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ST-IS Beta

Sterility Testing Isolator

ST-IS Beta is a cGMP-compliant Class A/ISO 5 isolation system designed specifically for Quality Control laboratories, pilot-scale pharmaceutical manufacturing, and pharmacies.

It is a flexible machine that ensures optimal working conditions for various applications, including sterility testing, filling, fractionation, sampling, and aseptic product transfer. Specific applications for beta emitters are available.

Designed and Manufactured by Tema Sinergie

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Settings and Customization

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Modular

The ST-IS is a modular and flexible system. In its basic configuration, it consists of a work chamber with 3–4 gloves and can be expanded later with a selection of available options. This makes the ST-IS perfectly suited to any need or process.

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 ergonomic design of the ST-IS Beta, operators are assured the most comfortable working conditions.

Sure

Insulation system fully controlled by a PLC.

Features & Benefits

Integrated Technologies and Systems

GUARANTEED STERILITY

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

  • an engineered filtration system consisting of High-Efficiency Particulate Air (HEPA) pre-filters and Ultra Low Penetration Air (ULPA U15) unidirectional and return filters;

  • an integrated vaporized hydrogen peroxide bio-decontamination system for very rapid bio-decontamination cycles (a complete 20-minute cycle in the Rapid Gas pre-chamber, including full ventilation);

  • inflatable seals made of FDA-approved Bio-Guardian® white silicone, with antibacterial inhibitors.

AUTOMATIC LEAK TEST

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

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, making remote access, support, updates, and maintenance possible anytime, anywhere. This also makes configuration even simpler.

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, 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 successive batches
  • Crimp and push-fit management (depending on the version)

product options

Built-in Features

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

DATA MANAGEMENT

The ST-IS Beta can also be supplied with an Integrated Supervisory Control and Data Acquisition (SCADA) system—iFix with Historian Data Management Software (DMS) from GE Digital.

GLOVE INTEGRITY TEST

The ST-IS Beta can be equipped with an Automatic Glove Leak Test System (AGLTS), capable of performing an independent test cycle for each glove installed on the isolator, in accordance with the positive pressure drop method specified in the international standard ISO 14644-7, Annex E.5. The system enables data transmission via a Wi-Fi connection using the TCP/IP protocol and automatically identifies the glove to be tested using RFID (Radio Frequency Identification) technology. The test’s high sensitivity enables the detection of holes with diameters as small as 50 μm, ensuring reliable verification of glove integrity.

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.

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)

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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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