Marya Validation Principles of Isolation Systems
for Biopharmaceutical Processes
Product Description
The Marya Sterile Barrier Design is an advanced isolation system engineered to ensure maximum sterility and contamination control in aseptic drug manufacturing. Utilizing cutting-edge barrier technology, it provides a fully enclosed environment to protect sensitive pharmaceutical processes from microbial and particulate contamination. Designed for compliance with stringent GMP and regulatory standards, the system enhances product safety while optimizing operational efficiency. Its ergonomic design allows seamless integration into cleanroom workflows, featuring HEPA filtration, automated sanitization, and real-time monitoring. Ideal for sterile fill-finish, lyophilization, and high-potency drug production, the Marya Sterile Barrier Design delivers unmatched reliability in critical aseptic applications.
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.
About Us & Why Choose Us
Workshop & Certificate
Product Category
Project Case & Our Customer
Exhibition & Our Team
Audited Supplier 
){kind=link}