Clean Room Services

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ); NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the government. This is NOT a Request for Proposal, Invitation for Bid, or an announcement of a solicitation. Response to this SOURCES SOUGHT is strictly voluntary and will not affect any firms' ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement. The purpose of this document is to identify potential sources. Any requests for a solicitation package will be disregarded. The Government does not intend to award a contract on the basis of this source sought or otherwise pay for the information solicited. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of preparing submissions in response to this sources sought and the Government's use of such information. Required Performance Capabilities: Information will be collected from Small or Large Manufactures and authorized distributors at this time to determine if the requirement can be met using a small business set-aside. All respondents are required to certify if they currently meet the small business requirements under the North American Industry Classification System (NAICS) code [541380], Testing Laboratories, as of the date of their submittal. STATEMENT OF WORK ****SEE ATTACHED FOR DETAILED STATEMENT OF WORK*** The subject contract shall cover testing, reports, support, and certify for non-viable and viable count in cGMP clean rooms located in the Cell Processing Section of the Department of Transfusion of the Clinical Center at NIH. The non-viable and viable count are required to comply with FDA 21 CFR part 11 and ISO 14644-1:2015 Standard. The non-viable and viable count testing verify that the cleanroom is operating within the required classifications. It is used to evaluate the effectiveness of microbial controls used in the manufacture of sterile products. It helps identify problems in the facility or process. It also help demonstrate the state of control of aseptic processing area. Period of Performance Service agreement: 6 Month base period with four 1 year options Minimum Vendor Qualifications and must provide the following with this sources sought notice ***A Site visit date for accurate samples requirement will be confirmed to those who qualify with the submittal of the following Capability Statement CAPABILITY STATEMENT - Any potential Manufacturer must demonstrate the following: 1) The offeror shall submit product literature for the services it is proposing. Capability Statement(s) should clearly identify the following: Provide confirmation that their sampling can will conform to the requirements of ISO 14644-1:2015 or 14664-2:2015 Provide sampling methods and equipment used Provide instructions on samples handling to ensure the integrity of samples is not compromised during transport Provide certification of equipment used - ISO 17025 The vendor uses equipment that conforms to 21501-4 Provide similar past performance Provide a service personnel who have had training and experience in the types of service, equipment and facilities as described herein If the vendor reports test results, they come from a lab that conforms to 17025. 2) Provide the following business information: a. DUNS number b. Company Name c. Company Address (including point of contact, phone number and email address) d. Type/Size of company, NAICS code as validated in SAMS. Respondents will NOT be notified of the results of the evaluation. Responses must be submitted by email to POC, Milton.Dartoozos@nih.gov, within 7 calendar days (2/5/16) from the date of this synopsis.