Marya Pharmaceutical Injection Aseptic Isolator System for Filling Machine Manufacturer

Product Description

Marya Pharmaceutical Injection Aseptic Isolator System for Filling Machine Manufacturer

Product Description

Main Application of Pharmaceutical filling line Isolator:

Pharmaceutical industry isolator filling production line: It needs to meet strict pharmaceutical production quality management standards (GMP) requirements, and has extremely high requirements for sterility, accuracy and reliability. It is usually equipped with high-precision filling equipment, strict sterilization systems and complete monitoring systems to ensure the quality and safety of drugs. According to the dosage form and packaging form of the drug, it can be further divided into injection filling production line, oral liquid filling production line, capsule filling production line, etc.
 

 Features of Pharmaceutical filling line Isolator:

• Highly sterile:
  Completely isolated from the outside world, air exchange is only carried out through a high-efficiency air filter (HEPA), which can effectively prevent the entry of external microorganisms, dust particles and other pollutants.
  Equipped with advanced sterilization systems, such as automatic gasification hydrogen peroxide sterilizers, it can fully and efficiently sterilize the internal space, equipment surface, etc.
  Pressure stability: It can maintain the pressure in the isolation cabin, generally maintain the internal positive pressure state, prevent the entry of unfiltered air from the outside, and ensure a sterile environment.
  Transfer safety: Double doors or rapid transfer systems (RTP) are used to ensure the safe transfer of materials or products in a sterile environment.
  Man-machine separation: The operator is separated from the filling operation area, and the operator operates and monitors the internal filling process from the outside through glove operation devices, etc., which not only protects personnel but also reduces the risk of contamination.
  Good compatibility: It has good compatibility with most devices, electronic components, and building materials, ensuring the stability and reliability of the equipment.
  Easy to clean and maintain: The structural design is simple and smooth, without dead corners and complex gaps, which is convenient for cleaning; the layout of each component is reasonable, easy to disassemble and replace, and easy to maintain.
  Intelligent monitoring: It can monitor the internal temperature, humidity, pressure, wind speed, suspended particle concentration and other parameters in real time, and automatically adjust and control them, and alarm when abnormalities occur.

 

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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