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ST-IS

Sterility Testing Isolator

 

ST-IS (Sterility Test Isolator) is a modular, cGMP Class A/ISO 5 isolation system specifically designed to ensure the safest working conditions during sterility testing or quality control operations.
The system is also available in a compact CST-IS configuration.

 

Used in contexts of:
Pharma · Biotech

Designed and Manufactured by Tema Sinergie

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OVERVIEW

Maximum Safety and Asepsis for Performing Sterility Tests

ST-IS is an aseptic isolation system designed to provide the best environmental and working conditions for performing sterility tests in accordance with the Pharmacopoeia.

ST-IS consists of two chambers with different characteristics and functions. The first step in the workflow involves placing the material for the sterility test into the Transfer Chamber, followed by the decontamination process using the integrated VPHP system.

Once the process is complete, the material can be transferred to the Process Chamber without compromising the aseptic conditions of the Process Chamber, which has previously undergone a decontamination process.

The Process Chamber is equipped with a state-of-the-art integrated peristaltic pump, which enables simple and reliable test execution.

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

Settings and Customization

Sterility Testing Isolator - Open - ST-IS Series Tema Sinergie

GUARANTEED STERILITY

ST-IS ensures the highest air quality inside the working chamber.

AUTOMATIC LEAK TEST

The airtightness of the chambers is continuously monitored by an automatic testing system, which performs an independent test cycle on each chamber in accordance with the method described in ISO 10648-2:1994(E) (5.2).

REMOTE SUPPORT

A VPN connection enables secure and private communication over the Internet, making remote access, support, updates, and maintenance possible anytime, anywhere.

ERGONOMIC DESIGN

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 Series, operators are assured the most comfortable working conditions.

ENERGY SAVING

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

HUMAN-MACHINE INTERFACE

ST-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.

The operator interface, developed by Tema Sinergie, offers simple and intuitive operation, thanks in part to the “one-touch” function and the ability to retrieve saved work programs.

The management software complies with GAMP5 and FDA 21 CFR Part 11 requirements.

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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)

Technical Specifications

Feature Value
Room Layout Made of AISI 316L stainless steel, with a Mirror Brite interior finish (< 0.3 μm) and a Scotch Brite exterior finish (< 0.8 μm).

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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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