A1b CDC Requirments Document.pdf
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- Solicitation number
- 75D301-26-Q-79196
About this file
This is a CDC Requirements Document for the procurement of Liquid Nitrogen Freezers (LN2s) specified as MVE 1426F-CDC models with Magnetic Lock systems and TEC-3000 compatibility for use in a BSL-4 laboratory environment.
The procurement requires replacement of end-of-life LN2 freezers to provide long-term, secure, monitored storage for Tier 1 Select Agents in compliance with CDC Select Agent Program and high-containment laboratory requirements. The freezers must be vapor-phase LN2 units modified with a welded-on magnetic locking lid system (MVE 1400) that meets CDC physical security standards. Vendors must specify gross and net sample capacity, rack configurations, temperature uniformity and stability specifications with supporting test data, and empty/loaded hold times at specified LN2 fill schedules. The equipment requires integration with CDC's in-house monitoring system and BSL-4 alarm systems via TEC-3000 monitor, with documented communication protocols (Ethernet, RS-232/485 compatible). Temperature probe B must be relocated to the fill valve with alarm logic to detect stuck valve conditions. Vendors must provide trained service representatives capable of on-site installation and perform Installation, Operational, and Performance Qualification (IQOQPQ) testing with documentation of successful completion and calibration certificates traceable to NIST standards. Acceptance testing includes visual inspection of physical modifications, temperature uniformity and stability verification, alarm integration demonstration, security lock operation testing, and documentation review. Evaluation criteria include technical compliance with functional and security requirements, proven experience supplying and servicing LN2 freezers in high-containment environments with references, demonstrated integration capability with sample interface documentation, total cost of ownership, and delivery within three months of contract signature. Equipment must be commercial off-the-shelf modified as necessary to meet CDC standards, with vendor declaration of conformity to applicable safety standards and supporting documentation.
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Other files
| File | Type | Posted |
|---|---|---|
| A19 75D301-26-Q-79196 Amend 003.pdf | ||
| A19 75D301-26-Q-79196 Amend 002.pdf | ||
| A19 RFQ 75D301-26-Q-79196 Amendment 001.pdf | ||
| A19 RFQ 75D301-26-Q-79196.pdf | ||
| AI Use Compliance and Risk Management Plan.docx | DOCX document |
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Text version
CDC Requirments Document
Liquid Nitrogen Freezers (LN2s) MVE 1426F with Magnetic Lock, TEC-3000 compatibility
Procurement Requirements
Purpose
• Replacement of existing LN2s MVE 1426F-CDC with Magnetic Lock MVE 1400 system, TEC-3000 compatibility that are at end-of-life for use in the Viral Special Pathogens Select Agent Program (BSL-4 environment).
• Provide long-term, secure, monitored storage for Tier 1 Select Agents in compliance with CDC Select Agent Program and CDC high-containment laboratory requirements.
Scope
• This document covers functional, security, monitoring, installation, validation, service, documentation, and procurement evaluation criteria for the MVE 1426F- CDC LN2 vapor-phase freezer(s) to be purchased and installed in a BSL-4 laboratory.
1. Functional Requirements
• Freezer Type: MVE 1426F-CDC Vapor-phase liquid nitrogen (LN2) freezer modifed with magnetic lid lock MVE 1400 system adapted for mounting on MVE 1426F to meet CDC requirements suitable for long-term storage of biological materials, explicitly rated for Tier 1 Select Agents, with mounted Magnetic lock lid system, .
• Capacity: Vendor must specify model and make of the proposed freezer, gross and net sample capacity (number of racks/tubes/boxes) and rack configuration options. The Freezers must be compatible with existing systems and be a MVE 1426F-CDC with magnetic lock system, TEC-3000 monitor able to communicate with e-control system and .
• Temperature Performance:
o Nominal operating temperature range: vapor-phase LN2 storage temperatures typical for cryogenic storage.
o Hold time: specify empty and loaded hold time at the stated LN2 fill schedule (vendor to provide data).
o Uniformity: vendor to provide temperature uniformity and stability specifications and supporting test data.
• Lid/Access:
o Locking lid must be mounted and magnetic o Lid design should minimize frost/ice and LN2 loss during normal use.
2. Security and Physical Modifications
• Mounted and compatible Magnetic Locking (Maglock) Lid System for use on :
o MVE 1426F-CDC freezer must be modified with magnetic lid lock MVE 1400 system (factory or post-sale modification by qualified personnel) with a welded-on magnetic locking system that meets CDC Select Agent Program physical security requirements.
3. Monitoring, Alarms, and Interfaces
• Monitoring System:
o MVE 1426F-CDC Freezer must include a monitoring system capable of communicating with CDC’s in-house monitoring system. Vendor must document communication protocol, network interface (e.g., Ethernet, RS-232/485), data formats, and any middleware required.
• Temperature Probe and Valve Monitoring:
o Temperature probe B shall be relocated into the fill valve and wired into the fill valve alarm software so that a stuck valve condition is detected and alarms are generated in a timely manner. Vendor must describe probe placement, wiring, and logic for the alarm.
• High-Containment Alarm Integration:
o MVE 1426F-CDC Freezer must communicate with the laboratory’s High Containment (BSL-4) alarm system using a TEC 3000 monitor.
4. Service, Installation, and Personnel Requirements
• Service Personnel:
o Vendor must provide trained service representatives who are authorized and capable of installing and servicing these modified LN2 freezers.
• On-Site Installation:
o Vendor to provide documentation of successful IQOQPQ following installation.
• Warranty:
o State warranty coverage period for equipment and modifications, including labor and parts. Specify remedies for defects discovered during warranty period.
5. Compliance and Documentation
• Regulatory Compliance:
o Equipment must be commercial off-the-shelf (COTS) modified as necessary to meet CDC specialized high-containment laboratory requirements and Select Agent Program standards.
o Vendor must declare conformity with applicable safety standards and provide supporting documentation (e.g., materials, pressure/vacuum ratings, CE/UL listings if applicable).
6. Acceptance Criteria and Testing Protocol
• Acceptance tests to be completed before final acceptance and payment:
o Visual inspection and verification of physical modifications (welded magnetic lock).
o Temperature uniformity and stability tests with instrumentation traceable to NIST (or equivalent); vendor to supply calibration certificates.
o Alarm integration verification: exercise alarms and demonstrate notification to CDC’S in-house monitoring system and BSL-4 alarm system; demonstrate probe B functionality (simulate stuck valve).
o Security test: lock operation, and access control behavior.
o Documentation review: all manuals, schematics, and IQOQPQ reports delivered and approved.
7. Procurement Evaluation Criteria
• Technical compliance: ability to meet functional, security, and monitoring requirements.
• Proven experience: vendor track record of supplying and servicing LN2 freezers in high-containment environments; references required.
• Integration readiness: demonstrated capability to integrate with CDC’S in-house monitoring system and BSL-4 alarm systems, including sample interface documentation.
• Total cost of ownership: equipment cost, modification costs, spare parts
• Delivery and lead time: within 3 months of the contract signature.
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