Pharmaceutical Isolators
A complete line of pharmaceutical isolators designed for aseptic processing applications, sterile preparation, containment, and material transfer in pharmaceutical and biotechnology production environments.
Tema Sinergie’s solutions are developed to meet the highest standards of quality, safety, and regulatory compliance, and to address the needs of the pharmaceutical industry with reliable, customizable, and high-performance equipment.
pharmaceutical isolators
Available Models
The product line includes isolators for compounding, aseptic filling, dispensing, high-containment applications, and material transfer .
Each solution is available in various configurations and can be customized to meet specific process requirements, incorporating dedicated technologies and accessories to ensure high performance, operational reliability , and maximum application flexibility .
Select the application context and key requirements to identify the models best suited to your needs and access the corresponding technical data sheet to learn about their features, configurations, and applications.
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Contesto
Requisiti
10 modelli disponibili
HC-IS High Compounding Isolator
HC-IS Containment Isolator
MT-IS Material Transfer isolator
HC-IS Dispensing Isolator
PT-IS Product Transfer Isolator
CLF-IS
AP-IS Aseptic Sampling Isolator
C-IS Aseptic Containment Isolator
CAP-IS Compact Aseptic Processing Isolator System
Nessun prodotto disponibile per questa selezione.
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 situations sound familiar? 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 optimized for 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 pathways 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 plant 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 Pharma & Biotech Solutions
Is this not the type you were looking for?
If Pharmaceutical Isolators aren't what you're looking for, check out the other Tema Sinergie solutions for the Pharma & Biotech sectors