Steritest Symbio ISL 2 System Pump-Brand Name and Equal (BNE)

Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The NAICS for this requirement is: 334516. The government is not obligated to make an award. The Government is not obligated to pay costs incurred by the Contractor during quote preparation and quote submission.

Background:
 

The National Forensic Chemistry Center (NFCC) in the Office of the Chief Scientist, Office of Specialty Laboratories & Enforcement Support, requires the purchase of one (1) One (1) Steritest Symbio ISL 2 Med US. The Steritest Symbio ISL 2 is designed to fit with the round isolator cut outs and can be installed into the existing NFCC Getinge ISO-FLEX-R Isolator. The Steritest® Symbio ISL Pump is suitable for sterility testing of large and small volume parenteral solutions in glass or plastic bottles, collapsible bags, ampoules, and vials, pre-filled syringes, lyophilized and other soluble products in ampoules or vials, antibiotics in ampoules or vials, medical devices, and difficult-to-dissolve powders. This will not only enable the analysis of forensic and regulatory sterility samples but will also support the development of new methodology for the NFCC and FDA.
 

Minimum Performance Requirements/Salient Characteristics:

All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the NFCC prior to purchase.

1. The System shall have all new components, include all necessary hardware to operate with the following specifications:
   
   System to shall be supplied with Steritest Symbio shipping case or equivalent
   System shall include Steritest Equinox Pressure Control Kit or equivalent
   System shall include Steritest Pump Footswitch or equivalent
   System shall include Steritest Symbio Hub Holder or equivalent
   Pump housing must be stainless steel and be compatible with Vaporized Hydrogen Peroxide decontamination cycle. Must be compatible with prefabricated hole in Getinge IsoFlex-R Isolator
   All components must be compatible with use within Getinge IsoFlex-R Isolator.

Trade and Service Specifications

• The system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.
• A minimum one (1) year warranty on all components
• Including parts, labor, travel, telephone support, software updates with an option for yearly service agreements. The Contractor shall be responsible for the system during transit. All costs including parts, labor, travel, and other expenses necessary to repair any machine equipment will be borne solely by the contractor at no additional cost to the U.S. Government. Onsite installation and training. The contractor shall conduct one (1) training session for up to three (3) users on-site. The training shall provide a thorough demonstration of all system/solution functions, maintenance, data administration, and basic troubleshooting. The training may be completed on-site immediately after installation/set-up and on-site measurements demonstrating that no damage or misalignment issues arose during transportation and installation but shall be completed no later than 30 days after installation.
  • Unlimited free telephone, e-mail, and/or FAX technical support for one year.

Place of Performance:

US Food & Drug Administration

 National Forensic Chemistry Center
 6751 Steger Dr.

 Cincinnati, OH 45237
 

Period of Performance:

Performance begins on the date of formal government acceptance and continues through the end of the manufacturer's warranty period.

Quotes are due by email on or before September 22, 2025, by 4:00 P.M. (Eastern Standard Time) and should be sent to brandon.rafus@fda.hhs.gov.