SOURCES SOUGHT
66 -- Bathless Dissolution System
- Notice Date
- 2/18/2015
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory 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-15-1145309-SS
- Archive Date
- 3/12/2015
- Point of Contact
- Tiffany R. Williamson, Phone: 3018277182
- E-Mail Address
-
tiffany.williamson@fda.hhs.gov
(tiffany.williamson@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Notice to Small Businesses The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns. The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses. The Food and Drug Administration (FDA) is conducting a market survey to assess the availability of small business firms as defined by NAICS code 334516 that has the capability to provide a Bathless Dissolution System and a one (1) 12 month option period for preventative maintenance and service In the event a solicitation is posted. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that procurement will be accomplished. FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted of FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required. Background The Detroit Laboratory, Office of Regulatory Affairs (ORA), U.S. Food and Drug Administration (FDA) require a Distek Dissolution instrument with UV/Vis spectrometer to run dissolution analysis on pharmaceutical medications for shelf life and drug survey samples. The dissolution system and HPLC with PDA detector will be essential to the Detroit Laboratory efforts to ensure the U.S. DOD and VA medication supply meets acceptable dosing limits for the medication. The dissolution system will allow the Detroit Laboratory to respond to testing requirements in a timely and efficient manner. The Bathless Dissolution System shall include a one year manufactured warranty and preventative maintenance service agreement. Specific Tasks and Deliverables: Item 1: Quantity = 2 Symphony 7100 Bathless Dissolution System (Part ID 2022-7106) or Equal The dissolution instrument must meet or exceed the minimum requirements listed below: • The instrument must include dissolution test parameters which are monitored and reported to confirm compliance with stated USP guidelines for temperature and RPM. This feature is user selectable to OFF, ALERT, and ABORT. • The instrument must have high watt heaters that raise media temperatures from ambient to 37 degrees Celsius. • The instrument must have security and password protection • The instrument must store and sort up to 100 methods by name and create date. • Serialize paddles and vessels • Dissolution Vessels - Minimum of 6 vessels with programmable volume of 500 mL - 1000mL • Vessel Heating Rate 2ºC per Minute • RPM Control Range 25 - 350 RPM, Digitally Controlled • Resolution 0.1 RPM • Accuracy ± 0.2 RPM • Motor High Torque, Permanent Magnet • Vessel Temperature Control Independently Controlled Two-Zone Heater Jackets • Bathless Display Resolution 0.01ºC • Accuracy ±0.25ºC • Calibration Built-in Calibration Probe • Shaft Wobble Less than 0.010" (0.254 mm) • Program Modes Manual (Individual Vessel Control) • Automatic (Up to 100 Pre-Programmed Methods) • Interface Ports RS-232 (2), RS-485 (1), Parallel Printer (1) • Solid State Heating Elements • Dimensions 26"(w) x 39"(h) x 20"(d) (66 cm x 99 cm x 51 cm) • Weight about 150 lb (67.5 kg) • Electrical Power 115V 50/60Hz 15A or 220V 50/60Hz 8A (operating voltage pre-set at factory) Sipper Sampler • Must be capable of pulling samples from multiple baths and run samples through the UV/Vis Spectrometer • Variable pump, delay, and return time • Flow cell with 10-mm path length, 3-mm diameter, and 80-μl volume • Constant-speed peristaltic pump with pump tubing • Minimum sample volume of approximately 1 ml • Typical sampling time of ~20 seconds (with <1% cross-contamination) • Test Tube and HPLC Vial collection, for Extended Release testing. • 8 Channel Syringe Pump • Test Tube Rack • HPLC Vial Rack UV/Vis Spectrometer • Compliance must be in line with all requirements of the United States Pharmacopeia (USP) • Must include a pre-aligned deuterium and tungsten lamp light sources • Must include built-in buttons to measure sample, standard, and blank for convenient measurements even when wearing gloves • Must be thermally stable for a wide operating temperature range • Communication through GPIB or LAN for dedicated or networked PC control • Firmware upgrade from PC for easy participation in future developments • Built-in GPIO interface for control of accessories • Serial and firmware revision number held in firmware • Own clock for time and date stamps of the spectra • Extensive self-test procedures that check the electronics and key optical characteristics to ensure consistent performance between validations • Built-in electronic logbooks which contain the results of self-tests, notes on instrument • Maintenance, events and errors Optical performance Must be in compliance with all requirements of the US Pharmacopeia and American Society for Testing and Materials (ASTM) • Wavelength range 190-1100 nm • Slit width 1 nm • Stray light <1 % • Wavelength accuracy <±0.5 nm 0.5-second scan (NIST 2034) • Wavelength reproducibility <±0.02 nm ten consecutive scans (NIST 2034) • Baseline flatness <0.001 A 0.5-second blank Physical dimensions The unit will be stored on a bench. Due to space limitation, the dimensions and weight must be: • Approximate Height × width × depth 185 × 344 × 560 mm (7.3 × 13.5 × 22.0 inches) • Approximate Weight about 16.5 kg (36.3 lb) Environmental conditions • Operating temperature 0-50 °C (32-122 °F) • Non-operating temperature -40-70 °C (-4-158 °F) • Humidity <95 %, at 25-40 °C (77-104 °F) Instrument Software The instrument shall be supplied with software to control the dissolution system, spectrometer, and sipper sampler delivery system. All parameters including but not limited to solvent flow rate, solvent composition, injection volume, bath position, bath temperature, switching valve(s) position and pump shall be controlled from the UV/Vis spectrometer data system and software. The software shall comply with 21 CFR, Part 11 laboratory standards. In addition to instrument control, the software shall provide data analysis including but not limited to peak detection, peak integration, quantification and data reporting. Software qualified upon installation. Data System The instrument shall include a data system. At a minimum the data system shall include: Dual Core computer, 2.66GHz processor or faster, minimum 4 GB RAM, minimum 320GB hard drive, DVD RW (CD RW capable), mouse and keyboard. The internal video card shall support a maximum resolution of 1920x1200 (DVI) and 2048 x 1536 (Analog). No less than 3 network connections. The computer shall be RoHS compliant. Include color laser jet style printer. Data System Display The data system display shall be one flat panel LCD display at least 15" wide. Training: The contractor must provide 8 hours of on-site training for 10 employees at the delivery location listed below. Installation: The contractor shall provide a full installation of the equipment. IQ/OQ Performance Verification: The vendor shall provide Instrument Qualification/Operational Qualification (IQ/OQ) and Instrument Performance Verification (IPV) for the system offered, which includes a qualification report. Technical /Support Services: The contractor must provide one year manufacture warranty for all parts, labor, travel, technical, on-line, and telephone support service for a 12 month (one year) period after complete delivery, installation, and training at no additional cost to the government. The contractor shall provide full service support for the installed equipment, including but not limited to labor, parts, travel on-site support, telephone support, retesting and re-qualification of the unit, software updates and enhancements. The contractor must provide continuous online and telephone support for the instrument. The support services shall include, but not limited to trouble shooting, equipment maintenance and repair, and provide responses to operator questions. Preventative Maintenance: The annual on-site preventative maintenance/service agreement shall include the support of qualification and calibration service, test guidelines to USP 711, software and hardware updates, technical, on-line/telephone support services, and replacement of parts, labor, and travel in support of the instrument at the location. General Instructions Contractors that believe they possess the ability to provide the required equipment must submit documentation of their ability to meet each of the characteristics listed above to the Contracting Officer (i.e. brochure, information on equipment that meets specifications, etc.) The capability statement must also include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code. Capability statements that do not provide sufficient information for assessment will be considered non-responsive. When submitting the information, please reference the solicitation number FDA-15-1145309-SS. Responses must be submitted via email to Tiffany Williamson at Tiffany.Williamson@fda.hhs.gov by 12:00 pm on February 25, 2015.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-15-1145309-SS/listing.html)
- Place of Performance
- Address: 300 River Place, Suite 6900, Detroit, Michigan, 48207, United States
- Zip Code: 48207
- Zip Code: 48207
- Record
- SN03645151-W 20150220/150218235219-4a7a447601427240b618cea1e0b45e6c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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