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.
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.
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Appendix 1
EU GMP
Class A
EU GMP
ISO 5
ISO 14644-1
GAMP5
FDA 21 CFR Part 11
Request a technical consultation
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 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.
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 accessibility for operators and maintenance personnel
- 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 various stages
- 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 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.
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