Changes to ISO-14644-1 & 2

Marsha Stabler Hardiman

 Presenter
Marsha Stabler Hardiman
Over 20 years experience in the Pharmaceutical and
Medical Device industries
Microbiologist
Former ISO Notified Body Auditor Microbiology Expert
Senior Consultant, ValSource LLC
 Presentation Outline
ISO 14644 Series Overview
Background ISO 14644
Changes to ISO 14644 Part 1
Changes to ISO 14644 Part 2
Q&A
 Where To Purchase ISO 14644-1 &2 FDIS

www.iest.org
DOCUMENT TITLE STATUS
ISO 14644-1 Classification of air cleanliness ANSI Standard 1999

ISO 14644-1 Classification of air cleanliness FDIS Aug. 2015

by particle concentration (827//15 10/27/15 voting)

DIS Sept. 2014

(9/18/14 11/18/14 voting)

ISO 14644-2 Specifications for testing and ANSI Standard 2000

monitoring to prove
continued compliance with
14644 -1

ISO 14644-2 Monitoring to provide FDIS Aug. 2015

evidence of cleanroom (8/27/15 10/27/15 voting)
performance related to air
cleanliness by particle DIS Sept. 2014
concentration (9/18/14 11/18/14 voting)
DOCUMENT TITLE STATUS
ISO 14644-3 Test methods ANSI Standard 2005

ISO 14644-4 Design, construction and start- ANSI Standard 2001

up

ISO 14644-5 Operations ANSI Standard 2004

ISO 14644-7 Separative devices (clean air ANSI Standard 2004

hoods, gloveboxes, isolators,
minienvironments
ISO 14644-8 Classification of air cleanliness ANSI Standard 2013
by chemical concentration
(ACC)
DOCUMENT TITLE STATUS
ISO 14644-9 Classification of surface cleanliness ANSI Standard 2012
by particle concentration

ISO 14644-10 Classification of surface cleanliness Standard 2013

by chemical concentration

ISO/DIS 14644-12 Classification of air cleanliness by DIS April 2013

nanoscale particle concentration
 ISO 14644 Background
US Federal Standard 209E Airborne Particulate
Cleanliness Classes in Cleanrooms and Clean Zones
Fed Std 209E published June 16, 1988
As time progressed
Cleanrooms became more sophisticated
Need for wider ranging standards
Need for a single standard for cleanroom
classification and testing
This lead to the formation of ISO 14644
 ISO 14644 Background
The first document of ISO 14644 was published in
1999, ISO 14644-1
In 2000, ISO 14644-2 was published, which began the
process of FED-STD-209E being cancelled
The U.S. General Services Administration (GSA)
released a Notice of Cancellation for FED-STD-209E,
Airborne Particulate Cleanliness Classes in Cleanrooms
and Clean Zones, on November 29, 2001 and FED-STD-
209E was then superseded by ISO 14644-1 and ISO
14644-2
 ISO 14644 Background
In December 2010, revisions of ISO 14644-1
and -2 were released as Draft International
Standards.
In September 2014, a second edition of
revisions to ISO 14644-1 and -2 were released
as Draft International Standards
August 27, 2015 FDIS released for final 2 month
vote
Some ISO Abbreviations for Some
ISO Standards Process Steps
Creation of a New Technical Committee (TC)
New Work Item Proposal (NWIP)
Form Working Group (WG)
Committee Draft (CD)
Draft International Standard (DIS)
Final Draft International Standard (FDIS)
DIS 14644-1 & 2 Dec 2010
A draft with revisions to 14644-1 was
published Dec 2010 for the DIS review,
comment and vote
The vote was undertaken
This period is the first time that draft
documents were opened up beyond the TC
group for review and comment
Comments went back to the ISO central
secretariat with the national vote
DIS 14644-1 & 2 Dec 2010
National voting was in favor of approval of
both ISO 14644-1 & 2 subject to comments
being addressed
Rules require that ALL comments are
considered and reported for the record
DIS Period was Dec 2010 May 2011
Technical and/or editorial comments needed
to be addressed
DIS 14644-1 & 2 Dec 2010
ISO TC209 WG1 met to consider the comments
and issues raised by the industry
They determined that the nature of the
comments and the likely changes were so
significant that a new DIS would be needed
and a new vote would be required
DIS 14644-1 to FDIS 14644-1
Edits made by WG 1
Sept 18, 2014 DIS went out for 2nd DIS vote
November 18, 2014 voting closed
Post voting - WG 1 met to resolve new
comments from 2nd DIS vote
August 27, 2015 FDIS issued for vote
FDIS 14644-1 Highlights
Exclusion of particles > 5 microns from the
classification table for ISO Class 5
Determination of sample points required for
classification of a cleanroom compared to the 1999
version
Locating sample points within a cleanroom
Removal of 95% Upper Confidence Limits
Risk based locations
Dealing with super huge cleanrooms
Instrument Calibration
 Title Changes
ISO 14644-1 1999 Classification of air cleanliness
ISO/FDIS 14644-1 2015 Classification of air
cleanliness by particle concentration
ISO 14644-2 1999 Specifications for testing and
monitoring to prove continued compliance with
14644 -1
ISO/FDIS 14644-2 2015 Monitoring to provide
evidence of cleanroom performance related to air
cleanliness by particle concentration
 Particle Concentration Table
Table to be used for airborne particle
cleanliness classification
Intermediate Classes in Annex
 Removal of 5 micron particle at
ISO 5
Removing the > 5 micron particle
concentration in ISO 5
Note - In the old FS209E, Class 100 did not have a
5 micron testing requirement
 Incorporate ISO 21501-4
The requirement that all light scattering
airborne particle counters be calibrated to ISO
21501-4:2007 criteria
Guidance on what to do if you cannot meet this
Number of Sample Locations
Significant change in the standard
Adoption of a more consistent statistical
approach to the selection and the number of
sample locations and the evaluation of data
collected
Approach allows for each location to be
treated independently
Number of Sample Locations
The minimum number of sample locations compared to
1999 has changed increased to give 95% confidence level
Table replaces the square root of the area of the room
equation
Quick look-up table to define required number of samples
Dividing room into sectors and sampling at locations in
each sector
Allows for additional sample locations to be selected for
critical locations based on risk analysis
 Remove 95% Upper Confidence
Limit
The requirements to calculate the 95% upper
confidence limit(s) for 2 to 9 sample locations was
removed
 Positioning of Sample Locations
Discusses how to select sample locations once
the number has been determined from the
lookup table
 Other 14644-1 Changes
Annexes reordered
 Larger Cleanrooms
FDIS version says use the Table for cleanrooms
up to 1000 m2
Use equation for larger cleanrooms
 ISO 14644-2
Emphasizes the need to consider a monitoring
strategy in addition to the execution of the
classification of a cleanroom or clean zone
As you collect more data after initial
classification, your on-going monitoring will
help you better assess how your cleanroom
operates
Benefits From Routine Monitoring
Faster response to adverse events and
conditions
Ability to develop trends from data over time
Enhanced knowledge of installation and
process allows for more effective risk analysis
Reduction in operation costs and product
losses
 Risk Assessment
ISO 14644-2 specifies the requirements of a
monitoring plan, based on a risk assessment of the
intended use
Data will provide evidence over time of continued
cleanroom or clean zone performance related to air
cleanliness by particle concentration
 Regulatory
Relevant regulatory agencies may impose
supplementary policies or restrictions
You must adapt the monitoring procedures to
comply
 In Operation Results
The level of airborne particles measured during
monitoring will likely be higher than the levels
observed during at rest classification
Number of people present, airflow rate,
ventilation effectiveness, operation of
machinery/equipment, activities in adjacent
spaces will impact observed results
Changes to Monitoring Plan
Significant changes require revisions to
the monitoring plan
Periodic reviews of the monitoring plan
should be conducted based on data and
experience
 Monitoring Plan
Guidance given for:
Creation of the Plan
Use of Risk Assessment
Review and approval of your monitoring
Implementing
Data analysis
Review the monitoring plan periodically
 Periodic Classification
Periodic classification requirements
Use of risk assessment and data to help you
determine frequency
 Annexes
Informative Annexes provided to guide you in
how to set your plans
 Next Steps
FDIS voting closes end October 2015
 References
ISO/FDIS 14644-1.2
ISO/FDIS 14644-2.2
Revision of ISO 14644-1:1999 A progress
report and explanation of some of the key issues
and principles, G. Farquharson, June 2012
Overview and History of ISO 14644 Standards,
IEST, http://www.iest.org/Standards-RPs/ISO-
Standards/ISO-14644-Standards
 Thank You
Marsha Stabler Hardiman
ValSource LLC

mstabler@concordiavalsource.com
949-412-6683