Preface: biological medicine industry as during the "difference" to build innovative industry always walk in the front of the pharmaceutical industry development, as a pharmaceutical engineering EPC leader, modern group to build international biomedical project consulting, design, construction team, the team members have international design concept and frontier engineering concept, promote the rapid development of biomedical engineering field, for biomedical designers tailored the international biological engineering practice class related courses.

When the apricot flowers slightly rain, the spring is fading. On May 6, day group international biological engineering practice class through live online course officially began, the international famous biomedical design planning experts, day group director, biomedical chief technology officer, CBC founder Mr Christian personally, senior English translation experts Liang Jie (Monica) teacher synchronous translation, day group biological medicine division, process technology center and other online, a total of more than 50 employees participated in the course.

Students will conduct course training in the Wu Yafeng conference room

Look to the world, and seek new intentions

At the opening ceremony, Song Xiaohui, director, vice president and chairman of biomedical Business Division, made an opening speech. He said the course is a key opportunity for contemporary designers to collide with cutting-edge design ideas. It is hoped that through this series of courses, all students can understand the international cutting-edge design concepts, and boldly innovate the application, so as to better bring more efficient, flexible and sustainable design and plant facility construction services to Chinese biomedical enterprises.

Song Xiaohui made a class-opening speech

In a simple way, explore the frontier

Mr Christian in the first class in the biotechnology workshop building planning process as the theme, first introduces the current international biopharmaceutical status, summarizes the series of courses each class learning content, then from the life cycle of pharmaceutical facilities, GMP requirements, create a healthy and safe environment these three aspects carried out the first phase of the course. Detailed industry data, classic operation cases and theoretical analysis from shallow to deep, has greatly mobilized the enthusiasm of students for learning, so that students have a more comprehensive and systematic understanding of biotechnology, has been widely recognized and praised by everyone.

Mr.hristian class Mr.Christian course real-time picture sharing process

Students listen carefully to the course explanation

The future has come, but only the change remains unchanged. Modern university will be with Mr Christian in the next two months, open nine courses, closely around the international and domestic market demand, based on Mr Christian's practical experience and the ideas and international design of the design requirements, through the international case, from the process, hvac, engineering and other angles for thorough analysis and explanation, systematically help students improve design ability, improve the modern biomedical sector design team level, achieve a "high, fine, sharp" design team goals.

Instructor link: ChristianBachofen

Mr.Christian Bachofen is an internationally renowned biomedical design and planning expert, with a bachelor in bioengineering at Zurich, and a founder and chief designer of CB Consultancy AG. He has served as a visiting professor at Basel and Jilin University in Switzerland. Mr.Christian has rich experience in the planning and design of pharmaceutical factory facilities, GMP clean room and HVAC system design, pharmaceutical water system design, quality management system, etc. As a project leader participated in several international famous biomedical design projects, including Johnson & Johnson pharmaceutical freeze-dried antibody production plant and mab-Xilin bottle packaging line design project, novartis pharmaceutical research and development park office building and for laboratory building design project, baekje shenzhou Suzhou pilot production workshop and Guangzhou commercial production workshop design project and sheng group new crown vaccine production workshop, and many other projects. The F2P2-Centocor's New R & D Fill Finish Pilot Plant project won the best project of the International Association of Pharmaceutical Engineering (ISPE). Christian In the design and implementation of the project, it proposed and realized a highly integrated unique design concept, cleverly balanced the requirements of flexibility, efficiency and compliance, and ISPE awarded it the best engineer.

01 "Pharmaceutical professional English vocabulary manual" was released heavily Blockbuster Released In recent years, with China's accession to ICH and the launch of PIC / S pre-accession application, the international development of Chinese pharmaceutical enterprises has become inevitable. In the face of the constantly updated and iterative global pharmaceutical regulations and the growing demand for multinational business cooperation, English has gradually become an important competitiveness for the innovation and development of pharmaceutical enterprises, and the mastery of pharmaceutical professional English ability has also become a necessary condition for many pharmaceutical enterprises to select excellent employees. In this context, The Times Group and the Medical Translation Center jointly produced the "Pharmaceutical professional English vocabulary manual". Relying on the years of consulting, design and engineering service experience in the pharmaceutical industry and the dual technical background of "Pharmaceutical major" and "English major", we have organized more than 20 experts. After half a year, careful preparation, detailed planning and heavy launch. We hope to help the Chinese pharmaceutical industry to go to the world through this manual!

02 Wonderful content first understanding First to Know In order to facilitate the learning needs of people in different positions, this book classifies vocabulary according to five parts: quality assurance (Quality Assurance), monitoring and analysis, facilities (Facility & Equipment), production process (Production & Process), registration and R & H and development (Registration & R & D), with a total of 2000 + professional words. Each vocabulary contains Chinese, English, English phonetic symbols and vocabulary application example sentences, which is a necessary professional "application dictionary" for pharmaceutical professionals.

03 Hundreds of books are free of charge Free to Receive activity time: From April 22nd- -May 6th participation way: ① replied to "Pocket Book" on the wechat official account of [Times Group] to generate your exclusive English pocket book help poster;

② generates your exclusive English pocket book booster poster;

③ forwards this poster to friends or shares it to Moments;

④ invites him / her to identify and scan the QR code in the poster to follow the [All Times Group] wechat official account. With 5 people invited, you can get a set of Pharmaceutical Professional English vocabulary Manual for free!

The ⑤ starts with 100 sets, first come, first served!

04 Pocket Books has released series

TIANS Pocket Book

In order to promote the progress of the industry and help pharmaceutical people continue to learn, The Group sincerely create a perfect pocket book-pharmaceutical people "bag" brand, has launched 12 series, bringing knowledge sharing to thousands of industry personnel, become a necessary tool book for pharmaceutical people, won praise in the industry.

Modern pocket book pharmaceutical man "bag" to walk

No.1-Drug Production Quality Management Specification and its appendix series

No.2-Compilation of Chinese biomedical related laws and regulations

No.3-ICH Quality Guidelines (1)

No.4-ICH Quality Guidelines (2)

No.5-ICH Quality Guidelines (3)

No.6-ICH Quality Guidelines (4)

No.7-ICH Quality Guidelines (5)

No.8-Compilation of Chinese Drug Tracking Standards (1)

No.9-Compilation of Chinese Drug Tracking Standards (2)

No.10-Wastewater Treatment Standards and Specification Compilation (1)

No.11-Wastewater Treatment Standards and Specification Compilation (2)

No.12-Wastewater Treatment Standards and Specification Compilation (3)

Gather your strength and create a new chapter in the industry. On April 13th, the online forum of "Big Charity Cloud Forum- -WHO Vaccine Pre-Certification (PQ)" jointly hosted by Times Group and Yunzhi Pharmaceutical Technology was held as scheduled. Mr.Christian Bachofen, an internationally renowned biomedical design and planning expert, director of The Group and chief technology officer of biomedicine, shared the special topic of "WHO Pre-certification Product Review Document Architecture and Good Document Specification". Nearly 3,000 professional guests of r & D, verification, quality management from biomedical enterprises across the country watched it online.

Mr.Christian Cloud Forum live course live

At present, a total of 7 Chinese enterprises have passed the WHO vaccine pre-certification, 5 of which are professional services provided by Mr.Christian, and they have rich practical experience in Chinese localization in the WHO-PQ field. At the same time, Mr.Christian explained the system document system of WHO pre-certification products in combination with his concept of serving international and Chinese pharmaceutical enterprises in nearly 20 years. He pointed out that WHO drug pre-certification is a service provided by WHO to evaluate the quality, safety and effectiveness of drugs, and explained the operation process mode of WHO pre-certification from seven steps, including the pre-submission meeting, application letter and pre-certification documents.

Mr.Christian shared the special topic of "WHO Pre-certification Product Review Document Architecture and Good Document Specification" in the cloud forum

First of all, we introduced the basic situation of WHO-PQ, he pointed out that the WHO drug pre-certification is a service provided by the WHO, used to evaluate the quality, safety and effectiveness of drugs, after he from the pre-submission meeting, application letter, pre-certification documents and other seven steps to explain the operation process mode of WHO pre-certification.

WHO pre-certification process mode explanation

Electronic general technical document (eCTD), as the current internationally recognized drug declaration data preparation format, has replaced the previous product master document (PSF). Mr Christian detailed the general technical documents (eCTD) in the specific content of the five modules, for the more important quality, the clinical trial report and clinical trial report the three plates, Mr Christian listed each plate need to write content and need to pay attention to the technical difficulties, for you to effectively solve the file writing questions and confusion.

Explanation of eCTD Electronic General Technical Document course

Good document processing specification (GdP) is an indispensable part of the WHO pre-certification process. Mr.Christian started with an overall overview of how to record, data entry and recording notes, and the integrity and reliability of the data, and stressed that the more important aspect now is to ensure the source of information while ensuring the traceability and consistency of the document.

First appearance, connect to the world

In this online forum, we also released the "Pharmaceutical Professional English Vocabulary Manual" jointly produced by Times Group and Yunzhi Pharmaceutical Technology. The pocket book is classified by five parts: quality management (Quality Assurance), monitoring and analysis (Monitoring & Analysis), facilities (Facility & Equipment), production process (Production & Process), and registration and research and development (Registration & R & D), with a total of 2,000 + professional words. Each vocabulary includes Chinese, English, English phonetic symbols and vocabulary application examples. Under the wave of globalization of Chinese pharmaceutical enterprises, the Pharmaceutical Professional English Vocabulary Manual will also become a necessary professional "English dictionary" for pharmaceutical professionals.

Connect with the world and build the future of the industry. As the leader of pharmaceutical engineering EPC, The Group always takes science and technology as the source power of development, shares cutting-edge information in the pharmaceutical and environmental protection industries, spreads international cutting-edge ideas, and promotes the rapid development of the pharmaceutical industry.

Character link：ChristianBachofen

Mr.Christian Bachofen is an internationally renowned biomedical design and planning expert, with a bachelor in bioengineering at Zurich, and a founder and chief designer of CB Consultancy AG. He has served as a visiting professor at Basel and Jilin University in Switzerland. Mr.Christian has rich experience in the planning and design of pharmaceutical factory facilities, GMP clean room and HVAC system design, pharmaceutical water system design, quality management system, etc. As a project leader participated in several international famous biomedical design projects, including Johnson & Johnson pharmaceutical freeze-dried antibody production plant and mab-Xilin bottle packaging line design project, novartis pharmaceutical research and development park office building and for laboratory building design project, baekje shenzhou Suzhou pilot production workshop and Guangzhou commercial production workshop design project and sheng group new crown vaccine production workshop, and many other projects. The F2P2-Centocor's New R & D Fill Finish Pilot Plant project won the best project of the International Association of Pharmaceutical Engineering (ISPE). Christian In the design and implementation of the project, it proposed and realized a highly integrated unique design concept, cleverly balanced the requirements of flexibility, efficiency and compliance, and ISPE awarded it the best engineer.

ABOUT TIANS

TIANS Engineering Technology Group Co., Ltd. is a leading intelligent equipment manufacturer and one-stop service provider in the fermentation industry in China. Headquartered in Shijiazhuang, with branches in Shanghai and Shandong. The business areas include intelligent instantaneous continuous energy dissipation machine, engineering consulting and design, environmental protection technology and engineering general contracting, biomedical engineering general contracting, chemical and pharmaceutical engineering general contracting, automation and information engineering, etc.

The intelligent manufacturing equipment division of TIANS group has mastered a number of core technologies such as biological fermentation, sterilization, energy conservation and environmental protection, and is specialized in the R & D, design, manufacturing, installation, commissioning and other comprehensive services of intelligent instantaneous continuous consumer.

TIAN'S INSTANTANEOUS STERILIZING EQUIPMENT

TIAN'SIntelligent Instantaneous Sterilizing Equipmentis a sterilization equipment that makes full use of steam latent heat and achieves pure countercurrent heat exchange through a new heat exchanger according to the principle of short-time high-temperature sterilization.

The equipment is composed of heat exchanger, maintainer, ejector and automatic control system. It is widely used in fermentation pharmacy, amino acid, enzyme preparation, food and beverage and new materials.

EQUIPMENT ADVANTAGES

1. High sterility rate: sterilization rate 99.9%

2. Less damage to culture medium: rapid sterilization at high temperature for a short time to reduce the nutritional damage of materials under high temperature for a long time. It is widely used in a variety of materials, such as corn pulp, corn flour and other materials can be completely sterilized.

3. Energy saving and environmental protection: save steam by more than 70% and cooling water by more than 90% compared with actual consumption. Carry out it in a closed environment to avoid exhaust steam discharge with culture medium.

4. Stable operation: intelligently control the sterilization temperature and time, and the sterilization effect is stable and reliable. The ejector selects special channel size, and the heat exchanger adopts special process welding, which will not damage the plate, cause no perforation, internal or external leakage.

5.Convenient operation: integrated design, automatic control, no noise and vibration, improve the working environment and improve work efficiency.

EXPERT SHARING

>Time: March 30, 2022

>Venue: Jinan (Shandong International Convention and Exhibition Center) · conference room 4

>Theme: special meeting on facility and equipment management of pharmaceutical enterprises

>Organizers: Dandelion (Yangtze River Delta Suzhou) medical service platform and international biological fermentation Exhibition

《Application of intelligent continuous elimination system in biological fermentation industry》

Tian Linsheng

■ technical expert in controlling fermentation infection

■ general manager of intelligent manufacturing equipment division of TIANS group

Fermentation process design concept

Gao Zhiqiang

■ fermentation process design expert

■ chief engineer of intelligent manufacturing equipment division of TIANS group

PROJECT CASE

TIANS Engineering Technology Group Co., Ltd

Floor 23-26, block a, Tianshan Science Park, No. 310, Changjiang Avenue, Shijiazhuang, Hebei, China

TIANS technology innovation center · equipment manufacturing center

No. 11, Sanxia Road, Liangcun Development Zone, Shijiazhuang, Hebei, China

Good gift

First come first served first time, and 50 quick action will be made when we are concerned about the official account of the group and return to the "发酵展".

For more wonderful content, please visit booth a-23 of hall 1. We look forward to your visit!