ENVAIR CDC F 2G2D アイソレーター

2012 Envair CDC F 2G2D & 2012 REUKO

Isolator and cleanroom

Last filter change and last maintenance were on 09.01.2014 (see test report in the appendix)

The air handling unit is designed for a room size of approx. 12 m2 (file room 3.46 in the appendix).

The isolator has the complete documentation incl. test reports.

It has been used very little (see current operating hours below) and is connected to an air handling unit (designed for approx. 12 m2).

These are the technical parameters:

REUKO climate service ENVAIR

Isolator (Cytostatic isolator (CMR) 1.2m)

a. Manufacturer: Envair Deutschland GmbH

b. Type: CDC F 2G2D (2-Hand, Isolator clean room class A)

c. Build: 06. 2012

d. Use: Reconstitution during 2 clinical trials (including cytostatics); idle operation for several months

e. Details: isokinetic measuring probe,

For the processing of:

- Cytostatics

- antivirals

-hazardous substances that are subject to TRGS 525

are subject to

- all toxic substances

Characteristics:

-air quality cleanroom class A

(unidirectional displacement flow

LF)

according to EU-GMP-Guide in the entire

work area

- Ergonomically designed work area

-High air exchange rate in the working area and

airlocks

- Airlocks are equipped with transfer trays

equipped with transfer trays

- Airlocks have a reciprocal

electromagnetic door lock

- Sterile glove changing system

- Easy cleaning of the interior and

external surfaces

- Easy to clean control unit

Membrane keypad

- Simple monitoring, testing

and maintenance

-Automatic pressure test

Standards:

EN ISO 14644-7

EN ISO 14644-1 Class 5

EN 61010

VDI 2083-1

VDI 2083-3

VDE 57789

Filter: H14

Filter class: DIN EN 1822

Separation efficiency: 99.995

Exhaust air volume:

0.1 m/s 360m³/h

=

Air exchange rate per hour:

Airlock:

3400

Useful space:

1800

Exhaust air:

860

Working area:

1180 x 520 x 690mm

External dimensions:

2432 x 720 x 2680mm

(incl. non-return valve)

Useful space stainless steel: 1.4404

Outer housing: Epoxy powder-coated

Colour: white

Optionally also completely in stainless steel

1.4301

available

Stainless steel: Roughness depth < 0.5μm

Noise level:

<60 dB(A)

Temperature increase in usable space:

4-6 °C

Weight:

330kg

Clean room incl. ventilation technology

a Manufacturer: REUKO Klima-Service GmbH & Co. KG

b. Type: individual solution

c. Date build: 2012

d. Use: idle operation for several months, reconstitution of medicinal products in 2 clinical trials (including cytostatics)

e. Clean Room Classes: D (for Isolator environment)

f. Area/rooms: Slice and laboratory (with separate air lock for goods)

g. Control: Individual solution by ELREST (DDC controller)

Particle measuring device

a. Manufacturer: KM-Optoelektronik

b. Type: PCSS

c. Date build: 2010

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