SOURCES SOUGHT
J -- SMALL BUSINESS SOURCES SOUGHT NOTICE: MAINTENANCE FOR FILLER/CAPPER AND PRINTER/LABELER SYSTEMS
- Notice Date
- 3/7/2013
- Notice Type
- Sources Sought
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- SBSSNoFDA-SOL-13MaintenanceforFiller-CapperandPrinter-LabelerSystems
- Archive Date
- 3/29/2013
- Point of Contact
- Daniel Gregory Laidlaw Feldman, Phone: 301-827-0359
- E-Mail Address
-
daniel.g.feldman@fda.hhs.gov
(daniel.g.feldman@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTE: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition (811219, Other Electronic and Precision Equipment Repair and Maintenance, Size Standard: $19 million). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). BACKGROUND The U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC) serves as a standards preparation and testing laboratory for CBER. DBSQC is also an International Organization for Standardization (ISO) 17025 accredited testing laboratory. The DBSQC prepares and distributes standards and reference reagents to other regulatory agencies and sponsors (i.e. industry) in support of licensure, lot release, and other regulatory decisions, including for use in testing of biological products, such as influenza vaccines. DBSQC has custom designed, manufactured, assembled, and installed filler/capper and printer/labeler systems for the preparation and distribution of standards and reference reagents, including influenza vaccines. To ensure proper functioning, the customized filler/capper and printer/labeler systems must be maintained by highly specialized technicians. System Descriptions: The filler/capper and printer/labeler systems were custom designed, manufactured, assembled, installed, and qualified by FP Developments, Inc. (FP). The systems have the capability of filling various volumes in different size vials. The systems operate via a High-Definition Multimedia Interface (HDMI), which have been programmed to perform several automatic functions. The systems have many integrated and interconnected components. In particular, the filler/capper system has the following specifications: • The frame of the system is fabricated from stainless steel and FDA accepted plastics. • The system is designed to run in a clean room with a restricted access barrier system (RABS) unit as an option. • The system incorporates a FP model 1249 linear peristaltic pump system for dispensing. • The filling system is a modification of a bench top syringe filling and tip capping system. • The system includes a check weighing system. • The system is capable of integrating into the new Genesis capper with optional infeed and discharge turntables to integrate the capper. • The filling and stoppering mechanisms are driven using a combination of mechanical, stepper motors, and pneumatic devices. The pneumatic devices have all exhaust air, including pilot air discharged through a common exhaust line outside the controlled field. • An Allen Bradley Micrologix programmable logic controller (PLC) is used to control the system's functions and sequencing. • An Allen Bradley Panel View Plus 700 touch screen is used as an operator interface. • The system handles pharmaceutical vials from two cubic centimeters (cc) to 20 cc, 13 and 20 millimeters (mm) stoppers, and aqueous fluids from.50 milliliters (ml) to 20 ml. • The system is designed to fill and stop 30 vials per minute. • The system is capable of filling approximately five vials per minute during continuous weight checking, and the controls are programmed to check weight on a count or time basis prior to a run. • The system includes a Hypack manual filling station holding a Hypack syringe rack and has a needle bar with five dispensing needles, which can be operated by a foot pedal to the model 1249 pump to dispense fluid. The printer/labeler system has the following specifications: • The frame of the system is fabricated from stainless steel and FDA accepted plastics. • A Genesis West Capper PW-500 is integrated with the labeling system. • The system consists of two turntables 36 inches in diameter, where one is used to feed vials to the West Capper and the other is used to accumulate vials from the vial labeling machine. • A standalone Toshiba TEC color printer is used to print high quality color labels for vials. The vials are automatically transferred to a conveyor after capping for labeling. • All line integration interconnections between machines and transfers were provided by FP. • Typical glass vials of 17.5 to 30 mm are used with the printer/labeler system. The systems are located at the Nicholson Lane Research Center (NLRC), which is located at 5516 Nicholson Lane, Building B, Rockville, MD 20895. Within NLRC, the filler/capper is located in Room Number 2316 and is uniquely identified in CBER's Laboratory Quality Database (LQDB) as 001279, and the printer/labeler is located in Room Number 2300 with 001163 as its unique LQDB identifier. PURPOSE/OBJECTIVE The purpose of this requirement is to provide preventive and corrective maintenance services for DBSQC's customized filler/capper and printer/labeler systems, which are used to support the preparation and distribution of standards and reference reagents. PROJECT REQUIREMENTS To meet the purpose and objective of this requirement, the Contractor shall perform the following preventive and corrective maintenance on-site at NLRC, unless otherwise indicated: • The Contractor shall perform the following annual preventive maintenance services at least once per year: o Inspect, adjust, and perform general preventive maintenance services to ensure optimum operation. o In particular, for the filler/capper, the Contractor shall: • Test and adjust all sensors • Check and adjust the infeed belt • Clean and inspect all change parts • Check all feeder bowl drive springs • Check all servo drive couplings • Check and adjust all timing belts • Check all bearings and slides • Check all contact surfaces for wear • Visually inspect all wiring and controls • Rebuild the pump, which shall occur at the Contractor's facility o In particular, for the printer/labeler, the Contractor shall: • Test and adjust all sensors • Clean and inspect all change parts • Check all servo drive couplings • Check and adjust all timing belts • Check all bearings and slides • Check all conveyor chains • Check all contact surfaces for wear • Visually inspect all wiring and controls • Check and clean all print heads • Check all labeler belts and rollers The Contractor shall work with the Contracting Officer's Representative (COR) to schedule a time to perform the preventive maintenance. The Contractor shall expect to perform the preventive maintenance shortly after the effective date of the order. The Contractor shall also provide corrective maintenance services by delivering unlimited technical support and troubleshooting assistance throughout the period of performance of the order. The Contractor shall perform the technical support and troubleshooting assistance on-site, except the Contractor can provide this support off-site with the approval of the COR when off-site support is most practical and effective. The Contractor shall respond to the FDA's technical support and troubleshooting requests within 24 hours of the FDA's initial request to the Contactor for assistance. The Contractor may be permitted to respond initially to the FDA's inquiries for assistance by phone, email, or live-chat interface. All preventive and corrective maintenance shall be performed by trained, skilled, and experienced technicians following original equipment manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc., where applicable. For all on-site maintenance, the Contractor's personnel are required to use the NLRC parking lot and report to the security guards in NLRC's Building B, who will contact the COR or his or her designated FDA employee. The Contractor's personnel must be escorted by the COR or his or her designated FDA employee at all times while working on-site under this order. ANTICIPATED PERIOD OF PERFORMANCE The FDA anticipates a base period of one year with two one year options. For each option period, the Contractor shall perform the same tasks and produce the same deliverables as delineated in the base period. The FDA anticipates an award date on or around March 25, 2013 with preventative maintenance expected to be performed shortly after award. OTHER IMPORTANT CONSIDERATIONS Qualifications: The Contractor shall propose and provide technicians with documented evidence that they have the knowledge, skills, and abilities to perform the above described preventive and corrective maintenance on the custom designed, manufactured, assembled, and installed filler/capper and printer/labeler systems. Place and Time of Performance: The Contractor shall perform all on-site maintenance service at the NLRC during the hours of 9:00 am to 5:00 pm ET, Monday through Friday. Pricing and Payment: This requirement is anticipated to be a firm-fixed-price order, inclusive of all costs, including labor, travel, and components with firm-fixed-price payment upon completion of the base and each option, if the FDA decides to exercise the particular option. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement electronically to Dan Feldman at daniel.g.feldman@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement shall be no more than five pages, excluding a cover page and table of contents, and shall include examples of successfully completing similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses shall also include company information to determine eligibility, including their contact information, DUNS number and size and business type (e.g. 8(a), HUBZone, etc.) based on the applicable NAICS code for the proposed acquisition (811219, Other Electronic and Precision Equipment Repair and Maintenance, Size Standard: $19 million). Potential offerors have until 8:00 am ET, Thursday, March 14, 2013 to respond to the FDA.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/SBSSNoFDA-SOL-13MaintenanceforFiller-CapperandPrinter-LabelerSystems/listing.html)
- Place of Performance
- Address: 5516 Nicholson Lane, Rockville, Maryland, 20895, United States
- Zip Code: 20895
- Zip Code: 20895
- Record
- SN03005835-W 20130309/130307234230-5b2c717e5ad0374325d1854fd4985efd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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