Vial Filling Machine

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the below requirement under Simplified Acquisition Procedures. The solicitation number is FDA_13-223-1115886. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66, February 28, 2013. The associated North American Industry Classification System (NAICS) Code is- 333993 - Packaging Machinery Manufacturing; Size standard 500 in number of employees. This acquisition is a 100%Total Small Business set-aside requirement. For information regarding this solicitation, please contact Howard Nesmith by e-Mail at contact@example.gov. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 9:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on April 10, 2013 to contact@example.gov, Fax +1 (555) 000-0000, or mail to the U. S. Food and Drug Administration (FDA), OO/OFBA/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC) is in need of and soliciting for the purchase of a Vial Filling Machine. Any award resulting from this solicitation is contingent on the availability of funds within the 2013 Fiscal Year. Vendors shall state on their quotes that price quotes shall be valid thru September 30, 2013. Item #1 Rotary Unscrambling Table - 42" Specifications: --Unscrambling tables designed with Class 100 clean room environment --Constructed of heavy gauge stainless steel --Heavy gauge stainless steel threaded legs complete with stainless steel pads for adjusting table height from 33"-37" --Stainless steel loading shelf --Stainless steel cabinet with access panels Quantity: One Make: _________________________ Model: ________________________ Unit Price: _____________________ GSA Contract Number (if applicable): ________________________ Item #2 Filling Machine The filling machine shall fill one size vial with one set fill volume during a filling run. However it shall have the ability to switch over to accommodate different size vials and fill volumes for different filling runs. A machine that can fill 1 mL fill volumes into either a 2 or 3 mL vial and a 2 mL fill volume into a 5 mL vial will satisfy most (i.e., 99%) of the Government's manufacturing needs. To cover the remaining 1%, the fill volume range shall be able to accommodate any fill volume between 1 and 2.5 mLs. The fill volumes shall be accurate within 1% of the intended volume - thus, allowing for a range of 2%. There shall be only one scale for use of both taring the vial and measuring the fill volume to decrease the risk of measurement error. The machine shall have the ability to: 1) Download an electronic report (thumb drive data transfer is fine) that contains the vial number (starting at the start of the run), its fill weight, and the time the weigh check was performed during the fill; 2) Have fill alert limits to alert the user when the fill volumes are starting to drift close to the action limit (1% on each end of the intended fill volume); 3) Have action alerts when fill volumes are outside of the 1% that stops the machine; 4) Filling speed count requirement (60-70 vials/min) includes only vials that have been filled and stoppered; and 5) Have the ability for the user to perform programmed weigh checks by interval (e.g., every 100 vials), count (e.g., first, middle and last twenty files) and user requested checks (for example, Government might want the machine to perform weigh checks on 20 vials during the beginning, middle and end of the fill; but during this fill we might want to have some manual checks in-between these set fill volumes); also the set count and interval checks should have the ability to be reprogrammed during the run. Quantity: One Make: _________________________ Model: ________________________ Unit Price: _____________________ GSA Contract Number (if applicable): ________________________ Item #3 Check Weight System Specifications: --Pharmaceutical check weigher consisting of a tare weight unit, a gross weight unit and controls which identifies and stores in the memory the net weight of each bottle. At the same time this information is being transmitted to the printer. In addition, the controller will send a signal, visual (light tower) or audible (buzzer), or to an optional reject system, any time a gross weight is over or under pre-set limits. --Accuracy level within +/- 0.001 gr. = 1mg for up to 10 gr, or +/-0.01 gr = 10mg up to 500 gr. The system accuracy is +/- 10mg up to 10 gr, or +/- 40mg up to 500 gr. --All Stainless Steel construction --Parts in contact with bottles shall be Stainless Steel --The design of the equipment shall meet the laminar airflow requirements for a clean room environment Quantity: One Make: _________________________ Model: ________________________ Unit Price: _____________________ GSA Contract Number (if applicable): ________________________ Item #4 High Speed Stoppering Machine Designed to meet the performance requirements and production standards with the pharmaceutical industry. Capable of full insertion of standard stoppers and partial insertion of slotted stoppers. Should there be insufficient stoppers at the lower portion of the delivery chute, the machine will stop. Quantity: One Make: _________________________ Model: ________________________ Unit Price: _____________________ GSA Contract Number (if applicable): ________________________ Item #5 Trayloader Heavy duty, high performance machine designed for the loading of vials into trays after the filling process. With fully or partially inserted stoppers, the filled vials are gently loaded into 3-sided trays. This machine has been specifically designed for the use in a class 100 clean room environment. Provided with a shuttle table that holds two trays simultaneously. While one tray is being loaded with vials, an operator places an empty tray into position. The shuttle table is servo motor driven and can be shifted back and forth during loading, allowing for a stagger pattern if desired. Traying patterns may be stored in memory and recalled as needed. This includes the number of vials per row and number of rows, usually based on tray dimensions and the vial diameter. Quantity: One Make: _________________________ Model: ________________________ Unit Price: _____________________ GSA Contract Number (if applicable): ________________________ Item #6 Glass Safety Enclosure w/HEPA Fan The complete line shall be surrounded by a Glass Safety enclosure. Access doors shall be provided with Stainless Steel frames and safety interlocks.. Convenient exterior trays shall be provided for supplying consumables- stoppers, product and vial trays (in/out) without interruption of production. The overhead HEPAfilter/Fan units can be ceiling mounted or supported by the enclosure. Differential manometer gauging, and mounting for particle count sensors shall be provided. Stainless steel framed glass doors, shall be interlocked/open detect doors, are tied directly into the line's record keeping. Quantity: One Make: _________________________ Model: ________________________ Unit Price: _____________________ GSA Contract Number (if applicable): ________________________ FOB Destination - U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC), 5516 Nicholson Lane, Kensington. MD 20895. Contract Type - Commercial Item - Firm fixed price. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Solicitation Clauses The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (Feb 2012) The following addenda have been attached to the clause: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Other Terms and Conditions Maintenance and Repair All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications. Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov/far/ FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper. (MAY 2011) FAR Clause 52.204-7 Central Contractor Registration. (DEC 2012) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.202-1 Definitions JAN 2006 352.203-70 Anti-Lobbying JAN 2006 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009 352.223-70 Safety and Health JAN 2006 352.231-71 Pricing of Adjustments JAN 2001 352.242-71 Tobacco-Free Facilities JAN 2006 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contracting Officer for this order is: To be completed at time of award: Phone: (870) 543-XXXX Email: xxxx The COR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance. The COR for this order is: to be completed at time of award. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Nov 2012), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.204-10, 52.209-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-40, 52.223-18, 52.225-3, 52.225-13, and 52.232-33. Solicitation provisions The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award the purchase order to the responsible offeror who offer conforming to the solicitation will be the most advantageous to the Government on price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the services offered to meet the Government's requirement. (ii) Price. The government will award the purchase order to the lowest price technically acceptable quote. Technical capability will be determined by review of information submitted by the respondent, which must provide a description in sufficient detail to show that the service quoted meets the Government's requirements. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items (Nov 2012), applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically via http://www.acquisition.gov/far/. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Clauses and provisions incorporated by reference can be obtained at http://www.acquisition.gov/far/ .