UltimaPro Single Pot Processors

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

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

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

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

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.