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Specialized cGMP Cleanroom Cleaning Services

Active
Federal

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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This subcontract for Specialized cGMP Cleanroom Cleaning Services involves providing expert cleaning for compounding pharmacies and cGMP manufacturing facilities at the National Institutes of Health Clinical Center in Bethesda. The primary objective is to maintain strict contamination control and regulatory compliance within pharmaceutical environments through the use of cleanroom-grade agents, HEPA vacuums, and specialized personal protective equipment. To qualify for this engagement, the provider must hold ISO 9001:2015 certification and demonstrate strict adherence to current Good Manufacturing Practice standards. The ultimate goal of the contract is the delivery of a fully compliant and certified cleanroom environment that meets all necessary health and safety regulations for the agency.

General Info

Subcontract for ISO 9001 certified cGMP cleanroom cleaning services at NIH Clinical Center.

NAICS

561720 - Janitorial Services

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

This scope was carved out of NOI-CC-26-001957.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Notice of Intent to Sole Source – Advanced Cleanroom Microclean

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Timeline

Posted

subcontract

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Performs specialized cleaning of cGMP manufacturing facilities and compounding pharmacies for prime contractors on NIH Clinical Center projects. Executes cleaning protocols to ensure regulatory compliance and contamination control for pharmaceutical environments. Uses cleanroom-grade agents, HEPA vacuums, and specialized PPE. Requires ISO 9001:2015 certification and adherence to cGMP standards. Delivers a compliant, certified cleanroom environment.

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Solicitation # NOI-CC-26-002091
The National Institutes of Health Clinical Center is issuing a Notice of Intent to Sole Source a preventative maintenance service contract for the PEAK Genius XE SCI gas generator. This acquisition is conducted under FAR Part 13 Simplified Acquisition Procedures, specifically 13.106-1(b)(1), as Peak Scientific Inc. is the sole manufacturer and authorized provider of proprietary parts, diagnostic tools, and certified technicians for this equipment in the United States. The contract consists of a one-year base period with three optional one-year extensions, for a total potential performance period of four years. All services will be performed on-site at the NIH Clinical Center in Bethesda, Maryland. The procurement utilizes the Complete Service Plan 48 (SL3), an all-inclusive package that eliminates unexpected costs by covering all labor, travel, and parts. Key deliverables include one to two annual on-site preventative maintenance visits featuring full system checks, component retrofits, and software upgrades. The plan provides 100 percent coverage for breakdowns, including internal compressor repair or replacement and a guaranteed on-site response time of 48 hours within the mainland USA. Additionally, the contract includes online technical support and adherence to Peak Scientific's warranty statements and terms and conditions.
Analytical Laboratory Instrument Manufacturing

POSTED

10 months ago

DEADLINE

N/A
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