Класс чистых комнат

Классифицируемые чистые комнаты

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Сообщение #1 admin » Вс, 21 января 2024, 22:53

В этой теме собираем информацию по требованиям к чистым комнатам

Class R” and “ISO” are two different classification systems used in the pharmaceutical industry, to describe just how clean various cleanrooms are. Cleanrooms are enclosed spaces, designed to minimise the introduction, generation, and retention of airborne particles. In the context of the pharmaceutical industry, these can include dust, powder, droplets, aerosols, or other microscopic particles that are suspended in the air. These particles can be generated during the manufacturing, packaging, or transportation of pharmaceutical products, and can pose a risk to product quality and patient safety.

The American Federal Standard 209E (FS 209E) encompasses the following cleanroom classifications: Class 100,000; Class 10,000; Class 1,000; Class 100; Class 10; Class 1 (where ‘Class 1’ is the cleanest). The cleanroom ‘class’ standard has the advantage of being easy to understand, as it relates to a real-world metric. For instance, Class R100,000 is a controlled environment, with a maximum of 100,000 particles per cubic metre of air. Although it was superseded in 1999 by ISO-14644-1, and officially withdrawn in 2001, it’s still widely used by pharma professionals to describe cleanroom standards.

The modern ISO standard uses the following cleanroom classes: ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. On this scale, ISO 1 is the ‘cleanest’ and ISO 9 is the ‘least clean’ – but remember, an ISO 9 environment is still cleaner than a normal room. For a breakdown of the ISO classification system in reference to the ‘Class R’ equivalents, please see the table below.

https://www.mecart-cleanrooms.com/learning-center ... tions-iso-8-iso-7-iso-6-iso-5/

Cleanroom Сlass А, B, C, D classification
Class A, class B, class C, class D cleanrooms refer to cleanroom cleanliness requirements for the pharmaceutical industry in European and some Asian countries.
- The classification is contained in “Revision of the Annex to the EU Guide to Good Manufacturing Practice-Manufacture of Sterile Medicinal Products.”
https://vietnamcleanroom.com/en/post/https://viet ... ss-d-cleanroom-887.htm-887.htm

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