Aseptic Containment Isolator

Esco's Aseptic Containment Isolator (ACTI) works in conjunction with advanced material transfer techniques and bio-decontamination agents, providing a 6 log reduction of microbial burden.

ACTI provide standard configurable designs able to adapt to various batch sizes and process flows. Through an entirely user-selectable operating system, the same isolator can be set up to operate under recirculation or full exhaust airflow and in positive or negative pressure modes - this allows the system to be multifunctional and cater for all requirements of toxic or nontoxic aseptic materials. For toxic materials, the system incorporates safe change filters.

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Unidirectional airflow – 0.45 m/s ± 20% measured 150 mm from the distribution screen face during normal operation provides ISO Class 5/ Grade A aseptic environment
Knife edge gel-sealed U15 supply and optional U15 return filters
Gasket-sealed F8 room inlet and outlet filters
The system automatically compensates for containment breach in +ve or -ve mode via an egress or inward rush, respectively

Optional VHP Ports for automated aseptic processing allows chamber or system decontamination
Optional humidity/temperature sensors for environmental monitoring
Biodecon loop for decontamination of viable or non-viable monitoring systems
External sensors protected by instrument filters
Optional distribution manifold allows more accurate sampling of upstream filter PAO concentration (since this manifold draws in PAO, it is advised that this be cleaned before every filter change)

Filter scanning ports for downstream filter integrity testing
Automated Raise / Lower system adjusts to pre-set operator preferred heights upon login
Safe change glove port assembly allows for either single-piece or split cuff gloves to be changed without any breach of isolator condition
Enhanced uniformity and entrainment of powders via our PLF screens

Smooth, flushed interior of isolator glazing means fewer crevices to improve cleanability and decontamination
Glazing is made of toughened laminated safety glass
PLF diffuser screens provide uniform airflow throughout the internal work zone
Single-piece 316L stainless steel chamber hand polished to less than 0.4 Ra with 19mm coved corners

Stainless steel is passivated post-fabrication with citric acid
Clean finishing and perforated multi-piece work tray enhance unidirectional airflow for ultimate entrainment of contaminants and potent powders
International brand safe change filters mean lower replacement costs and quicker turnaround time
HMI/PLC control architecture with four defined levels of hierarchy
Access for standard replaceable items such as lights and ballasts are done all from the front of the unit

Guide to Models
ACTI - __ __
Isolator	Code	Nominal Size Process Chamber	Code	Electrical Code	Code
Aseptic Containment Isolator	ACTI	1200 mm	2G	220-240 V, AC, 50 Hz, 1Ø	1
		1600 mm	3G	110-120 V, AC, 50 Hz, 1Ø	2
		2000 mm	4G	220-240 V, AC, 60 Hz, 1Ø	3

Option :

Integrated automated pressure testing
Filters can be upgraded to safe change with additional bags and BIBO rings.
Bypass option can be retrofitted with additional safe change housing
The system runs in any airflow regimes* in both positive and negative pressure and can be configured in-situ by administrator access

Volt free contacts provided for the client connection to HVAC and optional 21 CFR Part 11 chart recorder for storing of process data
Additional options and accessories
- Carboys for draining of fluid waste
- Additional factory integrated transfer ports
- Custom sanitary shelving or IV bars
- Sterility test pumps
- Pass chamber
- Bio-decontamination Steris and Bioquell
- Non-viable and viable sampler
- Glove tester
- Waste bag grommet
- Sterile continuous liner
- Bag-welder with table
- RTP Ø270 – Alpha
- RTP Ø270 – Beta Canister
- RTP Ø270 – Liner