Freeze Drying & Freeze Dryers
Please note: some of the freeze dryers advertised in the picture above are not featured on the website, however if you would like to find out about these machines do not hesitate to contact us. We represent international manufacturers who are recognised experts in their specialisation. If you are new to freeze drying, why not talk to our sales team and take advantage of our expertise. We are sure to have the right system for you.
For more information or to request a quote:
Line of Sight
Improved diagnosis is driving precision in treatment, along with more stringent regulation from agencies such as the MHRA and FDA, to ensure processes as well as the products themselves, are fully understood.
Data-rich environments are increasingly desired by both manufacturer’s of a drug product, and purchaser of a drug product, whereby real time data corroborates a batch produced under controlled conditions, ensuring product submission are more compelling from a regulatory perspective.
By establishing an expanded design space, users can develop a more flexible approach in development and manufacturing process and it is then easier to implement continuous process improvement and maintain product integrity within the boundaries of that design space.
SP Scientific’s Line of SightTM approach does just this, providing a breakthrough suite of freeze drying equipment, with scalable lyophilization technologies and process analytical technologies (PAT), designed to assist pharmaceutical developers and manufacturers achieve drug commercialization objectives, whether the focus be scale-up or scale-down.
SP Scientific’s development and scale up using scalable technologies and process analytical tools (PAT), are compatible with the following techniques:
- AutoMTM/SMART™ Freeze Dryer Technology – Primary drying cycle optimization tool for in depth product information
- LyoFlux® TDLAS Sensors – Accurate measurement of vapor mass flow for calculation of critical product attributes
- Tempris® Wireless Sensors – Real-time accurate and reliable product temperature measurement
- ControLyo® Nucleation Technology – Precise control of the freezing point
- LyoCapsule™ Freeze Dryer – Accelerating freeze-drying cycle development with just 7 vials
All our freeze dryers are fully supported with a range of technical services from our service department. We maintain close links with our suppliers and with an installed base of over 350 freeze dryers of all sizes and configurations, you can rest assured of our experience. Alternatively, if you have your own service engineers, we are able to train them in the care and maintenance of your equipment. We have invested in a range of high quality calibration equipment and can bring to the site all instruments necessary to complete a full calibration of all instruments to UKAS standards.
- Installation and Training
Installation and operator training is available on all of our systems and is provided as standard on most. This includes operation and programming of control systems and PC software where applicable and instruction on basic care and maintenance.
We also provide training courses in freeze drying technology
We aim to support your system long after installation and regular scheduled maintenance is the best way to ensure the equipment continues to function as standard. Depending on the system and requirements, this can include replacement of consumables such as gaskets, refrigerant charging, instrument calibration, leak testing, shelf and sterilisation mapping, and vacuum oil change.
We currently support a range of systems throughout the UK and Ireland from small laboratory systems to large integrated production systems.
- Qualification and Validation
Qualification and validation packages are increasingly common even for smaller systems and we are able to provide an experienced service either to our own standard or to customer requirements. Qualification packages can be tailored to include elements such as supervised Factory Acceptance Tests and Site Acceptance Tests and protocols can be provided or written to specification. We are also able to advise and assist with the preparation of User Requirement Specifications (URS).
For more information or to request a quote:
Advanced Microscopy and Thermal Analysis for Freeze Drying Characterization
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 behavior 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.
Biopharma has developed three advanced analytical instruments – the Lyostat freeze-drying microscope, the Lyotherm DTA and impedance analyser and the MicroPress and involved in the development of a compatible DSC Stage – to provide exactly these answers. During the past decade, both instruments have been improved and updated to give the current instruments which are described and the in the overview brochure below:
Lyostat Freeze Drying Microscope
Lyostat identifies critical formulation parameters including collapse temperature (Tc), eutectic melting temperature (Teu), crystallisation phenomena, the potential for skin/crust formation, and the effects of annealing on ice crystal growth, solute structure and critical temperature. The Lyostat freeze drying microscope is PC controlled to provide sophisticated image and data capture along with analysis functions, which allows the user to determine the failure point of their formulations.
Lyotherm provides information about the behavior of your formulation in the frozen state, identifying changes in molecular mobility and giving an indication of thermal events such as glass transitions, crystallisation events and eutectic melting.
The MicroPress was designed and developed by the Biopharma Group specialists as a solution for determining the robustness (Young’s Modulus) and strength (max stress at failure) of lyophilized cakes. MicroPress uses a linear actuator to gently compress the cake while a load cell accurately measures the force applied. The resulting stress-strain profile captured by the integrated software is then exportable to Microsoft Excel for further interpretation and analysis.
By performing this analysis, the user can determine how the cake will behave during storage and shipment.
The application notes below can help with how MicroPress can be used with your products:
WE’VE RELEASED THE FIRST DATES OF OUR 2020 SCHEDULED LYOPHILISATION TRAINING COURSES
Presenting topics from practice and experience, our specialist tutors are active in the field of lyophilisation, with many years practical experience. They have substantial knowledge of the challenges of operating an efficient and robust freeze drying process and the experience to trouble shoot your problems. Our courses are regularly updated in response to feedback from course attendees, changes in cGMP and advances in processing technology. Our objective is to embed an understanding of freeze drying theory in our training courses and ground the course in real world practice.
Bespoke/Customized On-Site & Webinar Courses
Bespoke (customized) on-site and webinar courses present an opportunity for a company looking for instruction in the field of lyophilization technologies to create a programme specific to their individual needs.
Ideal for those with a large training requirement, or when a specific training need has been identified, we offer complete flexibility as to the duration and location of the courses, be it on-site or in a webinar format, whichever proves most beneficial to you as the client. The content of these courses can be customized to requirements and to the specific situation requested thus ensuring focus is placed exclusively on the areas required for your team members.
Customers with a specific product type or process issue can request time to be allocated for consultancy with regard the product, equipment or process in question.
Please see below a list of general topic suggestions that your course could be designed around.
- Introduction to FD technology
- Product Freezing Primary and Secondary Drying
- Concepts of Formulation Formulation Characterisation
- Process Monitoring and PAT methods Conventional Cycle Development
- Alternative Approaches to Cycle Development SMART and ControLyo technologies Quality by Design (QbD) for Lyophilisation
- Freeze-Dried Product Analysis Freeze-Drying of Liposomes
- Freeze-Drying of Small Proteins and Antibodies Freeze-Drying of Particles
- Freeze-Drying of Bacteria and Probiotics Freeze-Drying of whole cells Lyophilisation from Non-Aqueous solvents
- Workshop 1 – Appearance and Visible Defects Workshop 2 – Multidisciplinary Problem Solving
- Systems 1 – Thermal Fluid & Refrigeration Systems 2 – Practical Refrigeration & Stoppering
- Vacuum Systems (incl. leak testing)
- Containers, Stoppers & Barrier Technology Condensers
- Cleaning and Sterilisation Maintenance Maintenance & Qualification
- Qualification & Validation
Learn from the Experts
We present the topics from practice and experience – not just theory & textbooks. Our tutors are currently active in the field, with many years practical experience. They have substantial knowledge of the challenges of operating an efficient and robust freeze drying process and the experience to trouble shoot your processing problems. The courses are regularly updated in response to feedback from course attendees, changes in cGMP and advances in processing technology. Our objective is to embed an understanding of freeze drying theory in our training courses and ground the course in real world practice.
Biopharma have joined forces with The National Institute for Bioprocessing Research and Training (NIBRT) to provide our Product, Process & Systems course this September. NIBRT is a world-class institute that provides training and research solutions for the bioprocessing industry. Their mission is to support the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial bioprocessing facility, demonstrated successfully through their world class facility in Dublin, Ireland.
Lyophilisation is a complex science and as a result, personnel with extensive freeze drying experience are very rare in the industry. Combining the expertise of Biopharma and NIBRT, this course is the ideal way to ensure your training needs are met.
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