Advances in pharmaceutical research are also leading to changes in production technology requirements. For example, highly potent active pharmaceutical ingredients (or HPAPIs) are making it possible to tailor drugs for specific applications with increasing precision. As a result, however, the health and safety requirements are also increasing to protect the employees who have to deal with these substances. We spoke with Heinrich Behrmann, Head of Design at Fette Compacting, about the special requirements of pharmaceutical machines.
Mr. Behrmann, what development trends are you seeing in WiP and containment machines?
The demand for presses that can safely process highly potent substances is steadily increasing. This trend is being driven not only by the medical advantages these drugs offer patients, but also by increasing health and safety requirements. In the USA in particular this used to be an important reason for investing in machines of this kind. This development is also reflected in regulatory rules that oblige pharmaceutical manufacturers to guarantee absolutely safe production conditions to prevent any contamination of operating personnel. Recently, however, we have also been receiving more enquiries from pharmaceutical firms that have developed new products involving high-dosage active ingredients. One example is hormone treatments. These used to be administered in relatively large tablets. Today, however, patients want smaller products that are easier to take. That means the active ingredients have to be more highly concentrated.
What additional demands does this make on tableting technology?
Dust can be set free during the tableting process. After all, the raw material is fed into the machine as powder or granules and then compressed at high speed. Dust particles must be prevented from leaving the press under any circumstances to achieve the maximum protection for operators. These particles have to be sucked up by a special collection device, which is why the whole pressing area is kept under negative pressure. In turn, that means we have to fit special seals, among other things. The small amounts of product particles that become deposited during pressing have to be dissolved and rinsed out with water using a special cleaning fluid.
Therefore when we design our WiP presses we ensure the pressing cell is washable – as are all the components that come into contact with the product – and use corrosion-free materials. We also have to adapt the electronics of these systems to monitor additional parameters.
How long does it take to build and commission a machine of this kind?
The project times for WiP and containment machines are significantly longer than other tablet presses because of the construction-related infrastructure. Between 4 and 12 months can pass before a machine is commissioned at a pharmaceutical company. However, that is only the first step. In addition to the hardware and software, the “brainware” is also important – in other words, the know-how required to operate this kind of machine. The so-called validation of production with this machine by the operator is crucial. This involves an investigation of the entire production environment – in other words, everything from the feeding in of material and the tableting process to the disposal of residues and the approval of the machine itself. A decisive factor here is the training of operators, which is carried out not only here in Schwarzenbek at the LMT Group Academy, but also on the spot at the customer’s own premises. Our experienced engineers also support the initial production phase. This offers the advantage that once the operators have been trained the machines become very easy to use because all Fette Compacting presses use a standardized operating strategy.
What makes Fette Compacting machines special?
What sets us apart from other machine manufacturers is our comprehensive experience in the project engineering of these kinds of presses. In particular, our standardized WiP and containment solution is unique on the market. We offer a complete system with air management, appropriate WiP Center, control cabinet and just one isolator with integrated, washable process Equipment such as vertical dedusters and metal detectors. That enables us to guarantee absolutely safe products. By remaining in close communication with users we have built up a wealth of experience that gives us a competitive edge. Additionally, we do not only offer the pharmaceutical industry technological solutions, but also an all-inclusive service as well as operator training. And thanks to our global network we can very quickly provide on-site support to our customers should they need our help.