Anke Geipel-Kern

Precision and flexibility over speed — this is what is needed in manufacturing test preparations for clinical studies. With an eye to these requirements Harro Höfliger has developed an automatic powder dosing system for microvolumes. PharmaTEC talked to Dr. Elke Sternberger-Rützel, Head of Pharma Services, about the trick with piezoelectric crystals and the ideal application.

Filling infusion bags with biopharmaceuticals and therapies using gene and cell-based active ingredients is demanding, which makes it a case for specialists. Harro Höfliger presents a new concept for aseptic filling of infusion bags which offers pharmaceutical customers a comprehensive carefree package.

Many suppliers in the pharmaceutical production industry want to move away from individual machines and towards complete systems, even though the turnkey segment is just as competitive. In this interview by PROCESS PharmaTEC, Thomas Fricke, Commercial Director at Ima Pharma, reveals the company’s competitive positioning, where he sees the company’s strengths and why he needs to keep a close eye on Chinese competitors.

Before new active ingredients can achieve market success, comes drug delivery. OSDs continue to rank highly as the formulation of choice. Why the pellet is probably the most versatile active ingredient formulation, but at the same time the most underestimated.

Personalized medicine, automation, sustainability: How the pharmaceutical industry is dealing with the upheaval and what it means for the supplier industry.

When it comes to originator companies and drug development, there is a lot of money at stake. Faster development and faster time-to-market means more time to benefit from patent protection — that’s the motto. Here we examine why so much depends on a systematic approach and the role of the scale-up.

Behind any complex pharmaceutical project, stands the supplier with a well-oiled machine, ensuring smooth internal processing and creating an important link between sales, the project manager and the pharmaceutical client. In an interview with Glatt expert Stephan Rüscher, PROCESS took a look inside the engine room. His credo: To make things easy for the customer!

Pharmaceutical projects are becoming increasingly complex. This is a truism. But what does it actually mean for project execution? How should operators, equipment builders, and engineering companies work together to keep everything on schedule even when changes are made? And what competencies does this require from the supplier?

How good, agile service enhances a company’s reputation and becomes a gateway to the customer?Germany is not a service desert: For pharmaceutical machinery manufacturer Glatt, the after-sales service team is a source of pride. Martin Zemke’s technicians are available around the clock for customers worldwide. In an interview, Zemke reveals what makes the difference.

Sartorius offers technologies for every phase of the biopharmaceutical value-added chain – having already recognized the potential of biopharmaceuticals at quite an early stage, the company has since carefully aligned its product and service portfolio with the requirements of the industry. Today, Sartorius presents its capabilities as an innovative solution provider for biopharmaceutical research and industry.

From filter supplier to full-service provider — Since taking the groundbreaking decision around 25 years ago to concentrate on the biopharmaceutical industry, Sartorius has seen a rapid rise in its fortunes. In conversation with us, Bettina Berendsen and Fritjof Linz explain the significance of single-use technology and report on the latest developments within the company and across the industry as a whole.

Featuring a range of finely tuned enhancements, a new drum coater speeds up the coating process by 30 percent — The proven GCC range now has an equal in terms of process technology: the GCSmart, which is designed to make the coating process significantly faster. An optimized nozzle arm and consistent air guidance with reduced turbulence promote reproducibility, even with minimal charging, while a WIP automatic system, integrated exhaust air chamber, and automatic discharging simplify handling for the user.

The IECEx system is breaking through the jungle of standards. IEC/TC 31 standardizes and harmonizes international explosion protection standards. Cooperation in the committees creates real added value for suppliers of explosion-protection components. This year, the IEC/TC 31 Committee met for 14 days at R. Stahl in Waldenburg, Germany.

Diosna — the German machine and system manufacturer is known for its high quality of its pharma machines and customized concepts — Since May 2018, Henrik Oevermann has been in charge of Diosna’s business as CEO. One of his first challenges was the changing of existing structures. The pharmaceutical and food divisions are now working more closely together in order to create synergies, delivering flexibility in engineering and in production. Now he is thinking intensively about the next steps in Diosna’s progress.

A lot of development work has gone into the expansion of Engineering Base — and now Aucotec is reaping the rewards. Having often been pioneers, the developers at software designer Aucotec have pulled off a masterstroke with the revamp of the EB platform. The team around Uwe Vogt is seeing something of a boom in orders at the moment, but the Hanover company is keeping its feet firmly on the ground.

From the Elcad CAD system to Engineering Base, the cooperative engineering tool, the German software designer Aucotec has often set trends in software development — and it wants to maintain this trailblazing position in the age of digitalization, too. The SME's recipe for success is based on constantly thinking outside the box, picking up on industry trends and a cooperative management structure and culture that put the emphasis on flexible, agile teams.

Innovation needs space and an optimal environment in which to develop. That’s why the Glatt Innovation Center in Binzen, Germany, is more than just a building — it’s a communication platform that is open to new people and ideas. Development Manager Jochen Thies explains more in this interview with PROCESS Worldwide.

Always in tune with the times and just that little bit better than the others — that has been the motto of Hima ever since the company was first founded. Many years of safety experience and a huge passion for the topic of safety have driven the family-run business, which is now already in its fourth generation. Since the strategic repositioning in 2017, Managing Partner Steffen Philipp and VP R&D and Product Management, Dr. Alexander Horch, believe that they are well set up for the digital future.

Hima keeps redefining the benchmark for safety technology with its safety solutions — ever since the company developed its first safety controller in 1970, “Safety without compromise” has been the motto that Hima from Brühl/Germany has always followed. Since then, the company has defined Smart Safety as its core competence and has helped shape the industry with pioneering innovations. Despite now having a global presence, Hima has preserved its status as a medium-size company and is still family-run, now in the fourth generation.

The specialists from Hima Paul Hildebrandt understand from decades of experience that there can be no compromises when it comes to safety. Since 1970, the company from Brühl near Mannheim/Germany has dedicated itself entirely to plant safety, an area in which it has constantly set new standards. Today, from its global presence of 50 locations around the world, the leading specialist in safety automation solutions provides safety solutions to its customers in the process industry to safeguard safety and productivity.

Software developer Aucotec is only around 30 years old, but in the company's young history it has already achieved a number of milestones. Earlier than anyone else, the Hanover-based company backed database technology and object-oriented programming and developed Engineering Base, one of the most state-of-the-art engineering tools currently available. In time for Achema 2018, Aucotec brought EB up to speed for Industry 4.0 and thus catapulted itself to the forefront of this development.

PROCESS celebrates its 25th anniversary — and we look forward to taking you on a journey through time to the high points in the process industry. We hope to present technology that will excite and companies that have impressed us as pioneers and trendsetters. In the period up until the summer of 2020, we are going to show off a glittering range of innovations that will thrill and inspire in equal measure. We promise!

Lots of companies are talking about the digital transformation. But how do you turn theory into practice? Gas specialist Linde shows how it can be done with its Digital Base Camp which combines the look and feel of a start-up with the know-how of the company's core business. The entrepreneurial spirit brings urgency, while experts from the different business units offer a reality check. PROCESS was offered insight into the work and its first projects.

The petrochemical industry is booming in North America, and Bilfinger North America wants its share of the growth. The service provider is currently doing good business with three large projects, and the orders already received for 2019 are promising another good year. The PROCESS editorial team was able to get a picture of these projects during a press trip.

Pharmaceutical production is becoming more digital and connected. Players who can deliver coherent, logical concepts will be part of the next major Industry 4.0 project. The five members of Excellence United have made great progress with their IoT Hub and have shown what it is already capable of. But this is just the beginning. In the interview, the five executive directors explained why. The strategic corporate alliance Excellence United presents its new Industry 4.0 concept, which sets new standards.

Chemspec Europe will take place on June 20th and 21st in Cologne — The annual event is a major attraction for professionals in the fine and specialty chemicals industry worldwide. This year, a new partnering program will take communications to the next level. The platform gives visitors and exhibitors the opportunity to build networks with potential partners and arrange meetings.

Containment, continuous production and Industry 4.0 were the focus of this year’s Interpack presentation of the five German Excellence United partners Bausch+Ströbel, Glatt, Fette, Harro Höfliger and Uhlmann.

Three production plants, more than 170 employees, and a turnover of over 22 million Euros characterize Vitabalans Oy. This Finnish company develops, manufactures and markets prescription medicines, OTC medicines, food supplements and veterinary products. Now the company expands and builds up a new factory in Finland.

 — In recent years, formulations based on pellets have been the trend. New technologies make it possible to circumvent property rights for active ingredients and are therefore very popular with pharmaceutical customers. But which technologies are the most important?

The 11th colloquium on Process Analytics was held in the historical dome hall of TU Vienna under this motto. The nearly 200 participants were unanimous: process analytics must come out of the ivory tower and finally shed the perception of complexity. How is this to happen? How will the much admired trialogue between device manufacturers, science and industrial users be wrapped up finally?

Challenges for manufacturers of explosion protection solutions – LNG, hydrogen, and digitalization of process plants with Ethernet-APL are focal points for manufacturers of explosion protection solutions. We talked to Dr Andreas Kaufmann, Head of Marketing and Innovation at R. Stahl, about how the Ex specialist is dealing with these future challenges.

With fast data communication and high bandwidths, Industrial Ethernet paves the way to Industry 4.0 in the chemical, oil/gas and petrochemical industries. But what about in zone 0, 1 or 2? From A for antenna to W for WLAN: typical problems that can arise with Ethernet installations in hazardous areas and the right solution.

Sartorius offers technologies for every phase of the biopharmaceutical value-added chain – having already recognized the potential of biopharmaceuticals at quite an early stage, the company has since carefully aligned its product and service portfolio with the requirements of the industry. Today, Sartorius presents its capabilities as an innovative solution provider for biopharmaceutical research and industry.

How good, agile service enhances a company’s reputation and becomes a gateway to the customer?Germany is not a service desert: For pharmaceutical machinery manufacturer Glatt, the after-sales service team is a source of pride. Martin Zemke’s technicians are available around the clock for customers worldwide. In an interview, Zemke reveals what makes the difference.

The digital twin is the future of infrastructure and engineering. This is why Bentley last year has presented the new Itwin Services cloud platform. For the company this is only the beginning of future developments.

From filter supplier to full-service provider — Since taking the groundbreaking decision around 25 years ago to concentrate on the biopharmaceutical industry, Sartorius has seen a rapid rise in its fortunes. In conversation with us, Bettina Berendsen and Fritjof Linz explain the significance of single-use technology and report on the latest developments within the company and across the industry as a whole.

Maintenance in automatic machines is usually addressed on a time basis. This means that parts are checked or substituted at regular time intervals or at a predetermined amount of working hours. This approach is called ‘pre-emptive maintenance’. An alternative approach, called ‘predictive maintenance’, suggests performing maintenance only when necessary.

Pharmaceutical Contract Manufacturing is growing rapidly. Main reasons are the expiring drug patents and that India is known to have low-cost manufacturing centers.

This paper investigates the technical and economical feasibility of several concepts for a 30 % capacity increase of an old ammonia plant. It shows an interesting way to overcome the limitations in the two most critical plant units: Reforming capacity is increased by a newly added autothermal reformer, while capacity is added to the ammonia synthesis by the Uhde Dual Pressure Process.

Daring to do something new, but preserve the tried and tested values. That is the motto of Dechema Managing Director Dr Andreas Förster. In recent years, the professional society has become more practical and application-oriented. And there are even more ideas. Förster reveals what these are in the PROCESS interview.

Losan Pharma adds a new granulation line for pellet manufacturing to an existing production: The process of upgrading existing inventory means an intervention into existing production facilities, so it requires surgical precision. The combination of existing machinery with new equipment, which can only be allowed to take up an extremely limited amount of space, is a real challenge for everyone involved in the project. The practice report describes the concept design and installation of a mixer/granulator for pellet production.

Treating Pharmaceutical Wastewater is a challenge, because of its diverse characteristics and varies. But it’s not necessary to make new developments. It might be a valid strategy finding a workaround based on existing solutions.

Even though the corona virus has turned private and professional life upside down, many things are now running smoothly again despite home offices, video conferences and trade fair cancellations. How does the Process Analytics business unit of Hamilton Bonaduz AG deal with travel restrictions and where are the challenges in approaching new customers? Frank Wolpers, Global Sales Director Process Analytics, focuses on webinars and the new corona vaccines.

Lots of companies are talking about the digital transformation. But how do you turn theory into practice? Gas specialist Linde shows how it can be done with its Digital Base Camp which combines the look and feel of a start-up with the know-how of the company's core business. The entrepreneurial spirit brings urgency, while experts from the different business units offer a reality check. PROCESS was offered insight into the work and its first projects.

Behind any complex pharmaceutical project, stands the supplier with a well-oiled machine, ensuring smooth internal processing and creating an important link between sales, the project manager and the pharmaceutical client. In an interview with Glatt expert Stephan Rüscher, PROCESS took a look inside the engine room. His credo: To make things easy for the customer!

Pharmaceutical projects are becoming increasingly complex. This is a truism. But what does it actually mean for project execution? How should operators, equipment builders, and engineering companies work together to keep everything on schedule even when changes are made? And what competencies does this require from the supplier?

Personalized medicine, automation, sustainability: How the pharmaceutical industry is dealing with the upheaval and what it means for the supplier industry.

The IECEx system is breaking through the jungle of standards. IEC/TC 31 standardizes and harmonizes international explosion protection standards. Cooperation in the committees creates real added value for suppliers of explosion-protection components. This year, the IEC/TC 31 Committee met for 14 days at R. Stahl in Waldenburg, Germany.

A lot of development work has gone into the expansion of Engineering Base — and now Aucotec is reaping the rewards. Having often been pioneers, the developers at software designer Aucotec have pulled off a masterstroke with the revamp of the EB platform. The team around Uwe Vogt is seeing something of a boom in orders at the moment, but the Hanover company is keeping its feet firmly on the ground.

Hima keeps redefining the benchmark for safety technology with its safety solutions — ever since the company developed its first safety controller in 1970, “Safety without compromise” has been the motto that Hima from Brühl/Germany has always followed. Since then, the company has defined Smart Safety as its core competence and has helped shape the industry with pioneering innovations. Despite now having a global presence, Hima has preserved its status as a medium-size company and is still family-run, now in the fourth generation.

Featuring a range of finely tuned enhancements, a new drum coater speeds up the coating process by 30 percent — The proven GCC range now has an equal in terms of process technology: the GCSmart, which is designed to make the coating process significantly faster. An optimized nozzle arm and consistent air guidance with reduced turbulence promote reproducibility, even with minimal charging, while a WIP automatic system, integrated exhaust air chamber, and automatic discharging simplify handling for the user.

From the Elcad CAD system to Engineering Base, the cooperative engineering tool, the German software designer Aucotec has often set trends in software development — and it wants to maintain this trailblazing position in the age of digitalization, too. The SME's recipe for success is based on constantly thinking outside the box, picking up on industry trends and a cooperative management structure and culture that put the emphasis on flexible, agile teams.

Innovation needs space and an optimal environment in which to develop. That’s why the Glatt Innovation Center in Binzen, Germany, is more than just a building — it’s a communication platform that is open to new people and ideas. Development Manager Jochen Thies explains more in this interview with PROCESS Worldwide.

Software developer Aucotec is only around 30 years old, but in the company's young history it has already achieved a number of milestones. Earlier than anyone else, the Hanover-based company backed database technology and object-oriented programming and developed Engineering Base, one of the most state-of-the-art engineering tools currently available. In time for Achema 2018, Aucotec brought EB up to speed for Industry 4.0 and thus catapulted itself to the forefront of this development.

The specialists from Hima Paul Hildebrandt understand from decades of experience that there can be no compromises when it comes to safety. Since 1970, the company from Brühl near Mannheim/Germany has dedicated itself entirely to plant safety, an area in which it has constantly set new standards. Today, from its global presence of 50 locations around the world, the leading specialist in safety automation solutions provides safety solutions to its customers in the process industry to safeguard safety and productivity.

When it comes to originator companies and drug development, there is a lot of money at stake. Faster development and faster time-to-market means more time to benefit from patent protection — that’s the motto. Here we examine why so much depends on a systematic approach and the role of the scale-up.

Machine learning can create the basis for higher plant availability, says Richard Irwin, Senior Product Marketer for Asset Wise at Bentley. But the implementation of such systems must be well-prepared. Only then can real added value be created.

PROCESS celebrates its 25th anniversary — and we look forward to taking you on a journey through time to the high points in the process industry. We hope to present technology that will excite and companies that have impressed us as pioneers and trendsetters. In the period up until the summer of 2020, we are going to show off a glittering range of innovations that will thrill and inspire in equal measure. We promise!

An effective method is now available for testing safety shutdown valves, which does not interrupt ongoing operations. Integration of the testing function into the process control system can make the technique even simpler, safer and more cost-effective. This article presents a solution which has a proven track record.

Always in tune with the times and just that little bit better than the others — that has been the motto of Hima ever since the company was first founded. Many years of safety experience and a huge passion for the topic of safety have driven the family-run business, which is now already in its fourth generation. Since the strategic repositioning in 2017, Managing Partner Steffen Philipp and VP R&D and Product Management, Dr. Alexander Horch, believe that they are well set up for the digital future.

Quality Metrics — Regulatory requirement or business opportunity? — Inspections yes, but only as many as necessary. The FDA has been acting on this principle for many years. With the recent FDA Quality Metrics Initiative, the agency is pushing ahead with this project and is trying to bring greater responsibility to the pharmaceutical industry.

 — In recent years, formulations based on pellets have been the trend. New technologies make it possible to circumvent property rights for active ingredients and are therefore very popular with pharmaceutical customers. But which technologies are the most important?

Continuous production is steadily gaining momentum as a practical strategic option for pharmaceutical manufacture —  The market is actively looking for technical solutions and equipment manufacturer Glatt presented a new continuously operated process system at Achema which addressed the topic of Traceability and showed a solution which guarantees the operator a high level of pharmaceutical safety.

When using High Containment-Technology Rapid-Transfer-Ports are State-of-the-Art for sterile transfer. The authors are presenting a study which compares different systems showing need for improvement.

Anyone designing, building, operating or further developing plants today must at the same time depict state-of-the-art process technology, anticipate the paths of digitisation, take into account accelerated innovation cycles and be meaningful to all disciplines involved at all times. The advantages of the universal data model of Aucotec's cooperative engineering platform EB 2019 become clear in demanding engineering phases such as FEED or during the cause-and-effect check.

Continuous tablet coating is now part of the Modcos continuous production line — Following the introduction of the continuous Glatt Modcos system, Glatt is working together with partner Driam to close a gap in the production process by incorporating continuous tablet coating. Like Modcos, the continuous Driaconti-T system enables complete traceability of every tablet as well as precise and reproducible setting of the retention time in the process.

Pharmaceutical production is becoming more digital and connected. Players who can deliver coherent, logical concepts will be part of the next major Industry 4.0 project. The five members of Excellence United have made great progress with their IoT Hub and have shown what it is already capable of. But this is just the beginning. In the interview, the five executive directors explained why. The strategic corporate alliance Excellence United presents its new Industry 4.0 concept, which sets new standards.

Before new active ingredients can achieve market success, comes drug delivery. OSDs continue to rank highly as the formulation of choice. Why the pellet is probably the most versatile active ingredient formulation, but at the same time the most underestimated.

Softing joins Emerson’s Delta V Alliance Product Program and extends intelligent device management across the field to islands of devices and out to the enterprise to remote subject matter experts. To meet the increasing requirements for energy efficiency and flexibility in modern process manufacturing, information about processes and plant statuses is required which can be exchanged across systems. To achieve this, sensors, devices, control systems and production plants have to be networked horizontally and vertically.

A new biomanufacturing plant uses a comprehensive digital enterprise solution based on the concept “from integrated engineering to integrated operation”. Cathay’s new Wusu plant adopts Siemens’ complete digital factory solution, covering the entire lifecycle of the plant in design, construction, operation and maintenance, enabling Cathay to fully upscale every step of its process from R&D to production.

Diosna — the German machine and system manufacturer is known for its high quality of its pharma machines and customized concepts — Since May 2018, Henrik Oevermann has been in charge of Diosna’s business as CEO. One of his first challenges was the changing of existing structures. The pharmaceutical and food divisions are now working more closely together in order to create synergies, delivering flexibility in engineering and in production. Now he is thinking intensively about the next steps in Diosna’s progress.

If you are keen on upgrading your capsule filling machine, read this space. With the global capsule filling machines market predicted to reach 440 million dollars by 2025, many new interesting features including dosing precision, in-line control of critical quality and handling of difficult products have been enhanced in these machines.

This could change the market: Samson and Krohne set up a joint venture. The 50:50 joint venture is called Focus-On and will initially help a new intelligent process node that integrates valve functions with flow, pressure and temperature measurement to break through the market.

The benefits of single-use technologies include cost savings, reduced risk of product contamination, and increased flexibility in multi-product facilities. Current biomanufacturing trends have brought the demand for single-use to a new level.

Catalysts, whether heterogeneous or homogenous, ignite the turbo in reactors and have what it takes to make future dreams come true. The wish list includes things like the age-old dream of using carbon dioxide as a chemical feedstock.

An extended recovery period for crude oil prices, exceeding five years, would have dramatic implications for the global petrochemical industry and could mean a “Back to the Future” experience for some companies and regions -- creating a more competitive environment for naphtha producers, according to a new IHS report.

Against the backdrop of the restructuring of its refining capacities, mineral oil companies are often anticipating a mammoth task: the complete dismantling of a production site. The fact that a sustainable and economically viable concept for a site conversion can be successfully implemented is exemplified by the dismantling of the Ingolstadt Refinery — a pioneering project

Specialty Medicines and Facilities of the Future are the new challenges–The biggest pharmaceutical products are now specialty medicines. Not 'biggest' from a volume perspective, but from a value perspective. This has significant implications for manufacturing, especially on flexibility needs.

Technip is going to buy Zimmers Technology Business from Air Liquide Global E&C Solutions. This step will strengthen Group’s position as a technology provider to the petrochemicals industries.

The R. Stahl Expert Forum welcomed its participants with a vast wealth of information about guidelines and standards, as well as offering plenty of hands-on knowledge as well — So which sets of technical rules are used as the basis for a hazard assessment? How do you assess the risk posed by a cellphone or by a smart watch with integrated heart rate monitor? And which rules apply in North America? As all-rounders, safety experts need to have the answers to many different questions at their fingertips. We have summarized all their answers for you in this article.