Marya Design Principles of Isolation Equipment
for Biopharmaceutical Process Validation
Product Description
Marya's isolation equipment redefines sterility standards in aseptic pharmaceutical production, integrating advanced RABS/cRABS systems with HEPA filtration (≥99.995% efficiency) to create a hermetic sterile barrier. Equipped with in-line SIP (Steam-in-Place) sterilization and automated pressure decay integrity testing, the system ensures continuous compliance with FDA and cGMP requirements. Constructed from passivated 316L stainless steel, the equipment resists contamination and supports seamless integration with vial filling, lyophilization, and aseptic transfer processes. Its modular design allows rapid configuration for different production scales, while real-time monitoring of differential pressure and airflow parameters enables proactive sterility management. Engineered to achieve SAL, Marya's solution optimizes both process reliability and regulatory compliance for critical biopharmaceutical manufacturing.
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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