QC Isolators
A complete range of isolators for sterility testing and microbiological quality control, designed to ensure aseptic conditions and protect both the product and the operator during testing procedures.
Ideal for pharmaceutical and biotechnology applications, sterility test isolators provide a controlled environment for microbiological testing procedures, reducing the risk of contamination and ensuring the reliability of results.
QC Isolators
Available Models
The product line includes modular, compact, and custom isolator solutions for sterility testing and microbiological control, which can be configured to meet specific process and laboratory requirements.
The various configurations include microbiological isolators for quality control and solutions for pharmaceutical sterility testing, featuring VPHP biodecontamination systems and controlled management of process parameters.
View the corresponding technical data sheet to learn about features, configurations, and applications.
Contesto
3 modelli disponibili
CST-IS Compact Sterility Testing Isolator
ST-IS Sterility Testing Isolator
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 scenarios sound familiar? Talk to an expert
Approach: Synergies
Beyond the Product: Design, Integration, Continuity
Hot Cells isn't just a "catalog" option. Its value lies in how the solution 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 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 material 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 the Pharmaceutical and Biotech Sectors
Is this not the type you were looking for?
If CQ Isolators aren't what you're looking for, check out Tema Sinergie's other solutions for the pharma and biotech industries