Product Description
ASEPTICARE is a flexible, multipurpose isolator designed to support a wide range of aseptic and aseptic-toxic operations in regulated life sciences environments. By providing a fully closed and controlled aseptic barrier, it enhances contamination control while improving operational efficiency across multiple sterile processes.
The system enables the safe transfer and preparation of critical components—such as EM plates, change parts, and consumables—directly into filling lines, maintaining sterility throughout the process. It also supports aseptic formulation of sterile and sterile-toxic products, including vaccines and suspension-based formulations, ensuring process integrity from preparation to final handling.
ASEPTICARE is well suited for small-scale filling and finishing operations, whether automatic or semi-automatic, accommodating formats such as vials, prefilled syringes (PFS), IV bags, and medical devices. Its modular and flexible design allows for easy customization and rapid deployment, without the need for construction work or dedicated HVAC connections.
Integrated H₂O₂ catalyzers enable fast and efficient decontamination cycles, minimizing downtime and supporting higher productivity. Each system can be delivered as a fully validated, tailored solution, seamlessly integrating equipment and devices through a smart, unified control platform—providing reliability, compliance, and operational simplicity in one versatile isolator.
Main Features and Benefits
- EU-GMP Class A (ISO 5) Compliance
- Automatic Decontamination
- Modular, Plug & Play Design
- Compact and Sustainable with Enhanced Safety
- Ensures the highest level of product and operator protection for aseptic operations
- Integrates cGMP standards and Quality by Design (QbD) principles to elevate operational performance
- EU-GMP Class D environments, reducing operational and energy costs
- SCADA system integrates with MES through UPC UA, complying with 21 CFR Part 11 and GAMP5 standards for seamless process control
