Höfliger, Harro Verpackungsmaschinen GmbH

Many multi-unit dose dry powder inhalers (DPI) on the market or in development contain injection-molded annular dose carrier, which carry the single powder doses in closed cavities. These pockets can be round or oblong shaped and may be arranged in symmetric or asymmetric circles or even spirals.

Current micro dosing systems like dosator, vacuum drum or membrane filler, which are suited to dose powders for inhalation, possess significant limitations when being used to fill inhaler discs, like insufficient robustness, inadequate output or limited flexibility regarding the filling level.

Starting from Harro Höfliger’s membrane filling technology a new dosing system to fill such discs has been developed. Discs with any number or shape of cavities can be filled in one process cycle, and only two format parts have to be exchanged to adapt the filler to new discs. The system can be integrated into automated machines to fill, assemble and package disc-based DPI and it can be up-scaled by simply increasing the number of filling heads. The system has been developed for inhaler discs, but is not limited to this application. It may be used for other micro-dosing tasks, too, e.g. in the field of diagnostics, serial analysis or laboratory automation.

Your Benefits:

• Fast and simultaneous filling of multiple cavities with small powder portions
• Accurate micro-dosing of various powders, from free-flowing to very cohesive, even in the range below 10mg
• Higher output compared to existing Technologies
• Suitable for  various filling levels in the target cavities
• Smooth handling of the powder formulations to avoid attrition or compaction
• Suitable for different geometries and geometrical arrangement of the target cavities 
• Integration in automated assembling and packaging lines
• Easy upscaling by multiplication of the filling heads

Adaptable to different powders or targets to be filled with only two format parts

New Service at Höfliger – over 450 qm of laboratory space for tests under controlled climatic conditions

Strategy as a success formula
Nowadays innovative corporations use strategic alliances to minimize development costs and the time to market. This is where it is advisable to have Harro Höfliger as your development partner for product-specific and process-specific lines.

For example, as an introduction to a joint powder project Harro Höfliger offers a comprehensive analysis of the products on the basis of which a preselection of the dosing system can be performed. Further optimization of the system selected can be performed in Höfliger’s own laboratory area together with the customer using original product under controlled conditions.

At the end of the multistage development ranging from the pilot installation to the production line the possibility exists of already producing time-saving stability samples with the qualified machine at Harro Höfliger and of operating the complete line with verum under production conditions.

The 4 GMP test rooms and the pharmaceutical laboratory open up new possibilities.
Service & Consulting:

• Analysis and classification of powder formulations
• Process development and optimization
• Support in formulation and packaging development
• Qualification and GMP training sessions

Tests under controlled environment:

• Testing of customer-specific trial aggregates (“POPs”)
• Line run in with “true” product (Verum) instead of placebo
• Optimization of process parameters and machine settings
• FAT and qualification runs based on future production conditions

The customer benefits of a widespread service performance:

• High efficiency due to direct availability of development and manufacturing
• Time savings, for example by producing the first stability samples onsite
• Well-coordinated team with pharmaceutical-technological know-how:
  • pharmacist with many years of industrial experience
  • engineers from the internal development department
  • experts from the qualification department
  • well-trained and experienced installation, assembly and service staff
• Availability of machine modules / test systems for:
  • dosing of micro volumes of powder
  • thermoforming / cold-forming / sealing of innovative films and foils
  • feeding / dosing of liquid and non-liquid components
  • laminating and delaminating
  • punching and cutting
  • forming

As an independent laboratory table top device, the MicroVibe TT is suited for the dosing of small quantities. The System is easily adjustable to the required weight and powder properties.

• Dosing system for free-flowing and slightly cohesive powders
• Minimum target weight 1 mg (depending on powder properties)
• Gentle product handling
• Easy to clean
• Target containers: vials blisters, capsules, diagnostic strips
• Easy assembly and disassembly of format parts
• Aseptic dosing of micro quantities is possible

Modularity and flexibility from lab to production – capsule filling machine
product family Modu C.

With the development of the Modu-C High Speed (HS), Harro Höfliger is proud to present a complete family of high-performance capsule filling machines.

With an output of 200,000 capsules per hour, the Modu-C HS combines maximum productivity with unmatched flexibility thanks to the patented trolley system. GMP-compliant design and complete accessibility enable optimum cleaning of the machine. In combination with the capsule check-weigher, Accura-C, the Modu-C HS is an ideal pairing for efficient capsule production at its best. The Modu-C HS is characterized by its operational reliability and robustness. The performance of the machine is based on the proven operating concept of the Modu-C series and the control system is fully 21 CFR Part 11 compliant. The innovative trolley system offers the possibility of exchanging filling systems - by means of the Plug & Play concept.

In addition, customer-specific solutions can easily be implemented by customizing the dosing trolleys. Therefore, the Modu-C HS is ideally prepared for the demands of the future and makes for a future-proof investment. Come, see for yourself and be inspired by the innovative features of the Modu-C HS.

More information of the product family:

Modu C MS:
http://www.hoefliger.com/maschinen/dosier-und-fuellmaschinen/modu-c-ms/

Modu C LS:
http://www.hoefliger.com/maschinen/dosier-und-fuellmaschinen/modu-c-ls/

Handling and dosing of micronized powders

Powder at the centre of consideration
The behavior of powders is determined by numerous parameters, such as particle size distribution, particle shape, particle density, melting temperature, hygroscopicity and the tendency to electrostatic charging etc. This explains the very differing behavior of the various powders, for example during feeding and dosing, and requires knowledge as exact as possible about the material to be handled. Harro Höfliger therefore offers its customers as an introduction to a joint project a powder material analysis which is then invoked as the basis for selection of the most suitable dosing system. At the same time this analysis provides valuable indications as to which environmental conditions, such as temperature and relative humidity, have to be ensured during the later processing of the powder in the machine or in the production rooms. The adhesive behavior to different materials can also already be investigated at this stage. This has a decisive influence on the material selection for all parts that come into contact with the product.

Höfliger has made a name for itself on the „micronized powder“ method during the past 10 years by developing and implementing production methods and possible solutions for its customers, as regards manufacturing and packing pharmaceutical products.In this case, a predetermined dose of powder is applicated into the lungs (pulmonary) or over the nasal mucous membrane (nasal) and distributed in the blood stream.

At Höfliger, the competence necessary for handling pharmaceutical products is combined with highly technical expertise in the sectors for process, monitoring and control engineering.If one takes the example for processing different types of micronized powder, it is possible to demonstrate how the obstacles arising during the development of a new procedure can be successfully overcome. The ability to process micronized powder and the selection for a certain dosing procedure depends largely on the physical properties of the respective powder involved.

Not until a powder has been defined and classified can the selection of one or several suitable dosing systems be made. Once the selection has been made, further steps towards developing the optimum production process can be taken. Here it is decisive that the pharmacist has authoritative involvement in the development and also plays a role in deciding what steps should be taken next. These are, for instance, questions as to whether experiments with differing dosing procedures should be undertaken or whether experimental set-ups should possibly be designed and installed. Depending on the complexity of such a development project, a step-by-step process is of decisive advantage compared to a direct machine development. This process clearly focuses on dialogue and communication with the pharmacist.

The selected dosing systems should be tested with the agent-containing original formulations, if possible. While in theory it seems to be simple to produce constant conditions, hands-on tests will show that problems can occur quite frequently, such as:

• Tolerances in the powder production process
• Fluctuations of the ambient environmental conditions (temperature, relative humidity)
• Uneven distribution of the powder density
• Change of powder structure (grain size distribution, agglomeration, desagglomeration)

Starting with the production of the powder, critical parameters must be kept within very narrow tolerances, which, however, will not automatically exclude that for example the powder density may change during the downstream filling process. This is dependent, for instance, on the time between the production and filling and on the mechanical treatment of the powder during the filling procedure. Using constructive means, influence can thereby be brought to bear at an early stage.