Upgrade of the freeze-drying microscope for determination of the collapse temperature (Tc) and the eutectic point (Teu) of formulations

Agency need to upgrade existing Freeze-Drying Microscope, as the current unit is more than 10 years old. A replacement system/unit must be able to perform to the same or higher capability as the current unit. It should be able to reproducibly determine the collapse and eutectic temperatures for a range of formulations and biological materials. Thus, allowing for the optimisation of lyophilisation cycles.

Description: A suitable freeze-drying Microscope unit should consist of: 1. A temperature controller, ideally with a temperature and pressure readout and a programmable profile function for full control of the system during analysis. 2. A digital camera with a specification of at least 2.3 million pixels and a 12-bit digital colour output. 3. A Liquid nitrogen pump and Dewar containing a twin pump mechanism for faster cooling. 4. A vacuum gauge with a pressure range from atmospheric to 10-4 mBar and a motorised valve. 5. An imaging Station with articulated head for easy sample loading and cleaning, with dimmable LED source in combination with an efficient, custom-designed electronics module and polarised light filter. The lifetime of the LED should adequate such as but not limited to 60.000 hours and good to be maintenance free. Electrical power should be a maximum of 10.0W. The LED colour temperature ideally about 4500K. 6. A cryostage, such as but not limited to, FDCS 196 or equivalent. 7. A Workstation featuring minimum specification; Intel core i7 3.2GHz processor, 8GB RAM, 500GB hard drive, motherboard, Windows 10 (64 Bit), NET framework 4.0, USB 3.0 connection, HD Monitor, keyboard and mouse is preferable. 8. The temperature control, real-time digital video and measurement software should ideally have a live temperature and pressure information, allowing full monitoring and adjustment of experimental conditions, up to 80Gb file sizes with all captured images and experimental conditions and image compressors to create JPEG image files or AVI videos of the analysis. 9. Set-up, test and full system validation against a range of standard solutions with documented critical temperatures prior to dispatch. 10. Ongoing support for interpretation of results as required and an image analysis software package that helps to minimise subjectivity in determining Tc and Teu is desirable. Manufacturers would be required to demonstrate that their instrument can measure a range of standard solutions and their documented critical temperatures should be provided. Equipment size should be designed for benchtop and should not exceed: Width = 170cm (includes all the components), Depth = 60cm, Height = 100cm. A demonstration of each instrument capability at NIBSC (MHRA) is essential as well as onsite installation and training if successful. Potential suppliers if they feel they can meet the requirement should email [email protected] to register an interest by close of play 19 February 2019.