أداة تحليل جودة الهواء ENVAIR CDC F 2G2D

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Marke: ENVAIR
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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