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Measurements of total particle count in the cleanroom

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Measurements of total particle count in the cleanroom

Postby vertak » 25 Nov 2016, 01:58

Facility design - Design Clean Room Project that support the process within the cleanroom should be established by the user organization. Parameters such as temperature and humidity may be process driven or comfort driven, and therefore selected to accommodate specific comfort or process requirements as determined by the end user

Local control - Under some circumstances, cleanliness requirements can be achieved through the use of localized controls such as clean tents, glove boxes or isolators. These provide unidirectional filtered airflow within a limited area. They may be located within a facility that provides the necessary temperature and humidity conditions or they may be provided with integral environmental control equipment designed to maintain necessary conditions.

Measurements of total particle count in the cleanroom is described in Federal Standard 209. This count may be composed of viable, non-viable, or non-viable host particles with a viable traveler. There is no generally accepted relationship between total particle count and viable particle count. While maintaining appropriate particle counts is important in design and operation, a protocol designed to identify viable particles should be inherent in the certification/validation testing of a bio-pharmaceutical cleanroom.

No facility will compensate for excessive contamination generated within it. In addition to effectively facility design, the user must also institute a routine maintenance program as well as maintain personnel and operational disciplines that limit particles generated within the facility as well as entry of particles into the facility.

As the demand for complex cleanrooms in the life sciences grows, construction challenges mount. Making the right decisions during the building and commissioning phases of Clean Room Panels will help to ensure that they are successful, better integrated, more operable and sustainable. Generally speaking, teamwork among designers, operators, maintenance people and builders that focuses on project timelines will achieve the best results. The suggestions below will help drug and device manufacturers step back and better envision the whole facility during the build process.
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