Freeze Drying & Freeze Dryers

Freeze drying is our speciality.

From equipment to product and process development, maintenance and validation to analytical equipment, we provide a complete package.

Our range of freeze dryers are divided into three size categories to meet your needs: See Below.

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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:

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FREE GUIDES

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Laboratory & Benchtop Freeze Dryers

Benchtop Pro Freeze Dryers

Benchtop Pro freeze dryers are ideal compact research machines that encompass a range of lab processing requirements. They are flexible, powerful and user-friendly.

  • Condenser temperature options from -55°C to -103°C to enable processing a wide range of products and solvents
  • Extensive range of accessories allows for flexibility in terms of shape or size sample to be freeze dried including trays, flasks, ampoules, vials and 96 well microtiter plates
  • Range of manifolds in clear acrylic or stainless steel for superior corrosion resistance
  • Precise vacuum control enables you to achieve better, more repeatable results.
  • One-button auto start-up and shut-down activates all operating parameters in a correct and safe sequence, protecting the product and equipment
  • Hot gas defrost and smooth-walled condensers for fast turnaround and minimal delay between runs
  • Samples should be frozen externally, prior to introducing to the vacuum. If you prefer or require a system capable of freezing in-situ, but still at benchtop scale, please refer to our Virtis Advantage Pro range.

AdVantage Freeze Dryer

The AdVantage series is a unique range of benchtop freeze dryers with temperature-controllable shelves similar to those found on larger research and scale-up systems.

  • Ideal for pilot or R&D laboratories that need an advanced level of process control but lack the space for free-standing research units
  • Advanced software allows for data capture and analysis
  • Up to 16 multi-step program recipes which control shelf temperature (-62°C to +60°C), condenser temperature and vacuum levels can be selected
  • Thermocouple probes are included for product and process monitoring, and complementary PC software is also available for data capture and analysis
  • Up to 3x stainless steel 316 shelves can be selected (0.27m2 shelf area, in total) and condenser temperatures as low as -82 °C
  • Pneumatic stoppering can be chosen to allow containers to be closed at the end of a product run, under either vacuum or an inert gas, such as nitrogen
  • The precise freeze drying control supplied by AdVantage makes it ideal for processing valuable or sensitive biological materials. – Commonly used by biotech and pharma corporations, research institutes, pharmacy departments of universities, and diagnostic companies

Freezemobile Shell Bath Freezer

These automatic, refrigerated shell bath freezers provide an easy method of pre-freezing many flasks at a time. The flasks are automatically rotated to create an even layer and a flask lift device prevents fouling of lid and opening.

Freezemobile Shell Bath Freezers are typically used in conjunction with Benchtop Pro freeze dryers.

The Freezemobile Shell Bath, is a floor model available in a -75C configuration for flask freeze drying which helps to decrease manifold freeze drying time, and rotates the flask on its axis thereby coating the interior surface of the flask with frozen product. This increases the surface area of the product-to-energy input, as well as vapor removal; thus helping to reduce the freeze drying process to the shortest time possible when utilizing flasks and a manifold system.

KEY FEATURES

  • Compact, bench-top design
  • Temperature to -75°c
  • Reliable motor driven rollers for flask rotation.
  • Single or Dual Bath

KEY BENEFITS

  • Decrease drying time by shell freezing product (vs static freezing) thereby increasing surface area for energy input and vapor removal.
  • Accommodates a variety of flasks
  • Easy install, requires standard laboratory utilities
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Pilot & R&D Freeze Dryers

Genesis Freeze Dryer

Unequalled for design and capabilities, the Genesis is the most versatile freeze dryer for pilot, research or small scale production applications.

Its advanced product monitoring and process control make it ideal for research and with a user-friendly interface it is perfect for laboratories with multiple products or formulations to investigate. An ergonomic layout allows easy inspection of the vacuum pump and facilitates oil changes, which can be made quickly and cleanly in the laboratory environment.

Genesis is available with up to six bulk drying shelves (five vial processing shelves).  An expanded range of shelf arrangements, available with a shelf latching kit, allows you to configure it to process a wide variety of vial sizes.

The user friendly ‘Wizard 2’ microprocessor control system allows storage of up to 16 different multi-step freeze-drying recipes.

With shelf area up to 0.85m2 shelf area and condenser capacity up to 35litres, Genesis can also be used for scale-up work and small-scale processing. The extensive range of options includes:

  • Stoppering
  • Cleanroom configuration
  • Isolation valve
  • Water cooling
  • Sample thief
  • Installation and operator training
  • IQ and OQ options
  • Control system options for 21CFR11 and cGMP compliance
  • PC software for data storage and handling

Ultra Freeze Dryer

Highly flexible and with multiple configurations, the Ultra is similar to the Genesis but with expanded capacity to enable those involved in small-scale production or scale-up research to process larger batches.

Control options are available to provide cGMP and 21CFR11-compliant data monitoring, security restriction and automation applications, and stainless-steel cleanroom flanging and water cooling can be specified to allow Ultra to be used in controlled environments. The chamber can be isolated so that pressure rise tests can be carried out to give an indication of the end of primary or secondary drying.

Additional vacuum gauges and product probes can be specified to provide in-depth process documentation for research or regulatory requirements.

With shelf area up to 2.13m2 shelf area and condenser capacity up to 50litres, Ultra is often used for scale-up work and production. The extensive range of options includes:

  • Stoppering
  • Cleanroom configuration
  • Isolation valve
  • Water cooling
  • Sample thief
  • Installation and operator training
  • IQ and OQ options
  • Control system options for 21CFR11 and cGMP compliance
  • PC software for data storage and handling

Ultra is commonly used by pharmaceutical, biotech and diagnostics companies.

Lyostar Freeze Dryer

The Lyostar3 operates a cutting edge R&D system, moving users away from the ‘trial-and-error’ elements during the development processes, toward unique SMART technology that enables fast and easy optimisation of cycles, and ensure the smooth transfer from laboratory to production scale.

Independent studies have confirmed the use of SMART Freeze Drying Technology™ software from SP Scientific (available with the Lyostar), has offered a time reduction on an average cycle development in the order of 78%. The technology reduces the average cycle development to one or two runs, rather than the conventional series of six to eight runs – thereby not only reducing development time, but also lowering materials costs by at least one third.

Difficulties involved within the freezing parameter of the overall process is a stage that many agree remains the only portion of freeze drying that is largely uncontrolled due to ice nucleation. This is because ice nucleation is generally a stochastic process, so the degree of super-cooling varies both inter and intra-batch.

To combat this, the Lyostar3, utilises ControLyo Nucleation technology with its rapid decrease in pressure that causes each vial to nucleate at the same time; this is very important when considering batch to batch reproducibility. To discover more about the advantages of using controlled nucleation technology, take a look at this white paper from SP Scientific: ‘Adoption of Controlled Ice Nucleation Technology, ControLyo’

Utilising controlled ice nucleation technology such as ControLyo, offers more than just improved product characterisation and efficiencies in cycle run-times though; watch the short video below to discover more:

Another technique at the forefront of freeze drying science is TDLAS (Tunable Diode Laser Absorption Spectroscopy) which is explained in brief summary through the image below, that enhances process performance understanding using non-intrusive measures, such as water vapour presence, flow velocity, & water mass flow (dm/dt) measurements – this too is available with the Lyostar3.

Therefore, given its adaptability to a range of contemporary tools for monitoring pharmaceutical freeze drying, R&D scientists have made the Lyostar3 their preferred developmental freeze dryer, to ensure the capture of these critical data-sets.

VirTual Freeze Dryer

VirTual model freeze dryers are designed for processes with high vapour loads, such as bulk processing or fast cycles.

The high-capacity 50 litre internal condenser is configured to add the enhancements of an external condenser whilst preventing any vapour impedance during bulk drying.  All chamber surfaces are manufactured from polished, stainless steel and are easy to clean. Multi-step, multi-recipe storage and optional external PC control provides the user with flexibility in cycle development, historical trending and repeatability. Options are also available to enable compliancy with modern industry manufacturing and laboratory standards, including 21CFR11, if required.

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Production Freeze Dryers

Ultra Freeze Dryer

Highly flexible and with multiple configurations, the Ultra is similar to the Genesis but with expanded capacity to enable those involved in small-scale production or scale-up research to process larger batches.

Control options are available to provide cGMP and 21CFR11-compliant data monitoring, security restriction and automation applications, and stainless-steel cleanroom flanging and water cooling can be specified to allow Ultra to be used in controlled environments. The chamber can be isolated so that pressure rise tests can be carried out to give an indication of the end of primary or secondary drying.

Additional vacuum gauges and product probes can be specified to provide in-depth process documentation for research or regulatory requirements.

With shelf area up to 2.13m2 shelf area and condenser capacity up to 50litres, Ultra is often used for scale-up work and production. The extensive range of options includes:

  • Stoppering
  • Cleanroom configuration
  • Isolation valve
  • Water cooling
  • Sample thief
  • Installation and operator training
  • IQ and OQ options
  • Control system options for 21CFR11 and cGMP compliance
  • PC software for data storage and handling

Ultra is commonly used by pharmaceutical, biotech and diagnostics companies.

Production Freeze Dryers For The Pharmaceutical Industries

In the pharmaceutical and biotechnology industry, devices must be of very high quality with high precision control tools. Biopharma Group has worked for over 30 years with manufacturers recognized worldwide for the quality and technological advances of their industrial freeze dryers. We supply their equipment to the largest industrial groups in the world in the health, life sciences and pharmaceutical sectors.

Freeze Drying Expertise

It is our extensive freeze drying and project management experience that allows us to select the system that is best suited to your specific production process needs. We have installed devices with specifications and configurations as varied as they are numerous: CIP and SIP systems for cleaning and sterilization, loading systems for rows of products, flap doors (‘pizza oven’ type), automatic loading and unloading (ALUS), all compliant with 21CFR11 international standards and GMP (cGMP and GAMP5). Complete documentation is available for each device, to meet the requirements of users and applicable authorities. We are at your disposal to advise and assist you through your purchasing project and beyond.

<h2″>Installation and Qualification

Our Technical Service team can assist you with commissioning, operator training and installation qualification to ensure that your system remains in compliance with your practical requirements as well as applicable regulatory standards. We also offer an after-sales service for the regular maintenance for the life-time of your machines.

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