Marya GMP-Compliant Isolator System
for Closed Processing of Vaccines and Biologics
Product Description
The Marya GMP-Compliant Isolator System provides an advanced aseptic containment solution for sensitive vaccine and biologic manufacturing. This fully closed system maintains ISO 5/Class A conditions through HEPA-filtered unidirectional airflow and automated bio-decontamination cycles, ensuring sterility for critical processes. Designed for fill-finish operations, it features ergonomic glove ports, integrated transfer hatches, and CIP/SIP capabilities to minimize contamination risks. The system's modular design accommodates various container formats while complying with cGMP, FDA, and EU Annex 1 requirements. With real-time particle monitoring and data logging (21 CFR Part 11), the Marya Isolator delivers regulatory-ready, high-integrity processing for modern biopharmaceutical production.
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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