Produits >
Glove Leak Testing System
Réf : AGLTS2 | Fabricant : Tema Sinergie
AGLTS 2 is the brand new fully automatic GMP compliant glove integrity testing system for isolators and RABS in the pharmaceutical industry, developed referring to the Positive Pressure Decay Method which follows the international standard ISO 14644-7 Annex E.5. As the name suggests, AGLTS 2 is an evolution of the first automatic glove testing system developed by Tema Sinergie, from which it inherits features, know-how and stability.
Principales caractéristiques
- SIMPLE AND FUNCTIONAL INTERFACE: capacitive 10” color touch display for immediate access to all commands, even when wearing gloves, and optimal visualization of real-time data and reports
- AUTONOMOUS: no need for external connections for electrical or pneumatic supply
- PRACTICAL: battery recharge via wireless inductive system, via its dedicated charging station
- FLEXIBLE: the system hosts an integrated PC, for data management from the system interface directly
- CUSTOMIZABLE: the system can test any type of glove port available on the market, thanks to a customizable adapter
- ERGONOMIC: the ergonomics of the system have been designed to minimize any downtime and speed up the necessary test procedures. The materials are easy to clean and compatible with sanitizing agents and bio-decontamination processes
- SIMPLE AND IMMEDIATE MANAGEMENT: the recognition and identification of the glove to be tested happens by means of RFID technology (Radio Frequency Identification), for simple and clever management
Spécifications
- FULL COMPLIANCE TO
- EU Annex 1
- GMP
- ISO 14644 7 Annex E5
- GAMP5
- 21 CFR Part 11
- CONNECTIVITY
- LDAP INTEGRATION: for an easy integration of the system into the customer’s Active Directory Domain
- OPC UA DATA EXCHANGE: compatible with OPC UA servers for exchanging and reading data via Open Platform Communications
- VPN REMOTE ASSISTANCE: VPN connection with remote system access for assistance, updates or maintenance activities
- WIRELESS WI-FI DATA TRANSMISSION: wireless network connection for data transmission via Wi-Fi technology. Either a dedicated router (AGLTSnet) supplied by Tema Sinergie or a direct connection to the customers’ Wi-Fi network can be used
- DATA MANAGEMENT
- GLOVE LIFE CYCLE MANAGEMENT: new feature to provide the operator with a clear and prompt view of all the data and parameters of the gloves, both tested and yet to be tested; and the entire life cycle of the glove itself
- iAGLTS REMOTE SUPERVISION SYSTEM: iAGLTS - iFIX based Remote Control Unit for Automatic Glove Leak Testing System (iAGLTS) – for data archiving and management, and report consultation
- PDF REPORT GENERATION: direct report creation in PDF format, in compliance with the provisions of 21 CFR Part 11