SOLICITATION NOTICE
66 -- Universal Mechanical Testing System
- Notice Date
- 8/26/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334519
— Other Measuring and Controlling Device Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-09-1062344
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 334519, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This synopsis is designated for full and open competition for a firm fixed-price purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to obtain an Universal Mechanical Testing System. Background A non-hydraulic high speed universal mechanical testing system with high displacement resolution but long stroke and the capability for high and low force applications and fatigue loading is needed in OSEL/DSFM to support ongoing research in polymer mechanical characterization and cardiovascular stent testing. The system shall come with instrument controller computer and software that will be dedicated solely to the operation of the mechanical testing system. Specifically, the universal mechanical testing system will immediately be used to measure static mechanical properties in bioabsorbable polymers and for axial fatigue testing of cardiovascular stents. These are ongoing projects in our laboratory, some of which have active ASTM participation. It is critical to the success of our projects that the mechanical testing system has significant versatility and be able to support numerous projects with strokes ranging from less than 1mm to 30mm and be compatible with a range of forces. The mechanical testing system should be capable of static, monotonic tests as well as fatigue loading. The mechanical testing system should be versatile enough to allow for future add on components including temperature controlled saline chambers, additional load cells, and fixtures for different types of loading modes including pulsatile fatigue testing of stents. Performance Work Statement The need for a high quality axial universal mechanical testing system that is capable of static, monotonic and fatigue loading is critical for the success of our projects. The system shall allow for full user control and be versatile enough to use long and short strokes, high and low forces, allow for tension and compression applications, and be service-able for future applications in biomaterials. OSEL/DSFM reserves the right to reject the system if it uses hydraulics due to maintenance difficulties and noise issues, cannot perform fatigue loading (100Hz), and/or has a stroke displacement of less than 10mm. Specifications The requirement shall include the following specifications for the non-hydaulic high speed universal mechanical testing system: Actuator technology based on linear motors; not hydraulic actuation Table top system for easy fit in the laboratory. System must be compact enough to fit within existing laboratory benchtops within DSFM (30inches x 72 inches). Dual column frame with adequate stiffness Axial loading for tensile and compression Ability to maintain axial alignment when lateral or offset eccentric loads are induced by grips or fixturing Load and displacement control tests available Capable of static and dynamic testing Static load capacity of at least 2000N Dynamic load capacity of at least 2500N A standard tension/compression load cell included in the base system with a force rating of 2000N and capable of functioning at high speed (greater than 10Hz, a fatigue rated tension-compression cell) Ability to also interface with very low force load cells down to 1N with an accuracy of 1/250th of the max reading Automatic load cell recognition within the instrument controller software Load cell accuracy of 1/250th of the max rating Brake engaged on power loss Electrically powered by 208-240V Crosshead status indicator to show system status (on, off, ready, etc) Optical encoder for axial displacement resolution of at least 2 microns or better A minimum of 500mm free space between table and max crosshead position 50mm displacement stroke or greater Electronic crosshead adjustment with manual locking features for safety and user control Position of linear axial actuator should be in upper crosshead Load cell position shall be above the sample or top fixture position and not within the t-slot table or below the specimen System shall be complete with instrument controller software and computer for user control The software shall allow for selection and modification of standardized mechanical tests in addition to custom tests defined by the end user. For example, the user should be able to upload data points as test parameters. The instrument controller software shall allow for fatigue loading as well as monotonic static loading The instrument controller software shall allow for calculation of common mechanical property constant including E, , yield stress, total elongation, etc. Temperature controlled air cooling of the instrument Automatic tuning capabilities for force control experiments Compatibility with immersion chambers for testing at physiologic conditions Compatibility for temperature controlled immersion chamber via an RS232 interface for easy access A frequency speed range of 0-100Hz Vertical configuration to allow for tensile and compressive testing On site training for OSEL/DSFM users T-slot table included Emergency stop Hand-held or move-able actuator jog and grip controls so that user can fine tune crosshead positioning while visually watching the sample and without the need to use the computer interface 1 year warranty On site training Able to operate under standard lab conditions with no additional heating or cooling requirements EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," (2) Past performance and 3) Price. Technical Capability and past performance when combined are significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before August 28, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before September 3, 2009. Telephone calls will not be accepted. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1062344/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN01927877-W 20090828/090827001421-39de0d2ef37593ffc0c7866080bccb26 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |