Sterile Subpackage Isolation System
- The sterile filling isolator is a core precision barrier equipment applied in the fields of pharmaceuticals, biological preparations, medical aesthetic consumables and sterile testing. In strict compliance with GMP, YY/T 0567.6 and other industrial specifications, it adopts fully enclosed physical isolation and dynamic environmental regulation technology to build an independent ISO Class 5 (Grade A) sterile microenvironment. It thoroughly eliminates cross-contamination risks caused by personnel and external cleanrooms, and fully ensures the sterility safety of key processes such as material batching, feeding, filling and partial stoppering.
The equipment features a seamless and hermetic rigid cabin structure, equipped with sterile glove operation ports and RTP rapid transfer ports, enabling fully enclosed operation without material exposure or direct human contact. It fundamentally blocks the invasion of core pollution sources such as dander, droplets and dust. Built with a high-efficiency HEPA filtration system and vertical unidirectional airflow organization, it accurately controls key parameters including suspended particles, temperature, humidity and differential pressure inside the cabin, maintaining a high-level clean environment continuously with superior local sterility assurance performance compared with traditional cleanrooms.
Product Description
Technical Features
Double - door transfer technology: Ensures that the dean space is not affected by material transfer and personnel operations, and solves the problem thatthe 100 - class cleanliness of traditional aseptic rooms cannot be continuously maintained.wind speed nd exhaust voume wich fees tne aniragenter efgthe isoltso ro presure, temperature, humidiy, cleaniness, planktonic bacteriatCControl system: Automaticaly controlled by a microcomputer with a large - screen touch -type human - machine interface, compliant with computerized validation software Adjustable positive and negative pressure: Can meet the protection requirements for toxic substances and prevent pollution.
Sealing method: Double - layer sealing to achieve zero leakage.
Sterilization modes: Two modes, ozone or vaporized hydrogen peroxide (VHPS), are available for configuration.
