SAM #IHS1528591

USP-797 Cleanroom Certification and Equipment Maintenance for Lawton Indian Hospital

This opportunity is for the Lawton Indian Hospital, part of the Indian Health Service under the Department of Health and Human Services, seeking biannual cleanroom certifications and equipment maintenance services. - Government Buyer: - Department of Health and Human Services - Indian Health Service - Lawton Service Unit, Lawton Indian Hospital - Services Requested: - Biannual cleanroom certifications for ante room, buffer room, hazardous drug buffer room - Maintenance and certification of biological safety cabinets (BSC) and laminar airflow workstations (LAFW) - HEPA filter integrity testing, airborne particle counting, microbiology sampling - Equipment diagnostics, troubleshooting, repairs, and ceiling HEPA filter changes - Detailed reporting including certificate of analysis, microbiology sampling maps, and trending reports - Compliance Requirements: - Must meet USP Chapters and standards - Must comply with ISO14644-1:2015 and ISO14644-3:2019(E) - Security and confidentiality protocols required - No specific OEMs or part numbers are mentioned; proprietary maintenance is required for specialized equipment - Period of performance includes a 12-month base period with four 12-month option years, and services are performed every six months

Description

The Lawton Service Unit (LSU), specifically Lawton Indian Hospital (LIH), has a requirement for cleanroom certifications and equipment maintenance. Cleanroom certifications, sampling, and required testing are required every 6 months per USP Chapter <797> in order to compound category 2 compounded sterile products. Proprietary equipment maintenance is required for biological safety cabinet (BSC) and laminar airflow workstation (LAFW).

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