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Containment processes for solid dosage production

20th June 2018


The BFC 100 offers its user various benefits when it comes to handling process technology and cleaning
The sampling lance of the BFC 100 ensures that the product can be inspected during operation

Tobias Borgers introduces new technologies for filmcoating and roller compaction

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 independent, medium-sized, family-owned company requesting, among other things, containment solutions for film coating applications and a dry granulation process.

Two projects are examples of this. Firstly, the Filmcoater BFC has been a sophisticated technology on the market for years and has guaranteed top-quality product processing and high profitability. The BFC Filmcoater 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 roller compactor from the BRC series. Already at the product launch in 2012, the BRC 25 and 100 were in high demand among customers. The roller compactors 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 successful 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)

Additional functionality in fully integrated version
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. This means that customers
have been relieved of some tasks involving the clarification and implementation
of interfaces between the system components.

Both complex individual solutions are going to create added value in daily operation.

Tobias Borgers is with L.B.Bohle





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