G
cGMP Cleaning Supplies.
POTS: 24-000584
This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.
The National Institutes of Health (NIH) intends to award a fixed priced purchase order on a sole source basis to VWR INTERNATIONAL, LLC., Westchester, PA 19380, United States, UEI: J6CNECEBTK23 for the Clinical Center/ Materials Management and Environmental Services Department (MMESD)
The Food and Drug Administration and international certified Good Manufacturing Practice (cGMP) regulations, especially those on sterile manufacturing, require stringent cleaning and hygiene programs in pharmaceutical manufacturing areas. The Regulations require that aseptically produced biologics be produced in a cleanroom environment. A critical component to contamination control is the cleaning program for the controlled areas, which must be well-defined, contain detailed cleaning processes that must be stringently followed by highly trained and competent cleaning staff, and use appropriate, in some cases sterile, and dedicated cleaning supplies and equipment.
The NIH Clinical Center, MMESD, Storage & Distribution Section must obtain cGMP Cleaning Supplies.
The MMESD, Storage & Distribution Section has a requirement for contamination control cleaning supplies for NIH biologics manufacturing sites and aseptic processing areas at the NIH CC (Bldg. 10) on the Bethesda, MD campus. It is vital that the Contractor provides Certificates for Analysis (COA), Certificates of Conformance and Packing Inserts in each packaged case of supplies. The requirement is to obtain cleaning supplies for the NIH, Clinical Center cGMP Clean Rooms for delivery to Building 10, Room B2C-123 Bethesda, Maryland. It is critical to adequately clean these rooms with the needed Government approved cleaning supplies to be able to pass the Joint Commission and FDA Certifications for cGMP pharmaceutical development practices.
A price analysis was conducted in accordance with FAR 13.106-3 using past contractual pricing and informal vendor estimates. After extensive comparative analyses using the aforementioned methods was determined to have been fair and reasonable for the Government.
ITEMS:
This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The total dollar value of this purchase order shall not exceed the SAT at $250,000.00.
Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
Each response should include the following Business Information:
a. UEI
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Type of Company (i.e., small business, 8(a), woman owned, HUBZone, veteran owned, etc.) as validated in System for Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1
e. Capability Statement
Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Gregory Noland, Contract Specialist, [email protected] by the due date (03/06/2024) and time (1400) marked in this notice.