ST-IS Custom

Custom Sterility Isolator System

The ST-IS (Sterility Isolator System) is a cGMP Class A/ISO 5 custom isolator system specifically designed to meet every type of quality control requirement and guarantees the safest working conditions.

Be it a question of developing an extremely specific process or the constraint being linked to a particular facility arrangement, ST-IS in its custom configuration is the solution to all your specific needs.
A compact configuration (CST-IS) is available.

Compatible with new Glove Integrity Testing System –  AGLTS 2.

Available downloads:
  • ST-IS Series

Are you interested in this product?

Testimonials

ITELPHARMA has acquired a Sterility Isolator designed and manufactured by Tema Sinergie. The isolator is composed of a Transfer Chamber and Testing Chamber, equipped with an integrated Open Loop / Single Pass VPHP Generator (HYPER). The isolator will support us with the considerable amount of tests weekly provided by Itelpharma, using rapid bio-decontamination cycles. The isolator has been installed in our radiopharmaceutical facility based in Ruvo di Puglia, Bari, Italy and it's currently full operational serving our sterility testing activities. Firmly believing in the positive value of technological and commercial partnerships, ITELPHARMA appreciated the collaboration demonstrated by Tema Sinergie during the project

Anna Tolomeo

Site Manager & Qualified Person (QP)
ITELPHARMA

OPERATION

 

ST-IS is an aseptic isolation system designed to provide the best environmental and working conditions for conducting sterility tests according to Pharmacopeia.

ST-IS consists of two chambers with different characteristics and functionalities. The first step of the workflow involves placing the material for sterility testing into the Transfer Chamber, followed by the execution of the decontamination process using the integrated VPHP system. Once the process is complete, the material can be transferred to the Processing Chamber without compromising the aseptic level of the Processing Chamber, which has been previously subjected to the decontamination process.

The Working Chamber is equipped with a state-of-the-art integrated peristaltic pump, allowing for simple and reliable execution of the test.

MAIN FEATURES

GUARANTEED ASEPSIS

The ST-IS assures the highest air quality in the isolated environment.

AUTOMATIC LEAK TEST

The ST-IS is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).

EASE OF MAINTENANCE

A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance anytime, everywhere.

ERGONOMIC DESIGN

Maximizing operators’ effectiveness is essential to minimize the risks of accidents, eliminate unscheduled downtime and boost production quality. Operators are assured the most comfortable working conditions by the outstanding ergonomics of the ST-IS.

ENERGY SAVING

Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.

GLOVE INTEGRITY TESTING

 
 

 

The ST-IS series is equipped with an integrated Automatic Glove Leak Testing System (AGLTS 2) in compliance with the international standard ISO 14644-7 Annex E.5 and Annex 1, EU Guidelines.

 

Main features

  • Charging with wireless inductive system.
  • Data transmission via Wi-Fi technology.
  • 10″ color capacitive touch display.
  • Compatible with any type of glove port.
  • Integrated calibration system.
  • Glove life cycle monitoring.
  • Easy integration with Active Directory.
  • RFID technology.
  • Detection of holes down to 100μm diameter.

Discover more:

www.aglts2.com

HUMAN MACHINE INTERFACE

 
 

ST-IS is controlled by a Siemens PLC of the S7-1500 series and a Siemens 12″ SIMATIC HMI, characterized by touch technology, with widescreen TFT color display and user-friendly graphics.

The operator interface, developed by Tema Sinergie, allows simple and intuitive use, thanks also to the “one-touch” function and the possibility of recovering stored work programs.

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

 

 

    Touch panel
    The comprehensive human-machine interface reliably records all relevant data of ongoing process.

    User friendly
    Intuitive graphical interface designed to facilitate the operator.

    Data management
    Flexibility in data management and storage.

Available downloads:
  • ST-IS Series

Are you interested in this product?

© 2024 TEMA SINERGIE S.p.A
C.F., P.IVA, VATn. IT00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
RAEE IT08020000002755
Capital Stock € 2.000.000,00 paid-up