New filling and closing machine
As part of an exclusive machine presentation in Crailsheim from September 18 through 29, 2017, Bosch Packaging Technology introduced the latest addition to its AFG series. The filling and closing machine for pharmaceutical powders in glass vials offers manufacturers a wide range of options. “During development, our main focus was on flexibility,” explains Dieter Bandtel, product manager at Bosch Packaging Technology. “With the AFG 5000, customers can choose between several different versions and various features. In addition, we have significantly increased the output rate in the high-performance segment.
New variable transport system
Based on a single machine platform, the system can accurately fill both large and small amounts of powder. Customers have the choice between one filling point for an output of 160 containers per minute through to three filling points for up to 480 vials per minute. Thanks to the vacuum-compressed-air filling system, the output remains high even with small filling amounts. For all versions, customers can choose between statistical or 100% in-process control of dosing weights.
“To optimize efficiency, we have developed a new, flexible transport system for the AFG 5000,” says Bandtel. “While the vials are continuously fed into the machine, the transport system adjusts the speed of the following processes to precisely match the rhythm of the individual work stations.” Whether filling, weighing or closing of vials – each stage is optimally paced. The new vertical transport system was designed to prevent idle time or bottlenecks. Rotating carrier systems, known as shuttles, transfer the vials quickly and safely to the respective work station. Once the vials have been sealed and taken out of the system, the shuttles quickly return to the infeed, ready for the next transport run.
Compact and efficient design
In addition to flexibility, we particularly focused on compact design during the development of the AFG 5000. “Our customers’ powder filling takes place in class B cleanrooms, where every centimeter counts in terms of operating, maintenance and cleaning costs,” explains Bandtel. Apart from the vertical design, the separation of the compact filling station from the intake and output reduced the amount of space that must be cooled and cleaned with sterile, dry air. A further space-saving feature is the optional air-treatment system, which can be installed outside the sterile area.
All components that come into contact with the product can easily be disassembled for cleaning and sterilization. The result is an easy-to use machine with only few format parts, offering customers substantial space- and cost-savings. In line with Bosch’s pharmaceutical line competence, the AFG 5000 can be combined with upstream cleaning machines and sterilizing tunnels, as well as downstream capping equipment to create a complete line for safe and reliable filling processes for pharmaceutical powders.
Shaping the future of Pharma
Artificial intelligence, robots and empowered patients are reshaping the pharmaceutical supply chain, says Dr Bertalan Meskó, Director of The Medical Futurist Institute. He will share insights on the trends influencing the future of the pharmaceutical industry at a free webinar for industry leaders on the 22nd February in the build-up to the opening of Connect in Pharma 2023 registration.
“In my webinar for Connect in Pharma, I plan to give a crystal-clear overview about where digital health technologies have been heading in the 21st century — with a special focus on AI — and why these changes are relevant to pharma companies,” says Meskó.
“From organizing logistics and equipment to drug design and drug repurposing, artificial intelligence has an immense power to automate and elevate what pharma companies have been doing,” says Meskó. “Chatbots can also revolutionize marketing by creating customized messages,” he says.
The pharmaceutical factories of the future will look more like an Amazon factory: “It will employ many robots while the staff look after them,” he says. “The workforce who service the robots will be equipped with augmented reality glasses to shorten the time required to train them for new tasks, which is similar to how the automobile industry has been using that technology,” says Meskó.
The new technology is being partially driven by the need for greater precision and advances in personalised medicine. “3D printing and bioprinting methods will be commonplace in the production of a range of products,” says Meskó. Precision bioprinters use cells and biomaterials to create organ-like structures that let living cells multiply.
Meskó says the coming changes will ultimately empower the patient: “We will see a paradigm shift in which patients become members of their own medical team. They want to engage with their health and diseases management. This means Pharma companies will have to engage directly with the patient as well as the physician. Patients will require similar information and insights about products.”
In an industry that faces heavy regulations and high stakes (patient safety understandably looms large), most pharmaceutical companies see themselves as conservative and change-averse, says Meskó. But pharmaceutical executives must embrace the changes that are now rapidly coming in order to stay competitive.
Bertalan’s talk will be followed by the official opening of registration for Connect in Pharma, a Geneva-based event focused on the pharmaceutical packaging and production sector.
As the director of The Medical Futurist Institute, Meskó helps companies, governments and other institutions understand advances in digital health technologies and bring healthcare into the 21st century. Meskó, who is a physician with a PhD in genomics, has been featured in top publications, including Forbes, BBC and the New York Times and is also a professor at Semmelweis Medical School in Budapest, Hungary. He is recognized as one of LinkedIn’s Top Voices in Healthcare.
Renan Joel, Divisional Managing Director at Easyfairs — the company organising Connect in Pharma, says industry leaders are welcome to sign up to attend the free online webinar. “Dr Bertalan Meskó is a truly modern and inspiring voice on healthcare technology,” says Joel. “His big picture analysis of the future of medicine and pharmaceutical technologies will help industry leaders get up to speed with the latest in digital innovations.”
Last patient included in Phase II clinical trial
AlzeCure Pharma a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that the last patient has now been included in the ongoing Phase II clinical study with ACD440, the lead non-opioid drug candidate in the Painless platform, which is being developed against peripheral neuropathic pain.
This double-blind, placebo-controlled, randomized cross-over study, which is carried out in collaboration with LINK Medical Research in Uppsala, is aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure’s lead drug candidate in pain, ACD440. The main results from the study are expected by the summer of 2023 at the latest.
AlzeCure’s drug candidate ACD440 is a TRPV1 antagonist for the local treatment of patients with peripheral neuropathic pain. The discovery of TRPV1 that underlies the project was awarded the Nobel Prize in Physiology or Medicine in 2021. There is thus a strong scientific basis for this biological mechanism, including its relationship to pain signaling. ACD440, which is also the company’s leading drug candidate within the Painless platform, completed a positive phase Ib study in 2021. It showed both very good tolerability and safety, but also a potent, long-lasting pain-relieving effect of the substance that is applied as a gel to the skin.
The medical need in neuropathic pain is very great, not least to find alternatives to opioids. The neuropathic pain market is the single largest market segment in pain management with annual sales exceeding 11 billion Dollar. Up to 80 percent of patients do not get a satisfactory effect with their current treatments.
”The study has developed well and the fact that we have now been able to include the last patient in the study means that we have good hopes that the study will also deliver the results according to what we previously communicated,” said Märta Segerdahl, MD, PhD, project leader and CMO at AlzeCure. “We see an exciting potential with ACD440, where you can broaden the further development with other formulations, thereby enabling several indications.”
“With the previous positive results from the phase Ib study, we look forward to the readout of this phase II study. There is already interest in the project and with phase II data, the project can generate even greater interest for out-licensing in a segment with a very high medical need,” said Martin Jönsson, CEO of AlzeCure Pharma.
AC-DC power adapters for medical and industrial applications
TDK Corporation announces the addition of the TDK-Lambda brand DTM70 and DTM160 series to the DTM family of compact medical and industrial AC-DC power adapters that are available in various power classes from 36 watt to 300 watt. Both series are available in Class I versions with a protective earth terminal on the input and Class II versions with double insulation protection. The adapters are housed in a robust plastic case with dimensions of only 120 x 52 x 31 millimetres (DTM70) and 150 x 70 x 38 millimetres (DTM160). The DTM70 is available with 12 volt, 15 volt, 18 volt, 24 volt, 36 volt and 48 volt output voltages and the DTM160 with 12 volt, 24 volt, 36 volt and 48 volt.
The DTM70 and DTM160 series are suitable for 2MOPP medical applications and general industrial use. Both adapter series are certified to the IEC/EN/UL 60601-1 medical safety standard for clinical applications. In addition, IEC 60601-1-11 certification is available for all Class II versions, allowing these adapters to be used in home healthcare applications. For all versions, EMC is tested according to IEC 60601-1-2 Ed 4, which simplifies use with medical equipment. For industrial and ICT (Information and Communication Technology) applications, all models are tested according to IEC/BS/EN 62368-1 and are certified for installation altitudes up to 5000 metres.
One special feature is the standard locking DIN output connector, which prevents unintentional disconnection of the output voltage of the adapter. Other connector versions and cable assemblies are available on request.
Due to the high efficiencies and the low no-load power consumption of less than 150 megawatt, the adapters comply with EU Regulation 2019/1782 (Eco-design requirements for external power supplies) and the US DOE Level VI specification. CE and UKCA markings confirm compliance with the low voltage, EMC and RoHS directives.