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Pre- And Post-Lyophilization Analytical Instruments
One-Stop Shop For Advanced Freeze Drying Analysis
World-class analytical instruments designed and developed specifically for advanced freeze-drying applications.
BPS Crowthorne is the only company to offer a complete one-stop shop solution for all your lyophilization analysis requirements – equipment, commissioning/installation, servicing/maintenance and training.
We create superior equipment because the lyo analysis service we offer doubles as a superb R&D facility for our design and manufacturing of specialist analytical lyo instrumentation.
Our in-house research scientists use freeze drying microscopes (FDM) and lyo analysers every working day. So their expert recommendations are at the heart of our market-leading technology, informing the innovation process in our analytical instrument design and development on a continuous basis.
That empowers you to create optimal formulations based on a wide range of factors including appearance, moisture content, physical structure, thermal characteristics and frozen state transportability.
Advanced Lyophilization Analysis Equipment
Biopharma has designed, developed and manufactured three advanced instruments for analysing freeze drying:
- Lyostat and Lyotherm – for the proof of concept and development stages
- MicroPress – for post-process analysis
- Modular Optical DSC Stage– for use in conjunction with the Lyostat & Lyotherm instruments.
Lyostat Freeze Drying Microscope (FDM)
Observe the sample structure to determine the exact point of collapse. Sharp visualisation enables easy and accurate identification of structural changes. Image, sample temperature and chamber pressure can be displayed on-screen in real time.
Lyostat is PC controlled – giving you sophisticated image and data capture along with analysis functions that allow you determine the critical event failure points at the formulation development stage, so you can develop formulations and cycles that are safe, robust and cost-efficient. Lyostat identifies critical formulation parameters including:
- collapse temperature (Tc) – the point at which the material is no longer to support its own structure
- eutectic melting temperature (Teu) – when the solute material melts, stopping any structure forming after the solvent has been removed
- crystallisation phenomena
- potential for skin/crust formation
- effects of annealing on ice crystal growth, solute structure and critical temperature.
Lyostat provides vital information on how products behave as they are freeze dried. In crystalline solutions this is the eutectic point (Teu); in amorphous products it is the collapse temperature (Tc).
Products that collapse during freeze drying can suffer from a range of problems including reduced shelf life, reduced activity and poor reconstitution. Knowledge of a product’s collapse behaviour is essential when:
- optimising existing processes
- developing formulations for freeze drying
- developing new cycles
- scaling up production.
This advanced freeze drying microscope enables the identification of crystallisation phenomena, the potential for skin/crust formation, and the effects of annealing on ice crystal growth and solute structure. Analysis uses just 2µl and takes just under an hour.
Lyostat is supplied as a complete working system:
- fully validated against a series of standard solutions
- software is also available in a 21 CFR 11 compliant version
- full installation and training (by freeze drying scientists) are offered as standard
- training includes interpretation of results
- installation and operation qualification (IQ/OQ) packages available (bespoke if required).
Lyostat uses Thermal Analysis by Surface Characterisation (TASC) software which:
- offers accurate and quantitative analysis
- reduces operator error when determining the precise collapse temperature
- provides reassurance to the assessor evaluating the data
- can be used for annealing and crystallisation development
- can check the validity of previous results to confirm past data
- can be utilised for applications outside freeze drying
- can be provided with upgrade packages to any existing Lyostat.
TASC analyses successive images (at pixel level) for incremental changes in brightness and colour. It produces a normalised TASC trace overlay on the analysis results. Simply inspect the data file to pinpoint the collapse in a selected area.
Watch this short video to see how TASC improves thermal analysis interpretation.
Lyotherm Frozen State Analyser
Lyotherm provides the most accurate analysis data available on the market. Unique dual analysis combines electrical and thermal techniques – enabling you to do two analyses at the same time.
It measures impedance analysis and differential thermal analysis – providing clear data and flexibility post-analysis.
Impedance analysis (Zsinφ) indicates molecular mobility, including events not picked up by Differential Thermal Analysis (DTA) or Differential Scanning Calorimetry (DSC). Differential Thermal Analysis (DTA) measures the temperature difference between a sample and a reference – highlighting exothermic and endothermic events (crystallisation, eutectic melting and glass transitions).
The Lyotherm impedometer:
- determines critical parameters of samples in the frozen state – glass transition (Tg’), crystal transitions, Teu, softening
- identifies viscosity changes within the frozen structure
- optimised for frozen state analysis
- typical analysis time is one hour
- alarms and liquid nitrogen precision allow greater control over analysis
- smaller benchtop footprint (due to updated control unit and wiring design)
- simple operation, making results more reliable
- exports data directly to Excel, tailoring the graph to the analysis.
On-site installation includes full training into operation and interpretation of results.
Watch the Lyotherm video for more information.
- sample volumes from 2mL-4mL
- two Pt100 temperature probes (accuracy of ±0.3°C)
- temperature range for analysis -196°C to +60°C
- impedance probe operating between 1Ω-14MΩ at 1,000 Hz
- 4-litre liquid nitrogen Dewar
- reusable stainless steel sample holders
- 220/240V 50Hz or 120V 60Hz variable power supply
- small benchtop footprint (approximately 500 mm x 400 mm)
- software allows for data collection, analysis, storage and reloading.
MicroPress – Analyse Lyo Cake Robustness
Designed and developed by instrumentation specialists at our UK sister company, Biopharma Group, the MicroPress can determine the robustness (Young’s Modulus) and strength (max stress at failure) of lyophilized cakes. It uses a linear actuator to gently compress the cake while a load cell accurately measures the force applied.
MicroPress analysis will leave a small indentation on the cake surface. But the cake can still be used for other types of analysis such as Karl-Fischer and DSC to provide further information.
The instrument’s integrated software captures the stress-strain profile for export to Excel – enabling you to determine how the cake will behave during transportation and storage. Will the formulation break up into a powder? Will it be difficult to reconstitute?
MicroPress enables you to screen out formulations that are less likely to survive transportation. It can quantitively determine the strength and physical characteristics of freeze-dried cakes in-situ – so you don’t have to depend on subjective qualitative analysis of cakes.
It provides precise data on the strength of lyophilised cakes and greater certainty that cakes will remain robust during transportation and handling.
- operating temperature -10°C to +40°C
- speed: 0.0012 mm/s to 10 mm/s
- force: 0.1-5 N
- accuracy: ± 0.03%
- up to 25 samples per group
- calibrates to any size vial
- custom indenters are available
- analysis time: 30-90 seconds
- nine customisable parameters.
Optical Differential Scanning Calorimetry (DSC) Stage
The modular optical DSC stage system is an ideal bolt-on for measuring glass transitions, crystallisation and melting events. The stage allows simultaneous imaging and DSC analysis; it is fitted with a quartz window for high quality image capture and recording.
Study small sample sizes (or thermal transitions at low heating rates) with no loss of sensitivity.
Track changes in surface structure with an optional Thermal Analysis by Structural Characterisation (TASC) module. It is highly sensitive to glass and melt transitions. Analyse different parts of the same sample to identify inhomogeneities.
- -180°C to +450°C for a wide variety of applications
- standard 2L liquid nitrogen Dewar provides cooling for several hours
- heating rate of 0.1°C to 30°C per minute
- <0.1°C temperature stability
- aluminium and sapphire sample pans
- option of silver or sapphire furnace lid
- 01mW accuracy
- 2 mm objective working lens distance
- designed to be compatible with the Lyostat5, sharing the same software, optical system and liquid.
Contact BPS Crowthorne – Your One-Stop-Shop For Lyophilisation
Get expert technical advice and support on freeze drying. Contact BPS Crowthorne for more information about:
- installation and training for new and existing systems – carried out by specialist engineers with practical experience of the equipment and interpretation of the data
- maintenance and requalification (to provide evidence of the accuracy of the data)
- R&D consultancy and analytical laboratory services (with complete access to the R&D lab team) – benefit from Biopharma Group’s 20+ years of experience in freeze drying (developing robust cycles in foods, small molecules, diagnostic reagents, bacteria, viruses and blood products and more)
- scheduled and customised training courses on freeze drying technology and applications.