Marya Flexible Isolator System for Potent Drug Compound Handling
Product Description
Marya's Sterile Dispensing Isolator System ensures uncompromised protection for aseptic pharmaceutical manufacturing processes. Designed to meet strict ISO 14644 and EU GMP Grade A standards, this advanced isolator system provides a fully enclosed environment for sterile powder dispensing, preventing contamination risks. Featuring integrated glove ports, HEPA filtration, and automated decontamination cycles (VHP or hydrogen peroxide), it maintains critical sterility while handling sensitive APIs and cytotoxic compounds. The ergonomic design enhances operator safety and workflow efficiency, with optional CIP/SIP functionality for seamless validation. Ideal for sterile injectables, vaccines, and oncology drugs, Marya's solution combines regulatory compliance with operational excellence-contact us to configure a system tailored to your facility's needs.
Product Prameter:
Cleanliness |
ISO4.8 |
Temperature and humidity |
Conventional 18-26ºC/45%-65%, can be customized according to the pharmaceutical process |
Differential pressure |
Regular 20-50pa |
Air flow rate |
0.36m/s-0.54m/s |
Air flow type |
Vertical one-way flow |
Sterilazation effect |
log6 and above |
Leakage rate |
0.5% |
Key Features:
Customization and Integration:
- Modular Design: Allows for the integration of various modules to create a customized isolation system.
- Accessories: Configurable with different shelves, cleaning water guns, and dehumidification systems to suit specific needs.
- Control System: Features automatic control of gas pressure, water and oxygen content, and self-adaptive cleaning air circulation.
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