Together, ACIC and Tema Sinergie provide a comprehensive range of totally contained aseptic solutions, fully compliant with cGMP and international regulations. Our core products service pharmaceutical, biological and hospital industries worldwide.

Typical applications are: Aseptic Filling, Sterility Testing, Aseptic Dispensing & Sampling, Aseptic Transfer. Upgradable cost-effective standard and fully customized isolator systems are available according to the specific process.

Aseptic Processing Isolator System (AP-IS)

AP-IS is a GMP Class A (ISO 5) modular isolator system, which has been designed for QC Labs, Pharmaceutical Production, and Pharmacies.

The high level of aseptic conditions achievable within in isolated environment makes the AP-IS isolator the perfect flexible equipment for different applications, such a Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Product Transfer.

The base isolator is composed of a single 4 gloves working chamber, but additional chambers and/or air locks can be also supplied upon request as option.

The isolator system is equipped with an unidirectional air flow system, and constantly guarantees a pressure gradient between the chamber(s) and the lab environment.

The advanced performances of the ventilation system are guaranteed by the exclusive automatic pressure & air flow control system developed by Tema Sinergie over the years; this system also permits to operate the isolator system in either positive or negative pressure with a simple switch of the software set-up parameters.

The high air quality isolated environment is assured by High Efficiency Particulate Air (HEPA) pre-filters, and Ultra Low Penetration Air (ULPA U15) unidirectional down flow and return filters.

AP-IS is equipped with inflatable seals to guarantee air tightness Class II (ISO 10648:2); the seals are made of FDA approved white silicon compound that contains anti bacteria inhibitors that prevent surface growth of micro organisms, and may achieve remarkable LOG reductions.

The AP-IS isolator system being based on a modular concept, any of the listed options might be added to a later date as further implementation of the module: Integrated gaseous hydrogen peroxide generators, Gaseous hydrogen peroxide sensor for TLV environment, Gaseous hydrogen peroxide sensors for chamber(s), Rapid transfer ports and transfer container, Integrated sterility testing pumps, Integrated viable & non-viable monitoring systems, Integrated glove leak tester, Integrated 21 CFR part 11 paperless graphic recorder, Integrated thermal printers, and Uninterruptable Power Supply (UPS).

  • Modular based configuration of the system
  • Fully PLC controlled isolator system
  • Advanced automatic pressure & air flow control system
  • Integrated VPHP generator & distribution circuit
  • VPHP resistant anemometer and humidity & temperature (rH%+T) sensor
  • Handles with integrated safety switch
  • LED lighting system
  • External monolithic control module made of stainless steel AISI 304
  • Main shell structure made of AISI 316L stainless steel
  • Sheathings and support structure made of AISI 304 stainless steel
  • Mirror Brite internal finishing (<0.3 µm) and Scotch Brite external finishing (<0.8 µm)
  • Weldings ground, smoothed, and polished
  • SIMATIC HMI TP700 Comfort Siemens, 7″ Touch Panel with TFT colour widescreen display
  • PLC Science S7 series
  • 21 CFR part 11 compliant
  • GAMP 5 compliant software development
  • VPN connection for remote access & assistance, updates, and maintenance
  • VPHP sensor for TLV environment
  • VPHP Hi/Lo sensors for chamber(s) monitoring
  • Rapid Transfer Ports, and Transfer containers
  • Integrated Sterility Testing Pumps
  • Integrated 21 CFR part 11 compliant Environment Monitoring System
  • On-board Automatic Glove Leak Testing System (AGLTS)
  • Integrated 21 CFR part 11 compliant paperless recorder or panel thermal printer
  • Complete documentation package according to Tema Sinergie standards
  • Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
  • Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
  • Performance Qualification (PQ) protocols and execution upon request

Some advantages of using isolator systems compared to the traditional cleanroom:

  • GMP Class A ISO 5 contained enclosure
  • Recirculation unidirectional flow airflow system
  • Integrated Gassified Hydrogen Peroxide Bio-decontamination Systems
  • Controlled reliability of the process
  • High quality product with total efficiency
  • Increased safety by reducing contamination risks, and consequently increased patient safety
  • Full process equipment integration