Key Characteristics
- Flexible technology for standard wet granulation, melt granulation, pelletizing or effervescent production, combined with vacuum or microwave drying
- Swinging bowl options during vacuum drying results in an improvement of the granule characteristics and a reduction in drying time
- Easy and efficient cleaning (CIP)
- Compact technology – reduce space requirement by incorporating several processing steps into one machine
Definition
A single pot processor is a high-shear mixer-granulator that is also equipped with drying technologies. Thus, single pot processing is the production of pharmaceutical granules using a wet granulation process in which dry mixing, liquid addition, wet granulation, drying and sizing of the granules is done in one machine.
Main Benefits
- By integrating granulating and drying capabilities into a single unit, capital investment in equipment and good manufacturing practice (GMP) floor space is lower than other alternatives.
- The number of material handling steps is decreased: consequently, the total processing time is shorter while maintaining a high yield and keeping production support to a minimum. At the same time also the number of required operators is reduced.
- Environmental variables, such as humidity, are eliminated from the manufacturing process, which may offer advantages for processing moisture-sensitive formulations.
- Requirements for solvent recovery systems are lower for single-pot processors compared with fluid bed dryers.
- Reaching a high level of containment is easy by application of the correct measures at in- and outlet valves.
- A single pot can be changed over in less than 2 hours, which makes it a very attractive technology if a large number of different products- demanding a high number of product changeovers- has to be produced.
Applications
- Contained production of highly active of toxic products
- Effervescent production
- Wet granulation using organic solvents
- Multiple product facilities requiring fast change-over
- ‘special’ applications (e.g. melt granulation, crystallization onto substrates)
Production Capacities
| UltimaPro size | 10 | 25 | 75 | 150 | 300 | 400 | 600 | 900 | 1200 |
| Bowl Volume (Litres) | 7.9 | 27 | 77 | 153 | 303 | 400 | 614 | 900 | 1166 |
| Typical Batch Weight @ 0.6 g/ml (kg) | 3 | 11 | 30 | 60 | 120 | 160 | 240 | 350 | 480 |
Effervescent Production
UltimaPro FZ
Effervescent granules and tablets are a popular dosage form for many active ingredients. The production of these products requires special attention. The UltimaPro FZ is specifically designed for the production of effervescent granules using the water-based reaction method, but its flexibility makes it suitable for all production methods of effervescents: 2-step and 1-step using solvents, 1-step using water.
Main benefits for water-based production
For effervescent processes using water, excellent control of the reaction process is required to achieve more stable formulations. The UltimaPro FZ enables this by fast onset of drying using vacuum (optionally assisted by microwaves for even faster drying times), leak-tight operation and a specially designed, balanced vacuum system.
Main benefits for solvent based production
The use of vacuum for drying, combined with an inertization system using minimal amounts of nitrogen, allows the use of solvents for processing. The ingenious vacuum system with condenser allows for easy recovery of the solvent, thus minimizing solvent emission and reducing waste.
For more information, take a look at the the tab on Solvent-based Production.
Suggested configuration for UltimaPro FZ
The UltimaPro FZ is a Single Pot Processor equipped with a very efficient vacuum system, with a special balanced design for water-based effervescents. The bowl is leak-tight to enable a vacuum level of <3 mbar to be achieved. Recipes can be integrated for standard effervescent formulations.
Vacuum drying is the basic drying technology with the option of adding microwaves for even faster processing times, higher yield and more stable end product.
Test Opportunities
The Single Pot Processing technology can be tested at the GEA Pharma Process Development Center in Wommelgem, Belgium.Contained Production
UltimaPro HC
The production of highly potent compounds requires special care to avoid exposure of the operators to the drug as well as cross-contamination of other products manufactured in the same facility. The UltimaPro HC is specifically designed to allow fully contained production of highly potent compounds, avoiding all contact between product, operator and environment.
Main Benefits
The concept of a Single Pot Processor in itself already ensures contained processing by executing granulation and drying in one vessel and thus avoiding product transfers. Additionally, the UltimaPro can be equipped with several features to optimize the containment of toxic pharmaceutical products.
The product feed and discharge valve can be equipped with Buck® Valve high containment technology and even isolator boxes if required by the customer.
A sampling valve that allows the operator to take samples during the process without having to stop the machine, open the bowl, or even open a port in the lid, can be integrated into the processing vessel and adapted to different containment levels. The sample container is completely contained allowing the sample to be transported to the QC lab without exposure to the atmosphere.
The concept of containment not only applies to the production area. When working with organic solvents, recovery and containment of these solvents is as important as containment of the product itself. The UltimaPro is equipped with a very efficient recovery system that can recover more than 99% of the used solvents.
Even for cleaning, the concept of containment is applied. The UltimaPro can be supplied with a wide range of washing-in-place and fully automated cleaning-in-place options.
Suggested configuration for UltimaPro HC
The UltimaPro HC is a Single Pot Processor equipped with appropriate containment tools for loading and discharging (Hicoflex®, MC valves, etc.); a full, validatable CIP system; contained sampling options or PAT for endpoint determination; and an optimized vacuum system with HEPA filter.
Vacuum drying is the basic drying technology with the option of adding microwaves for increasing yield through optimization of the process parameters, reducing wet lumps and sticking.
Extreme example of containment measures on a single pot processor
Solvent-based Production
UltimaPro ECO
Organic solvents are still widely used for pharmaceutical wet granulation for numerous reasons. The UltimaPro Eco is specifically designed for processing organic solvent based granulations in a safe and efficient manner by addressing the two main issues related to using solvents: explosion risk and solvent emission.
Explosion Risk
There is a risk of explosion when using solvents during granulation and drying or certain dry products with a low MIE. By eliminating one of the sources necessary to create an explosion, this risk can be effectively mitigated; the Single Pot System relies on an inertization procedure to achieve this. The oxygen in the bowl is replaced by nitrogen in an automatic cycle. Oxygen sensors can be provided to ensure the level is below the explosion limits.
Another advantage of using a single pot processor for solvent processes – related to explosion safety – is the fact that drying takes place in a vacuum, and is therefore in an oxygen deprived situation (even without inertization).
Solvent Emission
As the process takes place within a vacuum, only solvent vapors are created during the drying process, making simple condensation the ideal way of reducing and eliminating solvent emission. The vacuum system of the UltimaPro-Eco consists of a very efficient combination of condensers (chilled to an appropriate temperature for solvent condensation) and vacuum pumps to ensure both fast and safe drying and to minimize solvent emission and waste treatment.
Risk Analysis
GEA is available to help you with extensive in-house experience in establishing a risk-based approach for validation and for HAZOP studies.
Suggested configuration for UltimaPro-Eco
The UltimaPro Eco is a Single Pot Processor equipped with a very efficient vacuum system, allowing easy recovery of the solvent vapors up to 99.5%. Optionally, police condensers or active carbon filters can be integrated to eliminate all solvent emissions. The whole system is designed, executed and certified to comply with the ATEX guidelines.
Vacuum drying is the basic drying technology with the option of microwaves for faster processing times.
Drying Options
With the high-shear granulation technology as the basis, Single Pot Processing relies on the application of a vacuum within the bowl to dry the wet mass. This technique allows drying of pharmaceutical compounds at low temperature, and for minimal environmental exhaust through very efficient solvent recovery, even if organic solvents are used for granulation. The vacuum drying process can be enhanced by the Transflo technique or microwave drying.Vacuum Drying
Vacuum drying is the underlying drying principle of Single Pot processing. By lowering the pressure in the system, the evaporation temperature of the granulation liquid is decreased, thus reducing the processing temperature and the overall energy input required for drying. To achieve an optimal drying efficiency, the vacuum system of the UltimaPro range has been designed with special care. Excellent solvent recovery and a competitive drying rate can be achieved by incorporating condenser systems and selecting the right pumps. Different configurations are available to suit any process requirements.
Gas-assisted Vacuum Drying
The vacuum drying process can be enhanced by the addition of a small amount of gas, passing through the product during the drying phase. The gas-assisted vacuum drying (Transflo) technique results in shorter drying times and lower residual moisture content of the final product. The Transflo system for gas-assisted vacuum drying has been designed for optimal distribution of the stripping gas through the product, without compromising on inspection, validation or cleanability.
Microwave Drying
Microwaves can be added as an additional energy source to further advance the drying process. Because of the additional energy added to the process, microwave drying is without a doubt the fastest drying method available in Single-Pot Systems. Our system is equipped with control and safety features to ensure excellent process control and complete safety for product, operator and equipment.
Swinging Bowl
The use of the swinging bowl during vacuum drying results in an improvement of the granule characteristics and a reduction in drying time. It is a very gentle method to agitate the product during drying, producing less fines and therefore allowing the processing of formulations that were not explicitly developed for vacuum drying in a Single-Pot Processor.Downloads
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Approfondimenti GEA
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