New & Revised ISO Cleanroom Standards – An Update

Presented by Gordon Farquharson

August 2015

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Agenda

1. Summary status of the various ISO standards from TC209

2. A change of principle – What is a cleanroom???

3. WG1 - The revision of the basic classification.

4. WG2 - The microbiological cleanliness challenge/saga.

5. WG11- Equipment suitability.

6. WG12 - Cleaning

7. WG13 - Energy management.

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Cleanroom standards review

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Review of the standards [1]

Standard Scope

14644-1 & 2 Air cleanliness classification by particlesIn revisionPublish in mid 2015

14644-3 Test methodsIn revision Publish in Mid 2015Now just supplementary tests in addition to classification

14644-4 Design & constructionWill commence revision in 2015

14644-5 Cleanroom operations (current)

14644-6 DefinitionsWithdrawn Definitions in each standard

14644-7 Separative devices (current)

14644-8 Air cleanliness classification by chemicals (current)

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Review of the standards [2]

Standard Scope

14644-9 Surface cleanliness classification by particles(current)

14644-10 Surface cleanliness classification by chemical. (current)

14644-12 Air cleanliness monitoring by nano-particles

DIS 1st Qtr 2014 – approved.

Being revised for a 2nd DIS as a monitoring standard.

14644-13 Cleaning of surfaces

14644-14 & 15

Equipment suitability

New work recently started

Part 14 DIS passed vote

14644-16 Energy considerations

New work started in Nov 2014

14698-1 & 2 Bio-contamination

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What is a cleanroom?

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ISO TC209 – Conceptual approach for classification

Any of the surface cleanliness attributes

• Surface cleanliness by particle concentration.

• Surface cleanliness by chemical concentration.

• Surface cleanliness by microbial concentration.

Any of the air cleanliness attributes

• Air cleanliness by particle concentration.

• Air cleanliness by Nano-scale particle concentration.

• Air cleanliness by chemical (species) concentration.

• Air cleanliness by microbial concentration.

The standards were being developed with this very flexible approach!

You could classify a cleanroom by any ONE or more of the cleanliness attributes:

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ISO TC209 – Change of approach

The standards were developed following the “vision” that a cleanroom could be characterised by any one cleanliness attribute (or several in combination):

Then a change in direction

• Must be a cleanroom defined by air cleanliness by particles first;

• Then add other secondary attributes as required.

OR, if you want to use the secondary attributes alone…

Call it a Controlled Zone, not a Cleanroom or Clean-zone.

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WG1Revision of ISO 14644-1 & 2

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Why where the revisions to ISO 14644-1:1999 needed?

At the systematic review Vote, P-nations decided they wanted to improve standard:

• Reconsider the statistical model– consider removing the need to evaluate the 95% UCL for 2-9 test locations.

• When the work started, experts found problems with the existing statistical methods.

• There has been 3 years debate over the statistical confidence of finding non-compliant locations when classifying a cleanroom or clean-zone.

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Why where the revisions to ISO 14644-2:2000 needed?

This standard has to be kept in parallel with the revision of 14644-1:

• Existing standard has defined intervals between re-classification tests – Out of date concept with modern monitoring systems.

• Concept in title is not considered correct today-Cleanrooms and associated controlled environments —“Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1”

• Part 2: Monitoring to provide evidence of cleanroom performance by air cleanliness by particles (ACP)

• To become a monitoring standard only.

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ISO TC209 WG1 Timeline (9 years + in the making!)

Target publication Autumn 2015

• 2nd DIS enquiry PASSED vote in November 2014

• 1st DIS enquiry vote December 2010

• CD vote out October 2009 (This stage delayed due to challenging discussions)

• NWIP = WD 2 = CD complete Sept 06

• 4th WG 1 meeting Beijing 6-8 September 06.

• 3rd WG 1 meeting June 06 Sweden (SIS Stockholm)

Start 12th Nov 2005

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WG2The microbial cleanliness standards

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Where are we today with microbial cleanliness?

• EN ISO 14698-1:2003. Cleanrooms and associated controlled environments -- Biocontamination control -- Part 1: General principles and methods.

• EN ISO 14698-2:2003. Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data.

EN ISO 14698 1 & 2 are still in place:

• ISO TC 209 determined they needed ipdating 5+ years ago.

• ISO TC209 wg2 was re-activated to do this.

• In October 2014 (Seoul meeting), ISO TC209 decided this work should be suspended as the work hadn’t reached a technical consensus…. And was unlikely to do so.

To what extent are they used today?

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G Farquharson WG2 interim convenor observations1. WG2 covered a huge amount of ground and resolved many important

aspects of the work, but…

2. CD clearly did not contain consensus position. Needed at least another cycle of draft…….exhaustion had set in!

3. Original work item proposal was poor – not reflecting need.

4. Lack of clarity about what current guidance exists where, and what shape it is in.

5. Variable expert input, and not enough microbiologists.

6. Document too complicated for ISO.

7. Is a a cleanroom or broader contamination control standard ????

8. General confusion about Classes & Classification vs Levels & Monitoring.

• It seems to me the only way forward would have been guidance [Informative] on scientifically logical bands of progression of cleanliness + species of interest; with recommendations for monitoring.

9. Lack of agreement about Normative/Informative.

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WG2 conclusion

Unable to reach consensus position on the key scientific matters of defined classes/levels vs broader flexible approach.

In spite of Resolution ISO TC 209 N234 Resolution # 4.

No offer of convenorship.

• Time limit May 2016 DIS enquiry + possible 9 month extension.

• Means work cannot continue.

How to move forward?

With new convenor:

• Under current NWIP.• Try to work to consensus.• Deal with CD comments and prepare 2nd CD.

– Cooling off period.– Start new work sometime in the future.– Take work into CEN alone.– Take work into CEN/ISO with CEN lead, Vienna Convention.

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WG11EN ISO 14644-14EN ISO 14644-15

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Key principles

• ISO/DIS 14644-14. Cleanrooms and associated controlled environments -- Part 14: Assessment of suitability for use of equipment by airborne particle concentration.

• ISO/WD 14644-15. Cleanrooms and associated controlled environments -- Part 15: Assessment of suitability for use of equipment and materials by airborne chemical and surface chemical concentration.

− Targeted at purchasers and suppliers of equipment intended to be used in cleanrooms.

− Has normative and informative methods for evaluation of contamination risk.

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Equipment suitability

Normative method:

• In UDF zone.

• Looks at critical control point(s).

Informative method:

• Suitable for non-UDF zones.

• Total emissions approach (body box).

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WG12 Cleaning

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Principles

ISO/WD 14644-13

Cleanrooms and associated controlled environments -- Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications.

• A little controversial.• Tends to focus on

process component cleaning.

• Uses classification and monitoring techniques to determine the effectiveness of the decontamination activity.

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WG13EN ISO 14644-16

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Principles

Standard in development: BS ISO 14644-16

Cleanrooms and associated controlled environments Part 16: Code of practice for improving energy efficiency in cleanrooms and clean air devices.

• Intended for NEW and EXISTING facilities.

• Supports ISO 50001:2011 – Energy Management System.

• Defines aspects offering energy savings that should be considered:

− From choosing the right level of cleanliness to guidance about air-change rates in Non-UDF rooms based on source strength of loads.

− Includes good design practice.

− Includes operational options e.g. silent hour set-back etc.

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Conclusion

I hope you found this update of ISO standards changes useful.

• Look out for the new 14644-1& 2 this year.

• Keep track of all the developments – there are lots of them!

• The scope and depth is continually developing.

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Thank you for your time.Questions?

Gordon Farquharson

gordon.farquharson@pharmout.net

Executive Consultant

www.pharmout.net