SOURCES SOUGHT
66 -- IQ_OQ_PQ_Validation
- Notice Date
- 5/13/2016
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, 12501 Ardennes Avenue, Suite 400, Rockville, Maryland, 20857, United States
- ZIP Code
- 20857
- Solicitation Number
- IQOQPQValid
- Point of Contact
- Jolomi Omatete, Phone: 2402766561
- E-Mail Address
-
jolomi.omatete@nih.gov
(jolomi.omatete@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE: The IQ_OQ_PQ certification of 10 Heracell VIOS 160i CO2 incubators in cGMP Manufacturing Space Notice Number: IQOQPQValid Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: May 18, 2016 by 2:00 pm Eastern This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified Small Business concerns including 8(a), HUBZone or Service-Disabled Veteran-owned businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 334516 with a size standard of is 500 employees. As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The cell processing facility of the Surgery Branch of the National Cancer Institute is undergoing renovation. The NIH Office of Research Support and Compliance, mandated that new incubators be purchased for use in the manufacturing of cell therapies in the cell processing facility. Working Buildings LLC, a contract organization assisting in the renovation process, specified which make and model of incubator should be purchased. 10 Heracell VIOS 160i iCO2 incubators were purchased. In order to use these incubators to manufacture cell therapies for patients enrolled on Surgery Branch Sponsored clinical trials an installation and operational qualification process must be carried out. This project is the rate limiting step in using the incubators. The FDA mandates that all equipment used within cGMP facilities under go IQ/OQ certification. The purpose of the acquisition is to perform installation and operational qualification of 10 Heracell VIOS 160i CO2 incubators. The objective is to confirm correct installation and operation of the equipment to allow use of these incubators in the manufacture of cell therapies for patients enrolled on Surgery Branch of the National Cancer Institute sponsored clinical trials. The Contractor shall perform the following tasks: i. Qualification protocol review and approval ii. Qualification of content review iii. Verification of order form and deliveries iv. Verification of goods received v. Verification of installation site and ambient condition vi. Verification of equipment power supply vii. Verification of equipment and associated accessories installation viii. Verification of power on ix. User training x. Calibration of equipment with certification xi. Training certification xii. Installation qualification report xiii. Verification of functionalities xiv. Verification of alarms xv. Verification of unit temperature with calibrated reference probes xvi. Verification of CO2 instrumentation, against a calibrated reference analyzer xvii. Verify authorization certificate xviii. Operational Qualification report. xix. Verification of temperature stability and homogeneity during stable operation. xx. Verification of temperature stability and homogeneity after door opening, with temperature mapping xxi. Verification of temperature stability and homogeneity during a power failure, with temperature mapping xxii. Verification of the unit CO2 instrumentation. How to Submit a Response: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Statements should also include an indication of current small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 2. Due Date: Capability statements are due no later than May 18, 2016 by 2:00 pm Eastern 3. Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and emailed to Jolomi.Omatete@nih.gov. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) and the Online Representations and Certifications Applications (ORCA) through sam.gov. No collect calls will be accepted. Please reference number SBSS- IQOQPQValid on all correspondence. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a RFQ may be published in Fed Biz Opps. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: Jolomi Omatete at jolomi.omatete@nih.gov. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/PSC/DAM/IQOQPQValid/listing.html)
- Place of Performance
- Address: Cell Processing Core Facility, Surgery Branch, National Cancer Institute, NIH, CRC Room 3-5752, 10 Center Drive, MSC 1201, Bethesda, Maryland, 20892-1201, United States
- Zip Code: 20892-1201
- Zip Code: 20892-1201
- Record
- SN04116135-W 20160515/160513234022-598909722e74697ad97535889559a23c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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