Restricted access barriers systems for aseptic processing
Enhance product safety by separating operators from the critical aseptic core. Ideal for maintaining sterile conditions, this system provides effective product protection through a combination of a physical barrier and dynamic airflow, ensuring compliance with strict regulatory standards.
Separates Operators from Critical Aseptic Environments
Telstar’s Restricted Access Barrier Systems (RABs) are designed to optimize aseptic processing by creating a high level of separation between operators and critical environments in pharmaceutical production. These systems are essential for manufacturing sterile injectable drugs, vaccines, and various biologics, offering a unique combination of physical barriers and dynamic airflow. RABs can be tailored to integrate with third-party equipment, ensuring compliance with GMP and current regulatory standards. They feature unidirectional laminar flow (active RABs) to maintain an ISO 5 positive pressure environment, crucial for protecting sensitive processes. With aseptic transfer capabilities for powders and liquids, and advanced environmental monitoring systems, these units are ideal for cleanrooms requiring enhanced sterility without the need for fully leak-tight isolators. Telstar supports customization and offers technical assistance, ensuring the RABs meet specific operational needs while facilitating ease of cleaning and maintenance through integrated systems.
Benefits
- Enhances sterility and product protection through operator separation, ensuring product integrity.
- Complies with GMP and regulatory standards, meeting industry requirements for pharmaceutical applications.
- Reduces contamination risk by maintaining ISO 5 conditions with unidirectional airflow.
- Facilitates seamless integration with existing systems, enabling flexible production line adaptation.
- Streamlines cleaning processes, minimizing operational downtime and ensuring consistent high standards.
- Applications
- Biopharmaceuticals,Pharmaceuticals
- End products
- Sterile injectable drugs,Biologic drugs,Lyophilized pharmaceuticals,Cell and gene therapy products,Monoclonal antibodies,Sterile ophthalmic solutions,Plasma-derived products,Inhalant medications,Vaccine vials,Sterile oncology medications,Enzyme replacement therapies
- Steps before
- Aseptic processing preparation,Component preparation,Powder transfer,Liquid transfer
- Steps after
- Environmental monitoring,Product sterilization,Quality assurance,Packaging in controlled environments
- Input ingredients
- powders,components,liquids,viable particles,non-viable particles
- Output ingredients
- aseptic product,protected product
- Market info
- Telstar is known for specializing in the design, engineering, and manufacturing of advanced vacuum and aerospace solutions, gaining a strong reputation for their innovative and customized equipment in pharmaceutical, medical, and scientific research sectors.
- Flexibility in design
- Yes
- Third-party equipment integration
- Yes
- Compliance with GMP guidelines
- Yes
- Unidirectional laminar flow design
- Active RABs
- Positive pressure environment
- ISO 5
- Temperature monitoring
- Yes
- RH monitoring
- Yes
- Environmental monitoring
- Viable / non-viable particles
- Operating system control
- PLC
- Local HMI
- Yes
- Integration with third-party equipment
- Yes
- Working mechanism
- Physical barrier and dynamic airflow
- Batch vs. continuous operation
- Continuous via airflow
- Automation level
- PLC controlled
- Cleaning method
- CIP / Manual
- Environmental monitoring
- Viable / non-viable particles
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Control panel type
- PLC-controlled
- Discharge method
- Unidirectional laminar flow
- Integration with third-party equipment
- Yes
- Design Flexibility
- High
- Third-party Equipment Integration
- Possible
- Control panel type
- PLC controlled
- HMI
- Local / Integrated