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Vaccine production speeds up, who can share the billions of dollars?

Vaccine production speeds up, who can share the billions of dollars?

Jan. 20,2021

The research and development of the new crown vaccine has become the focus of continuous attention in the context of the normalization of the global new crown epidemic.The good news is that on December 30, 2020, Sinopharm China Bio-new Crown Inactivated Vaccine has been approved by the State Food and Drug Administration (SFDA) for conditional marketing.Recently, the production that media reported novel coronavirus inactivates vaccine, package flow, this cannot leave the support of industrial automation technology and auxiliary among them.

Light Inspection

In the automatic pre-filling packing line, the filled vaccine is first inspected by light.This process uses a high-speed camera instead of a human eye to detect and remove products that contain particles, foreign matter, glass slime or defective filling quantities.The lamp inspection machine has the advantages of high automation, high speed and high accuracy. It will pick out the unqualified products one by one, and the elimination rate is about 2%~3%.

Label

The vaccine that passes the lamp is then labeled and fitted with a syringe push rod.The label is marked with the product name, date of manufacture, serial number and other information.

According to reports, compared with the traditional bottle packaging, the pre-filling vaccine produced on the assembly line is more convenient.Health care workers can get the vaccine and inject it directly, without having to pump it into a syringe.

Packing

Next, the vaccine enters the packaging process.Each vaccine comes with an instruction sheet and will be weighed online once it is boxed.If the wrong weight is found, such as a missing instruction manual or putter, it will be removed, adding another layer of safety assurance.

Tagging

The final step is code assignment.Yang Xiaoming, chairman of Sinopharmaceutical's China Biotechnology Group, said the regulatory code is equivalent to the "electronic ID card" of vaccines, which can be divided into three levels: a separate code for each vaccine, a code for a 10-dose vaccine pack, and a code for a large pack containing multiple packs.

The supervision code can be used to check whether the process of vaccine production, storage, storage, delivery and transportation meet the standards, and track the person who receives the injection.

Huge market opportunity

The Ministry of Industry and Information Technology said on Jan. 5 that it will strengthen the linkage of industrial chains, encourage companies to accelerate the industrialization process of vaccines, and do everything possible to expand production capacity to ensure the production and supply of Novel Coronavirus vaccine.At present, 18 domestic enterprises have been carrying out production capacity construction of novel Coronavirus vaccine.With the further improvement of the production capacity of novel Coronavirus inactivated vaccine and the gradual completion of the production capacity construction of other technology route enterprises, the production capacity of novel Coronavirus vaccine in China can meet the domestic demand for large-scale vaccination.

In the face of huge market space and urgent market demand, the capacity of the new crown vaccine will become the second key link after vaccine development.In China, many companies have announced the construction of new crown vaccine production lines.The three leading companies of Sinopharmaceutical, Beijing Branch, Wuhan Branch and Beijing Sinovac, have completed the tasks of capacity construction.

However, due to the lag of vaccine production, it still needs time to release production capacity, which requires the deep integration of the upstream and downstream of the whole industrial chain. For the pharmaceutical industry, as well as industrial automation enterprises, there will be a huge development opportunity.

Intelligent technology helps

Although the entire vaccine industry chain faces huge market opportunities, it also faces various challenges. In order to achieve faster time to market, higher production efficiency and shorter development cycle, it is necessary to introduce or upgrade highly automated and intelligent equipment, so as to achieve the purpose of cost reduction, efficiency increase and compliance production.Therefore, pharmaceutical equipment will play a vital role in its development process, opportunities and challenges coexist.

In recent years, with the rapid development of industrial automation technology, pharmaceutical enterprises have also achieved rapid development, whether it is production quality or production efficiency, compared with some traditional enterprises, have made great progress and development.

For example, in the filling process of liquid vaccines, light checks are carried out, and although the time it takes for each bottle of vaccine to go through light checks can be measured in milliseconds, it is a crucial and important process.In the past, the traditional way is to use artificial light detection, but this method of low detection efficiency, detection quality is susceptible to many factors.

Compared with the manual visual inspection, the detection speed and quality of the lamp inspection machine have been a qualitative leap, so the use of automatic lamp inspection equipment for vaccine detection has become an inevitable trend.In the application of this technology, Xiaobian found that there have been mature cases.For example, Huichuan Technology and Intel launched a one-stop, intelligent lamp inspection solution for pharmaceutical enterprises, which can help pharmaceutical enterprises to obtain more efficient detection efficiency of liquid pharmaceutical preparations.

Informatization construction is imminent

Different from discrete manufacturing industries such as automobile and electronics, the pharmaceutical industry is related to the public's life and health, and all aspects are required to follow the quality standard, because it is not only related to the efficacy, but also has a direct impact on the life and health of patients.

In April 2020, the State Medical Products Administration revised the appendix of the Biological Products in accordance with the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision).Article 59 clearly states that vaccine manufacturers should use informationized means to truthfully record all data formed in the process of production and testing to ensure that the whole process of production continues to meet the legal requirements.For manual operation (including manual operation, observation and recording, etc.), the data formed in this process shall be timely input into relevant information system or converted into electronic data to ensure the authenticity, integrity and traceability of relevant data.

The Appendix shall come into force on July 1, 2020.For Article 59 of the Appendix, if an enterprise uses an information system for real-time data collection to record data, it shall meet the relevant requirements before July 1, 2022, because the information construction needs a certain period.That is, from the policy level, for vaccine companies, not only must be forced to carry out information construction, but also have a clear time cut-off point.

Vaccine safety concerns people's lives and health, public health and national security, and the pharmaceutical equipment industry has a great responsibility.Nowadays, with the continuous progress of pharmaceutical equipment and technology, especially the innovative development of digitalization and information technology, data can be automatically recorded, uploaded and excluded in the whole production process of vaccines, which fundamentally maximizes the interference of artificial factors and completely eliminates the phenomenon of falsefication of vaccine records.

From another point of view, the pharmaceutical industry also needs more industrial automation enterprises to help achieve transparent, controllable and intelligent manufacturing process, and ultimately achieve sustainable development.How to use information technology to meet the timeliness, efficiency, high quality, safety, energy conservation, environmental protection, compliance and other requirements of production and operation is a common challenge facing pharmaceutical enterprises.

For this reason, many industrial automation enterprises have launched comprehensive solutions for the pharmaceutical industry.For example, FactoryTalk PharmaSuite, Rockwell Automation's MES suite for pharmaceutical informationization, enforces processes and specifications, reduces the time required to review batch reports, and reduces the investigation effort, helping to address one of the biggest concerns of pharmaceutical companies -- compliance costs.

Siemens has also tailored solutions for vaccine manufacturers, including fully integrated automation systems, manufacturing Execution systems (MES) based on OpCenter Execution Pharma, a paperless manufacturing platform, and laboratory information management systems (LIMS) based on the OpCenter RD&L R&D & Lab suite.

Honeywell also has a solution -- Fast Track Automation -- that enables companies to accelerate the registration, approval and clinical trials of important vaccines, treatments, and therapies, leading to faster full-scale production.This technology enables customers to prepare manufacturing automation designs simultaneously with clinical trials, ensuring that therapies can be rapidly scaled up for mass production once they are approved.

At present, China is vigorously promoting the digital transformation of industrial enterprises, and the digital transformation of pharmaceutical industry is further accelerated by the factors of the epidemic.The epidemic highlights the importance of intelligence, digitalization and informatization. In this context, the pharmaceutical industry also shoulders a major mission, and it is urgent to transform and upgrade to help solve the pain points of pharmaceutical companies.In 2021, the opportunities brought by a new round of industrial outbreak and rapid development of the industry have been placed in front of you. Are you ready?

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