Attachment I - Statement of Work - Microwave Digestion System.docx

ATTACHMENT I - STATEMENT OF WORK

FOR

MICROWAVE DIGESTION SYSTEM

Description of Purpose This request is for the Division of Color Certification and Technology (DCCT), within the Office of Cosmetics and Colors, to acquire a new microwave digestion system. This equipment is necessary to allow the preparation of FDA-regulated color additives and cosmetic samples for elemental analysis by inductively coupled plasma – mass spectrometry (ICP-MS). The equipment will meet the requirements for color additive or cosmetic product digestion in preparation for analysis of a wide range of elemental analytes from trace to major component levels in these products. Additionally, the equipment will be used for the extraction of polycyclic aromatic hydrocarbons (PAHs) and for the digestion of samples that are difficult to break down using our current microwave digestion systems.

The instrument shall have a fully developed software package to allow the instrument to perform up to its design specifications and facilitate an easy transfer of existing methods.

DCCT staff will use the equipment for the following purposes:

· For analysis of color additives with regulatory limits on toxic and other elements

· For extracting of total PAHs from D&C Black No. 2 and D&C Black No. 3

· For digestion of copper phthalocyanine and phthalocyanine green (require >250 °C)

· For the development of new methods for quantification of low-level (parts per billion) heavy metals primary arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), manganese (Mn), and mercury (Hg) in various color additives and cosmetics

· For characterization of National Institute of Standards and Technology (NIST) standard materials or reference standard materials prepared in-house

· For the analysis of samples obtained during inspections Background DCCT is responsible for chemical measurements leading to certification or rejection of batches of color additives intended for use in food, drugs, cosmetics, and medical devices in the U.S. 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 identity and specifications described by the listings in the Code of Federal Regulations (CFR) as well as FDA's Closer to Zero (C2Z) initiative approach to reducing exposure to toxic elements in regulated products. The trace elements in the color additives are quantitated with ICP-MS following the dissolution of the metals into solution using microwave-assisted acid digestion.

Salient Characteristics The new microwave digestion system shall meet the following requirements/specifications listed below:

· The microwave digestion system shall be new, not used or refurbished, or previously used for demonstration.

· The microwave digestion system shall be a turn-key solution.

· The Contractor shall be responsible for providing all hardware, accessories, parts, and software required to meet operational performance without cost to the Government.

· The Contractor shall provide qualified personnel to conduct the end-user training for the microwave digestion system.

· The end-user training for the microwave digestion system shall cover, at a minimum, operation of the instrument, routine maintenance procedures, use of associated applications and software, and proper cleaning procedures.

· The end-user training for the microwave digestion system shall be conducted onsite over one (1) business day for up to three (3) end users during normal business hours.

· The end-user training for the microwave digestion system shall be conducted at the installation site of the instrument.

· The microwave digestion system shall be capable of digesting samples in concentrated acids such as nitric acid, hydrochloric acid or sulfuric acid for the purpose of trace element analysis.

· The microwave digestion system shall have solvent extraction capabilities.

· The microwave digestion system shall provide adaptable vessel holders and vessels allowing for both high throughput and high performance/temperature digestions.

· The microwave digestion system shall have contactless temperature and pressure sensors to allow continuous measurement and precise control of digestion and solvent extraction conditions.

· The microwave digestion system shall be able to maintain a controlled temperature and pressure of up to 300 °C and 100 bar, which are necessary in digesting color additives and cosmetic products that contain mineral compounds.

· The microwave digestion system and its vessels shall be capable of maintaining a minimum temperature of 250 °C continuously for the specified digestion duration.

· The microwave digestion system shall have magnetic stirring capabilities during the digestion process to handle oily or inhomogeneous matrices.

· The microwave digestion system shall come with integrated forced-air cooling to cool vessels after heating cycles.

· The microwave digestion system shall accommodate various sizes of vessels from 50 to 80 mL and offer variety of vessel types including disposable glass, Teflon, or quartz.

· The microwave digestion system shall be able to digest at least 20 samples at the same time.

· Vessels shall provide flexibility for processing samples with varying masses and incorporate controlled pressure release management during operation.

· Vessels shall support multiple sample preparation applications, including microwave digestion and solvent extraction, to provide flexibility during analysis.

· Vessels shall be designed for simple and efficient assembly and support future expansion or upgrades of rotor and vessel configurations to accommodate evolving sample preparation procedures and various samples with a wide range of matrices.

· The rotor and vessels shall be rated for a minimum operating temperature of 250 °C and designed to safely withstand pressures of up to 100 bar.

· The microwave digestion system shall not have constraints on sample types that can be digested together in a single batch, including but not limited to dye samples of any color used for batch color certification and method development.

Preventative Maintenance and System Updates One annual preventative maintenance (PM) visit shall be completed one month prior to the end of the warranty period. The Contractor shall be responsible for covering all travel, parts, labor, and consumables required to complete these services. All service conducted on the complete systems, including maintenance and repairs, must be performed by qualified engineers/technicians that are trained and certified following manufacturer specifications to service the specific models offered and using original manufacturer parts.

The PM shall include at minimum the cleaning of the equipment, replacement of consumable parts, calibration, and updates to the software and firmware. The Contractor shall assign a representative to serve as a point of contact in addressing issues with any system component and provide a services report after completion of the PM.

The one-year manufacturer’s warranty and two option years must cover at least one annual preventative maintenance (PM) performed by an authorized service technician. During the extended warranty and option years, the Contractor shall provide unlimited on-site visits and phone support. Additionally, travel, labor, consumables, and repairs shall be provided at no additional cost to the Government. The vendor shall provide phone, online, on-site service and phone and online application support with a 24-hour response time and complete on-site repairs within 3-5 days at no additional cost to the Government.

Installation The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The Contractor shall demonstrate upon installation that the system is fully functional and meets all salient characteristics. Any expenses, including chemicals and reagents, related to the demonstration are at the expense of the contractor.

Packaging and Marking

1. The instrument shall be delivered with all necessary supplies and accessories required for the installation and start-up. Cost of installation and user-familiarization training should be included in the price.

2. The instrument shall be covered under warranty for one year after installation. Vendor should provide insured shipping to:

U.S. Food and Drug Administration, CPK2 Office of Cosmetics and Colors, Room 1059 4300 River Road College Park, MD 20740 Inspection and Acceptance The inspection and acceptance of the instrument will be handled by any of the following individuals: To be determined at award