In recent years, with the development of science and technology, China's pharmaceutical equipment has made great progress
in terms of equipment functions and equipment cleaning and disinfection.
However, it is worth noting that with the continuous upgrading of the pharmaceutical industry and the continuous tightening of the country's supervision of drug quality and safety, the quality control requirements in the pharmaceutical production process are also continuously improved, such as air cleanliness, sterility standards, raw material quality, etc.
have more stringent requirements, and all pharmaceutical companies must meet GMP standards (Good Manufacturing Specifications).
Pharmaceutical companies vigorously build aseptic production lines, pharmaceutical machine companies usher in new opportunities (Image source: Pharmaceutical Network)
However, in the process of drug production, including air, personnel and other pollution sources will inevitably bring hidden dangers to the sterile environment, so sterilization and disinfection is a crucial link
.
It is understood that aseptic preparation filling is the last and most critical link through the production stage of drug development and clinical treatment, and "aseptic" production is the top priority
.
At present, in order to better improve the sterile production of pharmaceuticals, many pharmaceutical companies have launched active actions
.
For example, on November 30, WuXi AppTec's subsidiary, Hequan Pharmaceutical, announced that it has officially started production of another new fully automated isolation sterile injection line at its Wuxi formulation base
.
This is the second fully automatic isolation sterile injection production line put into operation by Heqing Pharmaceutical this year, with an annual production capacity of 10 million injections
.
In order to continuously improve the capabilities of the injectable platform, Heqing will also open the first high-activity sterile injection production line
at the Wuxi base in 2023.
In addition, it is worth mentioning that its formulation base in Middletown, Delaware, USA, is also expected to be officially put into operation in 2025, providing integrated injection R&D and production services
to global partners.
As early as December 2021, the aseptic and commercial lyophilization line of Xilin bottle, aseptic pre-filling needle and cassette filling line have also been officially put into operation, expanding the overall production capacity of the preparation filling production line, and the cumulative finished product filling capacity has reached 15 million pieces / year, which can meet the growing demand
of partners for the filling and loading capacity of different types of preparation production lines.
As of March this year, more than 70 batches of aseptic filling GMP production projects
have been successfully delivered.
In addition, at the 3rd CIIE 2020, Thermo Fisher Scientific announced the establishment of a new biopharmaceutical CDMO plant in Hangzhou, China, to integrate the development and production
of bio-stock solutions and sterile formulations.
At present, the plant is also about to be fully completed, and mass production
can begin by the end of this year.
It can be seen from the above that pharmaceutical companies have a very strong demand for aseptic production
.
In the future, aseptic filling technology and equipment are expected to play an increasingly important role
in the pharmaceutical industry.
The author learned that in fact, in order to meet the demand, many companies have introduced intelligent and robotic technology into aseptic filling equipment and systems, and achieved certain results
.
For example, as early as 2020, a biopharmaceutical technology platform company said that its preparation plant four (DP4) robot sterile biologics filling line has successfully completed two batches of prefilled needle filling at a rate of 30 bottles per minute per injection, and the pass rate is as high as 99.
1%.
In addition, there are also companies that have made some innovative modular designs
for aseptic filling systems in accordance with GMP specifications and aseptic process requirements.
No operator is required in the filling booth during production; The products are blanked, printed, tested, packaged outside the clean room, which can minimize the source of pollution in the filling room, and meet the requirements of GMP and the production requirements
of sterile drugs.
In general, as an important segment of pharmaceutical equipment, sterile drug production equipment is expected to usher in more development opportunities
under the background of continuous investment in the construction of aseptic production lines by pharmaceutical companies.
However, it is worth noting that in the case of continuous expansion of the market, the requirements of the pharmaceutical industry for aseptic filling and other equipment will continue to increase, so relevant enterprises need to continuously enhance equipment performance and improve equipment innovation level under the premise of ensuring equipment quality and safety
.
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