PharmaLytica 2021 Hyderabad review.

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.

Description: Operator        Description: Operator

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).

Key features

·         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

 

General characteristics:-

·         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

 









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