ACIC's Aseptic Processing Isolator
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.
Aseptic Processing Isolator
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 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
Some advantages of using isolator systems compared to the traditional cleanroom:
· GMP Class A ISO 5 contained enclosure
· Recirculation unidirectional flow airflow system
· Integrated Gasified 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
· Full process equipment integration