Requirements Document.docx

STATEMENT OF WORK

Purchase of two (2) Thermal Gravimetric Analyzer & Differential Scanning Calorimeter (TGA/DSC) Thermal Analysis Systems for IRVLMP and NYLMP

Background The regulatory laboratories of the Food and Drug Administration (FDA), conduct a range of chemical analyses on pharmaceutical products to determine if they meet regulatory requirements. A TGA/DSC Thermal Analysis System is necessary to complete United States Pharmacopeia analyses on pharmaceutical regulatory samples.

Purpose/Objective Purchase of two (2) TGA/DSC Thermal Analysis Systems, one each for the Irvine Medical Products Laboratory (IRVLMP), Irvine, CA, and the New York Medical Products Laboratory (NYLMP), Jamaica, NY.

Scope FDA IRVLMP and NYLMP each require one (1) TGA/DSC Thermal Analysis System that meets or exceeds the requirements below.

Minimum Requirements The contractor shall provide two (2) Metter Toledo TGA/DSC 3+ Large Furnace (LF) Thermal Analysis Systems with STARe software. The TGA/DSC system shall meet or exceed the following requirements:

I. TGA Requirements

· TGA must include a thermocouple in direct contact with the sample crucible to measure heat flow (DSC) information about the sample simultaneously with mass change.

· TGA furnace and balance must be arranged horizontally to minimize thermal gradients within the furnace and to improve transfer of gases for evolved gas analysis.

· TGA must have a temperature range from ambient to 1100°C.

· TGA must have a true parallel guided internal balance with a 5000mg sample capacity and a continuous resolution of 0.1 µg without range switching. Balance should be capable of being certified for both span and linearity.

· TGA must include an automatic sample changer. Sample changer should use a mechanical robotic gripper for handling crucibles and should be capable of handling a large variety of sample crucibles.

· TGA must include option of an automatic gas accessory controlled by the software to control both the flow and switching of up to three purge gases during an experiment.

II. DSC Requirements

· DSC should have a temperature range from ambient room temperature to 1100°C.

· DSC should have a sensitivity of 0.1mW or better.

· DSC should utilize a sensor that is available as a replacement part and can be easily replaced by the user without the need to replace the entire furnace/cell assembly.

· DSC should utilize a sensor that is ceramic coated for chemical resistance.

· DSC must include an automatic sample changer with at least 34 positions and a lid-piercing kit for working with samples that react with the atmosphere. This kit allows the robot to automatically pierce sealed aluminum crucibles just prior to their insertion into the furnace.

· DSC must be able to handle crucible sizes ranging from 20-900µL.

III. Chiller

· One (1) chiller with air-cooled refrigerating unit and circulation pump with the following specifications:

· Must be compatible with Metter Toledo TGA/DSC 3+ (LF) Thermal Analysis System (Product ID# 30139250)

· Stainless Steel Case

· Power Supply: 115 Volts 60Hz, 8.5A

· Operating Temperature Range: -20 to 40 °C

· Dimensions (W x D x H): 280 x 490 x 424 mm

· Cooling Capacity @ 15°C: 0.6kW or better IV. Computer and Data Acquisition Software

· Two (2) compatible computers running Windows 11 Pro OS (64-bit) or newer and monitor shall be included to run software and instrument components to include the DSC/TGA with the minimum specifications:

· CPU: 3 GHz

· RAM: 8 GB

· Free Disk Space: 7 GB

· Network Port: 2 ports

· One (1) software upgrade package to update Mettler Toledo STARe Version 16.30 program to its current released version.

· Software upgrade must be compatible with STARe Version 16.30 and Metter Toledo TGA/DSC 3+ (LF) Thermal Analysis System (Product ID# 30139250)

· One (1) complete thermal analysis software package and license that is compatible with Metter Toledo TGA/DSC 3+ (LF) Thermal Analysis System (Product ID# 30139250)

· Software package and license must be the current released version.

· Software must include options for TGA evaluation, method window, experimental window, data integrity, mathematics, quality control, and conditional experimental termination.

Trade and Service Specifications

1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

2. FOB Point destination to include inside delivery at IRVLMP (Irvine, CA) and NYLMP (Jamaica, NY) and clean-up of area after installation.

3. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

4. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

5. Sufficient familiarization training for 3-5 users at each delivery-onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training.

6. The Contractor shall provide installation and qualification with a trained and certified field service engineer. Calibration standards and consumables used for the installation are to be included.

Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Deliverables or Delivery Schedule

Two (2) TGA/DSC Thermal Analysis Systems; one each for IVRLMP, Irvine, CA and NYLMP, Jamaica, NY meeting or exceeding the requirements stated above will be delivered, inside delivery required, in accordance with the following:

NYLMP

NYLMP

NYLMP

Inspection and Acceptance

Upon arrival, the shipping container(s) will be inspected for damage. If significant damage is observed, such as a hole going through the container and packing to reach the enclosure itself, it will be rejected. All equipment shall be new, not used or refurbished.

Delivery Location(s) and Place of Performance

POC: To be identified at time of award.

FDA/IRVLMP

19701 Fairchild Rd.

Irvine, CA 92612

POC: To be identified at time of award.

FDA/NYLMP

158-15 Liberty Ave.

Jamaica, NY 11433

Period of Performance

The period of performance begins the date of contract award. All requirements shall be completed no later than 120 days after contract award.

Delivery will be accepted during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM Pacific Time for IRVLMP and 8:00am – 4:00pm Eastern Time for NYLMP.