SOLICITATION NOTICE
N -- Removal of old fermenter and installation of new government furnished 75-liter Bio-Reactor (fermenter)for operations in the Pilot Bioproduction Facility, Building 501, Forest Glen, WRAIR.
- Notice Date
- 7/29/2010
- Notice Type
- Presolicitation
- NAICS
- 236220
— Commercial and Institutional Building Construction
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-10-T-0355
- Response Due
- 8/5/2010
- Archive Date
- 10/4/2010
- Point of Contact
- David D. Denton, 301 619-6857
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(david.d.denton@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- PERFORMANCE WORK STATEMENT 1. Title: Installation and connection of a new government-owned 75-liter Bio-Reactor (fermenter) for operations in the Pilot Bioproduction Facility, Building 501, Forest Glen, WRAIR, for the manufacturing of GMP vaccines products. 2. Performance Work Statement (PWS) This PWS generally describes the work the Government needs to be performed and accomplished. The contractors offer should explain in some technical detail how it plans to accomplish the work, the schedule it will follow, its qualifications to do the work and experience in perfoming similar work 3. Scope of Work: General: Contractor shall provide all personnel and labor, equipment, and supplies to remove old Fermenter and install new Government provided Fermenter in Bldg 501, the same location per tasks described below. It is very important that the contractor explain its familiarity with the Good Manufacturing Practices (GMP) for the production of human vaccines with respect to the facility work required in replacing the ferementer and meeting quality assurance standards for a cleanroom facility. Although no certification is required, contractor must have clearoom experience. Cleanroom standards are described in the Code of Federal Regualtions at Food and Drug Administration, 21CFR Part 210 & 211, also 610 specifically for Biologics. GMP standards for this production facility and the cleanroom are class 10K. Class 10 K is where there exists no more than 10,000 particles larger than 0.5 microns in any given cubic foot of air. Since this facility already meets this classification, the contractor will complete this project accordingly and do nothing to adversely affect the integrity of the 10K classification of the cleanroom. The cleanroom must retain it's integrity after installation is complete. Maintaining this standard in part is by proper gowning prior to entering the facility. Contractor shall provide proof of prior successful gowning training at nearly any GMP facility. Although gowning experience is preferred, if the contractor has no experience, WRAIR can provide training, which involves 3 gowning attempts with successful test results. Training/testing is 3 times over 3 separate days. The Pilot Bioproduction Facility, operating under Good Manufacturing Practices (GMP) for the production of human vaccines, requires services to include the following: Task 1: a.Contractor will contact and interact with a representative from New Brunswick Scientific to make sure removal and installation of fermenters are completed within company specifications. COR will provide contact information. b.Service will include the removal of the existing 40-liter fermenter assembly and disconnect of all associated utilities from points within Cleanroom #44 of the Pilot Bioproduction Facility, Building 501, Forest Glen, WRAIR, and placement of existing old assembly parts in pre-determined location on WRAIR campus. This also includes detachment from the floor (requiring some demolition work and room repair) of the Cleanroom and moving the old fermenter to the loading dock. Task 2: a. Demolition and necessary room repairs will be followed by installation of a new government-owned 75-liter fermenter including the reconnection of all assembly parts and associated utilities and re-establishment of utilities necessary for the new 75-liter fermenter operation by qualified technician(s). Installation will include floor patching/room repairs as necessary to maintain or exceed existing cleanroom requirements. b.Provide start-up and commissioning necessary for placing the new fermenter in cGMP service, turn-over package and as-builts of new unit to include documentation as required by Quality Assurance to meet the needs of a GMP facility within 20 working days after installation completion. 4. Period of Performance: The Government desires the work to be completed within aapproximately four week from date this order is received by the contractor. However, contractor shall coordinate actual start date with Contracting Officers Representative within 24 hours of receipt of the order. 5. Site Visit: If potential offerors desire to inspect the site prior to preparing or placing their offer, please contact Brenda Mena @ 301-619-1013 or e-mail brenda.mena@us.army.mil. Site visit requests must be received by 4:00 PM 2 August 2010. 6. Government Personnel: The following Government personnel will oversee this contract: a. Contracting Officers Representative: Jason Copen PBF BioProduction Systems Mgr. Walter Reed Armyu Insititute of Research 9100 Brookeville Road B501 Silver Springs, MD 20910 301-319-9545 b. Contract Specialist/Purchasing Agent:Brenda Mena USAMRAA Orange Team 820 Chandler Street Fort Detrick, MD 21702-5012 301-619-1013 c. Contracting Officer:David Denton USAMRAA Orange Team 820 Chandler Street Fort Detrick, MD 21702-5012 301-619-6857 7. Quality Assurance Surveillance Plan: The Contractor is required to provide its own Qualty Assurance Plan showing how it intends to accomplish the work in a timely, efficient and quality manner demonstrating how it willmeet each of the performance objectives. The Quality Assurance Surveillance Plan explains how the Government intends to surveil the contractors work during the Installation and connection of a new government-owned 75-liter Bio-Reactor (fermenter) in the Pilot Bioproduction Facility, Bldg 501, WRAIR: Performance ObjectivePerformance TargetsMethod of SurveillanceMethod of Inspection 1. Provide removal services of existing 40-liter fermenter assemblyRemoval should take place within the first week of performance but may occur sooner.Daily site inspectionReview for satisfactory progression of install 2. Provide installation of new 75-liter Bio-Reactor (fermenter)Install should take place within weeks 2 and 3 of the performance period. but may occur sooner Continuation of daily site inspectionReview for satisfactory progression of install 3. Provide start up and commissioning for placing new fermenter in cGMP serviceComplete installation services and start-up during week 4 of the perfomance period by may occur sooner.Review of warranty documentation and start up activitiesFinal inspection of cold box and review of completed documentation
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-10-T-0355/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02221836-W 20100731/100729235010-3b7e8bbb067e7452ec9e5073c3caccda (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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