SOW Ultrawave Digestion System new service agreement -Final-.docx

Statement of Work (SOW)

Service Contract for OCAC’s Milestone UltraWAVE 3 Microwave Digestion System Background Batch certification of color additives is a regulatory premarket enforcement function. During the certification process, analyses are performed to determine whether each batch meets the specifications listed in the Code of Federal Regulations (CFR). Results are used to certify or reject batches of color additives intended for use in foods, drugs, and cosmetics in the U.S.

The microwave digestion equipment is an UltraWAVE3 single reaction chamber (SRC) with serial number 23090033. This is the primary instrument used to prepare color additives for elemental analysis by inductively coupled plasma (ICP) – mass spectrometry (MS) at the Division of Color Certification and Color Technology (DCCT) . The digestion process breaks down color additives into a clear, particle-free, and acidic solution. Service support for microwave digestion system at the DCCT ended on July 14, 2026.

Reliable and timely maintenance and repairs of the microwave digestion system is critical to the mission of the Color Certification Program.

Description of Work The following is a request for the acquisition of a new service agreement for the microwave digestion unit, which includes 24-72 hour on-site response time during normal business hours, unlimited labor and travel during normal business hours and unlimited emergency calls. Milestone, Inc. is the only factory-trained and authorized service provider for all Milestone Inc equipment, including the UltraWAVE 3 digestion system.

· The UltraWAVE 3 SRC microwave digestion unit manufactured by Milestone with the following configuration:

· Single Reaction Chamber (SRC) technology

· User interface: integrated touchpad using easyCONTROL 3 software

· Digestion chamber: Stainless steel with PTFE-TFM liner and cover

· All wetted components made of PTFE-TFM, fully compatible with acid mixtures to prevent/minimize corrosion

· Utilize a 20-position vial rack for vessels capable of 15 mL volumes, composed of PTFE-TFM or Quartz

· Heating system: water-cooled magnetron with noiseless operation

· Temperature control achieved through easyTEMP sensor to control digestion process

The equipment is essential to the Color Technology Team (CTT) in supporting the mission-critical Color Certification Program. CTT uses the equipment to digest color additives for heavy metals analysis via ICP-MS. This equipment is used in workflows to achieve the following:

· to confirm the identity and level of CFR-specified impurities in color additives submitted for batch certification

· to characterize reference standards synthesized in-house used to determine CFR-specified impurities in color additives submitted for batch certification

Specification necessary to meet the purpose/objectives:

The Division of Color Certification and Color Technology (DCCT) is requesting a new service agreement for the UltraWAVE 3 SRC microwave digestion unit that meets or exceeds the requirements/specification listed below.

· Service and Support:

· The Contractor shall provide at least one yearly preventive maintenance service.

· The Contractor shall provide unlimited phone support.

· The Contractor shall cover all travel, non-consumable parts, and labor at no additional cost to the Government.

· Written reports shall be provided for all on-site service work within 7 business days of completion.

· Repairs

· Repairs shall be performed on-site at CPK2 (see Section 9, Place of Performance) with parts, labor, and travel costs covered by the Contractor.

· Requests for repair visits are unlimited. The Contractor shall provide service and application support within 2 business days and on-site repairs within 7 business days.

· Repair services shall be provided by trained engineers/technicians/personnel authorized by Milestone Inc.

· Technical support shall be available by telephone as needed within the hours of 8 am – 5 pm.

· If parts must be shipped, the Contractor shall provide protective packaging supplies and cover all shipping costs.

Contractor Provided Special Material Requirements The contractor shall supply the necessary tools to perform the services and repairs. The contractor shall provide all parts required for maintenances and repairs.

Security This equipment is located in a government-secured building as specified in Section 9. Service engineer will adhere to security screening upon arrival and will be escorted into the building by personnel from OCAC. Additional security requirements will be communicated to visiting contractor when a visit is scheduled.

Travel The contractor will service the equipment at the FDA site specified in Section 9. Any travel expenses incurred by the service engineers will be covered by the contractor.

Evaluation of Vendors

Technical Experience

Offeror shall demonstrate the ability to provide Milestone Inc certified engineers for both on site and phone support. On-site engineers must regularly perform on site repairs to Milestone Ultrawave 3 single reaction chamber (SRC) microwave digestion unit. Phone support technicians must provide unlimited technical phone support for Milestone Ultrawave 3 SRC microwave digestion unit.

Location and Place of Performance

1. The vendor shall provide service to the following location:

Attention to: Kristen Reese, PhD and Nebebech Belai, PhD U.S. Food and Drug Administration University Station (CPK2) 4300 River Road College Park, MD 20740 Room 1081

· Service shall be scheduled with the Project Officers: Kristen Reese and Nebebech Belai.

· The Contractor shall perform service during the normal business hours (from 8:00 AM to 5:00 PM). Other times of performance shall be discussed and scheduled with the Project Officers: Kristen Reese and Nebebech Belai.

· Contractor shall perform maintenance and/or repairs as required by Project Officers: Kristen Reese and Nebebech Belai.

Inspection and Acceptance The inspection and acceptance of the service will be handled by Kristen Reese and Nebebech Belai.

Overall Price The offeror shall provide the best overall value for the FDA in terms of cost, relevant experience and approach.

Period of Performance The period of performance will be a 12 month base year

Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

· New Year’s Day

· Martin Luther King Day

· President’s Day

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veteran’s Day

· Thanksgiving Day

· Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).