Marya Pharmaceutical Aseptic Filling GMP Standard Isolator System

• Customization: Available
• Certification: GS, RoHS, CE, ISO9001
• Noise: >100db
• Application: Industrial
• Control Mode: Touch
• Usage: Fragrance, Dust Removal, Smoke Removal, Adding Negative Ion, Humidification, Formaldehyde Formaldehyde, Adding Oxygen, Sterilization
• Material: Stainless Steel 316L
• Power Supply: 380V 50Hz
• Design: Modular Design
• Control System: Siemens PLC+Ipc Control System
• Function: Inspection
• Transport Package: Wooden Package
• Specification: Customized
• Trademark: Marya
• Origin: Shanghai, China
• Package Size: 350.00cm * 150.00cm * 180.00cm
• Package Gross Weight: 3500.000kg

Product Description

Marya Pharmaceutical Aseptic Filling GMP Standard Isolator System

Introduction

The pharmaceutical filling production line isolator system is a key equipment used in the modern pharmaceutical industry to ensure the quality and safety of sterile drug production. It separates the filling operation area from the surrounding environment by physical isolation, creating a highly clean and sterile local environment for drug filling, preventing external microorganisms, dust and other pollutants from entering the filling area, thereby ensuring the sterility and stability of the drug.

Structural composition:
<sub>Isolation cabin: Mostly made of high-quality 316 stainless steel, it has good corrosion resistance and strength, and can withstand frequent cleaning, disinfection operations and hydrogen peroxide sterilization processes. Its structural design focuses on sealing, and ensures no leakage through welding, sealing strips, etc., to ensure the isolation effect. For example, a special sealing design is used between the door and the door frame of the cabin, which can form a tight seal when closed to prevent outside air from entering.

Air purification system: The core is a high-efficiency air filter (HEPA), which can filter out dust particles and microorganisms with extremely small particle sizes, so that the air entering the isolator reaches ISO 5 or even higher cleanliness standards. It also includes fans, static pressure boxes, air ducts and other components, which work together to maintain stable airflow organization and pressure balance.

Operation gloves and interfaces: Operation gloves are usually made of chemically resistant and flexible materials, such as neoprene, etc., and are installed on the operation port of the isolation cabin. Operators can operate the internal filling equipment through gloves without directly contacting the filling area. At the same time, it is equipped with material transfer interfaces, such as double-door transfer windows and RTP fast transfer interfaces, to ensure that the materials will not destroy the internal sterile environment when entering and leaving the isolator.

Sterilization system: The common sterilization method is vaporized hydrogen peroxide (VHP) sterilization. By vaporizing the hydrogen peroxide solution into a gaseous state and evenly distributing it inside the isolator, the air, equipment surface and materials in the cabin are efficiently sterilized, and a 6-log sterilization effect can be achieved. In addition, auxiliary sterilization methods such as ultraviolet sterilization and ozone sterilization are also included to further improve the reliability of sterilization.

Filling equipment: According to the dosage form and packaging form of the filled drugs, different types of filling equipment can be selected, such as liquid filling machines, powder injection filling machines, freeze-dried preparation filling machines, etc. These filling equipment usually have high-precision metering devices and stable filling performance, which can ensure that the filling volume of drugs is accurate and consistent and meets quality standards.

Control system: The use of advanced automatic control systems can realize real-time monitoring and precise control of various parameters of the isolator system, such as temperature, humidity, pressure difference, wind speed, hydrogen peroxide concentration, etc. At the same time, it has functions such as fault alarm, data recording and traceability, which facilitates operators to monitor and manage the production process.</sub>

Application advantages
<sub>Ensure drug quality: effectively prevent microorganisms, dust and other pollutants from entering the filling process, ensure the sterility and purity of drugs, reduce the risk of drug contamination, improve drug quality and safety, and meet the strict quality standards and regulatory requirements of drug production.

Protect operators: isolate operators from drugs and harmful substances in the filling process to prevent operators from contacting active ingredients, chemical reagents, etc. in drugs, reduce health hazards to operators, and prevent operators from contaminating drugs.
Improve production efficiency: A stable isolation environment can reduce production interruptions and equipment failures caused by environmental factors, improve the operating stability and reliability of filling equipment, thereby achieving continuous and efficient production, improving production efficiency and reducing production costs.

Comply with regulatory requirements: Meet the requirements of relevant regulations such as the Good Manufacturing Practice (GMP) for aseptic production environments, which helps pharmaceutical companies pass certification and inspection smoothly and ensure the legal production and sales of drugs.</sub>

Product Parameters
 

Name	Parameters
Material	316L
Polishing grade	0.4μm~0.6μm
Protection level	OEB 5 (OEL<1ug/m³)
Internal arc angle	R≥20
Cleanliness level	Class A
Power supply	380V 50Hz (Note: Other voltages require a transformer)