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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.

 

 

Used in contexts of:
RABS

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.

1 modello disponibile

Appendix 1

EU GMP

Class A

EU GMP

ISO 5

ISO 14644-1

GAMP5

FDA 21 CFR Part 11

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.

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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
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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
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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

Icon Theme: Synergies

Sales Services

Solutions and expertise to support your project, from the initial analysis phase through to full operation:

  • Consulting

  • Design and Ergonomic Analysis

  • Installation and Validation

  • Training

Explore Our Sales Services
After-Sales Services - Icon

After-Sales Services

Comprehensive support even after installation, to ensure operational continuity, efficiency, and maximum performance over time:

  • Maintenance Service

  • Spare Parts Service

  • Help Desk

  • Production Support

  • Training

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

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