SOURCES SOUGHT
B -- study for knowledge regarding appropriate SEM-Raman experimental parameters for characterizing crystal formation in transdermal drug delivery systems (TDDS) and an option for using coupled SEM-Raman to characterize TDDS samples in order to detect crystals
- Notice Date
- 8/19/2014
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation 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-SS-1137761
- Archive Date
- 9/6/2014
- Point of Contact
- Carrie Strachan, Phone: 2404027620
- E-Mail Address
-
carrie.strachan@fda.hhs.gov
(carrie.strachan@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information: Document Type: Sources Sought - FDA-SS-1137761 Release Date: August 19, 2014 Response Date: August 22, 2014 at 2:00pm ET via email to Carrie.Strachan@fda.hhs.gov Contracting Office Address: Food and Drug Administration, 5630 Fisher Lane, Rockville, Maryland 20857; Attn: Carrie Strachan, Contract Specialist Description of Services/Supplies: Sources Sought for a study to obtain knowledge regarding appropriate SEM-Raman experimental parameters for characterizing crystal formation in transdermal drug delivery systems (TDDS) and an option for using coupled SEM-Raman to characterize TDDS samples in order to detect crystals and determine the identity of those crystals. Description: This is a Source Sought Notice to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) for a study to obtain knowledge regarding appropriate SEM-Raman experimental parameters for characterizing crystal formation in transdermal drug delivery systems (TDDS) and an option for using coupled SEM-Raman to characterize TDDS samples in order to detect crystals and determine the identity of those crystals. Background: This request is for a study to obtain knowledge regarding appropriate SEM-Raman experimental parameters for characterizing crystal formation in transdermal drug delivery systems (TDDS) and an option for using coupled SEM-Raman to characterize TDDS samples in order to detect crystals and determine the identity of those crystals. TDDS are dosage forms designed to deliver a therapeutically effective amount of drug across a patient’s skin. Recently, some of these products have been recalled because of crystal formation within the TDDS matrix. Failure to control crystal size and distribution could result in loss of aesthetic appeal, skin irritation, and loss of adhesion; suggesting a manufacturing process that is not under control. Also, presence of excess crystalized drug might result in reduced delivery relative to the expected amount of drug when used by patients. Scanning electron microscopies (SEM) coupled with Raman spectroscopy has been proposed as a technique to detect, measure, and determine crystallization in TDDS. SEM is used for inspecting topographies of materials with a magnification range that encompasses that of optical microscopy and extends it to the nanoscale; therefore, the start of crystallization would be visible with SEM. A coupled SEM-Raman instrument will allow morphological, elemental, chemical, physical, and electronic analysis without moving the sample between instruments. Scope of Work: The purpose of this study is to determine the feasibility of coupled SEM-Raman to detect and confirm the identity of active pharmaceutical ingredient crystals in TDDS. For this preliminary study, SEM and Raman will be examined separately to determine the feasibility of coupled SEM-Raman. If feasibility is established via this study, the option for coupled SEM-Raman analyses will be exercised. For the preliminary study, seven (7) “as is” and seven (7) crystal containing (induced crystals) TDDS will be examined for crystals using reflected light microscopy. Seven (7) “as is” and seven (7) crystal containing (induced crystals) TDDS will be examined for crystals using scanning electron microscopy (SEM). The SEM analyses shall include variation in instrument parameters/conditions (kV, detector selection, ESEM settings) to find optimum settings for observation of crystals on or in the TDDS. The SEM shall observe crystals at maximum depth achievable. Seven (7) TDDS will be examined for crystals using Raman microspectroscopy and Raman microspectroscopy will be used for the four active pharmaceutical ingredients (Chlonidine, estradiol, levonorgestrel, and fentanyl.) A compact disk with the data files from SEM, light microscopy, and Raman tests will be required as well as an interpretive report. The interfaced SEM-Raman analyses will be performed without moving the samples between instruments. For the optional services, twelve (12) “as is” and twelve (12) crystal induced TDDS will be examined for crystals using coupled SEM-Raman analysis without moving the samples between instruments. Raman microspectroscopy will be used for the active pharmaceutical ingredients (Chlonidine, estradiol, levonorgestrel, and fentanyl) in the four TDDS. A compact disk with the data files will be required as well as an interpretive report. Responses to this notice shall be limited to 10 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 334516 (size standard 500 employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System for Award Management (SAM) to be considered as potential sources. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received via email to Contract Specialist Carrie Strachan at Carrie.Strachan@fda.hhs.gov no later than 2:00pm Eastern Time on August 22, 2014 for consideration. Responses to this announcement will not be returned, nor any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and the FDA may contact one or more respondents for clarifications and to enhance the Governments understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SS-1137761/listing.html)
- Place of Performance
- Address: 645 S. Newstead Ave, St. Louis, Missouri, 63110, United States
- Zip Code: 63110
- Zip Code: 63110
- Record
- SN03470595-W 20140821/140819235807-0d4ebbfdfc6e50f438db5b8c6a8d0683 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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