Isolator for aseptic cell culture processing
In the fields of regenerative medicine and tissue engineering, maintaining aseptic conditions during cell culture is paramount to avoid contamination and ensure successful outcomes. The challenge lies in creating an isolated environment that meets stringent regulatory standards while minimizing human error and operational costs.
Ensure sterile conditions with automated decontamination
The Modular Cell Culture Isolator (MCCI) by Comecer is designed to provide a controlled and sterile environment for cell culture processes. With its fully welded enclosure and integrated ventilation system, the MCCI ensures a consistent Class A environment in a more compact footprint than traditional clean rooms. Featuring a top-class sterilization protocol using a VPHP cycle, it minimizes manual interventions, thus reducing the risk of human error. The isolator’s ergonomic glove boxes facilitate operator comfort and efficient space utilization. It is equipped with H14 HEPA filters for both intake and exhaust, maximizing particulate control and flexibility in handling hazardous materials. The MCCI’s integrated H2O2 gas decontamination system allows for effective sterilization of both the entire internal volume and specific compartments like the transfer hatch. This modular system is ideal for tissue engineering and biotech labs constrained by regulatory bodies such as FDA, EUP, and USP. Additionally, it offers viable and non-viable continuous monitoring, managed by GAMP 5 software and SCADA systems for 21 CFR Part 11 compliance.
Benefits
- Minimizes risk of contamination
- Reduces operational costs compared to clean rooms
- Ensures regulatory compliance
- Ergonomic design enhances workflow efficiency
- Integrated H2O2 decontamination system