Under the implementation of the new version of the Pharmacopoeia, microbiological testing equipment in the subdivision of pharmaceutical equipment is promising

Whether in people's lives or in industrial production, microorganisms are almost everywhere
.
In the clean room of the pharmaceutical workshop, the concentration of microorganisms has a significant impact on the clean environment of the entire workshop.
Once drugs containing microbial contamination enter the market, they will also bring hidden dangers to human health and safety
.
Therefore, the indicator of microbial content has attracted much attention from pharmaceutical companies
.
In recent years, with the implementation of the new version of the pharmacopoeia, the pharmaceutical industry has become more stringent in supervision, and microbiological testing has become a very important link.
The subdivision of pharmaceutical equipment-microbiological testing equipment has also attracted increasing attention from major pharmaceutical companies
.
Pharmaceutical equipment (picture source: Pharmaceutical Network) Under the new regulations, the inspection of the microbial limit of drugs is becoming more and more important.
From the drug quality announcements notified by the drug regulatory bureaus in recent years, the microbial limit is the problem of the unqualified items of unqualified drugs.
Named frequently
.
The so-called microbial limit refers to the microbiological control requirements for pharmaceutical preparations that do not directly enter the human body.
The items for microbial limit inspection include the number of bacteria, molds, and yeasts
.
It is understood that there are many reasons for the unqualified microbiological limit inspection, including incomplete cleaning and sterilization of production equipment, causing pollution to drugs; improper operation by operators; incorrect microbiological inspection methods, etc.
, which require pharmaceutical companies to conduct daily production, operation, Do your homework carefully during the inspection
.
The 2020 edition of the Pharmacopoeia improves the sterility inspection method and the microbiological limit inspection method for non-sterile products, adds the microbiological limit inspection method for traditional Chinese medicine decoction pieces, and raises the microbiological limit standard for non-sterile drugs
.
And it is clear that the enterprise is responsible for controlling microbial pollution in the production process
.
Under strict new regulations, drug microbiological limit inspections have increasingly become an important inspection item for pharmaceutical companies to control drug quality
.
Microbiological testing equipment import substitution space to be excavated.
Microbiological testing equipment as a testing tool has also attracted more and more attention and attention from pharmaceutical companies
.
In recent years, with the rapid development of science and technology, instruments and equipment have been continuously updated, and microbiological testing equipment has great potential in the pharmaceutical field.

.
According to the industry, under the goal of "Healthy China 2030", the supervision of the pharmaceutical industry will only become more and more stringent.
In order to better guarantee the quality of medicines, pharmaceutical companies need to continuously improve their production management levels, and at the same time they will apply more modern testing instruments.
A wide range of related testing equipment is expected to usher in opportunities
.
It is worth mentioning that from the perspective of the domestic microbial testing equipment market, it is mainly based on equipment from imported manufacturers such as Germany.
It has high sensitivity, fast efficiency, continuous detection, real-time analysis and other functions.
The overall detection effect is better than domestic equipment.
Even better, it is widely used in domestic food, medicine and cosmetics
.
Among domestic manufacturers, the industry pointed out that at present, only small domestic giants such as Tailin Biotech have a place, and the scale is relatively small at present
.
The 2021 semi-annual report of Tailin Biology shows that the company's main business is the research and development, manufacturing and sales of pharmaceutical equipment such as microbial detection and control technology system products and organic matter analysis instruments
.
The main products include microbial detection and control technology system products, and organic matter analysis instruments
.
However, the industry also pointed out that from the perspective of R&D investment, the proportion of R&D investment of Tailin Biotechnology has been very high in recent years, basically maintaining above 10%
.
Financial data show that in 2017, 2018, and 2019, Tailin Biotech’s R&D expenses were 16 million yuan, 21 million yuan, and 29 million yuan, respectively, accounting for 16.
20%, 13.
29%, and 10.
93% of the current revenue
.
In the first three quarters of 2020, Tailin Biotechnology invested RMB 26 million in research and development expenses, accounting for 19.
35 percent of the total operating income for the current period
.
R&D investment plays an important role in supporting the high-quality development of enterprises.
With the continuous efforts of domestic microbial testing equipment companies in R&D, it is expected to continue to strengthen the innovation of enterprises.
The industry believes that the future of domestic microbial testing equipment import substitution space is also urgently needed Dig
.