RABS
A complete range of RABS ( Restricted Access Barrier System) systems designed to ensure high levels of protection and control in sterile production and aseptic processing in the pharmaceutical and biotechnology sectors.
These systems provide a controlled-access barrier for sterile, aseptic production, reducing the risk of contamination and ensuring high levels of protection and control. Designed for pharmaceutical and biotechnology facilities, they are ideal for retrofitting applications, in compliance with GMP and Annex 1 requirements.
RABS
Available Models
The product line includes closed and open RABS systems, which can be configured to meet specific process requirements and are available with customized solutions for various sterile production and aseptic processing applications.
The systems can be integrated into new or existing plants and are particularly well-suited for retrofitting projects, offering a flexible solution for process containment and protection.
The design complies with GMP and Annex 1 requirements, with a particular focus on safety, aseptic conditions, accessibility, and operational continuity.
View the technical data sheet to learn about features, configurations, and applications.
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Appendix 1
EU GMP
Class A
EU GMP
ISO 5
ISO 14644-1
GAMP5
FDA 21 CFR Part 11
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We'll help you find the configuration that best suits your needs.
Use Cases
When Shielded Isolators Are the Right Choice
Typical situations in which shielding, containment, and operational controllability become design requirements.
High shielding required
When potential exposure requires structural protection.
Segnali tipici:
High-risk, repetitive tasks
Repetitive, precision tasks
When reducing manual intervention is part of risk management.
Segnali tipici:
Close manual passes
Transfer of materials as a constraint
When pass-throughs and airlocks determine continuity and layout.
Segnali tipici:
Bottlenecks in the transfer process
Constrained layout
When space and access requirements call for custom-designed solutions.
Segnali tipici:
Difficult maintenance / limited access
Operational Repeatability
When consistent procedures across shifts and operators are essential.
Segnali tipici:
Variability Among Operators
Complex Regulatory Environment
When documentation, audits, and inspections are part of the decision-making process.
Segnali tipici:
Qualification/Validation Requirements
Do any of these situations sound familiar? Talk to an expert
Approach, Theme, Synergies
Beyond the Product: Design, Integration, Continuity
Hot Cells isn't just a "off-the-shelf" option. Its value lies in how the system is integrated and stabilized within your specific context.
Integration
Design that is consistent with actual access points, utilities, and operational sequences. In practice:
- layout and accessibility for operators and maintenance personnel
- technical procedures and system interfaces
- Compatibility with workflows and material transfers
Customization
Configuration based on constraints and requirements, not on “standard options.” In practice:
- layout and operator/maintenance accessibility
- technical processes and system interfaces
- Compatibility with workflows and transfers
Support in a Global Context
A structured launch and operational continuity over time.
In practice:
- Controlled commissioning and handover
- Operational training and procedures
- service plan, spare parts, technical support
Services
Project Support Services
Sales Services
Solutions and expertise to support your project, from the initial analysis phase through to full operation:
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Consulting
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Design and Ergonomic Analysis
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Installation and Validation
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Training
After-Sales Services
Comprehensive support even after installation, to ensure operational continuity, efficiency, and maximum performance over time:
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Maintenance Service
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Spare Parts Service
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Help Desk
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Production Support
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Training
Case Studies
Results in Real-World Settings
From the Clinic to Production: Case Studies Demonstrating Integration, Compliance, and Continuity.
Reliability
Quality and Compliance Integrated into the Design
Quality and compliance are an integral part of how we work, at every stage.
- Checks and verifications throughout the phases
- Traceability, Requirements, and Changes
Request a Technical Evaluation
Share your requirements and project specifications: we’ll provide you with initial feedback on the solution and configuration best suited to the application you’re developing.
- Application and process requirements.
- Layout, material flows, and transfer.
- Timelines and operational objectives.
Other Types in the Pharmaceutical and Biotech Sectors
Is this not the type you were looking for?
If RABS aren't what you're looking for, check out Tema Sinergie's other solutions for the pharma and biotech industries
QC Isolators
Sterility testing and pharmaceutical quality control isolators, designed to ensure fast processes, maximum result reliability, and compliance with cGMP regulations.
Integrity Testing Systems
Advanced devices for integrity testing of critical components of pharmaceutical isolators, such as glove ports and RTPs, designed to ensure process safety, result reliability, and full compliance with cGMP and Annex 1 regulations.
Pharmaceutical Isolators
Isolation systems for sterile and high-containment processes, designed to ensure product quality, operator safety, and regulatory compliance.