SOURCES SOUGHT
66 -- Photostability Chambers
- Notice Date
- 4/10/2014
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument 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-14-1130932-SS
- Archive Date
- 5/2/2014
- Point of Contact
- Tiffany R. Williamson, Phone: 3018277182
- E-Mail Address
-
tiffany.williamson@fda.hhs.gov
(tiffany.williamson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Synopsis Notice to Small Businesses The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns; 8(a), Woman-Owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, and Service-Disabled Veteran-owned Small Businesses (SDVOSB). The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses. The Food and Drug Administration (FDA) is conducting a market survey to assess the availability of small business firms as defined by NAICS code 334516 to provide four Photostability Chambers. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that a procurement will be accomplished. FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted of FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required. Background: The Food and Drug Administration laboratories will utilize the photostability chambers to support method development, optimize methods, and facilitate research conducted to support USP compendia monograph modernization efforts. Monograph Modernization has been an initiative pushed by the Center for Drug Evaluation in an effort to ensure drug product quality. Project Objectives: The Photostability Chambers will: • Allow FDA to complete the battery of tests required to complete forced degradation studies • Allow for studies to comply with ICH guidelines pertaining to forced degradation • Allow drug products and API's susceptible to photolytic degradation be evaluated under controlled conditions to allow for enhanced method evaluation • Allow ANDA/NDA development data be verified for photolytic studies submitted to the CDER • Allow for subjecting drug products/API's to "real world" environmental conditions Specific Tasks and Deliverables: Item 1: Quantity = 4 Caron 10.5 cu ft Photostability Chamber (Model 6545-1) or Equal Includes: • Independent control of near UV and cool white VIS lamp • In "automatic mode" lights turn off at the end of the exposure time • Programmable Alarms • Specular Aluminum reflective surfaces • Precise Temperature Control • Humidity Controls • Lamp location provides uniform distributions • Temperature range is allowable 10 C to 35C (lights on) • Light intensity 20W/m2 • Time to reach 200 W-hr/m2 10hrs • Time to reach 1.2 million lux-hr • Two access ports • Light meters are traceable • Unit should not be more than 40"W x 31"D x 48"H • Includes Chamber mapping • Humidity range from 40% to 70% RH • Unit allows for chart recoding or utilization of computer software • System must be viable for LIMS implementation • Includes IQ/OQ/PQ (installation qualification/validation qualification/performance qualification) (Qty: 4) • Includes Circular 12 inch Honeywell Truline chart recorder records and charts four variables (Qty: 4) • Includes Universal Condensate Recirculating System (Qty: 4) One Year optional Extended Maintenance Package. Coverage shall be the same as the new product warranty. Warranty: 1. Price should include a 12 month warranty agreement for all parts and labor. 2. Direct and trained service employees of the successful offeror shall provide maintenance and repair service. A toll-free telephone number for placing service calls is required. 3. Technician response shall be within 72 hours of a service call. Installation: 1. Only trained service personnel shall provide full system installation. 2. Service personnel shall provide a one-time training on basic operation and functionality. Each location will have between 1-4 employees to receive training. General Requirements: 1. The equipment supplied shall be new equipment and must meet manufacturer's performance standards for new equipment. 2. The new equipment shall not have been used previously, actively marketed as a new model and contains no used components or parts. Remanufactured, refurbished, or reconditioned equipment is not acceptable. 3. The system shall be delivered with all necessary supplies and accessories required for installation and start-up. Delivery: Potential contractor must be able to deliver to four different locations: San Juan, PR, Philadelphia, PA, Detroit, MI, and Jamaica, NY. General Instructions Contractors that believe they possess the ability to provide the required equipment must submit documentation of their ability to meet each of the characteristics listed above to the Contracting Officer (i.e. brochure, information on equipment that meets specifications, etc.) The capability statement must also include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code. Capability statements that do not provide sufficient information for assessment will be considered non-responsive. When submitting the information, please reference the solicitation number FDA-14-1130932-SS. Responses should be submitted via email to Tiffany Williamson at Tiffany.Williamson@fda.hhs.gov by 12:00 pm on April 17, 2014.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-1130932-SS/listing.html)
- Record
- SN03336106-W 20140412/140410235621-d95d8f5b81373a7c0269e90428796ca3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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