FDA-FY22-SS-1251863.pdf

FDA-FY22-SS-1251863

Notice of Intent to Issue a Sole Source Purchase Order for Mini Implants Manufacturing System

The Food and Drug Administration intends to issue a sole-source purchase order to Thermo Fisher Scientific located at Dieselstr. 4, Karlsruhe, 76227 Germany. The anticipated purchase order is for Mini Implants Manufacturing Systems. An Award will be made in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, only one responsible source and no other supplies or services will satisfy the agency requirements using Simplified Acquisition Procedures per FAR Part 13.5. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within seven (7) days after the publication of this synopsis, which will be considered by the agency. Responses received after seven (7) days or without the required information may not be considered. A determination by the Government not to compete as a result, of information received is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. For information concerning this acquisition, contact Linda Troutman, Contract Specialist at Linda.Troutman@fda.hhs.gov

Salient Characteristic for the Mini Implants Manufacturing System are as follows:

Item 1: Injection molding machine

• The system shall be able to process polymer materials through injection molding process to make implants with variable geometry.

• The max melt temperature shall be higher than 400 °C

• The max mold temperature shall be higher than 200 °C

• The max injection pressure shall be higher than 1000 bar

• The dimensions of the system shall be smaller than 100 cm x 90 cm x 100 cm (LxWxH).

Item 2: The laser based extrudate calibration and cutting unit

• The system shall have laser-based diameter gauge for extrudate diameter regulation

• The system shall have cooling system based on compress air

• The linear cutting unit shall have a max line speed higher than 10 m/min

• The max cutting speed shall be higher than 500 cuts/min

• The system shall have a second cutter

Item 3: Melt pump

• The system shall be able to produce constant and pulsation-free melt flow for the upstream implant manufacturing system

• The system shall have pressure sensor to monitor the pressure

• The system shall have a manual bypass pressure valve

• The max pressure shall be higher than 400 bar

• The dimensions of the system shall be smaller than 400 cm x 650 cm x 400 mm (LxWxH).

Item 4: Accessories The following accessories shall be included with the base equipment:

• Mold for the injection molding machine

• Adapter for the injection molding machine to connect with upstream implant extrusion equipment

• Sheet die adaptor

• Strand nozzle with 1.5 mm diameter

• Strand nozzle with 2.0 mm diameter

Item 5: Delivery, Installation, and On-site training The vendor shall cover all costs associated with the following:

• System crating, shipping, and delivery.

• Full system installation.

• On-site training.