When it comes to producing and coating granulates, contract manufacturer Klocke Pharma-Service GmbH puts its trust in fluid bed technology from Romaco Innojet. With its wide range of applications, short processing times, linear scalability, sparing use of raw materials and reliable, energy-efficient production processes, the VENTILUS technology is tailor-made for the requirements of a contract manufacturing organisation.
The Klocke Group is one of Europe’s leading contract manufacturing and packaging suppliers. Klocke Pharma-Service GmbH, at home in Appenweier in south-west Germany, processes a variety of raw materials into powder granulates and pellets, mainly for compression into tablets. The contract manufacturer first started using VENTILUS fluid bed processors from Innojet, a Romaco Group company, in 2014 and has continuously enlarged its stock of these technologies ever since.
Klocke presently has six Innojet-built fluid bed processors at its disposal for carrying out wet granulation processes with aqueous and solvent-based binder media as well as for drying and pellet coating. In addition to a VENTILUS® pilot plant for batch sizes up to 50 litres, three production plants for up to 400 litres and two for up to 800 litres are in use today. The systems are designed to be compatible as regards product filters and spare parts, and upscaling from a smaller processing machine to a larger one is a simple matter.
“The VENTILUS fluid bed processors from Romaco Innojet helped us achieve a technological leap forward”, reports Alexander Pergande, Managing Director Operations at Klocke Pharma-Service. “The uniform flow conditions in the machines and the precise bottom spray technology mean we can produce granulates with a more homogeneous particle size distribution and hence better flowability, leading to higher tableting speeds. What’s more, our service portfolio has been expanded on the basis of this technology, and we’re now also in a position to coat pellets or film-coat micro-tablets, which we couldn’t do with top spray technology.”
Patented air flow bed technology
It is the air flow bed technology developed by Dr. h. c. Herbert Hüttlin, which is internationally patented and has received numerous awards in the past, that makes this possible. The air used for this process is introduced through a special ORBITER® booster plate consisting of overlapping circular plates. The innovative ORBITER flow technology results in a toroidal product movement in the cylindrical product container that gently intermixes the batch. The speed of the particles and their path through the container are clearly defined and reproducible, enabling the spray liquid evaporation rate to be precisely calculated and the dosage adjusted accordingly.
Significant reduction in drying times and process air consumption
Drying is rapid and homogeneous because the flow of process air is heated. “The VENTILUS technology has improved the drying time of all of the products we manufacture – depending on the product properties, up to 30% shorter processing times can be realised compared to conventional technologies”, Pergande explains. Furthermore, with certain products, Klocke has managed to halve its process air consumption per kilogram of product (m3/kg) without any reduction in output – a powerful lever when it comes to cutting energy costs.
Improved raw material usage
The Innojet technology has also resulted in improved raw material usage. Sediment formation on the booster plate is virtually eliminated owing to the innovative process air distribution system of the ORBITER®. The central ROTOJET® bottom spray nozzle, via which the spray liquid is applied, allows precise adjustment of the spray angle, effectively preventing spray loss. The SEPAJET®filter system, featuring filter bags that are continuously cleaned by a blowing-air rotor system, likewise plays a decisive role with respect to raw material usage. It ensures that, in the case of granulation, the powdery substances are held back in the process area, whereas during coating processes abrasion and other fine particles are removed from the material to be treated. Hot, conditioned process air is used for filtering – avoiding any need for expensive compressed air.
“As a specialised contract manufacturer, efficient raw material usage is very important to us”, says Pergande. “Thanks to Romaco Innojet’s fluid bed processors, we can achieve the same output with 10-15% less material on average, meaning we save between 3% and 30% depending on the product.”
Granulation and pellet coating in one process
Klocke currently manufactures around 40 different products in the form of classic powder granulates using Romaco Innojet technologies. There are also a number of products for which the pellets are built up by coating. A simple parameter setting on the HMI panel is all it takes for machine operators to individually adjust the spray pressure, the volume of the airflow and the material sprayed when switching between granulation and coating. No mechanical conversion work is necessary on the machine and it is no longer essential to replace the spray nozzle. Accordingly, the VENTILUS does not have to be discharged at the end of the granulation step but can proceed directly to pellet coating. That not only adds up to a huge time saving for producers – also, the risk of cross contamination is reduced and employee health and safety improved whenever critical substances are involved, because the material is treated in a closed process.
Individual solutions
The fluid bed processors in use at Klocke were specifically adapted by Innojet to the contract manufacturer’s existing production infrastructure. Besides the standalone version, one 400 litre and one 800 litre VENTILUS system can be coupled up to a compulsory mixer. Innojet has come up with a multi-section transfer stainless steel pipe connection with a specially designed product conveying aid for combined lines comprised of a compulsory mixer and a fluid bed processor. For example, the process air from the VENTILUS is utilised here for pre-drying in the compulsory mixer. Depending on their customer’s requirements, Klocke can use these fluid bed processors and compulsory mixers either individually or in a tandem arrangement, giving the contract manufacturer considerable flexibility where production planning is concerned. The VENTILUS manages product drying extremely efficiently when installed in tandem, with upstream granulation in the compulsory mixer.
Development partnership for a new FLEXIJET nozzle
Romaco Innojet and Klocke Pharma-Service GmbH have steadily intensified their collaboration in recent years in the framework of a development partnership. At its facility in Appenweier, Klocke recently became the first user to go live with Innojet’s new FLEXIJET® nozzle. It is more robustly designed and easier to handle than its predecessor, the ROTOJET®, yet achieves the same spray quality and has already proven itself in practice at Klocke in all manner of applications.
“We greatly appreciate the open cooperation with Innojet, especially when the aim is to jointly develop strategies and solutions for meeting the daily challenges of contract manufacturing. In the opposite direction, we’re happy to share our experience – and assist in driving the ongoing advancement of Innojet technologies – with significant benefits for both companies in the long run”, asserts Alexander Pergande, Managing Director Operations at Klocke Pharma-Service. “The efficient, scalable and reliable technologies, backed up by competent and prompt service, make Innojet the ideal partner in our efforts to position ourselves successfully and permanently in the market as the contract manufacturer of choice.”
- Josef Brändlin, Product Sales Manager, Romaco Innojet
