Key Point Between Isolation Technology and Pharmaceutical Machinery

The isolation operation technology in the pharmaceutical field can effectively reduce contamination and achieve aseptic production. The GMP standard recognizes it as a key technology for controlling aseptic manufacturing of drugs, which can meet quality standards, prevent pollution, ensure personnel safety, and reduce costs. Utilizing advanced systems and various devices to separate biological products from pollution sources.

Isolation technology has significant advantages in the pharmaceutical industry. Isolate from a physical perspective using sterile isolator, sterilize with a gas sterilization device, replace air with HEPA filter, maintain constant negative pressure, and optionally transfer materials in pass box for self-cleaning sterilization, in compliance with GMP standards, ensuring that sterile isolation operations can be achieved in a generally clean environment. Isolation technology can protect operators from toxic and harmful substances, such as using VHP biological sterilization technology to avoid direct exposure of personnel and build a closed production line.

There are many key points between isolation operation technology and pharmaceutical machinery. Constructing physical isolation between humans and pharmaceutical machinery through various devices, with different isolation techniques required for different pharmaceutical machinery and dosage forms. Adhere to the principles of convenient operation and maintenance without compromising overall integrity, use isolator and other methods to achieve environmental and material area isolation, and control cleanliness. When applying, it is necessary to analyze product parameters, consider security requirements and the verifiability of physical shielding, and comply with relevant standards. Regularly inspect the integrity and airtightness of isolator, handle issues related to isolation restrictions, maintain system design with regulations, and ensure the integrity of sterile isolation operators through cleaning and disinfection.

In the pharmaceutical machinery of active pharmaceutical ingredients, there are issues of cross contamination and reliability of connection devices. Isolator can isolate production spaces, improve cleanliness levels, prevent pollution, and protect personnel; Equipped with in-situ cleaning function, negative pressure sealed operation, emergency exhaust mode and alarm function to ensure safety. In the production and operation of biological and traditional Chinese medicine pharmaceutical machinery, personnel are prone to particle pollution. Isolation operation of ingredient stations and isolation systems, replacement of high-efficiency hopper mixers, and reduction of dust exposure can achieve seamless docking and material transfer. The fluctuation of pressure difference can affect cleanliness, so it is necessary to configure isolation systems for coating machines, seal connection parts, improve monitoring and alarm functions, remotely adjust parameters, expand cleaning range, integrate small-scale production line machinery, use negative pressure isolator to control pressure difference, and ensure production operation.

Isolation is the development trend of pharmaceutical machinery, and sterility is the foundation of the pharmaceutical industry. Isolation operation technology is the key to improving pharmaceutical efficiency and product cleanliness. Isolation technology should be fully utilized in core pharmaceutical machinery to prevent risks and contamination, and achieve sterility and isolation.