In the pharmaceutical industry, one term is becoming increasingly important: containment. It describes the process of containing a substance within a defined space, a method that is suitable for protecting operators and the environment in case of high toxicity and product reactivity. At the same time, containment prevents dust, gases or vapours from being released into the environment and contaminating the product.
More than 60% of pharmaceutical products are produced as tablets, capsules, lozenges or similar solids. Especially in new products the active pharmaceutical ingredients (APIs) are becoming increasingly more potent. In some markets, the segment for high potency active pharmaceutical ingredients (HPAIs) is growing in the double-digit range, especially driven by oncology medication.
In addition to requirements set by manufacturing guidelines, it is essential that the product is safe for the machine operator and, of course, for the patient. As a result, machine manufacturers such as L.B. Bohle are faced with new challenges in all toxicity classes in which customers want to use plants and processes. In 2017, numerous customers with special specifications turned to the company requesting, among other things, containment solutions for film coating applications and a dry granulation process.
Two projects are examples of this:
The Bohle Film Coaters BFC have been an advanced technology on the market for several years and have guaranteed top-quality product processing and high profitability. The BFC Film Coater and its scaled-down version, the BTC, have achieved excellent market penetration.
According to customer specifications, the developers of L.B. Bohle designed a BFC 100 that meets the latest containment requirements.
The containment version of the BFC 100 enables operation in closed driving mode thanks to:
• automatic nozzle adjustment (stroke and angle)
• infrared product temperature measurement
• charging via a container flap
• the connection for cleaning the container flap and the charging pipe (also available for discharge)
• the connection for drying the container flap and the charging tube
• the sampling lance
• side doors with inflatable gasket (also standard for BFC)
• the demountable nozzle holder. This results in great advantages when it comes to cleaning.
A second successful project is the design of a dry granulator from the BRC series. Already at the product launch in 2012, the BRC 25 and 100 were in high demand among customers. The dry granulators of the BRC series are already popular in the market due to their flexible set-up or integration into the production process.
Continuous dry granulation has been an established process in the pharmaceutical industry for decades and is used not only for products sensitive to moisture or temperature, but also for classic wet granulation because no energy-intensive drying processes are required. This saves high investments in systems and production rooms, resulting in lower costs per batch.
Dry granulation is often the process of choice in particular for high-volume or moisture-sensitive products.
The BRC 100 Containment is proven through the typical BRC attributes. Just like the standard version, the Containment BRC features an advanced electro-mechanical drive, completely eliminating the need for hydraulics.
In addition, the special version is equipped with the latest and fastest control, which enables fully automated operation. The BRC is very user-friendly and low-maintenance, with very short set-up times.
Following a short project phase, L. B. Bohle supplied its customers with a BRC 100 according to the latest containment requirements.
The highlights of the BRC Containment at a glance:
• equipped for the containment level OEB 5
• integrated insulator unit in the compacting unit with corresponding vacuum monitoring
• glovebox with security prompt for the removal of scabs
• containment port for the collection of scab samples
• containment port underneath the sieve unit for the removal of granules
• convenient access, since no complete insulator unit is installed around the entire compactor
• residue-free removal of product by integrated WIP equipment (WIP is also integrated in the standard version)
For many years, L.B. Bohle has been known as a supplier of all-in-one solutions and successfully demonstrated this once again in this BRC project. The fully integrated solution also contains a lifting column and containment flaps for feed-in of the product as well as an integrated containment flap for transferring the granules into the receiving container. Thus, customers have been relieved of some tasks involving the clarification and implementation of interfaces between the system components.
As these two case studies show, L.B. Bohle does not only ensure premium technology in standard machines, but also develops complex individual solutions which instantly create added value in daily operation.
“Customers seeking help with solving a special challenge or problem can contact us any time,” says Thorsten Wesselmann, Technological Director. Thanks to the experts’ comprehensive know-how, the product teams can always find the best solution.