Class A
EU GMP
MT-IS
Material Transfer Isolator
A GMP Class A/ISO 5 isolation system designed for the external bio-decontamination of materials prior to their transfer through an RTP (Rapid Transfer Port) system.
MT-IS enables transfer operations to be performed under controlled aseptic conditions, helping to reduce the risk of contamination and preserve the integrity of pharmaceutical production environments.
overview
Safety and Sterility in a Compact Design
MT-IS is Tema Sinergie's solution for external bio-decontamination and the safe transfer of materials in pharmaceutical production environments.
ASEPSIS
The unidirectional airflow system with H14 HEPA filtration, the integrated VPHP bio-decontamination system, and the inflatable seals made of FDA-approved Bio-Guardian® white silicone ensure controlled environmental conditions for aseptic processing.
MAXIMUM SAFETY
The PLC control system and dedicated software allow for the monitoring and management of the isolator’s key operating parameters, and thanks to an interlock system on all doors, it is possible to prevent incorrect operations and ensure operational safety.
AUTOMATIC LEAK TEST
An automatic leak-test system that performs an independent cycle on each chamber, in accordance with the pressure-varying method described in ISO 10648-2 (E) (5.2).
EASY MAINTENANCE
Direct access to the control panel for on-site maintenance. VPN connection for support and remote updates.
ERGONOMIC DESIGN
Optimal ergonomics to provide operators with comfortable working conditions and promote safety, operational continuity, and production quality.
LIFETIME ENERGY SAVINGS
Thanks to the new sustainable low-voltage fans, the insulator has very low energy consumption throughout its entire life cycle.
Features
Additional Features
Inflatable Seals
Watertight doors featuring inflatable seals made of FDA-approved white silicone and an interlock system to minimize the risk of bioburden and contamination
Additional Features
Remote Control Module
Remote Control Module for All Maintenance Operations
A monolithic, sliding remote control module made of AISI 304 stainless steel, 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, making remote access, support, updates, and maintenance possible anytime, anywhere.
Additional Features
Shelving
316L stainless steel shelving system for storing products, materials, and tools
Additional Features
RTP Integrated System
Integrated system (RTP) for transferring products and instruments without breaking the aseptic barrier
Additional Features
Handles with built-in safety sensors
The transfer chamber access panel is equipped with a handle that includes a built-in safety switch, which allows the panel's closed status to be monitored and contributes to the isolator's operational safety.
Additional Features
Transfer Chamber
Features:
-
VENTILATION
A unidirectional airflow ventilation system that helps maintain controlled environmental conditions inside the process chamber.
-
FILTRATION SYSTEMS
High air quality is ensured by an H14 HEPA filtration system, featuring filters for both the unidirectional airflow and the return air.
-
MATERIALS
Constructed of AISI 316L stainless steel, with a Mirror Brite interior finish (< 0.3 μm) and a Scotch Brite exterior finish (< 0.8 µm). Welds are smoothed and polished to facilitate cleaning.
-
AUTOMATIC LEAK TEST
An automatic leak test system capable of performing routine tests in accordance with the pressure-variation method described in ISO 10648-2 (E), clause 5.2.
Additional Features
Human-Machine Interface
MT-IS is controlled by a Siemens S7-1500 series PLC and a 12-inch Siemens SIMATIC HMI, featuring touch technology, a widescreen TFT color display, and user-friendly graphics.
.png?width=4252&height=2835&name=MT_IS%20(5).png)
.webp?width=2000&height=1333&name=MT-IS-material-transfer-isolator%20(3).webp)
.webp?width=2000&height=1333&name=MT-IS-material-transfer-isolator%20(2).webp)
.jpg?width=2000&height=1333&name=MT_IS%20(3).jpg)
.png?width=4252&height=2835&name=MT_IS%20(5).png)
1/5
Settings and Customization
CRP Compact is highly customizable to meet specific production needs, vial types, and capping strategies.
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.
Open-Vial Filling Station
The refilling station is equipped with a 0.22 µm filter that sterilizes the radiopharmaceutical at the end of the dispensing line.
Capping Station
Crimping Station
Capping Station
Push-Fit Capping Station
The Plus version of the CRP Compact features a vial closure system with push-fit caps.
Disposable Plate Kit
Removable anodized aluminum plate, equipped with a dedicated mounting slot for quick, secure, and error-proof installation of the disposable kit.
External scale
High-precision external scale for weighing the stock solution.
Built-in scale
High-precision scale integrated into the filling station for weight-controlled dispensing.
Bubble Point Sensor
Additional Modules
Recommended Accessories
AGLTS 2
Automatic Glove Leak Test System.
Data Management
Supervision, Control, and Data Acquisition System.
Additional Features
AGLTS 2
Integrated Automatic Glove Leak Test System (AGLTS), which performs an independent test cycle for each glove mounted on the isolator, in accordance with the positive pressure decay method described in the international standard ISO 14644-7, Annex E.5.
Wireless data transmission via Wi-Fi based on the TCP/IP protocol. Identification of the glove to be tested using radio-frequency identification (RFID) technology. Detection of holes with diameters up to 100 μm.
Additional Features
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.
OTHER Pharmaceutical Isolators
Continue browsing other products
Explore other solutions in the Pharma category
10 modelli disponibili
HC-IS
HC-IS Compounding
HC-IS Dispensing
.webp)
AP-IS
AP-IS Sampling
CAP-IS Compact
.webp)
AC-IS
CLF-IS
.webp)
MT-IS
PT-IS
Nessun prodotto disponibile per questa selezione.
.jpg?width=2880&height=602&name=Banner%20Prefooter%20(1).jpg)