeutics program at DENL

1. Description of Work

1. BACKGROUND INFORMATION

The Food and Drug Administration - Denver Laboratory is responsible for the analysis of a wide variety of food additives and chemotherapeutic agents. Among our responsibilities is the analysis of antibiotic and veterinary drug residues in seafood, game meats, milk, as well as other food and feed samples. These types of samples usually equate to approximately 500-600 samples per year. The sample preparation for these analyses requires centrifugation at or below 5 degrees C, necessitating a refrigerated centrifuge. ORS has recently requested an increase in the number of agents that must be analyzed. To accommodate the additional analytes the Antibiotics section at the Denver Laboratory must perform additional sample preparation methods. It is necessary to have an additional operating refrigerated centrifuge unit to accommodate sample volume and ensure the analysis of samples in a timely manner to meet reporting timeframes.

1. OBJECTIVES

The objective for this work request is to provide a refrigerated centrifuge unit necessary for the continued use of the analytical method described in LIB 4562 for regulatory samples.  This purchase will relieve a bottleneck that adversely affects the preparation, analysis, and processing of samples.

1. SCOPE

The Contractor shall provide one refrigerated centrifuge unit meeting the stated specifications and the required accessories to the DENL laboratory.

1. STATEMENT OF WORK

The Contractor shall provide one new refrigerated centrifuge unit meeting the specifications below, with the following additional required components:

• A compatible fixed-angle high-speed rotor for spinning 50 mL conical tubes, per unit
• Fourteen adapter inserts to allow the use of 15 mL conical tubes, per unit

Contractor shall provide delivery of one centrifuge (with additional required components) to the  DENL laboratory.

Contractor shall perform on-site setup and installation at the laboratory (sometimes referred to as “Inside Delivery”), and demonstrate performance within specifications at time of installation.

Contractor shall provide a warranty for each entire system for parts and labor for a minimum of 12 months from the date of installation acceptance.

1. MINIMUM REQUIRED PERFORMANCE SPECIFICATIONS    

I. Minimum Required Performance Specifications

1. High speed centrifuge capable of reaching at least 20,000 RPM (33,000xg RCF), with +/- 25 RPM accuracy.

1. Refrigeration temperature range from -20°C to +40°C, with +/- 2°C accuracy

1. System should include pre-cooling and partial vacuum system to ensure temperature stability.

1. Centrifuge must operate on a 200-240V, 30A (60Hz) single-phase electrical outlet.

1. Centrifuge should utilize a high torque, brushless motor (or equivalent) drive system with a maximum of 60 dBA noise level.

1. Centrifuge must have overall dimensions not to exceed (40 in (H) x 32 in (W) x 32 in (L)), and weigh less than 800 lbs.

1. Centrifuge must have electronically-controlled timer, refrigeration setpoint, speed setting, acceleration and deceleration rates.

1. System must have a safety mechanism for detecting out-of-balance loads.

1. System must allow tool-less rotor swaps.

1. Rotor must accommodate at least 14 conical-bottomed polypropylene 50 mL tubes (tube length 115 mm, diameter 30 mm), and be capable of spinning at 14,000 rpm.

1. Rotor should be fixed angle and made of a carbon fiber composite material (corrosion-proof), and must be compatible with the centrifuge.

1. Fourteen tube adapters should be provided that are compatible with the rotor described above and allow the use of conical-bottomed polypropylene 15 mL tubes (tube length 120 mm, diameter 17 mm), and be capable of spinning at 12,000 rpm.

II. Trade and Service Specifications

1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.
2. FOB Point destination to include inside delivery and clean-up of area after installation. 
3. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance.  The vendor must also be capable of servicing the instrument through the covered warranty period.  The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer.  This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts.  The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs.  All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.
4. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. 
5. Preventative maintenance (PM) visit shall be included for the base contract year.  This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM.
6. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 5 days), such that operators may independently operate the instrument and with increased familiarity and proficiency.  The training shall include manuals and any consumables to be used during training.  
7. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification.

1. Records and Reports

                      The Contractor shall, commensurate with the completion of each service call relating to the first year warranty, provide the end-user of the equipment with a copy of the field corrective service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being repaired and detailing the reason for the warranty call, a detailed description of the work performed.  The parts and the test equipment used to repair the system shall be on the report.  This will include the name (s) and contact information of the engineer who performed the repair, and for information purposes, the on-site hours expended, and parts/components replaced.

1. Deliverables

Deliverable

Quantity

Delivery Date

Refrigerated Centrifuge

1

30 days from date of award

Setup, installation, and certification

1

30 days from date of delivery

Familiarization training

1

5 days from date of installation

1. Shipping Destinations:

U.S. Food and Drug Administration

Denver Laboratory FDA/DENL

One Denver Federal Center

6th Avenue and Kipling Street

Bldg. 20, Entrance W10

Denver CO 80225-0087

POC: Roy Jenkins, 303-236-3026

Delivery must be during regular business hours (Monday – Friday) between the times of 8:00 AM – 4:00 PM, excluding holidays as follows:

New Year’s Day

Martin Luther King, Jr. Day

Presidents Day

Memorial Day

Independence Day

Labor Day

ColumbusDay

Veterans Day

Thanksgiving Day

Christmas  Day

1. Security

When vendor arrives on site to deliver, they will need to check in with the Front Security Guards and provide proper identification.  They will receive an “Escort Required” temporary badge, which must always be worn in the building and will need to stay with lab personnel during their visit.  If vendors need to enter the laboratory, safety glasses must be worn. When their work is complete, they will check out with the same Security Guards, turning in their temporary badge.  Tobacco, of any form, is not permitted on Federal Property, in Federal Buildings or parking lots. 

1. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI)

None

1. Period of Performance

The Period of Performance begins the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance.