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CRE-IS Shielded

The Compact Radioemitter Isolator System (CRE-IS) is a compact isolator designed specifically for handling radioemitters.
The isolator is intended for use in the pharmaceutical and radiopharmaceutical industries for the safe handling of radioemitters and for performing dose calibration activities.
The CRE-IS is designed for optimal integration of the activimeter (dose calibrator with a vacuum lifter for vials) and the rapid transfer port for the Beta bag for solid waste.

Used in contexts of:
Radiopharma Production

Designed and Manufactured by Tema Sinergie

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Class A

EU GMP

Class II

ISO 10648:2

ISO 5

ISO 14644

GAMP5

FDA CFR 21 Part 11

Features & Benefits

Designed for Efficiency

Compact size, optimized energy consumption, and ease of use to meet the needs of modern laboratories.

Compact size

Its compact size allows for easy handling and installation through standard doors and elevators in hospitals, hospital pharmacies, and pharmaceutical companies.

Energy Efficiency

Thanks to the new low-voltage, energy-efficient fans, the isolator ensures lower energy consumption throughout its entire life cycle, contributing to more sustainable plant operations.

Ergonomics

Maximizing operator efficiency is essential for reducing the risk of accidents, preventing unplanned downtime, and ensuring high standards of production quality.

Settings and Customization

Insulator

Safety

Very strict containment levels, combined with a completely aseptic environment, thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and static seals to ensure Class II airtightness (ISO 10648:2).
All doors on the isolator system are interlocked to prevent incorrect operations. The PLC and software control all parameters.

HMI

The Shielded Compact Isolator is a fully PLC-controlled isolator.

Asepsis

Aseptic conditions in the work area are ensured by the HEPA-filtered unidirectional airflow (H14) and, if applicable, by an integrated vapor-phase hydrogen peroxide (VPHP) bio-decontamination system, supplied with the isolator upon specific customer request.

Automatic Leak Test

Shielded Compact Isolators are equipped with an automatic leak-test system, which is included as standard. The test can be performed independently for each chamber.

The Perfect Partners

Tema Sinergie isolators can be integrated with optional equipment—such as HYPER and AGLTS2—to customize the system to your needs.
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HYPER

HYPER® is a vapor-phase hydrogen peroxide (VPHP) generator specifically designed to perform bio-decontamination processes on clean, dry, and sealed containers used in medical, pharmaceutical, and biological applications. HYPER can be integrated into the isolator structure or installed remotely in an external cabinet made of AISI 304 stainless steel.

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AGLTS 2

AGLTS 2 is the brand-new, fully automatic, GMP-compliant system for testing the integrity of gloves used in isolators and RABS in the pharmaceutical industry, developed based on the Positive Pressure Decay method, in accordance with the international standard ISO 14644-7 Annex E.5. This next-generation device goes far beyond simply performing glove tests, supporting operators and pharmaceutical companies in managing all activities related to glove testing.

details that matter

Designed for Your Process

CRP Compact is designed to streamline a critical phase: the dispensing and capping of vials under sterile conditions, reducing manual intervention and batch-to-batch variability. Its value lies not only in automation, but in its ability to adapt to real-world production needs: handling of open/closed vials, various capping strategies, and customizable workflows.

In regulated environments, this operational consistency results in a process that is more controllable and easier to transfer between shifts and production lines.


  • Customized workflows with dedicated kits
  • Vial format change even between consecutive batches
  • Crimp and push-fit management (depending on the version)

Method

How We Handle Department Operations

A clinical-first approach: reduced surgical risk, consistent procedures, and support until stabilization.

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Step 01

Design Focused on Clinical Use

Solutions designed to accommodate shifts, schedules, and departmental constraints.

Step 02

Built-in security (not added)

Radiation protection and procedures: an integral part of the project, not an afterthought.

Step 03

Start-up and training to stabilize the department

Quality becomes apparent after delivery: commissioning and training reduce variability.

Step 04

Solutions designed to accommodate shifts, schedules, and departmental constraints.

Reduce downtime and manage the department's evolution with clear support.

Settings and Customization

CRP Compact is highly customizable to meet specific production needs, vial types, and capping strategies.

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Precise

It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.

Multitracer

It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.

Automatic

It automates the entire radiopharmaceutical dispensing process, minimizing the need for manual intervention by the operator.

Compact

Thanks to its compact size, it can be installed in any type of laminar-flow shielded chamber equipped with a well for a calibrator and a remote gripper.

PRODUCT OPTIONS

Additional Features and Options

Push-Fit Capping Module

Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.

Push-Fit Capping Module

Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.

Push-Fit Capping Module

Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.

Key Features and Functions

Technical Specifications

Feature Value
Volumetric Accuracy (Weight) <1% (deviation)
Vial Compatibility Open / Closed (with piercing module)
Type of closure Crimp (stopper + ring), Push-fit
Dispensing Speed Up to X ml/min (depending on the vial)
Volumetric Accuracy (Weight) <1% (deviation)

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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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