Advanced Microscopy and Thermal Analysis for Freeze Drying Characterization
Determining critical temperatures is fundamental to the freeze drying process. Biopharma Group specialists have designed and developed three advanced analytical instruments – the Lyostat freeze-drying microscope, the Lyotherm DTA and impedance analyser and the MicroPress specifically to aid those employing freeze drying technologies within their production or research projects as well as being involved in the development of a compatible DSC imaging stage.
A rational, knowledge-based approach to designing and developing successful freeze drying formulations and cycles requires information about how the product responds to different processing conditions. Candidate formulations should be analyzed in terms of their visible physical structure, thermal characteristics and frozen state mobility, in order to gain a sufficient understanding of its behaviour throughout the freeze drying process. This ensures that cycles can be developed that are tailored to the specific needs of every product, making them efficient, safe, robust and reproducible.
With each product and process recognised as unique, by entrusting us with your project, you will benefit from our depth of experience and knowledge to ultimately reach any project goal. Each project will be carefully managed by Biopharma Group’s team of scientists and consultants. Through the operation of proprietary and advanced equipment, both R&D and manufacturing activities will run efficiently.
Lyobead Generator
The latest addition to our instruments portfolio is the LyobeadPRO which is a lyobead (aka lyophilised sphere) generator that has been designed to enhance lyobead processing to meet the need for dosing material that is measured by finely adjustable controls to ensure repeatability from bead to bead.
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LyobeadPRO - Benchtop Precision Lyobead Generator
The LyobeadPRO is a benchtop device designed to produce high quality lyobeads in a controlled environment within the settings of a traditional laboratory. The versatility of the device provides an ideal tool for both R&D purposes and upscale for production use. High-quality bead production is provided by utilising accurate fine dosing control, ensuring each bead contains the same amount of material and is consistent in size and shape.With single or dual droplet nozzles and the in-built ‘drawback’ process, lyobeads with viscous or non-viscous formulations can be efficiently produced within a sieved container held within the liquid nitrogen. The sieved bead collection pan is easily retrieved from the dewar and allows for dispensing of the frozen beads into freeze drying vials or trays in a safe manner. The locked dispensing nozzles and segmented rotating head located inside the dewar ensures snap freezing is performed at the correct height without risk of amalgamation (clumping) of beads within the LN2. Batch sizes of up to 12,000 beads/hour can be produced with dual nozzle output.
Key features for users offered by the LyobeadPRO:
- Generate 100 – 10,000 beads/day for both R&D and production use with precise volume and shape.
- From 5ul to 50ul sizes
- Volume precision 0.10%
- Unparalleled ease of use and simplicity of design
Single or dual nozzle operation, and easy to fit dispensing nozzles.- Benchtop device that can be operated inside or out of a nitrogen-controlled environment
- Rotation of the segmented LN2 dewar is controlled to avoid clustering of the droplets during snap freezing within the liquid nitrogen.
- Easy product formulation testing
- Safe collection of frozen beads within sieve container.
- A count of the bead numbers is displayed on the easy to read controller.
- An in-built priming facility allows for easy interchange from product to product.
Lyostat 5 - Freeze Drying Microscope
This instrument is a freeze drying microscope (FDM) used for establishing critical events such as collapse annealing and as an aid in ensuring safe, robust, and cost-efficient cycle development. The Lyostat features real-time digital video and measurement which is achieved by using a high-performance digital USB camera to determine the exact point of collapse.
The Lyostat is an integral part of the R&D and CDMO services that we offer.- Achieve a safe, robust and cost efficient cycle development: identify collapse/eutectic temperatures, crystallisation phenomena, potential for skin/crust formation, and the effects of annealing on ice crystal growth and solute structure.
- Real-time digital video and measurement: using a high performance digital USB camera to determine the exact point of collapse, capture up to 80 GB of information.
- Optimised Optical System: fewer lenses than compound microscopes for clearer images, LED lamp with an efficient custom-designed electronics module and lifetime of more than 60,000 hours.
- Motorised vacuum control: chamber pressure displayed in mBar, kPA or mTorr enables close investigation of the effects of pressure on sample collapse.
- Liquid Nitrogen Cooling System: automatic twin-pump cooling system including 2L Dewar and flexible insulated tubing, twin pumps for faster cooling.
- User-friendly software: full control over temperature programmer active ramp information and stage pressure, create temperature profile of several ramping and holding steps in a simple on-screen data table.
>>Download application note featuring Lyostat 5 & Lyotherm 3
MicroPress - Mechanical Property Analyser
The MicroPress is a mechanical property analyser that works to determine key parameters for lyocake or lyobead quality.It can also assure product quality all the way to the point of delivery, as it is able to establish how the lyocake or lyobead will behave during handling and shipment.
- Determine key parameters for cake and lyobead quality: using a linear actuator to gently compress the cake to determine the stiffness (Young’s Modulus) and strength (max stress at failure) of lyophilised cakes and lyobeads.
- Easily measure physical properties: identify vials with collapse, microcollapse & crust formation.
- Quick analysis time: as standard, less than 1 minute, in situ analysis – no sample prep required, quickly compare multiple vials.
- Integrated software: the resulting stress-strain profile captured during analysis is then exportable to Microsoft Excel for further interpretation and data traceability.
>> How does micro-collapse affect lyophilised cake strength?
>> MicroPress: How Robust Are Your Cakes?
Lyotherm 3 - Frozen State Analyser
The Lyotherm analyser combines electrical and thermal techniques – allowing two analyses to be conducted simultaneously. It is capable of both impedance and differential thermal analysis.The Lyotherm 3 provides the most accurate analysis data on the market - reliability of results has been increased with clear graph data and flexibility during post analysis. It is also optimised for frozen state analysis, and boosts greater control over analysis.
- Add a new dimension to the data of this critical stage: the Lyotherm3 combines electrical and thermal techniques, enabling you to do two analyses at the same time:
- Impedance Analysis (ZSinφ): is a fixed frequency dielectric analysis providing an indication of molecular mobility, including events not picked up by thermal methods like DTA or DSC.
- Differential Thermal Analysis (DTA): measures the difference in temperature between a sample and a reference, highlighting exothermic and endothermic events e.g. crystallisation, eutectic melting and glass transitions.
- Most accurate analysis data available on the market: the Lyotherm3 simplified operation to increase reliability of results providing you with clear graph data and flexibility during post- analysis.
- Optimised for frozen state analysis: identifies viscosity changes and critical parameters of samples such as Tg', crystal transitions, Teu and softenings within the frozen structure.
- Great control and optimization: alarms and liquid nitrogen precision allow greater control over analysis, while the updated control unit and wiring design reduce the benchtop footprint.