04. Baseline Equipment and Calibration Needs.xlsx

XLSX spreadsheet 14 KB Posted Mar 8, 2021

Attached to: NIH CC Aseptic Processing Facility (APF) Certification and Testing Program Federal contract opportunity
Solicitation number: HHSN-21-Q-000048
Issued by: Department of Health and Human Services National Institutes of Health Clinical Center

About this file

Written by GovTribe AI · Dec 31, 2023

This combined synopsis/solicitation seeks proposals for an aseptic processing facility certification and testing program. The National Institutes of Health Clinical Center requires services including cleanroom certification, HEPA filter testing and maintenance, air visualization studies, equipment calibration, and controlled temperature unit qualification at its facilities in Bethesda, Maryland. Proposals are due by April 9, 2021 and award will be made by May 1, 2021. Evaluation will consider technical qualifications, past performance, and price, with technical/past performance more important than price. The contract has a one-year base period and four one-year options, covering May 2021 through April 2026. The solicitation was previously set aside for small businesses without success, so this open competition is unrestricted. The NAICS code is 541380 and size standard is $16.5 million. Questions are accepted through March 22, 2021.

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Other files for this federal contract opportunity

Other files attached to NIH CC Aseptic Processing Facility (APF) Certification and Testing Program, newest first.
File	Type	Posted
05. Solicitation Amendment # 0002.pdf	PDF	Apr 5, 2021
01. Price Schedule.xlsx	XLSX spreadsheet	Mar 31, 2021
05. Solicitation Amendment # 0001.pdf	PDF	Mar 31, 2021
04. Attachment C012 - Pharmacy P-IVAU - Reflected Ceiling Plan HEPA 65. pdf.pdf	PDF	Mar 8, 2021
04. Attachment C011 - Pharmacy IIVAU Reflected Ceiling Plan HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C005 - NCI TIL Modular Ceiling Plan HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C003 - CCE Terrace Modular Reflected Ceiling Plan HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C007 - NCI 1B42 Reflected Ceiling Plan HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C009 - PET GMP Lab B3 Layout HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C006 - NCI TR-10B Reflected Ceiling Plan HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C002 - CCE 2J Duct Layout West HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C001 - CCE 2J Duct Layout East HEPA Locations.pdf	PDF	Mar 8, 2021
04. Current and Future APF Room and PEC Needs.xlsx	XLSX spreadsheet	Mar 8, 2021
01. RFQ - HHSN-21-Q-000048.pdf	PDF	Mar 8, 2021
04. Attachment C010 - Pharmacy E-IVAU Reflected Ceiling Plan HEPA Locations.pdf	PDF	Mar 8, 2021
04. Attachment C008 - NCI 3W MECH Layout.pdf	PDF	Mar 8, 2021
04. Attachment C004 - DLM Sterility Lab Reflected Ceiling Plan HEPA.pdf	PDF	Mar 8, 2021
01. Price Schedule.xlsx	XLSX spreadsheet	Mar 8, 2021

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Sheet1

	Area	# BSCs	# Isolators	# Non-refr. Centrifuges	# Refr. Centrifuges	# Upright Refr.	# U.C./ Stackable Refr.	# Upright freezers	# U.C. / Stackable freezers	LN2 Freezers	# Upright Incubators	# U.C./ Stackable Incubators	# Vortex Mixers	# Balances/ Scales	# Baths	# Pumps
	Frequency of Calibrations (per year)	0	2	1	1	1	1	1	1	1	1	1	1	1	1	1
	Frequency of Qualifications (per year)	0	0	0	0	0.3	0.3	0.3	0.3	0.3	0.3	0.3	0	0	0	0
	CC DTM CCE PACT (QC Lab)	0		0	0	0	0	2	0	2	0	0	0	0	0	0
	CC DTM CCE PD Lab	4	0	0	3	2	3	3	0	0	0	8	0	5	0	0
	CC DTM CCE 2J	11	0	1	10	4	8	8	0	6	0	17	0	12	0	0
	CC DTM CCE 3T	15	0	3	12	9	6	6	0	2	0	14	0	10	0	0
	CC DTM CCE Storage	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0
	CC DTM CCE Future Terrace Modules	3	0	6	0	2	3	2	1	1	0	12	0	6	2	2
	CC DTM CCE Future 12E	16	0	21	0	7	9	11	0	21	0	68	2	17	3	6
	CC DTM Bloodbank	3	0	14	6	16	0	30	0	6	0	0	8	4	0	0
	CC DLM Sterility Lab	2	0	3	0	2	3	2	1	0	2	5	0	0	0	0
	CC DLM Future Sterility Lab	5	0	1	0	1	1	0	0	0	4	2	0	0	0	0
	CC PET Radiopharmacy	1	0	0	0	1	0	0	1	0	0	0	0	3	0	0
	CC PET GMP Mfg (B3)	4	0	0	0	3	2	2	0	0	0	6	2	5	1	0
	CC Radiology and Imaging Sciences: Future Radio pharmacy	3	0	1	2	0	4	0	0	0	0	1	0	4	0	0
	NCI cGMP Trailer 10B	3	0	0	1	0	2	0	1	0	0	6	0	0	1	0
	NCI CRC TIL (3W)	7	0	3	3	3	1	1	0	0	0	12	0	0	0	0
	NCI TIL (modular)	10	0	0	8	4	4	3	0	4	0	24	0	0	2	4
	NCI cGMP Trailer 10A	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	NCI QC	2	0	0	3	2	1	6	0	2	0	4	0	0	2	0
	NCI 1B42	2	2	0	1	0	1	0	0	0	1	6	0	1	1	0
	I-IVAU	3	0	0	0	10	0	2	0	0	0	0	0	6	0	0
	E-IVAU	4	0	0	0	9	0	2	0	0	0	0	0	0	0	0
	P-IVAU	12	3	0	0	33	0	10	0	0	0	0	0	0	0	0
	Pharm
3-1741	1	0	0	0	1	1	0	0	0	0	0	0	0	0	0
	NIAID 29B Pilot Plant	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Equipment Totals	111	5	53	50	109	49	91	4	44	7	185	12	73	12	12
Total Calibrations Per Year	0	10	53	50	109	49	91	4	44	7	185	12	73	12	12
Total Qualifications Per Year	0.0	0.0	0.0	0.0	36.3	16.3	30.3	1.3	14.7	2.3	61.7	0.0	0.0	0.0	0.0

	temp	RPM	humidity	CO2	Flow	pressure	weight
Total Calibration Types Per Year	551	24	192	192	115	10	73

File details come from the government source that posted it. Updated Mar 8, 2021.