New Changes in ISO 14644-1:Classification of Air Cleanliness
Most awaited update to ISO 14644-1 is released and it has good changes those are useful for pharmaceutical manufacturing facilities.
ISO 14644 Part 1 is a useful guideline to maintain the good manufacturing practices in sterile pharmaceutical manufacturing as well as the oral dosage
forms. This document provides the standards for the clean room classification. Revision of the guidance was started since 2007 and its drafts are already
published in 2011, 2012, 2014 and 2015 but none was finalized and 1999 version was applicable and expecting a new version.
Finally a 2015 version is released and following are the major changes those are made in 1999 version of the ISO 14644-1.
1. Title of the ISO 14644-1 is changed from “Classification of air cleanliness” to “Classification of air cleanliness by particle concentration”.
2. The number of sampling points in the area is no longer calculated as the square root of the surface area formula but it is now taken from the table given
below.
3. Formula to calculate the particle concentration (Cn) in respective classification number is no longer used and value is taken directly from the table.
4. Particles of 5 µm in ISO 5 class have been removed from the limit value table as given below.
5. UCL calculation is not required now: there is no need to perform an observation of all measuring points in the room any longer. Each single measuring
point is considered individually and has to meet the limit value.
6. The length of tubing used in particle counter should be less than 1 meter.
7. The classification number, the air sample volumes, measuring time as well as the cancellation criterion is not changed and remains as same to the
version ISO14644-1:1999.
All SOPs and qualification protocols in pharmaceutical manufacturing related to the HVAC system and cleanroom management should be changed
accordingly.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical
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