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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.

 

 

Used in contexts of:
qc-isolators

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.

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? 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.

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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 material 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
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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 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

All Solutions