SOW- OC-2026-134494.pdf

STATEMENT OF WORK

REQUIREMENT TITLE

One (1) Steritest Symbio ISL 2 Med US

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.

PURPOSE

NFCC regularly provides support to CDER, CBER, and various offices within the Office of Inspections and Investigations, such as the Office of Criminal Investigations and the

Office of Import Operations, as well as other agencies outside of the FDA in the analysis of sterile drugs and medical products that have been suspected of being harmful to consumers. The NFCC acquired a new state of the art Getinge ISO-FLEX-R isolator to perform aseptic operations, such as sterility testing. The Steritest Symbio pump is designed to fit within the isolator cut out and provides an easy-to-use design, reliable in nature, ergonomically designed, and user-friendly way to perform sterility testing of both small and large volume parenteral solutions.

Order Type

FDA intends to award a single firm-fixed-price order for the items described below.

SCOPE

The National Forensic Chemistry Center (OC/OCS/OSLES/NFCC) requires the purchase of 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 without rework. The system must meet or exceed the following requirements:

I. 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:

a) System to shall be supplied with Steritest Symbio shipping case or equivalent

b) System shall include Steritest Equinox Pressure Control Kit or equivalent

c) System shall include Steritest Pump Footswitch or equivalent

d) System shall include Steritest Symbio Hub Holder or equivalent

2) Pump housing must be stainless steel and be compatible with Vaporized Hydrogen

Peroxide decontamination cycle.

3) Must be compatible with prefabricated hole in Getinge IsoFlex-R Isolator.

4) All components must be compatible with use within Getinge IsoFlex-R Isolator.

II. 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.

Shipping Destination (FOB Destination)

One (1) system to be shipped to the following laboratory:

US Food & Drug Administration

National Forensic Chemistry Center

6751 Steger Dr.

Cincinnati, OH 45237

POC Name: Katie Penno

Period of Performance

Equipment shall be delivered no later than 90 days after contract award. The Period of

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