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Lyophilizer System for Drug Product Freeze Drying

Publication Date
01/10/2019 01:44 PM EST
Closing Date
01/16/2019 02:00 PM EST
Issuing Organization
University of Massachusetts - Lowell
Solicitation Number

Specifications include, but are not limited to: University of Massachusetts Lowell is going to implementing a project of scale-up and automation of freeze drying system for drug product formulation. In order to proceed the project a pilot scale Lyophilizer System is required. The required system components include or be compatible with the following technologies: Controlled Ice Nucleation, Freeze Dryer Technology, Tunable Diode Laser Absorption Spectroscopy (TDLAS) based water vapor mass flow rate monitor and TDLAS based Freeze Dryer Technology. Controlled Ice Nucleation: Controlled nucleation is becoming an important step in a freeze-drying cycle and our development work. The technology is to control the nucleation of the product solution in the freeze dryer, i.e. the solution in all vials (or bulk, syringes, etc.) allowing nucleation at the same time and the same temperature, which is predefined by the researcher. This is key to reducing cycle times and providing a cycle design which can be reproduced from one freeze dryer to another. Technology delivers a controlled process, improves product quality, shortens drying times, and requires no formulation change or introduction of foreign material into the vials. Freeze Drying: Freeze-Dryer Technology is based on major lyophilization principles, and allows an easy-to-use cycle development tool. Freeze-Dryer technology must eliminate the trial-and-error approach normally involved in developing new lyophilization cycles. It enables experts and novices alike to develop new cycles quickly, while also ensuring that those cycles are elegant and efficient. The tools provide instant feedback on important product data — such as product resistance, heat flow, and mass transfer — that was previously unavailable. Tunable Diode Laser Absorption Spectroscopy (TDLAS) Water Vapor Mass Flow Rate monitor: The sensor must be capable of accurately and sensitively measuring water vapor mass flow during freeze-drying. It is one of the new tools that are transforming pharmaceutical lyophilization from an art into an efficient, science-based manufacturing process. The advanced application of the sensor allows the non-intrusive determination of pharmaceutical product temperature during lyophilization. VirTis Freeze Drying Equipment and Lyophilizer: VirTis is one of the most established freeze-drying equipment manufacturers in the world. The system must be compatible and integrate with this. FTS Systems Freeze Dryers and Lyophilizers: FTS Systems is recognized as an industry leader in freeze dryers and low-temperature thermal management systems, offering unmatched application and implementation support, and specializing in customized system solutions. The system must be compatible or integrate with FTS’s products.

https://www.commbuys.com/bso/external/bidDetail.sdo?bidId=BD-19-1109-UMLOW-LOW-34434&parentUrl=activeBids (opens in a new window)

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