Cleaning for cGMP facilities from Advanced Cleanroom Microclean (Notice of Intent to sole source)
Closed Pre-Solicitation Posted
- Solicitation number
- NOI-CC-25-010153
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 561720 Janitorial Services
- PSC
- Q901 Healthcare Environmental Cleaning
- Place of performance
- Bethesda, Maryland 20814, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Health Clinical Center (NIH-CC) has issued a Notice of Intent for sole source procurement of specialized cleaning services for cGMP manufacturing facilities and compounding pharmacies. The agency requires comprehensive cleaning and contamination control services for approximately 33,000 square feet of aseptic processing facilities with varying ISO classification levels, encompassing pharmacy, research, and medical spaces across 14 specific facility areas. The contractor must maintain ISO 9001:2015 certification, possess pharmaceutical industry experience, and provide staff trained in cleanroom environments and microbiological contamination control with seven-day-per-week coverage including holidays. The procurement is justified as a sole source requirement under 41 U.S.C. 1901(a)(1) due to the urgent need for continuity of service to ensure patient safety and regulatory compliance. Interested parties may submit capability statements by 11:00 AM Eastern Standard Time on August 27, 2025, to lu-chang.lu@nih.gov with the subject line referencing NOI-CC-25-010153.
This procurement does not utilize any set-aside designations and represents a bridge contract intended to maintain continuity with the current incumbent contractor, Advanced Cleanroom Microclean, who has been providing these services under an existing contract and possesses 40 years of cleanroom industry experience with 5 years specifically working at NIH. The contract period of performance spans approximately two months from September 1, 2025, to October 29, 2025, serving as a temporary continuation of services until a new main cleaning services contract can be awarded. The contractor must provide a minimum of two staff members per facility, with staffing requirements increasing proportionally based on facility square footage. Services must be performed at the NIH Clinical Center in Bethesda, Maryland, with the contractor responsible for maintaining government-furnished equipment, conducting monthly reporting, and responding to ad-hoc cleaning requests with at least 12 hours' notice.
Notice text
Acquisition Description:
This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Advanced Cleanroom Microclean.
The National Institute of Health (NIH) requires cleaning services for cGMP manufacturing facilities and compounding pharmacies to continue to protect human safety and human healthcare. Advanced Cleanroom Microclean is ISO 9001:2015 certified with 40 years of industry experience in Cleanroom Facilities and 5 years working at the NIH. They meet all regulatory requirements with their accreditations and meet objectives within the current and proposed SOWs.
This is a sole source “bridge” contract because the services requested are urgent and immediate to provide continuity of service for patient safety and regulatory compliance. The existing contractor Advanced Microclean has been providing cleaning services under an existing contract and they meet all the necessary qualifications and certifications. This current requirement is to temporarily continue services for ~2 months until the new “main” cleaning services contract can be awarded.
Requirement:
Cleaning services for approximately two months.
Place of Performance or Delivery:
The estimated Period of Performance is: Approximately two months, from September 1, 2025 to October 29, 2025.
Place of Performance: NIH Clinical Center in Bethesda, MD
The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-25-010153) by 11:00 AM eastern standard time on 08/27/2025 to: lu-chang.lu@nih.gov
All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.
Files
| File | Type | Posted |
|---|---|---|
| 1. SOW -Statement of Work.docx | DOCX document |
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