클린룸 환기횟수 관련 가이드라인(1) FDA, WHO TRS.961

[FDA Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (2004)]   C. Clean Area Separation   Air change rate is another important cleanroom design parameter. For Class 100,000 (ISO 8) supporting rooms, airflow sufficient to achieve at least 20 air changes per hour is typically acceptable. Significantly higher air change rates are normally needed for Class 10,000 and Class 100 areas

ACH는 클린룸 디자인에서 중요한 요소로 Class 100,000(ISO 8)의 청정실에서 환기횟수는 적어도 20회/hr이 적절하다.

Class 10,000과 Class 100 지역엔 일반적으로 더 많은 환기횟수가 필요하다.

 

 

[WHO Technical Report Series, No. 961, 2011 Annex 5 Supplementary guidelines on good manufacturing practices for heating, ventilation and airconditioning systems for non-sterile pharmaceutical dosage forms] 4.1.4 Air filtration and air change rates should be set to ensure that the defi ned clean area condition is attained.   4.1.5 The air change rates should be determined by the manufacturer and designer, taking into account the various critical parameters using a risk based approach with due consideration of capital and running costs and energy usage. Primarily the air change rate should be set to a level that will achieve the required clean area condition.   4.1.6 Air change rates are normally determined by the following considerations (could normally vary between 6 and 20 air changes per hour): • area condition required: whether a specifi c room cleanliness condition is in fact required and whether the room condition is rated for an “at rest” condition or an “operational” condition (air change rate should be selected on need rather than tradition) • the product characteristics (e.g. odours, hygroscopicity, etc) • the quality and fi ltration of the supply air • particulates generated by the manufacturing process • particulates generated by the operators • configuration of the room and air supply and extract locations • sufficient air to achieve containment effect and to clean up the area • sufficient air to cope with the room heat load • sufficient air to balance extract rates • sufficient air to maintain the required room pressure.

환기횟수는 일반적으로 다음의 사항을 고려하여 결정한다(일반적으로 6~20회/hr 사이)

- 본 가이드라인은 '비무균제제'이므로 언급한 6~20회/hr는 Grade D/C 라고 생각할 수 있음.