DOCUMENT
A -- Nova Packing System - Justification and Approval (J&A)
- Notice Date
- 9/4/2009
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 333993
— Packaging Machinery Manufacturing
- Contracting Office
- Department of Veterans Affairs;Contracting Office (501/90C);New Mexico VA Health Care System;1501 San Pedro Drive SE;Albuquerque NM 87108
- ZIP Code
- 87108
- Solicitation Number
- VA-258-09-RQ-0203
- Response Due
- 8/7/2009
- Archive Date
- 11/3/2009
- Point of Contact
- Nicolas Nunez-HidalgoContracting Officer505-256-2826
- E-Mail Address
-
Nicolas Nunez-Hidalgo Contracting specialist
(nicolas.nunez-hidalgo@va.gov)
- Small Business Set-Aside
- N/A
- Award Number
- VA258-P-0293
- Award Date
- 9/4/2009
- Description
- Justification for Other ThanFull and Open Competition (JOFOC) Document The following Justification for Other than Full and Open Competition is prepared in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1"Only one responsible source and no other supplies or services will satisfy agency requirements" and the Department of Veterans Affairs Acquisition Regulation (VAAR) 806.304.1. Agency Identification U.S. Department of Veterans AffairsNew Mexico VA Health Care System (501/90C)1501 San Pedro SE Albuquerque, NM 87108 2. Description of Action Being Approved The VA Cooperative Studies Program Clinical Research Pharmacy (VA CSPCRPCC) has requests a sole source contract with Nova Packing Systems 7 New Lancaster RD, Leominster, MA 01453 to provide Swift vision 2 (SV2), twelve track, 3 tray tablet/capsule counter with EFS. This system will be used to package clinical drugs into bottles used in clinical trials. This Swift vision 2 will replace the current Swift vision 2 VACSP currently uses. The current machine is 10 years old and has to have frequent electronics repairs due to its age. The action to be approved is the use of statutory authority (only one responsible source and no other supplies or services will satisfy agency requirements) allowing use of other than full and open competition as addressed in FAR Part 6.302-1, 41 U.S.C. 253(c) (1),. 3. Description 4. Statutory Authority/Authority Cited The basis of this JOFOC is the criteria implemented in the Federal Acquisition Regulation (FAR) Part 6.302-1, "Only one responsible source and no other supplies or services will satisfy agency requirements." (a) Authority. (1) Citations: 10 U.S.C. 2304(c) (1) or 41 U.S.C. 253(c) (1). (2) When the supplies or services required by the agency are available from only one responsible source, or, for DOD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for. 5. Reason for Authority Cited The reason for citing FAR Part 6.302-1 as the statutory authority for this JOFOC is that it is appropriate in this situation where the agency's needs could only be satisfied by the unique supplies/services available through Nova Packing System Inc... Application. This authority shall be used, (1) when there is a reasonable basis to conclude that the agency's minimum needs can only be satisfied by- (i) Unique supplies or services available from only one source or only one supplier with unique capabilities; 6. Demonstrate Proposed Contractor's Unique Qualifications. The system required consists of a Swift vision 2 with (EFS) vision, color touch screen controller, 316 stainless steel contact parts, fully-adjustable automatic container indexing fingers, pre-weight automatic product feed control, power lift height adjustment stand, low level hopper sensor and vibrating discharge funnel attachment, dust extraction manifold, factory acceptance testing (FAT) and validation documentation and implementation. The SV2 Intellisense Counter features an electrostatic sensing system (EFS) to create an extremely accurate assessment of the tablet/capsule parameters which include size, shape, and weight during the counting process. It measures each aspect against pre-set specification parameters as the tablet/capsules fall through the field, and where tablets/capsules do not precisely conform to the counters parameter; they will be rejected as non-conforming product. Using the EFS technology means that, in addition to accuracy of count, you get an accurate measure of product quality in terms of physical properties variance, which is a vital issue where dosage form is concerned. Nova packing system owns the patented rights to the EFS technology and are the only ones certified to build and produce a tablet/ pill counter using such technology. IMA Swift Vision 2 1.Tablet/capsule counter must be compatible with current VACSP tablet/capsule counter tooling (12 tracks, 3 tray systems).2.Machine must have a "footprint" equivalent or less in size to (58"L x 25"W x H74").3.Capable of producing up to 100 bottles per minute.4.Capable of handling various types of tablets and capsules, including liquid gelatin and clear capsules and clear gel capsules.5.Can accommodate bottles ranging from 75cc to 625cc bottle.6.System must be integrated with the current gating and conveyor system. Due to room constraints, current bottling line was built around the footprint of the Swift vision 2.7.System must be accompanied by an Installation Qualification, Operational Qualification and Process Qualification (IQ, OQ, PQ)8.Manufacture must allow CSPCRPCC to conduct Factory Acceptance Testing (FAT) at the manufacturer's plant. VACSP currently has a Swift vision 2 (SV2) and 60% of the current change parts will serve as a back up to the new machine. These spare parts new would cost anywhere from $30,000 to $40,000 if purchased. Also, the current filling line has been designed around the current SV2 (gating, timing, and conveyors). This Swift vision 2 with EFS has been validated and tested on hundreds of different tablets and capsules. VACSP currently operates the SV2 system, which is similar in design and operation to the updated SV2. VACSP technicians will be more efficient and experience fewer problems on this machine due to their prior experience. We currently have a tablet/capsule bulk product elevator system that works side by side to the SV2, if a new counter were to be purchased this elevator would need to be replaced at an estimated cost of over $50,000. 7. Sources Sought Efforts. The agency has done a market survey using the GSA FSS Schedule Sources, and has searched the FBO database, and CCR database for similar manufactures. The survey resulted with no positive feedback from other manufacturers that can provide the needed instruments/implants. Five manufacturers were contacted by phone and stated that the technology sought was patented technology and did not own rights to such technology. NMVAHCS also intends to release a synopsis of the requirement utilizing FedBizOpps database, IAW FAR Part 5. 8. Determination of Fair/Reasonable Price. Price reasonableness has been established in accordance with FAR 15.402 CSP Albuquerque, NM has identified a technically qualified candidate(s) who can analyze the pricing information which includes number of personal hours, hourly rates and equipment/supplies necessary to meet the VA requirements. This person(s) have been identified and preliminary discussion held with the Contracting Officer before the solicitation is issued. 9. Description of the Market Research Conducted and Results. The items for this requirement are commercially available to private and public sector but only available from one vendor with (Nova Packing System Inc. 7 New Lancaster RD, Leominster, MA 01453). Search of both the Vet Biz and CCR site indicated no Veteran business who could provide the services requested. See Market Research Report for additional details. VACSP could not identify any other tablet/capsule counters at the packaging expo attended, that utilize the EFS system which is required. Companies that were researched are: CVC TechnologiesThis company had counters but also did not use EFS technology. 909-466 8324 NJM/CLIThis company had counters but also did not use EFS technology. 209-402-1055 An intent to sole source with Nova Packing System Inc. 7 New Lancaster RD, Leominster, MA 01453 will be advertise in the Federal Business Opportunities (FBO) 10 days prior to award which invites other interested parties to provide their qualifications or objections to the procurement.? 10. Technical Requirements Certification "I certify that the supporting data under my cognizance which are included in this document are accurate and complete to the best of my belief." ___________________________ ______Frank Lueddeke Chief, Clinical Materials Management Section Date 11. Contracting Officer's Certification The Contracting Officer's (CO's) signature on the Justification evidences that the CO has determined this to be accurate and complete to the best of the CO's knowledge and belief. "I certify that this JOFOC is accurate and complete to the best of my knowledge and belief." _____________________________ Patti J AmidonContracting OfficerDate
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/AlVAMC501/AlVAMC501/VA-258-09-RQ-0203/listing.html)
- Document(s)
- Justification and Approval (J&A)
- File Name: VA258-P-0293 VA258-P-0293_1.DOC (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=73895&FileName=VA258-P-0293-000.DOC)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=73895&FileName=VA258-P-0293-000.DOC
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA258-P-0293 VA258-P-0293_1.DOC (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=73895&FileName=VA258-P-0293-000.DOC)
- Record
- SN01941929-W 20090906/090905001222-22d5e127a24e3c4de3ff655240ae4117 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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