Isolator for washing procedures in pharma industry
Ensure complete isolation and safety during manual cleaning of pharmaceutical components with a system designed to compartmentalize the process, maintaining a sterile environment for precision handling of high-value substances.
Isolates and Cleans Pharmaceutical Components
The Isolator for Washing Procedures by Comecer is engineered to facilitate the manual cleaning of pharmaceutical and biopharmaceutical components while ensuring complete isolation with its glovebox chamber design. This system addresses the critical need for contamination control in the production of radioimmunotherapy agents, CAR-T cell therapies, and sterile APIs.
Operating with a turbulent airflow mechanism, the isolator maintains a negative pressure environment to prevent the escape of contaminants, crucial for maintaining the integrity of high-purity products. The fully PLC-controlled system enables seamless operation with integrated Clean-In-Place (CIP) capabilities, supporting up to 20 parts per hour throughput.
Its application primarily spans pharmaceutical, radiopharmaceutical, and biotechnology industries, offering a versatile solution suitable for cleaning components used in radiolabeled diagnostics and gene therapy vectors. This isolator is constructed for durability and ease of maintenance, featuring a bag-in/bag-out filter replacement method and fully washable components.
With compliance to stringent GMP standards, the equipment is ideal for facilities focusing on containment and isolation processes. Customers can expect exceptional support with potential customization to meet specific operational demands, making it a critical asset for hospital pharmacies and aseptic processing units alike.
Benefits
- Enhances safety with complete operator isolation during manual cleaning processes.
- Improves sterility assurance with integrated Clean-In-Place (CIP) system.
- Increases productivity with high-throughput capability of processing up to 20 parts per hour.
- Ensures compliance with GMP standards for consistent quality control.
- Offers flexibility with customizable configurations to fit specific operational needs.
- Applications
- Pharmaceutical components,Cell,Radiopharmaceuticals,Biopharmaceuticals,Gene therapy
- End products
- Car-t cell therapies,Radiolabeled diagnostics,Personalized cell therapy products,Viral vectors for gene therapy,Radioimmunotherapy agents,Sterile active pharmaceutical ingredients (apis),Therapeutic monoclonal antibodies,Mrna vaccines,Aseptic pharmaceutical components,Plasmid dna
- Steps before
- Machine disassembly,Component placement
- Steps after
- Material extraction,Bag-out process
- Input ingredients
- machine parts
- Output ingredients
- washed materials
- 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.
- Glovebox chamber pressure
- Negative pressure
- Airflow type
- Turbulent air flow
- Filter Replacement
- Bag-in/bag-out method
- Control system
- PLC-controlled
- Cleaning method
- Integrated CIP
- Material handling
- Barrier bag for unloading
- Operator Position
- Standing position
- Glovebox chamber pressure
- Negative pressure
- Air flow type
- Turbulent air flow
- Filter replacement method
- Bag-in/bag-out
- Control system
- Fully PLC controlled
- Cleaning procedure
- Integrated CIP
- Manual operation capacity
- More than 20 parts per hour
- Operator position
- Standing position
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- ISO 9001,ISO 13485
- Certified Quality System
- ISO 45001
- Health and Safety Management System
- ISO 14001,ISO 50001
- Environmental and energetic management system
- Glovebox chamber type
- Negative pressure
- Airflow type
- Turbulent
- Configuration
- Right-side door for washing,left-side door for extraction,circular hatch with barrier bag
- Material handling
- Bag-in/bag-out
- Operator position
- Standing
- Glovebox chamber
- Negative pressure
- Working position
- Standing position