SOLICITATION NOTICE
66 -- Bioreactor
- Notice Date
- 8/13/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- 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
- FDA-09-1060836
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 339112, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This synopsis is designated for full and open competition for a firm fixed-price purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. One of the important objectives of the critical path project on comparability of physicochemical parameters of manufactured proteins is to assess the post-translational modifications of the proteins produced out of mammalian cell culture. To this end we would like to employ a Bioreactor system in the laboratory that shall meet the following requirements in order to facilitate mammalian cell culture for laboratory scale protein production. (A). Shall have a built in computer or an on-board facility (built into the system rather than a separate computer) to control the various processes and input devices as well as a simultaneous display capability of the output parameters over time in a graphical format to understand the bio-reaction process. Shall be able to interface with multiple process controls, thus, it shall also be able to control and monitor multiple bioreactor vessels simultaneously, if and when deployed. (B). The system shall be able to display the data in real time in graphical format as well as be capable of exporting in other compatible formats for archiving and analyses. (C). The system shall be able to hold multiple programs (at least up to 10) and be capable of deploying them instantaneously without having to resort to program the system from a computer. (D). The system shall be able to control multiple processes up to at least 32. (E). The control system shall be customizable for process identification. Shall be able to accept analog inputs and outputs, for integration of multiple (up to 7 or 8) external devices. (F). Specifically shall have at least 3 pumps that can run at 2 to 100 rotations per minute and be capable of controlling additional number of pumps when needed. (G). The system shall be flexible to handle vessels of sizes 2.5 liter to 14 liter with ease. (H). The system shall be able to maintain temperature accurately at 5 C above the cooling water temperature. Further it shall be able to handle temperatures up to 80 C when needed at an accuracy of +/- 0.1 C. (I). The system shall be upward compatible for software upgrade and shall have the facility/ ports to accept improved software developed by the manufacturer as well as operating system developer in future. The following line item provides the above configuration: (1) M1287-2110 & M 1287-1010 Master Control Station, 120V. (J). The system shall have an overlay facility to minimize the frothing that commonly happens when high amount of excreted protein is produced by the cultured cells. In addition, the controller shall have at least 4 gas mixers (for air, oxygen, carbon dioxide and nitrogen), one thermal mass flow controller and facility to add more mass flow controllers if needed. These following items are required to achieve the above configuration: (2) M1287-2017 4 TMFC (0.1-5 slpm) (3) M1287-3550 Gas Overlay kit without TMFC (requires a rotameter) (4) M1287-3505 Gas Overlay Vessels Kit (5) M1287-3520 Rotameter (0-5 slpm) (11) M1287-9966 Barant variable speed pump 115V (13) M1287-5032 septum adapter kit (14) M1287-5002 (4manifold) Air Pre-filter assembly (15) M1287-9918 Pressure gage (0-30 psi) (K). The system shall be capable of accepting additional probes to the standard probes namely, secondary Dissolved Oxygen probe, a reduction-oxidation probe, a pH probe etc. The following items are required: (9) M1287-0401 5.0 L pH/DO Probe kit (10) M1287-0674 2.5 L/5.0 L pH/DO probe kit (L). Shall have a water jacketed vessels with stainless steel quick connections and shall not have glass projections for connecting hoses as they tend to break while handling. This facilitates controlling temperature in conjunction with a positive displacement chiller, without a need for cold water drain. (M). The impeller drive motor shall be magnetic and be capable of 25 to 500 rotations per minute to handle various types of impellers and also shall be controlled via the built in computer system. The following item is required to have the above configuration: (6) M1287-5069 5.0 L vessel assembly (N). The Bioreactor system shall be versatile in terms of handling various kinds of impellers required for different types of mammalian cells grown under specific conditions. Some of the commonly used impellers are: Spin filter impeller, pitched blade impeller, marine blade impeller. The following items are required: (7) M1287-5069 5.0 L Pitched blade Impeller kit EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," (2) Past performance and 3) Price. Technical Capability and past performance when combined are significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before August 17, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 4:30pm, EST on or before August 21, 2009. Telephone calls will not be accepted. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1060836/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN01911200-W 20090815/090814001104-fbbe46aaa46cf7db5dd70b7af7030a12 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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