Integrity Verification Systems

Tema Sinergie Integrity Testing Systems are designed to provide advanced, reliable, and repeatable solutions for verifying the integrity of critical components, such as gloves and transfer ports installed on isolators and RABS.

Using the pressure decay method, they enable leak testing on glove systems and RTP doors, ensuring safety, containment, and regulatory compliance.

The systems also feature a self-test function that ensures any detected leaks are actually attributable to the tested components.

Used in contexts of:

Radiopharma Production · Nuclear Medicine · Pharma · Biotech

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Integrity Verification Systems

Available Models

The product line includes devices for verifying the integrity of glove box systems, in accordance with the provisions of EU GMP Annex 1, and solutions for monitoring RTP rapid transfer ports—both alpha and beta—designed to ensure the reliability of barrier systems in regulated environments.

Select the system that best suits your needs and consult the corresponding technical data sheet to learn about all its features.

2 modelli disponibili

Automatic integrity tester for Alpha and Beta Rapid Transfer Systems (RTP)

ZEROC

Automatic Glove Leak Tester

AGLTS 2

Annex 1

EU GMP

Annex E.5

ISO 14644-7

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, delicate 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, Theme, 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 procedures 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

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

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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

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Case Studies

Results in Real-World Settings

From the Clinic to Production: Case Studies Demonstrating Integration, Compliance, and Continuity.

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Nessun case study disponibile.

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

Quality System

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.