Mr. Christian Bachofen, director of TIANS Group and chief technology officer of biomedicine, received an exclusive interview with Pharmaceutical Industry

"Customer success is our main goal." Recently, Christian Bachofen, the director of TIANS Group and chief technology officer of biomedicine, said in an exclusive interview with Pharmaceutical Industry. The following is the original interview, reproduced from the official account of Pharmaceutical Industry.

Pharmaceutical enterprises need a lot of investment in building pharmaceutical facilities. If the construction of facilities can meet the requirements of national standards, the cost can be predicted, the time to market of products can be shortened, and the flexibility of future re planning is significant for pharmaceutical enterprises.

 

Mr. Christian Bachofen

Internationally renowned biomedical design and planning expert, director of TIANS Engineering Technology Group, and chief technology officer of biomedicine

The preliminary design plays an important role in a project from planning to completion. The engineering industry generally refers to conceptual design and preliminary design as preliminary design, which is the basis of detailed and construction drawing design. Christian Bachofen pointed out that "the preliminary design stage of the pharmaceutical facility engineering project is an iterative process, which aims to help pharmaceutical enterprises find sustainable investment and operation technology solutions. This solution is very critical for the entire project, which can help customers achieve the optimization of the initial investment cost and the later operation cost within the life cycle, and achieve real lean production."

It can be said that the preliminary design affects all aspects of the whole project. The perfect preliminary design quality will make the design conform to the planned time schedule and the expected investment and operation cost. During the life cycle, it will ensure the lowest possible COGS (cost of product sales). Therefore, in the design of each engineering facility, we should pay attention to the preliminary design, and think about how to meet the design requirements of fast process, high quality, low cost, strong controllability and wide extension. Although these require the input of intelligence and time, they can bring rich returns to the owner in the life cycle.

Christian Bachofen, an internationally renowned biomedical design planning expert, founded CB Consultancy AG (CBC) consulting company in Switzerland in 2012, and is the major shareholder, president and chief designer of the company. For more than 30 years in the biomedical industry, Christian Bachofen has served many international and domestic biopharmaceutical enterprises, including Johnson&Johnson, Novartis, Zhongsheng Group, Green Leaf, Baekje Shenzhou, Hualan Biology, and has accumulated rich practical experience in the planning and design of biopharmaceutical engineering projects in the process of consulting many companies' biopharmaceutical plants, supporting projects, and environmental protection projects. "The adoption of risk-based and traceable design methods can avoid mistakes" is the philosophy Christian Bachofen believes in, which has been verified in many engineering projects. Christian Bachofen knows how to successfully plan and design biopharmaceutical facilities.

For many years, Christian Bachofen has been leading CBC to provide pharmaceutical and preparation manufacturers with whole process consulting services in the fields of conceptual design, basic design, detailed design, bidding and procurement support, 3D modeling, construction management, operation and maintenance in the world, including engineering consulting, pharmaceutical utilities, HVAC systems, automation control technology, etc. At the beginning of 2020, during the outbreak of the new coronal epidemic, Christian Bachofen overcame many difficulties and came to China across the sea to race against time and disease. It took 8 days to complete the conceptual design of the new coronal vaccine workshop of BioSino, which directly accelerated the full cycle of the R&D, design, production and vaccination of the new coronal vaccine in China. In 2021, Christian Bachofen started a new journey. TIANS Engineering Technology Group, a top EPC engineering service provider in China, acquired part of the equity of CBC Company founded by Christian, and the two companies reached a deep strategic cooperation. Christian himself served as the director of TIANS Group and the chief technical officer of biological medicine, moving forward with TIANS Group. He emphasized: "We hope that through our in-depth cooperation, we can jointly provide customers and the entire industry with real added value in terms of environmental protection and economic efficiency improvement, and make greater contributions to the development of China's biomedical industry."

Part 1 Value Creation By Following Processes

Many times, some designs in the country do not adopt a scientifically sound design approach based on process risk assessment, but adopt fixed numerical values or templates in their execution. Christian Bachofen argues that there is room for such an approach that is not risk-based and traceable in a way that will not enable rapid, safe, and compliant design and construction with international GMP. In his experience, wanting to help customers minimize risks as much as possible during the life cycle of a project, to have the entire design conform to international and domestic regulatory requirements, and at the same time to achieve cost optimization of the facility, requires following scientific, process based, and product based processes during the design process.

" we always start with the definition of a process critical quality attribute (CQA) followed by a process risk assessment to define a critical process parameter (CPP). Once a CPP has been identified, we can trace all decisions back to this CPP. This risk - and traceability based design approach avoids errors because we have a perfect source to review what has been done. " Christian Bachofen emphasizes that, " it takes a lot of effort and time to do this job. From the operation of the whole life cycle of the facility, the more the preparations made during the pre design phase, the safer and smoother the subsequent facility's operation. Therefore, the inputs made in the pre phase are worthwhile to the owner. During the long operation of the facility, the time verified scheme contributes to the energy-saving and carbon reduction, and the production cost of the product can be reduced substantially. "

 

Mr. Christian discusses design scenarios with Chinese customers

Each facility is an individual and the engineering design will be tailored to the customer product and production process. Using HVAC as an example, it is one of the very important systems responsible for room grading, temperature, humidity and pressure. Christian Bachofen notes that, "" our system design follows strict rules for sustainability and energy savings as well as energy recovery. In Europe, the energy demand of the system is about 50% - 60% lower than in China. Values such as room conditions, ventilation rate, and percentage air replenishment all follow a risk-based design approach and can vary from car to car. "" of course, all of these designs need to meet GMP specifications and achieve energy savings whenever possible. Another important aspect is system classification, except Outside the supply and exhaust end filtering, the systems are classified as non GMP and therefore the HVAC system (HVAC) and the building management system (BMS) are considered only commissioning systems. ""

That is, in a clean room design, the room is designed in a level C or D, depending on the outcome of the risk assessment, which, if a closed process is employed, means that the number of room air changes is greatly reduced and energy is substantially saved. The same is true for the temperature and humidity range of rooms, which needs to be set based on risk. For example, a process is closed and located in a cold chain where room temperature and humidity of the room are no longer critical aspects of GMP of the product and room conditions are in this case for operator comfort and to avoid microbial contamination of the operator. "" a risk-based design approach can lead to the optimization of the design and thus help customers save 50% - 70% of the running cost of energy. "" Emphasized by Christian Bachofen.

In addition, in terms of HVAC design, the foreign and domestic design concepts are different, foreign countries will separate the wind supplementation and exhaust systems to achieve energy efficient recycling, while the domestic design rarely adopts this way. At the same time in terms of thermal energy, the domestic utilization is not high, and the thermal energy generated by the air press is many times drained directly through the exhaust pipe, without recycling and reuse. This is different from foreign practices for the recovery of thermal energy generated from large equipment. Christian Bachofen notes, "" these are all aspects that need to be thought about in the design phase and where we can provide high added value to customers. ""

High quality designs guarantee efficient implementation in all phases of the project. And whether a project can be delivered quickly depends on the designer's technical level and project management capabilities. Christian Bachofen notes that a risk-based design approach with extensive experience allows for safe and rapid delivery of design and construction. This view was fully confirmed by the CBC for the incov 19 DS facility designed for China Biotechnology Co., Ltd. These rapidly delivered facilities are not only safe, compliant, compliant with cGMP and who requirements, but also highly efficient and lean. In addition, a high-quality design program will reduce the occurrence of changes and avoid incurring additional expense and time delays.

Part 2 Design Innovations Are Oriented To The Future

Future oriented design means creating multiple flexible spaces. Where the facility housing must be flexible. The life cycle of production workshops is typically 15-20 years, while the life cycle of an entire building enclosure is approximately 50-60 years. This means that the design of workshops with a period of 15-20 years in this building enclosure requires a minimum of 2-3 iterative processes to be considered. This design idea not only considers the current production situation of the facility, but also considers its potential operational issues for the next several years.

 

Concept and design of Shinda biopharmaceuticals (Suzhou) Co., Ltd

This is Christian Bachofen's innovative design idea, which breaks the inherent framework of thinking and implements a platform-based technology so that workshops can achieve multi variety production and the reusability of production space. Christian Bachofen stated, " we set out some preliminary infrastructure, such as purified water interfaces, air replenish or air exhaust ducts, when designing a building enclosure. Such a design idea provides flexibility for subsequent product production. When a certain product production is carried out in a workshop a day later, simply docking the pipelines in the production workshop with those of the infrastructure, that is, the " plug and play "idea. So we can adopt this platformized technology means to enhance the flexibility of the facility when it comes to overall facility design. This of course requires a deep integration of customers into the design philosophy, and the flexibility of design is beyond doubt important for workshops, buildings, maintenance, and the life cycle. "

Part 3 Strengthening Hands Promote Coprogression

In recent years, with the rapid development of the biopharmaceutical industry, the speed of listing of biopharmaceuticals has accelerated, and more and more pharmaceutical companies choose to invest in construction plants. Foreign engineering companies, by virtue of advanced design concepts, have gained the opportunity to provide design consulting services to pharmaceutical companies. But because there are differences between the engineering and design companies at home and abroad in design philosophy, design ideas, and usual practices, during the implementation of an engineering project, there are often cases in which the engineering companies at home are not familiar with the design philosophy of modernization. In an effort to increase compliance with international expectations, the time group worked with the CBC to fully and deeply implement international excellence design concepts into the construction of the project facility.

 

Song Xiaohui

Director, Vice President and Chairman of Biomedical Business Department of TIANS Group

Xiaohui song, director, vice president and chairman of biopharmaceutical operations of Tianqu group, said Dr, " by working deeply with the CBC team, the time group has enhanced their integrated strength in the field of biopharmaceutical engineering. They, as cutting edge teams in our biomedical division, will guide us in the biopharmaceutical market as a bellwether. " design extends downward and engineering extends upward. We are an organic service chain. We feel confident and have the capacity to enable Chinese biopharmaceutical companies to realize Now the Indigenization and landing of the international advanced design concept in China, in the future, we will improve our understanding of each other and tease out their respective responsibilities to provide customers with a complete set of robust EPC engineering services. "

Zero CO2, energy saving, energy recovery, lean manufacturing, massive staff reduction, closed processes and reduced room requirements will be the future trends in pharmaceutical engineering. In the face of industry development, the day time group has been thinking about ways to assist firms in reducing life cycle operating costs, using less energy, and achieving better quality control. Time group joined hands CBC will be developed to conform to future trends with an improved understanding of GMP regulations and a wealth of technical experience accumulated in energy-saving design concepts. " customer success is our primary goal. " Emphasized by Christian Bachofen.