Compressor, Oil-Free variable speed rotary tooth For medical grade compressed air VA Cooperative Studies, New Mexico

STATEMENT OF WORK (SOW)
CONTRACTING OFFICER S REPRESENTATIVE (COR).
Name:
Mark Valdez
Section:
Clinical Materials Management Section
Address:
VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center
2401 Centre Avenue, SE
Albuquerque, NM 87106-4180
Phone:
505-265-1711 #6309
Cell Phone:
505-218-2246
Fax:
505-248-3205
Email Address:
Mark.valdez2@va.gov
SUBJECT MATTER EXPER (SME).
Name:
Frank Lueddeke
Section:
Chief, Clinical Materials Management Section
Address:
VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center
2401 Centre Avenue, SE
Albuquerque, NM 87106-4180
Phone:
505-248-3203
Cell Phone:
505-975-8141
Fax:
505-248-3205
Email Address:
Frank.lueddeke@va.gov
SCHEDULE OF SERVICES AND/OR SUPPLIES.
#
Item/Stock#
Description
Est. Qty.
Unit
Unit Price
Estimated Amount
1
ZT-22 VSD (or equal)
30HP Oil-Free Variable Speed Drive Rotary Tooth Compressor
1
EA
2
Additional 500 feet of 1 Copper Piping for Air Line
1
EA
3
Compressor Installation
1
EA
TOTAL ESTIMATED COST
CONTRACT TITLE.
Oil Free Medical Grade Air Compressor
BACKGROUND.
The Department of Veteran Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) has a requirement to purchase an Oil Free Rotary Tooth Air Compressor. This oil free rotary air compressor is needed to supply medical grade compressed air to our packaging and manufacturing equipment spaces and equipment.
The compressor must allow for room air and equipment air to be supplied and maintained at an optimal low dew point requirement of -40 degrees Celsius for all equipment spaces and pharmaceutical drugs in the manufacturing stage, blister card production runs, bottle packaging and labeling runs. The CSPCRPCC currently has an estimated 50 pieces of high tech equipment that are used to support clinical research trials from tablet manufacturing machines to a fully automated bottle packaging line. The compressed air used in all manufacturing and processing procedures comes in direct contact with drug products and containers and must be of pharmaceutical grade and must be tested annually.
The CSPCRPCC currently utilizes an Atlas Copco ZT-18 which has been in use for nearly 13 years. This compressor has been extremely reliable; however, this model can no longer provide the amount of compressed air when all manufacturing and production lines are on line due to increase in equipment requirements. Requesting replacement to be an Atlas Copco ZT-22 (or equal).
SCOPE.
The contractor shall provide an oil free rotary tooth air compressor, and all other resources required to remove/replace outdated ZT18 compressor, install and integrate new compressor with the primary compressor to deliver system air through the desiccant air dryer, storage tank and then to facility equipment in order per this scope of work. Either compressor shall be able to be shut down for maintenance, with the second compressor available for operation with limited interruption in production, due to facility production schedule.
SPECIFIC TASKS.
The Oil Free Rotary Tooth Air Compressor, must have the capability of providing -40 degrees Celsius medical grade compressed air to our packaging and manufacturing equipment, and spaces ensuring Current Good Manufacturing Practices (cGMP), and FDA Regulation guidelines are met. The use of this equipment will be required when production controllers and manufacturing personnel are operating the high tech equipment used to support clinical trials, from tablet/capsule manufacturing machines to a fully automated bottle packaging line. This compressed air used in many manufacturing and processing procedures comes in direct contact with drug products and containers and must be of pharmaceutical grade standards and must be tested annually.
Task 1 Oil Free Compressor
30HP oil free, air cooled, variable speed drive rotary screw air compressor
Compressor outside dimensions cannot exceed
Length: 143
Width: 54
Height: 108
Produce compressed air for pharmaceutical manufacturing and processing
Air supply: 90PSIG, 113 SCFM
Power Supply: 120VAC, 1 phase, 60Hz, 5A
Automatic restart during power failures
TEFC main drive motor
High efficiency intercooler and aftercooler
Variable frequency drive
MK5 graphic controller
Oil free compression technology
Standard one year warranty
7.2 Task 2 Oil Free Compressor Design Proposal
The oil free compressor must be capable of integrating with existing ZT22 compressor plumbing, desiccant air dryer, storage tank and then to facility equipment. Either compressor must be able to be shut down for differing reasons or the use of other compressor brought on line (Started) for use. The Contracting Officer s Representative (COR) will provide the contractor with the specifications and layout schematic and then review contractor s proposal for acceptance (approval).
7.2.1 Subtask 1 Oil Free Compressor Proposal
The Contractor shall prepare an installation and placement proposal outlined in this statement of work. The Contracting Officer Representative shall review the design proposal ensuring specification requirements have been met.
7.2.2 Subtask 2 Oil Free Compressor Proposal Acceptance
Once the COR and Contractor reach consensus on the placement and connection specifications outlined in this statement of work, the COR shall accept (approve) the proposal so the contractor may begin processing their contracted work schedule.
Task 3 Compressor Crating, Delivery and Inspection
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.
7.4 Task 4 Compressor Onsite Installation
The contracted vendor shall provide a certified Service Technician to supervise/perform onsite installation and startup of the equipment.
7.4.1 Subtask 1 Compressor Plumbing Installation
Contracted vendor shall provide a certified Service Technician to supervise the onsite installation/integration of the plumbing system into the current ZT22 compressor so when either compressor is operational, the system air will be processed through the desiccant air dryer, storage tank, and associated air lines and to manufacturing/labeling equipment and automated bottle packaging line.
7.4.2 Subtask 2 Compressor Electrical Installation
Contracted vendor shall perform all connections and testing of all electrical wiring code requirements ensuring safety of personnel, equipment and facility power grid.
7.4.3 Subtask 3 Compressor Ventilation Installation
Contracted vendor/sub-contractor shall utilize current roofing ventilation setup so as to install ventilation ducting and air vent directly above the oil free compressor. Roofing material will be re-sealed as required to maintain the facility s initial roof warranty from defects open to the environment, and internal structure of ceiling.
7.4.4 Subtask 4 Installation of Additional 500 Feet of 1 Copper Piping
Contracted vendor shall install an additional 500 feet of one-inch copper line from the main compressor room (Rm 183) to Rm 308 (located in the ANNEX).
7.5 Task 5 - Compressor Training
The contracted vendor shall provide a certified Service Technician to provide basic training (overview of the compressor, setup and minor troubleshooting).
7.6 Task 6 Documentation
User/Service manual(s)
PERFORMANCE MONITORING.
Task
Standard
Acceptable Quality Level
Surveillance Method
7.2 - Oil Free Compressor Design Proposal/Acceptance
Compressor will be approved based on drawings and functional design
System must meet line integration specifications.
Management Information Systems
7.3 - Compressor Crating, Delivery and Inspection
Delivery of system delivered within agreement between contractor and VA
System will be delivered No Later Than 26 weeks after PO issued
Direct Observation
7.4 - Compressor Onsite Installation
Contractor shall provide a certified Technician to perform onsite installation, and startup of the equipment
- Integrate plumbing system into current ZT22 compressor, desiccant air dryer, storage tank, and associated air lines
- Connection and testing of all electrical wiring
- Install vent, vent ducting and roofing material
- Install additional 500 of Copper line
Direct Observation
7.5 - Compressor Training
Contractor shall send a technician to provide basic training (overview of the compressor, setup and minor troubleshooting).
Contractor shall send a technician to Albuquerque for a minimum of 3 working days
Direct Observation Management Information Systems
7.6 - Documentation
Contracted vendor shall provide:
- User/Service manual(s)
Appropriate Documentation accounted for and signed as required
Direct Observation
SECURITY REQUIREMENTS.
All contractor(s) will need to present a valid ID (driver s license or government issued ID) to our 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.
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.
GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI).
The CSPCRPCC will supply/assist the contractor with forklifts and pallet trucks to move and position equipment within the building.
The CSPCRPCC Plant Engineer will supply/assist the contractor with specialized hand tools and small shop supplies if needed.
OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS.
The location of contracted vendor is imperative to the pharmaceutical studies programs CSPCRPCC conducts. Manufacturing, labeling, and packaging of these items are ongoing, and the supply of -40 degree Celsius medical grade air is required at all times in the spaces containing manufacturing equipment, blister card machine, bottling line and labeling equipment. The need for urgent repairs during normal work hours and off shift hours are critical to the safe handling and processing of all pharmaceutical drugs and associated equipment and materials.
Identification of Possible Follow-on Work.
Possible multi-year maintenance and service contract recommended, un-scheduled critical repairs during normal/off duty hours, to include follow up work may include immediate urgent repairs on both compressors, desiccant air dryer and associated hardware.
Identification of Potential Conflicts of Interest (COI).
There are no potential conflicts of interest identified.
Identification of Non-Disclosure Requirements.
N/A
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 has adequate equipment to safely deliver purchased equipment.
Inspection and Acceptance Criteria.
Compressor, and supporting equipment shall be inspected upon arrival for damage, inclusion of all required manuals and parts in adherence to this Statement of Work. Any discrepancies will be noted on the packing slip(s) and the COR will be notified.
PLACE OF PERFORMANCE.
Equipment shall be delivered and installed at the
VA Cooperative Studies Program
2401 Centre Avenue, SE
ATTN: CSP Warehouse (151-I)
Albuquerque, NM 87106-4180
The oil free air compressor shall be delivered to the CSPCRPCC Warehouse dock. From there CSPCRPCC personnel will be responsible for moving the equipment into the building, and positioning it in the central compressor/vacuum room 183, with the assistance from the contracted vendor. This shall be accomplished using Government owned forklifts or pallet trucks, as needed.
PERIOD OF PERFORMACE.
The contracted vendor shall deliver equipment no later than 26 weeks after receipt of purchase order.
DELIVERY SCHEDULE.
SOW Task #
Deliverable Title
Format
Number
Calendar Days After CO Start
7.2
Oil free Compressor Design Proposal/Acceptance
Government specified format
One hard copy to COR
Two weeks upon purchase order
7.3
Oil Free Compressor Crating, Delivery and Inspection
Government specified format
One job
26 weeks upon receipt of purchase order
7.4
Oil Free Compressor Onsite Installation and Training
Contractor specified format
One hard copy
27 to 28 weeks upon purchase order
7.6
Oil Free Compressor Documentation
User/Service Manual(s)
Contractor specified format
One
Hard Copy
27 to 28 weeks upon purchase order
*Standard Distribution: One copy of the transmittal letter without the deliverable to the
Contracting Officer shall be emailed.
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.
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.
CSPCRPCC Cooperative Studies Program Clinical Research Pharmacy Coordinating Center.
VAMC Department of Veterans Affairs Medical Center
NMVAHCS New Mexico Veterans Affairs Healthcare System.