HPAPIFlexible Pharma Solutions for advanced containment and easy decontamination in pharmaceutical processes.
Within the landscape of Flexible Pharma Solutions, the open-bottom flexible dispensing isolator represents one of the most interesting solutions in terms of decontamination efficiency and handling of highly potent APIs. Designed to ensure containment and ease of wiping, this system combines flexibility and advanced technologies to meet the most stringent market requirements.
The isolator enables weighing and transfer operations while ensuring both operator protection and product integrity, achieving containment levels up to OEB5.
Flexible Design and Operational Adaptability.
Manufactured using 250-micron polyurethane film, compliant with major pharmaceutical and antistatic regulations, the isolator ensures durability, transparency, and protection against electrostatic charge accumulation. This design approach not only provides greater adaptability compared to rigid isolators, but also simplifies disassembly and replacement operations.
Additionally, spare isolators allow for small modifications to improve ergonomics. Based on operator feedback, design improvements can be implemented and updated spare parts supplied. This is a key advantage of Flexible Pharma Solutions and of the tailor-made approach offered by CSV Containment.
From a functional perspective, this dispensing isolator is configured with a double chamber: a pre-chamber for material introduction and a main chamber equipped with three gloves for dispensing operations. The workflow is designed to minimize contamination risks, thanks to gas-tight zippers and a side-mounted continuous liner for safe bag-out operations
Simplified Wipe-Down with Internal Nozzles and WFI.
Another key aspect is the ease of wipe, made particularly effective by the presence of a WFI nebulizer operating directly inside the isolator. This allows the use of internal nozzles for cleaning activity, significantly improving procedures and reducing downtime. Furthermore, the open-bottom design with a completely free stainless steel work surface enhances accessibility and cleanability.
Internal environmental control is managed by an advanced system that includes negative pressure regulation, temperature and humidity monitoring, and nitrogen injection. The entire system is supported by a CFR 21 Part 11, ensuring full data traceability.
Main features:
- Flexible PU structure
- Double chamber configuration
- Bag-in/bag-out system with continuous liner for safe discharge
- Internal nozzles for easy decontamination
- Open-bottom stainless steel work surface, easy to clean
- Gas-tight zippers
- Cable pass-through
- Integrated pressure, humidity, and temperature control
- Nitrogen injection and oxygen monitoring
- CFR 21 Part 11 system
In summary, this flexible isolator represents an ideal solution for pharmaceutical dispensing, standing out especially for the ease of its cleaning activities. A system designed not only for containment, but to optimize the entire operational process.
