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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 23, 2017 FBO #5630
DOCUMENT

66 -- Bottle Recovery System RX System that removes pills from bottles - Attachment

Notice Date

4/21/2017
 

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

VA25817N0327
 

Response Due

5/1/2017
 

Archive Date

5/31/2017
 

Point of Contact

Johanne Gingras
 

E-Mail Address

ntracting,
 

Small Business Set-Aside

N/A
 

Description

STATEMENT OF WORK (SOW) SCHEDULE OF SERVICES AND/OR SUPPLIES. # Item/Stock# Description Est. Qty. Unit Unit Price Estimated Amount 1 Model 1040 (or equal) Bottle Recover RX 1 EA 2 Infeed Turn Table 1 3 Infeed Loading Shelf 1 4 Content Separation Grill 1 5 Bottle Tapper 1 6 Onboard Vacuum Unit 1 7 AB Upgrade Kit 1 8 Factory Acceptance Test (FAT) 1 9 Start-up Assistance and Training Package 1 10 Packing & Crating 1 11 Installation Operational Qualification (IOQ) Documentation 1 12 Additional Knife Blade 3 13 Waste Holding Bin (plastic) 1 14 Bottle Holding Bin (plastic) 1 TOTAL ESTIMATED COST CONTRACT TITLE. Bottle Recovery RX, Model 1040 (or equal) BACKGROUND. The Department of Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) has a requirement to purchase a fully automatic bottle recovery system. This equipment is needed to de-bottle commercial prepackaged pharmaceutical bottles from the bottom and safely separate the tablet/capsule, soft gel capsule, coil (cotton, rayon and/or polyester) and descants into bulk containers ensuring product stability and prevent product degradation during product production evolutions. Recovery of drug from bottom of bottom is critical due to hard plastic enclosure may cause damage SCOPE. (VACSPCRPCC) carries out several research studies that utilize bottled commercial prepackaged drug, that must be de-bottled (drug removed) and then re-bottled in non-identifiable bottles, so as to adhere to packaging requirements for patient use enrolled in blinded; double blinded study format. Currently the de-bottling of these commercial drugs is performed manually by employees and it is estimated that throughout the years; hundreds of thousands of man hour dollars have been expended for this one process in the system. This machine must be capable of retrieving drug from bottom of bottle so as to prevent hard plastic enclosures from causing damage or injury to personnel and equipment when jettisoned from machine. Additionally the bottle recovery system must be capable of de-bottling commercial prepackaged bottles that will fulfill Current Good Manufacturing Practices and comply with our standard operating procedures. This bottle recovery system must also have the capability of to automatically recovering small, medium and large batches of product from finished containers at speeds up to 40 BPM, with minimal setup time and using only one operator as well as have the ability to separate the tablet/capsule, soft gel capsule from the coil (cotton, rayon and/or polyester) and desiccant within the bottle into bulk containers ensuring product stability and prevent product degradation during product production evolutions. The use of this bottle recovery system could be utilized for any study or project including manufacturing OE projects that require opening and recovering drug from commercial packaging or re-work on current studies that have been approved for changes. SPECIFIC TASKS. The Bottle Recovery system must be made of high quality stainless steel, built to current Good Manufacturing Practices (cGMP), and have FDA approved contact materials. 5.1 Task 1 Bottle Recovery RX, Model 1040 (or equal) Heavy duty Construction consisting of Stainless steel Anodized aluminum Approved plastics Machine outside dimensions NTE Length: 60 Width: 30 Height: 54 Power Supply: 120V, 60 Hz, 15 Amp Air supply: 90 psi (5 CFM consumption) Capable processing square, round and oblong container (bottles) in sizes ranging in size from 1 to 4 Must be designed for ease of movement from room to room (mounted casters) Process up to 40 bottles per minute (BPM) Dust extraction ports Interlocked safety guarding to prevent injury to personnel and moving parts Operator friendly touchscreen panel Machine self-diagnostics fault finding capability Metal detector in product chute Container full indication sensors Drug product Waste Loading table and feed conveyor for bottles Four station servo indexer with rotary motion Tool-less four jaw adjustment Variable speed on-screen adjustment Operators manual and illustrated parts break down manual 5.2 Task 2 Bottle Recovery Proposal and Acceptance: The Bottle Recovery RX, must be capable of being portable, so as to integrate in all rooms associated with the production of packaging, de-packaging commercial and OE bottles. All major equipment parts of bottle recovery system shall if needed be capable of being able to be separated for ease of movement. The Contracting Officer s Representative (COR) will provide the contractor with the specifications needed to design a proposal for the manufacture of the bottle recovery system to be utilized in our existing packaging rooms. The Contractor s design proposal will be reviewed by the COR for acceptance (approval). 5.2.1 Subtask 1 - Bottle Recovery RX, Proposal The Contractor shall prepare a design proposal according the specifications outlined in this statement of work. The Contractor and the COR shall review the design proposal to reach consensus on the specifications for the design of the Bottle recovery system. 5.2.2 Subtask 2 - Bottle Recovery RX, Acceptance Once the contractor and the COR reach consensus on the design of the Bottle Recovery RX, the COR shall accept (approve) the design so the contractor can begin manufacturing the equipment. 5.3. Task 3 - Bottle Recovery RX, Inspection: Contracted vendor shall prepare factory acceptance test documentation. 5.4 Task 4 - Bottle Recovery RX, Crating, Delivery and Inspection: The contracted vendor shall crate the equipment to prevent damage during shipment. Proper shipping documentation shall be securely enclosed in the crate or affixed to the outside of the shipping crate. 5.5 Task 5 Bottle Recovery RX, Onsite Installation and Training: The contracted vendor shall provide a certified Service Technician to supervise the onsite installation, startup of the equipment and to provide basic training (overview of tablet, capsule, soft gel counter, setup and minor troubleshooting). 5.6 Task 6 - Documentation: Contracted vendor shall provide: User/Service manual(s) FAT acceptance documentation Certified Installation Qualification (IQ) documentation Certified Operational Qualification (OQ) documentation 6. SECURITY REQUIREMENTS. The CSPCRPCC is a secure facility. All contractor(s) visiting the CSPCRPCC will be required to present a valid ID (driver s license or Government issued ID) to 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 will be escorted by a CSPCRPCC staff member at all times while within the facility. The contractor will not have access to any IT networks or patient information. The C&A requirements do not apply and a Security Accreditation Package is not required. 7. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). The CSPCRPCC Plant Engineer will supply/assist the contractor any power and compressed air If needed. 8. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. Identification of Possible Follow-up Work. There is no follow-up work that can be identified. Identification of Potential Conflicts of Interest (COI). There are no known potential conflicts of interest. Identification of Non-Disclosure Requirements. Non-Applicable Packaging, Packing and Shipping Instructions. The contracted vendor shall design and build a custom wooden crate to meet load requirements. They shall use proper cushioning materials, blocking and bracing based on item weight, fragility and vibration sensitivity. They shall adequately secure contents inside the crate to make certain shipment is able to withstand the rigors of the shipping environment. Inspection and Acceptance Criteria. Equipment and component warranties are 12 months. Wear parts and parts not installed according to the original manufacturer s instructions, abused, not used in accordance with the application originally intended, or modified without prior approval of the original equipment manufacturer are excluded. 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 located at 2401 Centre Avenue, SE, Albuquerque NM 87106-4180. 10. DELIVERY SCHEDULE. SOW Task # Deliverable Title Format Number Calendar Days After CO Start 5.2 Bottle Recovery RX, Design Proposal and Acceptance Government-specified format One (1) electronic copy for review by COR and SME 10 to 14 days after contract issued 5.3 Bottle Recovery RX, Factory Acceptance Testing (FAT) FAT performed at Contractor s site via you tube or other form of video media for acceptance prior to the equipment being crated and shipped One (1) video copy (i.e. you tube, Go Pro 16-18 weeks after contract issued 5.4 Delivery Inspection of Tablet/Capsule/Soft Gel Counter Detailed Packing Slip One (1) hard copy for review by Shipping and receiving personnel 20 to 21 weeks after contract issued 5.5 Bottle Recovery RX, Onsite Installation and Training Contractor-Determined Format One (1) electronic copy stating days labor onsite *Travel time *Living expenses * Expenses *Accommodation and Travel Expenses 23 to 24 weeks after contract issued 5.6 Bottle Recovery RX, Model 1040 documentation Government-specified format - User/Service manual(s) - FAT acceptance - Certified Installation Qualification (IQ) - Certified Operational Qualification (OQ) 24 to 26 weeks after contract issued *Standard Distribution: One copy of the transmittal letter without the deliverable to the Contracting Officer shall be emailed. 11. ACRONYMS. 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. COTR Contracting Officer s Technical 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. CSPCRPCC Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. VAMC Department of Veterans Affairs Medical Center NMAHCS New Mexico Veterans Affairs Healthcare System
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25817N0327/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-17-N-0327 VA258-17-N-0327.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3436676&FileName=VA258-17-N-0327-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3436676&FileName=VA258-17-N-0327-000.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: New Mexico VAHCS;CPSCRPCC;1501 San Pedro Dr. SE;Albuquerque, NM

Zip Code: 87108
 

Record

SN04480815-W 20170423/170421234203-97b43ff4de239a4a42f679d4c448b9ec (fbodaily.com)
 

Source

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

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