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In combination with the current market environment and pharmaceutical demand analysis, the aseptic filling equipment market is exploding, and there are many applications in terms of fill size, bottle type and compatibility.
“In the pharmaceutical equipment industry, in addition to innovation, flexibility is also an eternal theme.†Equipment companies say that in the current environment, many companies are actually facing more things with less money, which is right. The flexibility of the equipment places higher demands, especially in the pharmaceutical industry.
Therefore, in the aseptic filling equipment industry, how to better interpret the flexibility of equipment is a difficult point. The author understands that the introduction of “ready-to-use†parts with aseptic filling equipment has broken the traditional production mode of “old pharmaceuticalsâ€: ​​every filling line must have autoclaves, bottle washers, and disinfection tunnels. And numerous mechanical processing equipment that introduce line faults and sterility risks into it.
Some companies have designed clinical filling lines to be flexible enough to accept a wide variety of tubular components or bulk bottles, and to be able to add freeze-drying in the future, allowing users to enter the isolated modular filling line.
Of course, some companies have made technological innovations in aseptic filling equipment on the basis of compliance with regulations. “Our aseptic filling linkage line complies with international guidelines and specifications such as FDA, EU GMP, PIC/S, GxP, etc., and follows GAMP5, 21CFR Part11.†Enterprise technicians say that the ultrasonic power starts from the bottle mesh belt. Control, design of the bottle screw, to the lifting hub and the cleaning station three water and three gas, the bottle clamp and the star wheel of the handover and out of the bottle, in the design process to avoid the risk of broken bottles.
In addition, the material of the machine frame and the table top are made of austenitic stainless steel, without paint and cast iron parts. The hard tube of the cleaning medium meets the requirements of ASME BPE, and the sports hose meets the USP Class requirements.
The cleaning process formulation design, cleaning parameters and production reports are automatically generated by the computer. The bottle is delivered smoothly, the cleaning needle and the container are well neutral, and the verification requirements of the international cleaning effect are met. SIA, CCA, and CQA files allow for risk identification and control.
According to industry insiders, pharmaceutical production has higher and higher requirements for aseptic filling lines. Traditional filling lines are not only expensive, but also have a large footprint and complex verification. However, a growing number of cases show that aseptic filling lines with advanced technology not only meet the needs of small and diverse product sets, but also provide flexibility for biopharmaceutical production and small-volume commercial applications.
In addition, some people cautioned that although flexibility is a core requirement of the pharmaceutical industry for aseptic filling production, relevant companies should not simply follow current regulatory requirements. Because it is not enough to focus solely on “manual intervention and *difference conditionsâ€, comprehensive aseptic filling equipment production design should be carried out according to the process and production mode (based on key quality attributes and key process parameters), and necessary continuous processes should be carried out. confirm.
With the improvement and improvement of aseptic filling, the related technology has made outstanding achievements, and aseptic filling has officially entered a period of rapid development. In addition, in the pharmaceutical industry, the requirements for aseptic filling are becoming more and more strict, many challenges are waiting for the enterprise to solve and break through, and hope that more new technologies can be used to improve the aseptic filling equipment. Enhance equipment performance and improve equipment innovation.
Aseptic filling is a new type of packaging in a sterile environment. To ensure the quality of sterile drugs, GMP requires that the filling of sterile drugs should be carried out in Class A environment, and online suspended particle monitoring and dynamics. Microbiological monitoring (settlement and floating bacteria).