Attachment VI - Technical Compliance Matrix.xlsx

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Attached to
"New" Anton Paar Multiwave 5001 microwave digestion system or equivalent
Solicitation number
OC-2026-134415
Issued by

About this file

This is a Technical Compliance Matrix that serves as an evaluation tool for vendors responding to a microwave digestion system solicitation issued by the FDA's Office of Cosmetics and Colors. The matrix requires vendors to indicate Yes or No compliance with 43 discrete technical, operational, and service requirements and provide supporting documentation for each response.

The required system must be a new, turn-key microwave digestion system capable of digesting samples in concentrated acids (nitric, hydrochloric, sulfuric) for trace element analysis and color additive/cosmetic product analysis. Key technical specifications include: processing capability for at least 20 samples simultaneously, vessel sizes from 50-80 mL in multiple types (disposable glass, Teflon, quartz), temperature maintenance up to 300°C and pressure rating of 100 bar, contactless temperature and pressure sensors, magnetic stirring capabilities, forced-air cooling, and solvent extraction capabilities. The vendor must provide fully developed software enabling easy method transfer, all necessary hardware and accessories without cost to the Government, onsite end-user training covering operation, maintenance, software use, and cleaning procedures for up to three users over one business day, and delivery with installation demonstration. Support requirements include a one-year manufacturer's warranty with one annual preventative maintenance visit, two optional warranty years with unlimited onsite visits and phone support at no additional cost, and 24-hour response time for service issues with complete onsite repairs within 3-5 days. The vendor is responsible for all travel, parts, labor, consumables, installation expenses, demonstration chemicals/reagents, and insured shipping to the FDA facility in College Park, Maryland.

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Instructions

FieldPurposeRequired EntryExample
Comply (Yes/No)Indicates whether the offered system meets the stated requirement.Yes or NoYes
Vendor Response / Offered SpecificationDescribe how the proposed system meets the requirement and state offered values/features.Narrative / specificationMaximum operating pressure: 100 bar
Supporting Reference (Page / Document)Cite the exact proposal, brochure, manual, or data-sheet location supporting the response.Document title and page/sectionProduct Data Sheet, p. 6
Offeror Name / Make/ModelIdentify the bidder and proposed system.TextVendor Name / Model XYZ
Source BasisThe matrix requirements are based on Attachment I - Statement of Work.N/AAttachment I

Include company Name

Attachment VI - Technical Compliance Matrix
Microwave Digestion System - In accordance with Attachment I - Statement of Work
Offeror Name:Proposed Make/Model:
Authorized Representative:Date:
Offeror Instructions: Indicate Yes or No for each requirement. For each “Yes” response, identify the offered feature/specification and cite the supporting proposal, brochure, manual, or data-sheet page. Explain any “No” response in the Vendor Response column.
IDSOW SectionRequirement / SpecificationComply
(Yes/No)Vendor Response / Offered SpecificationSupporting Reference

(Page / Document)

A-01Description of PurposeThe 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.
SC-01Salient CharacteristicsThe microwave digestion system shall be new, not used or refurbished, or previously used for demonstration.
SC-02Salient CharacteristicsThe microwave digestion system shall be a turn-key solution.
SC-03Salient CharacteristicsThe Contractor shall be responsible for providing all hardware, accessories, parts, and software required to meet operational performance without cost to the Government.
TR-01Salient Characteristics - TrainingThe Contractor shall provide qualified personnel to conduct the end-user training for the microwave digestion system.
TR-02Salient Characteristics - TrainingThe 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.
TR-03Salient Characteristics - TrainingThe 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.
TR-04Salient Characteristics - TrainingThe end-user training for the microwave digestion system shall be conducted at the installation site of the instrument.
TC-01Salient Characteristics - TechnicalThe 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.
TC-02Salient Characteristics - TechnicalThe microwave digestion system shall have solvent extraction capabilities.
TC-03Salient Characteristics - TechnicalThe microwave digestion system shall provide adaptable vessel holders and vessels allowing for both high throughput and high performance/temperature digestions.
TC-04Salient Characteristics - TechnicalThe microwave digestion system shall have contactless temperature and pressure sensors to allow continuous measurement and precise control of digestion and solvent extraction conditions.
TC-05Salient Characteristics - TechnicalThe 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.
TC-06Salient Characteristics - TechnicalThe microwave digestion system and its vessels shall be capable of maintaining a minimum temperature of 250 °C continuously for the specified digestion duration.
TC-07Salient Characteristics - TechnicalThe microwave digestion system shall have magnetic stirring capabilities during the digestion process to handle oily or inhomogeneous matrices.
TC-08Salient Characteristics - TechnicalThe microwave digestion system shall come with integrated forced-air cooling to cool vessels after heating cycles.
TC-09Salient Characteristics - TechnicalThe 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.
TC-10Salient Characteristics - TechnicalThe microwave digestion system shall be able to digest at least 20 samples at the same time.
TC-11Salient Characteristics - TechnicalVessels shall provide flexibility for processing samples with varying masses and incorporate controlled pressure release management during operation.
TC-12Salient Characteristics - TechnicalVessels shall support multiple sample preparation applications, including microwave digestion and solvent extraction, to provide flexibility during analysis.
TC-13Salient Characteristics - TechnicalVessels 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.
TC-14Salient Characteristics - TechnicalThe 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.
TC-15Salient Characteristics - TechnicalThe 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.
PM-01Preventative Maintenance and System UpdatesOne annual preventative maintenance (PM) visit shall be completed one month prior to the end of the warranty period.
PM-02Preventative Maintenance and System UpdatesThe Contractor shall be responsible for covering all travel, parts, labor, and consumables required to complete the annual preventative maintenance services.
PM-03Preventative Maintenance and System UpdatesAll 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.
PM-04Preventative Maintenance and System UpdatesThe PM shall include at minimum the cleaning of the equipment, replacement of consumable parts, calibration, and updates to the software and firmware.
PM-05Preventative Maintenance and System UpdatesThe 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.
PM-06Preventative Maintenance and System UpdatesThe one-year manufacturer’s warranty and two option years must cover at least one annual preventative maintenance (PM) performed by an authorized service technician.
PM-07Preventative Maintenance and System UpdatesDuring the extended warranty and option years, the Contractor shall provide unlimited on-site visits and phone support.
PM-08Preventative Maintenance and System UpdatesDuring the extended warranty and option years, travel, labor, consumables, and repairs shall be provided at no additional cost to the Government.
PM-09Preventative Maintenance and System UpdatesThe 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.
IN-01InstallationThe systems shall be delivered with all necessary supplies and accessories required for installation and start-up.
IN-02InstallationThe Contractor shall demonstrate upon installation that the system is fully functional and meets all salient characteristics.
IN-03InstallationAny expenses, including chemicals and reagents, related to the installation demonstration are at the expense of the contractor.
PK-01Packaging and MarkingThe instrument shall be delivered with all necessary supplies and accessories required for the installation and start-up.
PK-02Packaging and MarkingCost of installation and user-familiarization training should be included in the price.
PK-03Packaging and MarkingThe instrument shall be covered under warranty for one year after installation.
PK-04Packaging and MarkingVendor 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.
Source: Attachment I - Statement of Work for Microwave Digestion System. Requirements have been separated into discrete compliance checkpoints where needed for evaluation.

File details come from the government source that posted it. Updated .