MT-IS Material Transfer Isolator

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mt is material transfer isolator

MT-IS

Material Transfer Isolator

The Material Transfer Isolator System (MT-IS) is a system that, thanks to a large, secure door integrated with VPHP technology, enables the fastest possible transfer process with decontamination.

The stainless steel design is suitable for various cleanroom classifications.

Used in contexts of:

Pharma · Biotech

Designed and Manufactured by Tema Sinergie

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Settings and Customization

Fast

Complete cycle in less than 60 minutes, including ventilation (VPHP concentration in the chamber ≤ 1 ppm)

Energy Savings

Thanks to the new sustainable low-voltage fans, the insulator has very low energy consumption throughout its entire lifespan.

Ergonomic

Maximizing operator productivity is essential for minimizing the risk of accidents, eliminating unexpected downtime, and improving production quality. Thanks to the MT-IS’s ergonomic design, operators are assured the most comfortable working conditions.

Sure

Process validation using the biological indicator Geobacillus stearothermophilus to routinely achieve a 6-log reduction in microbial count.

Features & Benefits

Integrated Technologies and Systems

GUARANTEED STERILITY

The MT-IS ensures the highest air quality within the isolated environment thanks to:

an engineered filtration system consisting of High-Efficiency Particulate Air (HEPA14) and Ultra-Low Particulate Air (ULPA U15) pre-filters, as well as Ultra-Low Penetration Air (ULPA U15) unidirectional and return filters;
an integrated vaporized hydrogen peroxide bio-decontamination system for very rapid bio-decontamination cycles;
inflatable seals made of FDA-approved Bio-Guardian® white silicone.

AUTOMATIC LEAK TEST

The MT-IS is equipped with an automatic leak test system that can be performed routinely; it carries out an independent cycle on each chamber, in accordance with the pressure variation method described in ISO 10648-2:1994(E) (5.2).

The automatic leak test is performed before each biodecontamination cycle to ensure maximum safety.

EASY MAINTENANCE

A monolithic, sliding external control module, made of AISI 304 stainless steel and housing the electrical and pneumatic components, provides direct access for all maintenance operations. A Virtual Private Network (VPN) connection enables secure and private communication over the Internet, allowing for remote access, support, updates, and maintenance anytime, anywhere.
The SECOMEA module can be installed, allowing for even easier access and configuration.

STANDARD DESIGN

MT-IS is available in several standard sizes.

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 production needs: handling of open/closed vials, different 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)

product options

Additional Features

The system can be equipped with optional modules for data management, monitoring, and glove integrity testing.

DATA MANAGEMENT

The MT-IS can be updated and integrated with:

an Integrated Supervisory Control and Data Acquisition (SCADA) system
DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.

GLOVE INTEGRITY TEST

The MT-IS can be equipped with an Automatic Glove Leak Test System (AGLTS) that performs an independent cycle for each glove mounted on the isolation system, in accordance with the positive pressure drop method described in the international standard ISO 14644-7 Annex E.5. Data transmission via Wi-Fi using the TCP/IP protocol. Identification of the glove to be tested using RFID (Radio Frequency IDentification) technology. Detection of holes as small as 100 μm in diameter.

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 an add-on)

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.

CRP-Compact-Dispensers-Injectors-NM-11-PLUS-copy1

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)