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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.

Number of sampling locations

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.

ISO Classification

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, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

10 comments: Post Yours! Read Comment Policy ▼

  1. please is there any mistake , it shows on area of 68 m2 is 12 locations, but for 64 m2 is 13 locations !!

    is this right ??

  2. yes that was a typo mistake and has been corrected.

  3. let me know recent usfda guidelines for purified water/wfi and hvac.
    and what 21 cfr says about pharmaceutical engineering

  4. is it reqired to monitor temperature and humidity for non classified areas in periodic performance qualifications.
    pls give me answer sir.

    we are monitoring 8hrs readings with interval of 30 minutes for each rooms after every two years periodic performance qualification for all AHU.

    1. Yes, you should monitor storage areas for humidity and temperature.

  5. Dear Sir
    Please suggest to me recoverY test of AHU With corelated with Power Failure

  6. Dear sir can we refers these sampling location for RLAF unit.

  7. what is the new limit of particle count of ISO-5 Rest & operation conditions.

  8. What is the particle counter run time in class - B


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