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ENVAIR CDC F 2G2D Isolador
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Dados técnicos
· ID 166200840Máquinas usadas
- Estado
- usado
- Ano de fabrico
- 2012
- Localização
- Erfurt, Germany
Identifikation
FabricanteENVAIR
ModeloCDC F 2G2D
Número do artigo4854392
Technik
Quantidade1
Descrição
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
Find more here - .ucymachines/
Contact us at - sales@ucymachines
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
Find more here - .ucymachines/
Contact us at - sales@ucymachines
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