Automatic integrity tester for Alpha and Beta Rapid Transfer Systems (RTP)
ZEROC is the new RTP tester developed to perform a complete integrity test on Rapid Transfer Ports (Alpha part), installed on isolators or RABS, and their containers (Beta part) in a fully automatic way.
It’s an extremely versatile system that guarantees an accurate and repeatable test based on the pressure decay method. It can be used for both aseptic and containment processes, offering the same highest reliability.
ZEROC is a completely self-contained device that does not need any electric or pneumatic connection. Each unit includes the necessary equipment for the complete execution of the test, as well as a user friendly touch screen control panel that allows to access the available features and reporting.
Each unit is equipped with a custom designed format part that connects the system to the RTP port to be tested.
Once connected, the system produces an isolated environment that includes the port seal. The test allows to evaluate the RTP port integrity in few minutes, thus making each associated process safer and more reliable.
ZEROC is able to perform a complete integrity test on the transfer system in a very short time.
ZEROC allows to test RTP ports both in negative and positive pressure, depending on the specific applications.
ZEROC is able to detect any loss or defect of the transfer system with the extreme precision.
On-board precision calibration and validation system, without additional devices or destructive tests.
RFID technology (Radio Frequency Identification) carries out the recognition and the identification of the port to be tested, for an easy and intelligent management.
VPN connection for the remote access to the system allows to realize assistance interventions, updates or maintenance activities.
ZEROC offers maximum flexibility in data management and archiving, in accordance with the main provisions on the subject, in particular with the FDA 21 CFR Part 11.
It is able to independently generate reports in PDF format which can be consulted via the interface or easily shared within the customer’s network, thanks to an integrated processor.
ZEROC is compatible with OPC UA servers for exchanging and reading data via Open Platform Communications.
Tema Sinergie has developed a proprietary SCADA system, based on zenon software platform by COPA-DATA, which implements specific functions for the simultaneous management of multiple devices.
ZEROC was designed for data transmission via Wi-Fi technology.
It is possible to use either a dedicated router, provided by Tema Sinergie, or connect directly to the customer’s Wi-Fi network without compromising data security and integrity, in compliance with the main provisions on the subject, in particular with the FDA 21 CFR Part 11.
ZEROC uses the main and most widespread communication protocols, such as LDAP or OPC UA server, in order to offer maximum integration flexibility and simple and immediate data access.
BODY
+ 4 wireless charging stations for AGLTS 2 and ZEROC
+ Blind Port stations
+ 1 internal compartment
ERGONOMICS
The design was created taking into consideration:
+ Height from the ground, for a better use of display while AGLTS 2 and ZEROC is placed on its station, as well as for moving the device
+ Symmetry, which allows two operators to work simultaneously on the Mobile Dock
+ Choice and shape of materials, aiming to ease the cleaning process of the surfaces
BLIND PORT
This option allows for the seals and the pneumatic circuit of AGLTS 2 and ZEROC can be checked, in order to guarantee their tightness during the test cycle. The Blind Port can be tailor-made to suit the different shapes and sizes of glove and RTP ports.
