SOLICITATION NOTICE
66 -- Brand Name or Equal for Elpro Services, Island Central Monitoring System in Cell Culture dataloggers
- Notice Date
- 8/8/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-14-T-0377
- Response Due
- 8/18/2014
- Archive Date
- 10/7/2014
- Point of Contact
- Abraham Pottenger, 301-619-2294
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(abraham.pottenger.civ@mail.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the 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. Minimum Essential Characteristics (MEC) for Per Cell Culture Laboratory Brand Name or Equal to Elpro Dataloggers US Army Medical Research Institute of Infectious Diseases (USAMRIID) requires fourteen (14) or more dataloggers with the following Minimum Essential Characteristics (MEC): Data loggers must be equip with 8 channels, or more, to monitor (6 or more) incubator stacks. Loggers must be able to capture temperature, humidity, and CO2 levels within incubator. Loggers must have an alarm built into the unit. Each logger must be able to capture 64,000 units or more of data. Logger must come with a display unit. Data logger accuracy must be between +/- 0.05mA. Must come with CO2 sensors for each incubator. Must come with temperature and humidity transmitter for each incubator. Software that captures data must be FDA 21 CFR Part / GMP / GLP compliant. Must be capable to run on Windows 7 OS. PERFORMANCE WORK STATEMENT quote mark Elpro Dataloggers or Equal to Installation, Training, and IQ/OQ for Cell Culture Lab quote mark Virology Division, Cell Culture I. BACKGROUND INFORMATION USAMRIID's Cell Culture Division is in need of a datalogger system to keep track of temperature, humidity, and CO2 usage. This documentation is required when performing cell culture work for future Good Laboratory Practices studies. Since USAMRIID is on the verge of beginning GLP studies in a BSL-4 environment Cell Culture needs to be equipped with a datalogger system that can keep track of these critical aspects. In the past, Cell Culture has used chart records and other devices to capture this data weekly, but that is not sufficient due to the lack of documentation needed when performing at GLP status. II. PURPOSE AND OBJECTIVE OF THE PROCUREMENT The USAMRIID Cell Culture Division would like to expand our datalogger system to capture and monitor temperature, humidity and CO2 for 1 incubator stack and 8 stand-alone, reach-in incubators (10 incubators in total). This system will be used to make sure all incubators are working properly and are complying with GLP regulations. The goal is to move Cell Culture forward toward GLP status by installing and qualifying the dataloggers to meet standards throughout the Institute. In addition, we are purchasing 4 dataloggers for the BSL-4 suites for Research Support to support the studies planned for Virology Department customers. III. CONTRACTOR REQUIREMENTS In order to be compliant with GLP-readiness goals, the Cell Culture Division will be purchasing installation and operational qualification services as part of equipment purchases to outfit the cell culture laboratory. The system will be installed by a vendor service member including setting up the dataloggers and sensors on each incubator. After all the dataloggers/sensors are IQ/OQed to NIST standards the software used to monitor the data will be installed on a standalone computer. This computer will be the only line of tracking data and information that comes from each input off of each datalogger. After completion of installing the software the vendor service member will then train ~5 Cell Culture and EMD personnel in the software used and the hardware involved. This will give USAMRIID personnel the knowledge to troubleshoot problems when they come up. THE SYSTEM: The system will use an island-networked system to monitor temperature, humidity, and CO2 for all incubators. SUMMARY OF REQUIREMENTS: 1.The vendor will conduct Installation Qualification (IQ)/Operation qualification (OQ) on each datalogger/sensor. 2.The vendor will provide appropriate documentation for the qualification of instrument performance at the time of instrument installation to include verification that all instrument functions meet published specifications in accordance with vendor procedures. 3.The vendor will provide training on hardware and software to ~5 Cell Culture and Equipment Medical Department personnel after installation is complete. 4.During the instrument warranty period, the vendor will offer technical support and replacements of the mechanical piece on the dataloggers in accordance with the warranty agreement. IV. TASK MEASUREMENT AND EVALUATION METHODS DELIVERABLES: Qualification reports will be generated at time of instrument installation verifying each function of the instrument is within vendor specified and published parameters. These reports will include qualification check lists which confirm each instrument parameter is performing in accordance with vendor published guidelines. V. QUALITY ASSURANCE SURVEILLANCE PLAN Performance RequirementPerformance standardAcceptable Quality LevelSurveillance Method and Frequency IQ/OQ Equipment QualificationStandard Report including OQ checklist verifying all equipment functions are operating within expected parametersAll equipment functions fall within vendor published specifications. Vendor standard report is completed and issued to USAMRIID upon completion of work.Qualification reports will be evaluated and verified by equipment responsible parties to ensure expectations are met. VI. WORK HOURS: The work performed by USAMRIID and the contractor will be performed during normal work hours which are 8:00am to 6:00pm. VII. TRAVEL/TRAINING: Training will be provided to USAMRIID personnel after installation of dataloggers are complete. Training will be completed at USAMRIID facility. VIII. POINTS OF CONTACT USAMRIID: Lucinda Leaman (301-619-1322) Shawn Guest (301-619-4907) 1425 Porter Street Fort Detrick, MD 21702 IX. PERIOD OF PERFORMANCE The installation, qualification, and training should take no more than 5 business days. The dataloggers will be under warranty for 2 years or more from date of install. IQ/OQ Due upon instrument installation. X. GOVERNMENT FURNISHED INFORMATION, FACILITIES, SUPPLIES, AND SERVICES At USAMRIID, there are no furnished information, facilities, supplies, and services available to support the needs requested in this contract. See attached document(s) for full information. Quotes should be submitted via email to: Abraham Pottenger Contract Specialist U.S. Army Medical Research Acquisition Activity 820 Chandler Street Ft. Detrick, MD 21702 Phone: 301-619-2294 Fax: 301-619-4084 abraham.g.pottenger.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-14-T-0377/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03458095-W 20140810/140808235242-e0a88e7e3f8763be661c95691c4012c7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |