Friday, May 26, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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6.1.5Clean Rooms and Laminar Flow Hoods Qualification

Following the steps described in the Equipment Qualification paragraph, the tests to be carried out for the Clean Rooms will include at least:

a)     Flow and rate of renewals per hour: the speed and rate of renewals per hour according to specified will be checked;

b)    Absolute filters Integrity: the grade of sealing of the filters and the absence of leaks in the filter material will be checked;

c)     Particle counting: the total count of airborne particles (viable or not) will be checked according to specifications;

d)    Temperature / relative humidity: the temperature and relative humidity will be recorded during the test and will be checked according to specifications;

e)     Differential pressure: the pressure differential between the different areas will be checked according to specifications;

f)     Recovery test (normally tested for A and B classified clean rooms): the time required for a clean room to recover the specified classification after an out of specifications will be checked.

 

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Following the steps described in the Equipment Qualification paragraph, the tests to be carried out for the Laminar Flow Hoods will include at least:

a)     Speed and uniformity of the Air: the average speed meets the specified acceptance criteria and that there is uniformity will be checked;

b)    Absolute filters Integrity: the grade of sealing of the filters and the absence of leaks in the filter material will be checked;

c)     Particle counting: the total count of airborne particles (viable or not) will be checked according to specifications;

d)    Electronic test: all the operating controls will be checked (light, UV light, fan) and alarms;

e)     Smoke Test (for biological safety cabinets).The test objective is to study the behavior of air inside and outside the cabin with the help of a smoke generator.

 

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Diccionario - Ver diccionario detallado

Traducir cualquier sitio web

·Onet.pl-polaco

·Telegraph.co.uk-United Kingdom

·Berlingske.dk-Denmark

·Tom.com-China

·Sueddeutsche.de-Germany

·Los Angeles Times–United Kingdom

·Zamalek Fans-árabe

·OneIndia- India

·G1 Globo-Brasil

·The Washington Post– United States

·USA Today-United States

·Komika Magasin-sueco

All these tests should be performed at least in an ‘at rest’ situation. Additionally, in both cases the particle counting test should be performed also in an ‘in operation’ situation. 

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