Lyophilization Stoppers

Added: Jan 30, 2017 3:52 pm Notice of Intent to Award a Sole Source Contract - FDA1176369

The U.S. Food and Drug Administration intends to make a sole source award to Aptar Stelmi for Lyophlization Stoppers to be used with the Cozzoli Vial Filling and Stoppering Machine. The performance qualification and validation of the Cozzoli Vial Filling and Stoppering Machine was performed using 13mm Bromobutyl Rubber Ultraclean, double Tyvek/Plastic Lyophilization Stoppers and 20mm Bromobutyl Rubber, Ultraclean Aptar Lyophlization Stoppers. The continued use of the Aptar Lyophlization Stoppers are required as using a different stopper would mandate revalidation and fabrication of new parts which ultimately take over a year to manufacture and additional funding. A delay of the delivery of these specified stoppers will delay testing and release of influenza vaccines which will have a great public health impact.

The NAICS Code for this action is 326299 - All other rubber product manufacturing.
This procurement is made under the authority of 10 USC 2304(c) (1) only one responsible source. This is a notice of intent to issue this solicitation on a sole source basis to Aptar Stelmi. This notice of intent is not a solicitation for competitive proposals. Any other firm desiring consideration must fully identify their interest and capability to provide these items by submitting a capability statement to Janice Heard at janice.heard@fda.hhs.gov no later than February 6, 2017. A determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. The projected award date is February 7, 2017.