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The Office of Regulatory Affairs (ORA) is seeking to identify sources with capabilities and prior experience to provide 12 Bench top Centrifuges and Accessories:
Brand Name or Equal (Thermo Fisher Scientific)
CLN 001: 75003638, Set of 4 adaptors 7 x 50 ml conical, (24) ea.
CLN 002: 75003639, Set of 4 adaptors 14 x 15 ml conical, (24) ea.
CLN 003: 75003733, Set of 4 adaptors 48 x 2 ml microtube, (24) ea.
CLN 004: 75003607, TX-750 Rotor, (12) ea.
CLN 005: 75003608, Set of 4 750 ml round buckets for TX 750 rotor, (12) ea.
CLN 006: 75004506, SORVALL LEGEND XT Centrifuge 120V, (12) ea.
Statement of Work
Background
The ORA pesticide laboratories are undergoing a paradigm shift. They are in the process of significantly increasing their sample analysis output and becoming high throughput laboratories. Due to the increased demand for high through put samples analyses on these laboratories, this benchtop centrifuge equipment is essential to helping them meet these processing needs. Pesticide residue analysis in food commodities proceeds in two separate phases: (1) extraction via wet chemical methods, and (2) analysis of the extract by instrumental methods (either gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/mass spectrometry (LC/MS). These centrifuges will be utilized in the extraction phase of the process. In the extraction phase the sample is first composited and then the pesticide residues are extracted into an organic solvent through two series of wet chemical techniques that are separated by an intermediate centrifugation step. Thus, the centrifugation step is a rate limiting step for the extraction process. The faster this step is completed in the extraction process the faster the entire process proceeds and thus the faster the sample extracts are placed onto the instruments for analysis. The MON seeks to provide two versatile, dedicated, bench top centrifuges to each of the laboratories responsible for pesticide residue analysis to support the significant increase in work requirements that they have been charged with.
Scope
The U.S. Food and Drug Administration ORA field laboratories identified in #3 below, screen hundreds of food commodity samples for pesticide residues on a daily basis. Pesticide residues have been shown to be unsafe and can pose serious health risks to humans when consumed. The ORA field pesticide laboratories have been notified that they will be expected to significantly increase their sample residue screening output in the near future. Thus, efficiency is vital to this process; these centrifuges will significantly contribute to increased efficiency in the extraction process prior to the analysis by GC/MS and/or LC/MS. The ORA field pesticide laboratories are seeking to procure centrifuges that are rugged, easy and fast to use, do not require a large amount of space, and can process a large number of samples in a short period of time. To meet these requirements the centrifuge must possess or be capable of the following abilities:
a. Must be a 120 V, 60 Hz bench top centrifuge with approximate dimensions (LxWxH) of 24 inches x 20 inches x 10 inches.
b. Must be able to process tubes in both a fixed angle rotor configuration and swinging bucket rotor configuration.
c. The benchtop centrifuge should have a broad range of rotor configurations (must include at least fixed angle and swinging bucket) with adaptors to support a variety of tube sizes to include 15 ml, 50 ml and 175 ml tubes.
d. Must have a quick rotor exchange system to allow for faster installation and exchange with just the push of a button. Also, easy chamber access for cleaning convenience to reduced contamination risk.
e. Must have a rotor imbalance detection system
f. Must have locking rotors
g. The fixed angle rotors should have an rpm range of at least 500 rpm to 12,000 rpm; the swinging bucket configuration should have a maximum rpm of at least 6,000 rpm.
In addition to the above listed requirements the vendor should deliver the centrifuges and accessories to the laboratories identified #3b below and include set up, IQ/OQ/PQ and training as part of the delivery.
Delivery or Performance-Period Requirements.
The vendor will deliver and set up 2 centrifuges that meet the specifications in the Statement of Work to each of the laboratories listed below. Set up will include IQ/OQ/PQ and in house training on the use of this equipment.
Period of Performance
Delivery of the Centrifuge between (approximately July 1, 2010 and Sept 30, 2010), with at one year initial warranty service after shipment for equipment and ninety days for all other products.
Each centrifuge package should include:
A Swinging Bucket Rotor consisting of four buckets which are capable of holding
• 4, 1 x 175 mL Nalgene bottle, 4 bottles simultaneously
• 4, 7 x 50 mL conical tubes adapters, 28 tubes simultaneously
• 4, 14 x 15 mL conical tube adapters, 56 tubes simultaneously
• 4, 48 x 2 mL microtubes, 192 tubes simultaneously
A series of Fixed Angle Rotors of dedicated sizes of the following approximate configuration:
• 8 x 50 mL
• 14 x 15 mL
Deliver Locations:
12 centrifuges/accessories, vendor to deliver 2 centrifuges/accessories to each location, as follows:
Pacific Regional Laboratory Southwest
William B. Martin, Ph.D., Laboratory Director
HFR-PA260
19701 Fairchild
Irvine, CA 92612
949-608-2907
Northeast Regional Laboratory
Michael Palmieri, Laboratory Director
RM2052 HFR-NE500
158-15 Liberty Avenue
Jamaica, NY 11433
718-662-5450
Southeast Regional Laboratory
Khalil Kerdahi, Laboratory Director
HFR-SE600
60 Eighth Street NE
Atlanta, GA 30309
404-253-1200
Arkansas Regional laboratory
Paul Norris, Laboratory Director
RMA203 HFR-SW500
3900 NCTR Road, Building 26
Jefferson, AK 72079
807-543-4099
Kansas District Laboratory
Ann Adams, Laboratory Director
HFR-SW360
11630 West 80th Street
Lenexa, KA 66214
913-752-2155
Pacific Regional Laboratory Northwest
Rick Long, Ph.D., Laboratory Director
HFR-PA360
22201 23rd Drive SE
Bothell, WA 98021-4421
425-483-4901
Part A. Capability and Technical Experience - Interested parties should submit capability statement describing adequate training and experience in scientific and technical appropriateness in reference to the potential work to be conducted in
Part B. Size of Business - Please provide your business size (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses) and submit copies of any documentation such as letters of certifications to indicate the firm status.
Part C. Organizational Conflict of Interest (OCI) - If any; provide disclosure of business activities of your company, your affiliates, and your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of the possible work on evaluation listed above.
Part D. Small Business - Describe your ability to meet the requirements in accordance with 52.219.14 - Limitation of Subcontracting.
Responses shall adhere to the following:
1. Reference the Request for Information number when submitting Capability Statement.
2. The capability statement shall be no more than five (10) pages in length.
3. The marketing materials shall not be included.
4. The capability statement shall be e-mailed to the attention of the Contract Specialist listed above.
FDA makes no implied or in fact contract by issuing this Request for Information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned.