FDA-FY22-SS-1254152.pdf

FDA-FY22-SS-1254152

Notice of Intent to Issue a Sole Source Purchase Order a new in-situ raman reaction probe and spectrometer with delivery, installation, training and preventive maintenance service agreement.

The Food and Drug Administration intends to issue a sole-source purchase order to Mettler Toledo Auto Chem, Inc., located at 6708 Alexander Bell Drive, Columbia Maryland 21046. The anticipated purchase order is for a new in situ raman reaction probe and spectrometer with delivery, installation, training and preventive maintenance service agreement. The 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

System Description:

The system (Raman spectrometer with- in situ probe) shall be able to work with round bottom flask necks for monitoring reactions between the range of 100 to 3000 cm-1.

The system shall have contact as well as non-contact modes for in situ reaction monitoring. Length and diameter of the non-contact probe should be in the range of 150 mm and 47 mm, respectively. The probe shall be stable within the temperature range of 0 ˚C and 100 ˚C.

The system shall be compatible with iC Raman software for data processing.

The system shall not utilize any cryogens, no water cooling, no additional venting requirements and no compressed gasses.

The system shall have a BallProbe with an interchangeable immersion optic.

The Probe shall be compatible with temperatures within the range of -40 to 300˚C and have a pressure rating of at least 413 barg.

Probe wetted material shall be either Gold or Sapphire.

The unit shall come with a Fiber head.

The system shall come with a computer desktop/ laptop with windows 10.

The system shall fit on a traditional laboratory benchtop, dimensions within 60 x 90 x 70 cm (H/W/D).

The portability of the In-situ reaction Raman probe is defined as being completely transportable by a standard-sized lab cart.

The In-situ reaction Raman probe system shall include a power supply, 785 nm laser and detector modules, PCBs, a LAN device and fiber-based sampling technology.

Optional maintenance plans for second and third year.

Below are specific technical requirements for the desired unit:

For Use In Laboratory

Software iC Raman 7

Optical Range (Base Unit) at least 100cm-1 to 3200cm-1

Excitation Wavelength 785 nm

Excitation Power at least a Max: 400mW; Standard: <250mW

Detector 2-stage TE Cooled CCD

Fiber Connections FC/PC (both excitation and collection)

Base Unit Temperature Range – at least a range of 5 °C – 35 °C

Laser Classification Class IIIB laser. Compliant with 21 CFR 1040.10 and 1040.11

Power 100-240 VAC, 50/60Hz, 1.5A

Sampling Technology Fixed or Interchangeable Probe

Probe Wetted Material Suggested C-276, Sapphire, Gold

Probe Temperature Range at least -40°C to 300°C

Probe Pressure Rating at least 413 barg [6,000 psig]

Installation Requirements

Any PCs networked to the instrument shall have .NET 3.5 in Windows Features installed.

The instrument shall be compatible with the environmental requirements of the area of intended use (provided by OTR) to assure functional qualification. These requirements include:

-- An ambient temperature of 5 C – 35˚ C

-- An ambient humidity of < 60%, non-condensing

-- No exposure of the system to direct airflow or extreme temperature ramps.

Requirement of Services

• The vendor shall install the instrument and software in the designated lab space according to the installation requirements above.

• The vendor shall perform and document IQ/OQ.

• The vendor shall provide software / hardware familiarization and an on-site training course at the place of instrument performance for 2-3 people.

• The vendor shall provide free unlimited technical support for the life of the instrument: phone AND internet contacts.

• A standard warranty shall apply, including at least 1 year for parts, travel, and labor from the date of IQ/OQ completion.

• The entire system shall be warranted for parts and labor for 12 months from the date of installation. The vendor shall provide a copy and pricing for any available extended warranties and service contracts. The vendor shall be capable of servicing the instrument through the extended warranty or service contract.