Attachment VI - Technical Compliance Matrix.xlsx
XLSX spreadsheet 16 KB Posted
- Solicitation number
- OC-2026-134415
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.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Attachment II - Pricing Sheet - Multiwave 5001.xlsx | XLSX spreadsheet | |
| Attachment V - 52.222-48 Exemption from Application of the Service Contract Labor Standards.docx | DOCX document | |
| Attachment III - Buy American Act Certification.docx | DOCX document | |
| Attachment IV - Past_Performance_Reference_Sheet.docx | DOCX document | |
| Attachment VII- Combined Synopsis Solicitation - Multiwave 5001.docx | DOCX document | |
| Attachment I - Statement of Work - Microwave Digestion System.docx | DOCX document |
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Instructions
| Field | Purpose | Required Entry | Example |
| Comply (Yes/No) | Indicates whether the offered system meets the stated requirement. | Yes or No | Yes |
| Vendor Response / Offered Specification | Describe how the proposed system meets the requirement and state offered values/features. | Narrative / specification | Maximum 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/section | Product Data Sheet, p. 6 |
| Offeror Name / Make/Model | Identify the bidder and proposed system. | Text | Vendor Name / Model XYZ |
| Source Basis | The matrix requirements are based on Attachment I - Statement of Work. | N/A | Attachment 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. | ||||
| ID | SOW Section | Requirement / Specification | Comply | |
| (Yes/No) | Vendor Response / Offered Specification | Supporting Reference |
(Page / Document)
| A-01 | Description of Purpose | 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. |
| SC-01 | Salient Characteristics | The microwave digestion system shall be new, not used or refurbished, or previously used for demonstration. |
| SC-02 | Salient Characteristics | The microwave digestion system shall be a turn-key solution. |
| SC-03 | Salient Characteristics | The Contractor shall be responsible for providing all hardware, accessories, parts, and software required to meet operational performance without cost to the Government. |
| TR-01 | Salient Characteristics - Training | The Contractor shall provide qualified personnel to conduct the end-user training for the microwave digestion system. |
| TR-02 | Salient Characteristics - Training | 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. |
| TR-03 | Salient Characteristics - Training | 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. |
| TR-04 | Salient Characteristics - Training | The end-user training for the microwave digestion system shall be conducted at the installation site of the instrument. |
| TC-01 | Salient Characteristics - Technical | 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. |
| TC-02 | Salient Characteristics - Technical | The microwave digestion system shall have solvent extraction capabilities. |
| TC-03 | Salient Characteristics - Technical | The microwave digestion system shall provide adaptable vessel holders and vessels allowing for both high throughput and high performance/temperature digestions. |
| TC-04 | Salient Characteristics - Technical | The microwave digestion system shall have contactless temperature and pressure sensors to allow continuous measurement and precise control of digestion and solvent extraction conditions. |
| TC-05 | Salient Characteristics - Technical | 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. |
| TC-06 | Salient Characteristics - Technical | The microwave digestion system and its vessels shall be capable of maintaining a minimum temperature of 250 °C continuously for the specified digestion duration. |
| TC-07 | Salient Characteristics - Technical | The microwave digestion system shall have magnetic stirring capabilities during the digestion process to handle oily or inhomogeneous matrices. |
| TC-08 | Salient Characteristics - Technical | The microwave digestion system shall come with integrated forced-air cooling to cool vessels after heating cycles. |
| TC-09 | Salient Characteristics - Technical | 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. |
| TC-10 | Salient Characteristics - Technical | The microwave digestion system shall be able to digest at least 20 samples at the same time. |
| TC-11 | Salient Characteristics - Technical | Vessels shall provide flexibility for processing samples with varying masses and incorporate controlled pressure release management during operation. |
| TC-12 | Salient Characteristics - Technical | Vessels shall support multiple sample preparation applications, including microwave digestion and solvent extraction, to provide flexibility during analysis. |
| TC-13 | Salient Characteristics - Technical | 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. |
| TC-14 | Salient Characteristics - Technical | 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. |
| TC-15 | Salient Characteristics - Technical | 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. |
| PM-01 | Preventative Maintenance and System Updates | One annual preventative maintenance (PM) visit shall be completed one month prior to the end of the warranty period. |
| PM-02 | Preventative Maintenance and System Updates | The Contractor shall be responsible for covering all travel, parts, labor, and consumables required to complete the annual preventative maintenance services. |
| PM-03 | Preventative Maintenance and System Updates | 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. |
| PM-04 | Preventative Maintenance and System Updates | The PM shall include at minimum the cleaning of the equipment, replacement of consumable parts, calibration, and updates to the software and firmware. |
| PM-05 | Preventative Maintenance and System Updates | 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. |
| PM-06 | Preventative Maintenance and System Updates | 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. |
| PM-07 | Preventative Maintenance and System Updates | During the extended warranty and option years, the Contractor shall provide unlimited on-site visits and phone support. |
| PM-08 | Preventative Maintenance and System Updates | During the extended warranty and option years, travel, labor, consumables, and repairs shall be provided at no additional cost to the Government. |
| PM-09 | Preventative Maintenance and System Updates | 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. |
| IN-01 | Installation | The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. |
| IN-02 | Installation | The Contractor shall demonstrate upon installation that the system is fully functional and meets all salient characteristics. |
| IN-03 | Installation | Any expenses, including chemicals and reagents, related to the installation demonstration are at the expense of the contractor. |
| PK-01 | Packaging and Marking | The instrument shall be delivered with all necessary supplies and accessories required for the installation and start-up. |
| PK-02 | Packaging and Marking | Cost of installation and user-familiarization training should be included in the price. |
| PK-03 | Packaging and Marking | The instrument shall be covered under warranty for one year after installation. |
| PK-04 | Packaging and Marking | 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. |
| 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 .