Marya Aseptic Medical Filling Production Line Ampoule Filling Line Vial Filling Line Isolator System
Main Application of Pharmaceutical Isolator:
Pharmaceutical inspection dispensing isolator is mainly used for injection production and inspection for API, dispensing, weighing, packing. It includes aseptic handling area, material transfer zone, bag in and bag out area, pneumatic sealing system, control system and monitoring system. Can be equipped with VHP sterilizer.
Features of Pharmaceutical Isolator:
- Double door transfer technology, make sure sustainable Class 100 grade to keep the cleanliness from affecting by human and material.
- Pressure can be adjusted, can prevent pollution.
- Cabinet can be easily moved and save cost.
1.The machine design, material, manufacture, assembly, debugging and so on met the new GMP pharmaceutical production specification requirements;
2. Can choose stainless steel material, the machine structure and operation platform at the top of the whole closed structure design, the sterilization system, integrated control unit, in and out of the air system and air filtration unit, more beautiful and easy to clean and maintain;
3.The machine body adopts smooth edges and corners, and the welding place is polished without burr. Internal arc Angle design, easy to clean;
4. Each chamber according to the functional requirements for design, gloves with a standard size, no blind spot operation, special hull bust garment design may be adopted;
5. Isolator equipment module design, uses the rat holes connection between each module, each part has obvious differential pressure gradient important areas to ensure that the amount of pressure difference relative to other areas for positive pressure;
6. Isolator equipment can design according to the need for two kinds of single side or double side operation; The equipment has two design methods: split type and integrated type;
7. Isolator can according to the function, increase the buffer tank shell, outgoing module or other chanbers were combined with the main hull, manufacture customized isolation system;
8. Equipment exhaust device, remove excess hydrogen peroxide decomposition, avoid residues;
9. VHP residue levels: < 1 PPM (residue level determined by the technological requirements);
10. Chamber sealing: chamber leakage rate is not more than 5% within 10 minutes under pressure of 500 pa;
Monitoring System |
Online checking the pressure, temperature and humidity and clean grade. Complying with GMP/GLP requirement. |
Control System |
PLC Auto control |
Sterilizer type |
Can adopt Ozone sterilization or VHP Sterilization |