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pt is product transfer isolator

PT-IS

Product Transfer Isolator

A custom Class A/ISO 5 isolation system compliant with cGMP, specifically designed for pharmaceutical companies that require a low relative humidity (rH%) aseptic environment for the semi-automatic transfer of liquid substances.

Used in contexts of:

Pharma · Biotech

Designed and Manufactured by Tema Sinergie

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Class A

EU GMP

Appendix 1

EU GMP

ISO 5

ISO 14644-1

GAMP 5

FDA 21 CFR Part 11

Features

Designed specifically for pharmaceutical companies that require a low relative humidity (rH%) aseptic environment for the semi-automatic transfer of liquids. The features included were developed to meet user requirements.

VPHP-Resistant Anemometer

VPHP-Resistant rH% and Temperature Sensor

Interior LED Lighting System

Virtual Private Network (VPN) connection

Features & Benefits

Technologies and Integrated Systems

GUARANTEED STERILITY

A PT-IS isolator ensures the highest air quality within the isolated environment thanks to:

an engineered filtration system consisting of High-Efficiency Particulate Air (HEPA) pre-filters
HYPER, an integrated vaporized hydrogen peroxide bio-decontamination system developed by Tema Sinergie, for very rapid 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 AP-IS Series insulator is equipped with an automatic leak-test system for routine testing, which performs an independent cycle on each chamber in accordance with the pressure-varying method described in ISO 10648-2:1994(E) (5.2).

EASY MAINTENANCE

An integrated control module made of AISI 304 stainless steel provides direct access to 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.

CUSTOM-DESIGNED

A PT-IS isolator is a custom-designed isolation system for aseptic processes that can consist of several modules.
The specific configuration of the isolator is a 4-glove work chamber. Certain optional features can be added to the configuration at a later date.

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 a PT-IS Series isolator, 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.

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

product options

Additional Features

The system can be equipped with tools for:

DATA MANAGEMENT

The PT-IS s isolator has been equipped with DataWall, software developed by Tema Sinergie, to make data management more efficient.

GLOVE INTEGRITY TEST

The PT-IS isolator can be equipped with an Automatic Glove Leak Test System (AGLTS) that performs an independent test 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 is transmitted wirelessly 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 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)