Marya Modular Hardwall Isolator System
for Containment of Potent Drug Compounds
Product Description
The Marya Modular Hardwall Isolator System provides maximum operator and environmental protection when handling highly potent active pharmaceutical ingredients (HPAPIs). This robust containment solution features hermetically sealed welded stainless steel construction with integrated glove ports and negative pressure control to ensure OEB4/OEB5 containment levels. The modular design allows flexible configuration for compounding, dispensing, and sampling operations while maintaining ISO 5 cleanliness. Equipped with CIP/SIP systems, particulate monitoring, and airlock pass-throughs, it enables safe processing of cytotoxic and hormonal compounds. Fully compliant with cGMP, ICH Q7, and FDA guidelines, the Marya system combines engineering controls, validated decontamination, and ergonomic operation for complete protection in potent drug 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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