Cell culture isolator for regenerative medicine
Ensure aseptic conditions for cell and gene therapy by maintaining a contamination-free environment with precise control over decontamination and material handling processes. Ideal for labs focusing on stem cell therapies and biologic drug development.
Maintains Aseptic Conditions for Cell Culturing
The Cell Culture Isolator from Comecer is expertly designed to maintain sterile environments essential for regenerative medicine and tissue engineering. This isolator features a fully PLC-controlled system offering automated decontamination through a Vapor Phase Hydrogen Peroxide (VPHP) generator, ensuring a safe and clean workspace for handling sensitive cell cultures and biologic drugs. Equipped with laminar airflow and positive pressure maintenance, it provides an ideal setting for laboratory-scale operations in pharmaceutical and biotech industries. The isolator includes a high-grade stainless steel construction with a fully welded chamber, enhancing durability and corrosion resistance. Compliant with GMP guidelines, the system supports processes such as centrifuging and material introduction, vital for applications like stem cell therapies and CAR-T cell treatments. Integration into existing production lines is seamless thanks to its friendly HMI interface, while its compact design allows for easy cleaning and low-maintenance operation, ensuring optimal functionality and longevity.
Benefits
- Enhances product safety by maintaining strict aseptic conditions.
- Minimizes contamination risk with automated VPHP decontamination.
- Supports flexible operations with seamless integration into existing workflows.
- Extends equipment lifespan with robust stainless steel construction.
- Ensures regulatory compliance with GMP guidelines.
- Applications
- Regenerative medicine,Biopharmaceuticals,Pharmaceutical products,Cell and gene therapy,Tissue engineering
- End products
- Monoclonal antibodies,Gene-edited cells,Stem cell therapies,Biologic drugs,Car-t cell treatments
- Steps before
- Material Introduction,Preparation
- Steps after
- Decontamination,Sterilization
- Input ingredients
- cell cultures,sterile products,materials introduced via pre-chamber
- Output ingredients
- analyzed cell cultures,handled sterile products
- Market info
- Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.
- Automation
- Fully PLC-controlled
- Software Compliance
- GAMP 5
- Decontamination System
- Vapor Phase Hydrogen Peroxide (VPHP)
- Material
- Stainless steel AISI 316L internally,AISI 304 externally
- Pressure
- Positive pressure relative to the laboratory
- Chamber Design
- Fully welded chamber with 20 mm radius
- Centrifuge Integration
- Integrated
- Material Introduction
- Quick material introduction mousehole
- Automation level
- Fully PLC controlled
- Airflow type
- Laminar airflow
- Positive pressure operation
- Yes
- Decontamination method
- Vapor Phase Hydrogen Peroxide (VPHP)
- Material introduction method
- Quick material introduction mousehole
- Integrated features
- Integrated centrifuge
- User Interface
- Friendly operator interface (HMI)
- Biological compatibility
- Compliant with GMP guidelines
- Cleanability
- Integrated decontamination system (Vapor Phase Hydrogen Peroxide)
- Corrosive resistance (e.g. acids)
- High grade stainless steel AISI 316L internally
- 21CFR Part 11
- Available upon request
- Chamber Material
- High grade stainless steel AISI 316L internally and AISI 304 externally
- Chamber Design
- Fully welded chamber with 20 mm radius
- Control Panel Type
- Friendly operator interface (HMI)
- Integrated Decontamination System
- Vapor Phase Hydrogen Peroxide
- Footprint
- Compact
- Pre-chamber Design
- For material introduction
- Main Chamber Design
- For cell culture handling
- Airflow
- Laminar airflow
- Control panel type
- Friendly operator interface (HMI)
- Integration possibilities
- PLC controlled,GAMP 5 compliant software
- Customization of decontamination system
- Integrated Vapor Phase Hydrogen Peroxide system
- Material introduction mechanism
- Quick material introduction mousehole
- Chamber construction
- Fully welded chamber with 20 mm radius
- Material type for construction
- High grade stainless steel AISI 316L internally and AISI 304 externally