Marya Aseptic Technology Pharmaceutical Vial Filling Machine Isolator Filling Line Solutions
Main Application of Pharmaceutical Vial Filling Line Isolator:
The isolator system of the vial filling machine is an integrated system used in the pharmaceutical industry to ensure the sterility, safety, and reliability of the vial filling process. It is mainly composed of two parts: the vial filling machine and the isolator:
Vial filling machine:
Function: Specially used to accurately and quantitatively fill the liquid medicine into the vial. According to different drug needs and production scales, the filling method and speed of the filling machine will be different. Common ones include piston filling and peristaltic pump filling. Piston filling is suitable for high-precision and high-viscosity liquid medicine filling, while peristaltic pump filling is suitable for some liquid medicines that are sensitive to shear force.
Features:
High precision: It can accurately control the filling volume to ensure that the filling volume of each bottle of liquid medicine meets the drug standard requirements with minimal error.
High speed: In order to meet the needs of large-scale production, high-speed filling production efficiency.
Strong compatibility: It can adapt to vials of different specifications, 0.5ml-100ml, and can be accurately filled.
Isolator:
Structure:
Shell: Usually made of stainless steel or other corrosion-resistant and easy-to-clean materials, with good sealing performance, which can effectively isolate the external environment from the internal filling area.
Glove system: Equipped with glove ports and gloves, operators can control the internal filling operation outside the isolator through gloves to avoid direct contact with the filling area and reduce the risk of contamination.
Transfer window: Used to transfer materials such as vials and liquid medicines into and out of the isolator. The transfer window usually has a double-door structure and sterilization function to ensure the sterility of the material during the transfer process.
Air filtration system: Install a high-efficiency air filter (HEPA) to filter the air entering the isolator, remove microorganisms, dust and other impurities in the air, and ensure that the internal air quality reaches the sterile level.
Function:
Provide a sterile environment: Prevent external microorganisms, dust and other pollutants from entering the filling area, ensure that the vial filling process is carried out under sterile conditions, and thus ensure the quality and safety of the drug. For example, when producing some highly active and highly sensitive biological products, a sterile environment is particularly important.
Protect operators: If the filled drugs are toxic or radioactive, the isolator can isolate the operators from the drugs to protect their health and safety.
Maintain pressure difference: By adjusting the pressure difference between the inside and outside of the isolator, the air always flows from the outside to the inside, preventing the internal air from leaking into the external environment, further ensuring the stability of the sterile environment.
Features of Pharmaceutical filling line Isolator:
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 |
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