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Cell&Gene Therapy Isolators

A complete range of isolators for cell and gene therapies, designed to operate under aseptic conditions, ensuring excellent contamination control and operator protection in the production of ATMPs, including autologous and allogeneic cell therapies, cell activation and transduction, viral vector handling, and gene therapy processes.

Ideal for biotechnology applications and advanced therapies, cell and gene therapy isolators offer customizable configurations and integration with process equipment.

 

 

Used in contexts of:
cell-gene-therapy-isolators

Cell&Gene Therapy Isolators

Available Models

Isolators for cell and gene therapies are configured according to specific process requirements and intended applications. These solutions can incorporate process equipment such as incubators, centrifuges, digital microscopes, and handling systems, as well as systems for controlling environmental conditions and biodecontamination.

The configurations are designed to support ATMP manufacturing processes, ensuring aseptic and controlled conditions during critical process steps and a high level of protection for both the product and the operator.

Access the relevant 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 scenarios sound familiar to you? Talk to an expert

Approach: 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 accessibility for operators and maintenance personnel
  • 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 goals.

Other Types in Biotechnology

Is this not the type you were looking for?

If Isolators for Cell and Gene Therapies aren't what you're looking for, check out Tema Sinergie's other solutions in the biotech field.

All Solutions