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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 21, 2014 FBO #4684
DOCUMENT

35 -- De-Blistering Machine - Attachment

Notice Date

9/19/2014
 

Notice Type

Attachment
 

NAICS

333993 — Packaging Machinery Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25814Q0970
 

Response Due

9/23/2014
 

Archive Date

10/23/2014
 

Point of Contact

William Corson
 

Small Business Set-Aside

N/A
 

Description

STATEMENT OF WORK (SOW) Brand Name or Equal. Meet or Exceed. Lowest Price Technically Acceptable FOB Destination 1.CONTRACT TITLE. Automated De-Blistering Machine 2.BACKGROUND. The Department of Veteran Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) has a requirement to purchase a custom designed automated de-blistering machine. This machine is designed to take tablets or capsules that have been packaged in a thermal formed blister package and remove them utilizing an automated process. Blister packages are fed automatically from the magazine stack to a cutting station. A cut is made in the lidding material around the base of the blister pocket. The tablets or capsules are gently de-blistered from the blisters and collected separately from the blister packaging. This machine will allow CSPCRPCC to take commercially packaged drugs, remove them from their blister card packaging, and repackage in a blinded clinical trial package. This process is currently done my by hand (manually) which can take weeks to complete. This machine can remove the same amount of clinical drugs without damaging them in about eight hours. 3.SCOPE. The contractor shall provide the custom designed automated de-blistering machine to custom design specifications. The contractor shall provide installation, training, and all other resources required to deliver the requirements stated herein, except as may otherwise be specified in the statement of work. 4.SPECIFIC TASKS. 4.1Task 1 - Pharmaceutical Automatic De-blistering Machine "Fully automated, high speed de-blistering machine capable of removing product from up to 50 blister packs per minute "Capable of de-blistering tablets or capsules "Must handle push through blister packs "Must handle child resistant blister packs "Capable of handling a blister pack width of 105mm and a height of 140mm "Fully cGMP compliant "Zero contamination levels "All product contact areas need to be made of 316 stainless steel and aluminum "Dimensions can be no larger than 28" w x 40" L x 63" H to fit in designated equipment storage area when not in operation "Maximum weight cannot exceed 600 lbs. "Must have heavy duty casters and be portable "Must utilize a single phase electric supply for use in multiple locations "Must have an automatic feeding system "Must be designed to have minimum impact on the product. This would ensure that capsules and tablets that are fragile are not damaged during this process. This can be accomplished by the back of the blister card to be pierced instead of forced through utilizing rollers alone. "Must have a loading magazine or other system to hold blister cards in larger quantities than one bister card at a time. This will allow for a single operator to fill the magazine, start the machine and observe that no product is being damaged and that there are no issues with the machine operation. "Must be able to handle heavy gauge aluminum blisters on aluminum backing (cold formed blister cards) "Must be able to handle paperback blister packs "Must be able to handle curled or bent blister packs "Lidding material in each pack shall be precision cut around the base of each pocket using pack specific tooling to ensure zero product damage and contamination "Must have variable speed and operator control "Must be designed so the foil or paperback is not contaminated with the drug product "Must have quick change over parts that take no longer than 5 to 7 minutes to change "Must separate tablets or capsules from the empty blister pack "Must have a three stack beacon light "Single phase electricity 110v/230v; air supply;: 6 bar (90psi) "Capable of tool-less changeover "Manufacturer shall provide detailed drawings for review and approval by CSPCRPCC plant engineer "Manufacturer shall provide complete machine no later than 12 weeks ARO 4.2Task 2 - Product Tooling "Machine shall have four change over tooling sets oSize 1- Drawing-2-85/126a oSize 0- Drawing #- S-59/595-004B oLithium- Drawing #- 79812488-01 oPlacebo 500- Drawing #- VA0001-1 4.3Task 3- Spare Parts Kits "Machine shall have a spare parts kit "Contents of spare parts kit shall be determined by the manufacturer of the automated de-blistering machine 4.4Task 4- Validation Package "Contractor shall provide an Installation Qualification and Operational Qualification (IQ/OQ) package with machine. 5.PERFORMANCE MONITORING. TaskStandardAcceptable Quality LevelSurveillance Method Design Acceptance by VA CSPCRPCCCustom designed automated de-blistering machine will be approved based on drawings and functional designSystem must meet line integration specifications.Management Information Systems Factory Acceptance Testing (FAT)Vendor will provide FAT via internet and will provide documents to CSPCRPCCSystem will meet requirements specified in SOWDirect Observation Delivery of automated de-blistering machineDelivery of system delivered within agreement between contractor and VASystem will be delivered within 16 weeks after PO issuedDirect Observation Inspection of automated de-blistering machineSystem will be packed and shipped to prevent damageSystem will be unpacked upon delivery and inspected for defectsDirect Observation Installation of automated de-blistering machineEquipment and complete system installed within agreement between the contractor and VASystem installation will not take longer than two working weeksDirect Observation 1.METHODS OF QUALITY ASSURANCE SURVEILLANCE: Various methods exist to monitor performance. Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor's performance in meeting a specific performance standard/AQL. oDIRECT OBSERVATION - Can be performed periodically or through 100% surveillance. oMANAGEMENT INFORMATION SYSTEMS (MIS) - Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections. oPERIODIC INSPECTION - Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required. oAnalysis of contractor's progress reports (evaluate cost, schedule, etc.) oPerformance reporting Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the Contracting Officer's (CO) actions. 6.SECURITY REQUIREMENTS. All contractor(s) will need to present a valid ID such as a driver's license or government issued ID to CSPCRPCC Security Officer(s) in order to be physically checked in and given a visitor's badge. Contractor(s) must wear their visitor's badge and be escorted by a CSPCRPCC staff member at all times while in the facility. This requirement will not need the VA Form 2280. The contractor will not have access to any IT networks or patient information. 7.GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). There shall be not government furnished equipment for this contract. The VA CSPCRPCC will have all electrical and compressed air requirement installed prior to the delivery of the de-blistering machine. 8.OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. This is a custom automated de-blistering machine that must be designed and implemented to work with various sizes of blister packs as well as materials. There were no contractors that we are aware of that manufacture and sell this type of system as a commercial off the shelf (COTS). a.Identification of Possible Follow-on Work. None b.Identification of Potential Conflicts of Interest (COI). None c.Identification of Non-Disclosure Requirements. Not Applicable d.Packaging, Packing and Shipping Instructions. Equipment components shall be packed in wooden crates and secured with adequate straps and with a proper barrier made of industrial plastic. The contractor shall utilize a shipping vendor that can safely deliver purchased equipment without damage to the equipment. e.Inspection and Acceptance Criteria. The equipment shall be inspected upon arrival for damage, inclusion of all required manuals and parts in adherence to the Statement of Work. Any discrepancies will be noted on the packing slip(s) and the COR will be notified. 9.PLACE OF PERFORMANCE. Equipment is to be delivered and installed by the contractor at the: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE ATTN: CSP Warehouse (151-I) Albuquerque, NM 87106-4180 10.PERIOD OF PERFORMACE. The period of performance will be from when the contact is issued to selected contractor until all items listed have been delivered and installed. 11.DELIVERY SCHEDULE. SOW Task #Deliverable TitleFormatNumberCalendar Days After CO Start 8.1Delivery of design drawings and specifications(design review) to be approved by VA CSPCRPCCDetailed Schematics and dimensionsOne (1) electronic copy for review by plant engineerThree (3) weeks after contract issued 8.1-8.3Delivery of De-blistering MachineDetailed Packing SlipOne (1) Copy to be used at deliveryEight (12) weeks after contract awarded 8.4Delivery, Installation Qualification (IQ) and Operational Qualification OQ)Detailed IQ, OQ packageDetailed IQ/OQ packageEight (12) Weeks after contract awarded *Standard Distribution: One copy of the transmittal letter without the deliverable to the Contracting Officer shall be emailed. 12.ACRONYMS. A.CO - Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts. B.COR - Contracting Officer's Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. C.CSPCRPCC - Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. D.VAMC - Department of Veterans Affairs Medical Center E.NMAHCS - New Mexico Veterans Affairs Healthcare System
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25814Q0970/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-14-Q-0970 VA258-14-Q-0970_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1643635&FileName=VA258-14-Q-0970-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1643635&FileName=VA258-14-Q-0970-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;1501 San Pedro Dr. SE;Albuquerque, NM

Zip Code: 87108
 

Record

SN03520499-W 20140921/140919235706-427028dfa2fd08fa6c637982d8015c60 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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