Product/Service

Compact Aseptic Processing Isolator System: CAP-IS

CAP-IS

CAP-IS (Compact Aseptic Processing Isolator System) is a cGMP Class A/ISO 5 isolation system, specifically designed for pharmaceutical production laboratories.

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The system is engineered to provide top-tier aseptic performance even in confined spaces: within just 2.5 meters, it integrates a process chamber connected to a transfer chamber and a built-in VPHP bio-decontamination system.

Fully compatible with the new Glove Leak Test System – AGLTS 2.

GUARANTEED ASEPSIS

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

AUTOMATIC LEAK TEST

The CAP-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).

REMOTE ASSISTANCE

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 CAP-IS.

ENERGY SAVING

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

The AP-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.

HUMAN MACHINE INTERFACE

CAP-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.

TEMA SINERGIE