Micro Solutions / Life Science

Isolator for cell therapy ISOCell PRO

Class A Modular Insulator for Closed Production of Cell and Gene Therapy Drugs

Product overview

ISOCell Pro
BioAir
Italy
ISOCell / SAFE³
ISOCell Pro

Class A Modular Insulator for Closed Production of Cell and Gene Therapy Drugs

combines a work area, airlock, incubator, microscope and waste system in one circuit

ISOCell PRO is BioAir’s modular insulator for the closed-loop production of cell and gene therapy drugs in a Class A environment. It combines work area, airlock, incubation, microscopy, waste disposal and process traceability, reducing the dependence of production on an expensive Class B clean room.

The vertical, unidirectional flow of HEPA-filtered air supports Class A in the work area and the airlock. Materials are introduced through a transfer airlock that speeds up the flow when the external door is opened and restores Class A in less than 120 seconds after closing. The built-in CO2/O2 incubator allows cells to be stored and cultured without output. The aseptic circuit is used; the 15-inch monitor microscope registers images on the network; the integrated waste port provides a safe container replacement; the work area and the airlock are decontaminated with H2O2 pairs; and the SCADA registers critical parameters, alarms and cycle data in accordance with the requirements of GAMP and 21 CFR Part 11.

Characteristics of the reference module: weight - 1500 kg; external dimensions - 1500 × 2900 × 2350 mm; noise <55 dB(A); external and internal surfaces - AISI 304. Working area - class A according to GMP/EU and ISO 4.5 according to EN ISO 14644-1; tightness - class 3 according to ISO 10648-2, leakage 0.1 l / h, loss of volume 1% / h. Illumination > 750 lux, power <3000 W, power - 220-240 B, 50/60 Hz, 16 A. In the working area, 100% external air is used without recirculation: input H10 and H14 sequentially, exhaust H14; table speed - 0.30 m / s ± 20%, pressure +30 Pa ± 5 Pa. In the airlock: 15% external and 85% recirculation air, two input H14 and one exhaust H14; pressure +50 Pa ± 5 Pa. GMP process.

Key figures

Class A

GMP/EU environment in the working area

ISO 4.5

according to EN ISO 14644-1

<120 s

lock-up

21 CFR Part 11

declared conformity with SCADA

Applications

Aseptic production of cell products
Cell therapy
Gene therapy
Tissue engineering

Models and configurations

ISOCell PRO

Product details

ISOCell PRO Isolator

work area, airlock and control panel

System and operator

Work through Class A work area

Closed aseptic circuit

The vertical unidirectional flow of HEPA-filtered air supports Class A in the work area and airlock.
Materials are inserted through a transfer airlock that restores Class A in less than 120 seconds after the outer door is closed.
The work area and the airlock are decontaminated by H2O2 pairs from a compatible third-party generator.

Built-in modules

Integrated CO2/O2 incubator allows cells to be cultured without being removed from the aseptic circuit
Microscope with 15-inch monitor and network image storage for observation without leaving the clean zone
Built-in waste port with quick-separable connection allows you to change the container without losing sterility

Monitoring and traceability

The SCADA system records critical parameters, alarms and cycle data in accordance with the requirements of GAMP and 21 CFR Part 11.
The system is designed to work in validated GMP processes
Module configuration is adapted to the specific technological process of the customer

Class of cleanliness and tightness

Class of cleanliness of the working area	Class A for GMP/EU, ISO 4.5 for EN ISO 14644-1
Tightness	Class 3 according to ISO 10648-2, leakage of 0.1 l / h, loss of volume 1% / h
Flow speed on the desktop	0.30 m/s ± 20%
Pressure in the work area	+30 Pa ±5 Pa
Lock pressure.	+50 Pa ±5 Pa

Ventilation

Air in the work area	100% external air without recirculation; input H10 and H14 sequentially, exhaust H14
Air in the lock	15% external and 85% recirculatory; two input H14 and one exhaust H14

Dimensions and power supply (reference module)

Weight	1500 kg
External dimensions (W×D×H)	2900×1500×2350 mm
Noise level	<55 dB(A)
Materials of construction	AISI 304 (exterior and interior lining)
Lighting	>750 lux
Power supply	220–240 V, 50/60 Hz, 16 A, single-phase with grounding
Power consumption of the module	<3000 W
Compressed air	filtered, particle-free, 6 bar
Laboratory gases	CO2, N2 (by process)

Related equipment types

CO2 incubators
Class III cell insulators
Cryopreservation and cryopreservation systems

Classification

Cellular technology and ART
Cell insulators
Equipment of cell technologies and reproductive medicine
Aseptic workplaces
Class III insulators and boxes
ISOCell Pro