Raising productivity and reducing downtime is now possible in a continuous aseptic process, with constant monitoring from fermentation to final packaging.
IMA Life LYNFINITY spray-freeze-drying has been conceived to minimise risks and increase controls compared to the traditional FD process.
The only continuous aseptic spray-freeze-drying process.
Enabling simple access to exclusive continuous aseptic spray freeze-drying technologies developed by IMA Life, LYNFINITY LAB is a high-tech, stand-alone module. Featuring an identical freezing process to the one implemented on LYnfinity at production scale, the laboratory version facilitates model building and cycle development. Scientists and lab technicians can easily test a formulation and collect vital data before switching to a production scenario.
LYNFINITY LAB, the coolest laboratory spray freezing module, where continuous aseptic spray freeze-drying starts.
Sentinel-LYO is IMA Life’s Cloud-based system for Freeze-Drying Data Analytics and Health Monitoring.
The pharmaceutical aseptic processing industry needs to monitor the entire manufacturing fleet with data-driven, real-time analytics to minimize predict process deviations and minimize equipment downtime. Anticipating such needs for informed manufacturing, the Lab4Life team at IMA Life, has developed a product that performs big data analysis for monitoring the overall health of freeze-drying processes and equipment.
The goal of this system is to move towards a predict-and-schedule model, which aligns well with guidance issued by the United States Food and Drug Administration and the European Union’s commission on Health and Food Safety regarding Continued Process Verification and maintenance of a validated system. By developing freeze-dryer-specific algorithms deployed on a secure cloud and augmenting with a framework of sensors to collect process and equipment data, a real-time comparison against historical performance of a freeze dryer is now possible.
An advanced innovative controlled nucleation technology capable of producing sterile cryogenic ice fog and circulating it with a lyophiliser chamber to ensure reliable and prompt top-down nucleation of the vial-contained pharmaceutical formulations at an optimal temperature.
The search for a low environmental impact, high performance, safe, refrigeration system for freeze drying is now complete. The KryoAir air refrigeration system circulates ultra low-temperature air as the refrigerant. It is composed of three parts: an expander integrated with a compressor (compression and expansion), a primary cooler (heat dissipation) and a heat-recovery heat exchanger (heat recovery).
To better cope with peak heat demands, the KryoAir system combines a novel thermal energy storage system, along with the turbo compressor expander. The energy storage system has no moving parts, is compact, and environmentally friendly. The combination offers a high performance, efficient refrigeration system that has zero environmental impact caused by using refrigerants with a global warming potential.
A system composed of wireless battery-free sensors integrated in the vial stopper, capable of making three measurements with a spatial resolution of less than 1 mm. Such multi-point sensing capabilities allow temperature gradient measuring within the product across the entire batch.
A smart miniature mass spectrometer, a non-invasive technique capable of performing quantitative real-time process-relevant measurements. A multipurpose device designed for use in pharma freeze-dryers, it detects contaminants and process gases at concentrations down to ppm levels.
IMA Life’s patented FusionTM shelves are built in-house by a fully automated manufacturing process, ensuring higher quality and increased process reliability. They are designed and finished to improve the lyophilisation outcome and to reduce operating costs and energy consumption. The Fusion TM shelves are lighter and more resistant than conventional solutions and offer enhanced heat transfer properties.
The machine offers the most comprehensive range of custom-built freeze-dryers for those who require more than a standard solution. Lyomax can provide the answer from 1 m2 to 100 m2 applying state-of-the-art engineering in vacuum, refrigeration, stoppering and heat-transfer technology.
A range of freeze dryers providing support for all lyophilisation requirements. Lyofast offers superior quality, reduced lead times, cost-effectiveness and simplifies the validation process. The machine features freeze-drying areas from 4 m2 to 50 m2.
MINIMAX is a GMP small-scale freeze dryer developed to address the demands involved in handling small production batches. Similarly to the LYOMAX industrial freeze dryer, MINIMAX benefits from all-round performance, a high level of redundancy and various configurable options making it a reliable and versatile solution for each application. MINIMAX can be integrated with isolation technology and automatic vial-loading systems. The unit is pre-arranged to support the processing of non-aqueous solvents and high potent products. Available in six configurations with shelf areas from 1.0 up to 3.9 m2, MINIMAX ensures an ice condenser capacity ranging from 29 to 78 kg with minimum condenser temperatures of – 75°C.
Designed for laboratory developments, pilot and industrial production, Lyofast Mini features a very compact design. It is available in four different configurations with shelf areas from 1.1 to 2.8 m2 and ice condenser capacity ranging from 28 to 58 kg with minimum condenser temperatures of -75°C.
It is the connection between bench-top and industrial freeze-dryers and the ideal solution for product development and process cycle optimisation. Minifast is available in two models with shelf areas of 0.4 and 1.1 m2 and the ice condenser capacity ranging from 8 to 20 kg with minimum condenser temperatures of -85°C.