SPECIAL NOTICE
99 -- Special Notice of Intent to make a sole source purchase of the Antaris II Lyocheck Solution Kit from Thermo Electron Corporation of 5225 Verona RD, Madision, WI 53711.
- Notice Date
- 9/14/2006
- Notice Type
- Special Notice
- NAICS
- 339111
— Laboratory Apparatus and Furniture 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
- USA-SNOTE-060914-004
- Archive Date
- 12/13/2006
- Description
- Special Notice of Intent to make a sole source purchase of the Antaris II Lyocheck Solution Kit from Thermo Electron Corporation of 5225 Verona RD, Madision, WI 53711 to check the percentage of water upon lyphophilization of platelets. The governmen t believes Thermo Electron to be the only source to purchase equipment meeting all of criterial listed below. This notice clsoes 29 Sep 2006 noon EST. Please respond via email only to micaela.bowers1@us.army.mil or aaron.wade@amedd.army.mil with document ation substantiating otherwise. No telphonic inquiries will be accepted. The system must include at minimum an automated transmission module with the following unique specifications: shall include integrated solid sampling, liquid sampling, and vial auto sampling capabilities. These options must be permanently aligned, and not required system reconfiguration or alignment. The system shall include a complete system qualification package and automated validation wheel. The validation package must inc lude complete design qualification (DQ) documentation. It must also incorporate all USP recommended tests for wavelength accuracy, photometric linearity, spectrophotometric noise and stability. All standards must be individually calibrated and NIST t raceable. The interferometer must employ an active digital dynamic alignment system based on laser detection feedback for optimal system performance and maintenance of accurate line shapes. The dynamic alignment mechanism must be of sufficient sophistication to make intrascan corrections at a frequency interval corresponding to one laser fringe of the Helium Neon laser interferogramAutomatic interferometer alignment necessary for periodic system optimization must be under complete computer control. There sho uld be no need to perform manual interferometer alignment adjustments. Under no circumstances shall the only mechanism for adjusting the interferometer be limited to an on-site service call. The HeNe reference laser must be pinned-in-place, pre-aligned and completely user replaceable without the use of an oscilloscope. The laser must be coaxial with the infrared beam to insure accurate infrared peak positions. The interferometer control circuitry should employ a Digital Signal Processor (DSP) for precise laser referenced interferogram positioning. DSP referencing of the laser interferogram provides for high speed correction compensation during a scan. In a ddition, DSP referencing enables the user to replace the laser without the need of an oscilloscope to monitor the critical alignment required by laser quadrature detection. Source must be mounted on a pinned-in-place, pre-aligned holder. The source replacement must occur without opening bench and must not require alignment, manual electrical wiring connections, or specialized tools. The solid sampling module must include an internal gold reference for the automated collection of backgrounds. The system must not require the removal of samples for background collection. The integrating sphere must include optional tablet sampling capabilities. The tablet analyzers must be optimized for opaque and softgel sample collection. The system must offer the ability to collect reflectance and transmission data of a single samp le without detector coupling. The liquid sampling module must include three position automated holder. One position must be an integrated background collection position. The system must not require the removal of liquid samples for background collection. The holder must be capable of accepting 4-6 mm culture tubes and standard sized cuvettes. Optional three position holders must also be available for heating samples and transmission cards. For the heated holder, the temperature control must be software controlled. The software must be fully compatible with Microsoft Windows XP Professional edition, 2000 and NT4. On-line tutorials mixing video, audio, art and text must be provided to show the user how selected functions are performed. These tutorials must include: Standard Maintenance and Troubleshooting. The soft ware must include digital si gnatures for authenticity of reports, SOPs and data. Electronic SOPs must be integrated in software. The software must provide secure data archiving and report generation. All files must have the globally unique identifiers (GUID) for ultimate file integrity. Audit trails must be available to track any and all operations performed by operators. The software must include HTML report files that are viewable on any standard web- package. The software suite must include beers law, stepwise multiple linear regression (SMLR) classical least squares (CLS), partial least squares (PLS), and principal component regression (PCR) for quantitative method development. It must also include search standards, distance match, similarity match, QC Compare and Discriminant analysis for classification analysis. The software must include method development wizards for suggesting pathlength, feasibility assessment, suggesting standards, suggesting ana lysis region, and evaluating standards. Optional augmented classical least squares (ACLS) algorithm must also be available. Documentation and validation of all algorithms must have been performed and maintained by the vendor. Full validation software must be included. System must make use of automated sample wheel. Wheel must include NIST traceable polystyrene and 2%,10%, 20%, 40% and 80% linearity standards. Automated collection of all USP 1119 recommended tests must be ava ilable. Optional validation algorithms must be available for all chemometric methods. Must provide verification of mathematical integrity using external software package such as excel. Lyocheck" Solution The system will include 5 days of training (to include onsite software and methods training). The system should include documentation and Work Flows for the collection of calibration samples, as well as, data collection, quantificatio n and reporting of results for Lyophilized materials. The system must be warranted for 2nd year from the date of installation. The system should include Qualification for the 2nd year of operation. The system should include a multi-position auto-sampli ng capability for the vials of Lyophilized material.
- Web Link
-
US ARMY MEDCIAL RESEARCH ACQUISITION ACTIVITY
(http://www.usamraa.army.mil)
- Record
- SN01144024-W 20060916/060914221816 (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 |