bc-technology GmbH Reinraumtechnik

Our cleanroom portal is a collection of useful links concerning the subject of cleanroom technology
and also offers definitions of specialist cleanroom terms.

Service sites

Support, training, comments, standard work in GMP environment.
Here you can find, for example, the famous "GMP Guide"
www.gmp-verlag.de
Here you can find all international authorities and associations
www.gmp-verlag.de/links
A comprehensive information portal concerning the subject of "GMP"
www.gmp-navigator.com
Here you can find interesting articles on the subject of cleanroom technology
www.reinraum-online.de
DIN EN ISO 14644 and all other DIN standards
www.beuth.de/langanzeige/DIN+ISO+14644-2/35431737.html
VDI Directive 2083 and all other VDI Directives
www.vdi.de
The RLT Directives are a valuable aid and reflect the latest technical standards
www.rlt-geraete.de/joomla/index.php
Freeware for visualisation of climatic processes in the Mollier hx diagram
http://www.ilkdresden.de/hxdia/index.htm 

terms of the cleanroom technology

Cleanroom
= a delimited area in which the number of airborne  particles is kept as low as necessary.
This number of particles is controlled by air flow, humidity, air pressure and room temperature.
 
A cleanroom is used for example in the , pharmaceutical industry, for medical technology, biotechnology, food technology,  microelectronics, laser technology, optics, semi-conductors and solar technology.
Further information is available at:

http://en.wikipedia.org/wiki/Clean_room

Laminar flow
= the movement of air and gases where no turbulence (swirls/cross-flows) occurs.
Generally this is understood as a usually vertical, low-turbulence air flow which reduces the re-suspension of existing particles and carries them off via the downward air flow.
Laminar flow conditions are created by special systems with fans, filters and air diffusers . The room in which laminar flow occurs has a defined  cleanroom quality, as possible particles  are blown away.
Further information is available at:

http://en.wikipedia.org/wiki/Laminar_flow

GMP = Good Manufacturing Practice
= This refers to the directives for quality assurance of production processes and environments in the production of pharmaceuticals, active agents  and medical products but also of food and feedstuffs.
In  pharmaceutical production , quality assurance plays a central role, as here quality deviations can have a direct effect on the health of the consumers. A GMP-compliant quality management system serves to ensure product quality and fulfil mandatory requirements of the health authorities for marketing.
Further information is available at:

http://en.wikipedia.org/wiki/Good_manufacturing_practice

HEPA filter
For the classification of various filter efficiencies, the particle filter classes 1 to 17 are used in Europe. The higher the number used, the higher the guaranteed degree of filtration.
In accordance with the known filter effects, particles of 0.1 to 0.3 micrometres are the most difficult to filter. Therefore, HEPA filters are classified on the basis of their effectiveness with regard to these particle sizes by means of a DEHS (=di-2-ethylhexyl-sebacate) test aerosol.
Further information is available at:

http://en.wikipedia.org/wiki/HEPA

Particle filter classes
http://de.wikipedia.org/wiki/Partikelfilterklassen

Air-conditioning unit
In the cleanroom, an air-conditioning unit serves to generate and maintain even climatic conditions in the room. The required temperature, humidity and air quality are produced and kept constant in the room.

Air types
http://de.wikipedia.org/wiki/Luftarten

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