Manufacturing and packaging
Blending
Process
We blend our excipients and active ingredients in Bohle pharmaceutical blenders, with amounts ranging from a few kilograms (laboratory standards) to large-scale industrial projects with 3,000 litres, depending on individual needs. Our blenders can be used in combination with any screening machine, ensuring that unwanted particle sizes are discarded.
Our facilities
Bohle pharmaceutical blenders
Compaction
Process
Compaction or dry granulation is completed without using a spray and is especially gentle on products. It is therefore particularly suitable for products that are sensitive to moisture and temperature. Thanks to electronic pressure regulation, the process can be operated continuously and can handle up to 60 kg of material per hour.
Our facilities
Hosokawa Bepex
Granulation
Process
HENNIG ARZNEIMITTEL is your reliable partner for all granulation services. Our technologies and extensive experience meet the toughest requirements in reproducible, consistently high quality. This means that reliable and economical production processes are guaranteed.
Our granulation systems process everything from laboratory-standard amounts to those on a production scale. Vertical manufacturing allows for particularly quick and effective results. The temperature of our high-shear mixers can also be adjusted thanks to their double-jacket design. Regardless of whether wet or dry granulation is required, we have the right technology for your product.
Fluid bed granulation and drying
Fluid bed granulation using our facilities makes for loose granules with low bulk density and excellent water solubility. The top spray process also prevents de-mixing, ensures even distribution and improves compressibility. For batch sizes of 1.5 kg to 150 kg, we can guarantee that the quality will be consistent in every batch. Preliminary laboratory-scale tests are also possible.
These are ideally complemented by our systems for both the air dehumidification process and the particularly effective fluid bed drying process that is gentle on products.
Forced-action mixing/granulation
Our high-shear mixers also mean that the manufacturing and drying of granules can be carried out in the same facility as the preliminary stages of compression.
Our facilities
- Fluid bed granulators from Glatt, with Wurster insert or rotor insert and top spray
- Forced-action mixer from Diosna
Compression
Process
High quality and consistent reproducibility are essential requirements for modern, efficient compression processes. Thanks to our machines and manufacturing processes, we can ensure high throughputs that can reach up to 250,000 parts per hour, depending on the product properties. Our facilities are equipped with high-speed and double rotary presses with de-dusting, metal testing and tablet quality control centres. They are also suitable for the production of mini tablets (> 1.7 mm in diameter) and multi-layer tablets.
The tablet press range is being expanded to include a special unit called the STYL'One. It can also be used to manufacture individual tablets. It is therefore suitable not only for the development stage, but also for troubleshooting and for optimising processes.
Our facilities
- Five Kilian tablet presses in various sizes
- One Kilian STYL'One
Film coating
Process
Coating is an important process step in pharmaceutical manufacturing, as it has an impact on, for example, the colour and taste of the product. Coating also promotes product protection and can alter the release of active ingredients. Our fully automatic coating facilities are very efficient, enabling aqueous and organic coating (with class A solvents). The air dehumidification process and options for regulating relative room humidity promote gentle manufacturing.
Our facilities
IMA facilities in four sizes, from laboratory to industrial scale
Encapsulation
Process
Capsule filling with maximum safety and reliable results: with our facilities, we can process up to 150,000 capsules per hour. Depending on the product requirements, they can be filled with powder, granules, pellets or mini tablets. Additional safety is ensured by 100% weight monitoring. Depending on your requirements, we use hard gelatine or HPMC capsules in sizes 00 to 4 as a base.
The choice between single or multiple dosing means it is possible to fill the capsules with up to three components and thereby produce complex formulations.
Our facilities
- Two IMA encapsulation facilities
- An IMA facility for weight monitoring
Special forms – multi-layer tablets
Process
We also have sound expertise, a great deal of experience and specialist machinery available in the field of manufacturing multi-layer tablets and coat-core tablets. We will provide you with needs-based support, even in the development of individual components and later at the blending stage. Depending on your requirements, we will produce highly specific release profiles – all with minor substance requirements.
Our facilities
- Two Kilian tablet presses in various sizes
- One Kilian STYL'One
Special form – coat-core tablets
Process
The coat-core tablet is a very special form that combines an inner core and an outer coat, each with different properties. The aim of this process is to create a highly specific release profile that is able to combine several active components.
In this process, core and coat initially undergo targeted development and are tested for compatibility. They are then combined to form individual tablets, the nature of which is no longer visibly recognisable. A special press is used in the development stage such that small amounts of active ingredients suffice.
Our facilities
- One Kilian tablet press
- Kilian STYL'One
Special form – pelletised
Process
Due to their round shape, pellets offer particularly good flow properties in comparison with other granules. Their uniform nature is ideally suited to the application of a film to achieve the controlled release of active ingredients. In order to manufacture optimised pellets for each specific requirement, we put all our experience into our machinery, tailoring it to specific products. This means that we can produce between 0.8 and 70 kg of pellets per batch.
We use the most efficient technology for this – the Wurster bottom spray process, rotor technology (pelletisation development and coating) or extrusion with subsequent rounding in the spheroniser. The latter enables a particularly high active ingredient load.
Our facilities
- Glatt – fluid bed facilities with Wurster or rotor insert
- Gabler – extruder and spheroniser
Extrusion
Process
Extrusion with subsequent rounding in the spheroniser is a potential alternative to granulation and especially suited to manufacturing pellets.
We find the right solution to every problem! The technology that is used and is the most advantageous in technical and financial terms depends heavily on the input material.
Our facilities
Extruder and spheroniser from Gabler
Packaging
Process
As part of our full service, we can also take care of the assembly and packaging of your products. Regardless of whether the batches are large or small, HENNIG ARZNEIMITTEL provides an end-to-end service. Economical and safe.
As part of the serialisation process (Richtlinie 2011/62/EU), installing data matrix codes and applying additional labels to guarantee counterfeit protection are part of the daily routine.
Our facilities
Three assembly lines from Mediseal and Klöckner
Primary packaging
The choice is yours: we can use mono, duplex and triplex films as well as Alu/Alu and Aclar to blister wrap, all at a rate of up to 250 blisters per minute. As a potential additional option, you can choose between horizontal and vertical perforation, and either random or controlled printing. We also package stability and clinical samples (blister).
Analytical services
Our highly skilled team uses various processes for seamless quality control. The high level of automation means that you can benefit not only from high-quality products and processes but also from noticeable cost efficiency.
Our processes include:
- Ultra-high-performance liquid chromatography (UHPLC)
- High-performance liquid chromatography (HPLC, including with amino acid derivatisation and UV, DAD, RI and fluorescence detectors)
- UV-VIS, GC, IR
- Determination of particle size by laser diffraction
- Automated release analysis
- Pharmacopoeia analysis
- Microbiological testing (at an external partner)