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.
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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 m 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.