ZEROC

Automatic Integrity Verification System for Alpha and Beta Rapid Transfer (RTP) Systems

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360°

Automated Test
Fast, accurate, and repeatable
Compatible with Alpha and Beta
Self-contained and versatile

ZEROC is the new RTP tester developed to perform a fully automated, comprehensive integrity test on rapid transfer ports (Part Alpha) installed on isolators or RABS and their enclosures (Part Beta).

It is an extremely versatile system capable of performing accurate and repeatable tests based on the pressure drop method.

Used in the following contexts:

Pharma · Biotech · Radiopharma Production

In-house

Designed and Manufactured by Tema Sinergie

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GAMP 5

FDA 21 CFR Part 11.

Appendix 1

EU GMP Guidelines

OVERVIEW

Autonomous Integrity Check of RTP Ports

ZEROC is a fully self-contained device that does not need to be connected to any electrical or pneumatic power sources.

Each unit is equipped with a custom-made adapter that allows the system to be connected to the RTP port to be tested.

Once connected, the system creates an isolated environment that includes the door gasket. The pressure drop test will allow, in just a few

minutes to assess the integrity of the RTP port, making every associated process more secure and reliable.

Each unit includes the instrumentation necessary to perform the test in its entirety, as well as a touchscreen control interface that provides access to features and reporting.

It can be used for both aseptic and containment processes, always offering maximum reliability.

Fast

ZEROC can perform a comprehensive integrity test on transfer systems very quickly.

Versatile

ZEROC allows you to test RTP valves under both negative and positive pressure, depending on the specific application.

Accurate

It is capable of detecting any leaks or defects in the transfer system with the utmost precision.

Reliable

On-board precision calibration and validation system, requiring no additional devices or destructive testing.

Features

The door to be tested is recognized and identified using RFID (Radio Frequency Identification) technology, ensuring simple and intelligent management.

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Features

Data Management

ZEROC offers maximum flexibility in data management, archiving, and retrieval, ensuring compliance with key industry regulations, including FDA 21 CFR Part 11.
Thanks to its built-in processor, the system automatically generates reports in PDF format, which can be easily accessed through the user interface and quickly shared within the corporate network.

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Connectivity

Communication Protocols	Description
LDAP INTEGRATION	For easy integration of the system into the customer's Active Directory domain.
OPC UA DATA EXCHANGE	Compatible with OPC UA servers for data exchange and retrieval via Open Platform Communications.
VPN REMOTE ASSISTANCE	VPN connection for remote access to the system for support, updates, or maintenance.
WIRELESS WI-FI	Wireless network connection for data transmission via Wi-Fi technology. You can use either a dedicated router provided by Tema Sinergie or connect directly to the customer's Wi-Fi network.

Configuration

Each unit is equipped with a specific adapter, which can be customized based on the system being tested and makes the device compatible with virtually all transfer ports available on the market.
By using two test units—one dedicated to RTP (Part Alpha) and the other dedicated to the corresponding containers (Part Beta)—it will be possible to monitor the entire transfer system.

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Alpha

ZEROC beta

Beta

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accessories

Mobile Dock

A solution designed to organize, charge, use, and move up to four ZEROC devices simultaneously.

It features four wireless charging stations and an internal compartment.

Easy-to-Use AGLTS 2.

Practical and comfortable handling.

Effective cleaning.

Two operators working simultaneously.