iso cleanroom standards orrg july 2012 - conor murray
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Conor MurrayChairman - Irish Cleanroom Society
Head of Delegation for Ireland at ISO TC 209
Update on ISO CleanroomStandards – 14644 & 14698
www.cleanrooms-ireland.ie
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Conor Murray, an Engineer by profession is an independent Technical Expert on GMP Cleanrooms and Biosafety Labs Conor is a founder member and Chairman of the Irish Cleanroom Society, (ICS). Conor is a past Chairman of the ICCCS, (International Confederation of Contamination Control Societies) and currently Chairman of the ICEB, (International Cleanroom Education Board)Conor is Head of Delegation for Ireland representing the NSAI at ISO TC 209 and is on WG 01 & WG 02Conor is Convener of Sub Group 13, (Cleanrooms) on the Health Care Standards Consultative (HCSC) committee Conor's particular areas of expertise include Green and Energy Efficient Modular Design, Lifecycle Sustainability, Process Integration, RABS and Fast Track Clean Build Construction
Conor Murray Bio
Irish Cleanroom Society
ISO 14644 & 14698 Overview
ISO DIS 14644 -1 & -2:2011 – WG 01
14698 -1 & -2:2003 – WG 02
Presentation Content
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Irish Cleanroom Societywww.cleanrooms-ireland.ie
The Irish Cleanroom Society (ICS) is a not for profit membership subscription based organisation formed in 1998 to represent cleanroom professionals in IrelandThe ICS is affiliated to the International Confederation of Contamination Control Societies (ICCCS)The primary focus is to promote best practice knowledge and skills, understanding and harmonisation of cleanroom and contamination control technology and standards among users and professionals in Life Sciences, Healthcare, Food, Microelectronics and Micromanufacturing
Irish Cleanroom Society
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ICS Objectives
Promote the development of cleanroom and contamination control technologies throughout Ireland
Heighten the awareness of cleanroom and contamination control technology among all users inc industry, educational, institutional establishments, government bodies & the public
Assist in the standardisation and harmonisation of cleanroom and contamination control
Organise seminars, exhibitions and peer to peer forum workshops for the dissemination of knowledge & experience gained in cleanroom and contamination control technology
Represent Ireland on the international stage
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ICS & Education
Education and Training are at the core of ICS activitiesThe ICS has been a major contributor to the CTCB-I (Cleanroom Testing and Certification Board -International) since its inauguration in 2002 and has provided nearly 20 Cleanroom Technology and Testing courses with over 200 candidates from Ireland and around the world Since 2005 the ICS has helped lead the ICEB initiative of the ICCCS to accredit, harmonise & licence cleanroom training courses across national cleanroom societies with the emphasis on certification through examination
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ICS on the International Stage
The ICS represents Ireland at international level on ISO TC 209 for cleanroom standarisation where Ireland is a voting member Conor Murray is Head of Delegation for Ireland & a subject matter expert on the TC & a number of WGs The ICS is an active member of the ICCCS, International Confederation of Contamination Control SocietiesICS an active member of the International Cleanroom Education Board (ICEB)Ireland hosted the 21st biennial symposium in 2008
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ICS Linkages in Ireland
The National Standards Authority of Ireland are the Irish representative body in CEN and ISO Standards organisationsTheir Health Care Standards Consultative (HCSC) committee has established a subcommittee, SC 13 concerning cleanroomsThe Irish Cleanroom Society play a leading part in this. Conor Murray is Convener of SC 13 and represents Ireland at ISO TC 209 concerning Cleanrooms and associated controlled environmentsThe ICS works closely with FAS on cleanroom training and up skilling
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International Cleanroom Education Board (ICEB)Part of International Confederation of Contamination
Control Societies (ICCCS)Set up in 2007ICS playing a significant leadership role internationallyCTCB-I initiative set up with S2C2 in 2001CTCB-I now includes Scandinavian Countries (R3) of
Norway, Sweden and Denmark & The Netherlands (VCCN)
Capturing interest from the US, Baltic, Far East, South Africa, Egypt
ICS Initiatives - Education
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5 ICEB accredited coursesCleanroom Testing – CTCB-I (‘03 250)Advanced Cleanroom Technology - CTCBi
(‘05 100)Airborne Particle Counting – CTCB-I (‘08 20)Introduction to Cleanrooms - SSE (‘09 50)Cleanroom Cleaning - FLO (‘09 40)
ICS Initiatives - Education
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ICS & International Associations
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Participation in Working Groups in TC 209 on
cleanroom standards
WG 01 - revision of ISO 14644 - 1 & 2 Classification by
total airborne particles
WG 02 - revision of ISO 14698 – Biocontamination
(Irish Biocontamination Mirror Group)
WG 03 - revision on ISO 1464 - 3 Metrology
ICS Initiatives - ISO TC 209
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ICS & ISO TC 209
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ISO 14644 & 14698
- Overview
ISO 14644 & 14698 Standards
ISO Document Title
ISO-14644-1 Classification of Air Cleanliness - 1999
ISO-14644-2 Testing for Continued Compliance to -1 - 1999
ISO-14644-3 Test Methods & Metrology - 2005
ISO-14644-4 Design, Construction & Start Up
ISO-14644-5 Cleanroom Operations
ISO-14644-6 Terminology - 2007
ISO-14644-7 Separative Enclosures
ISO-14644-8 Classification of Airborne Molecular Contamination - 2007
ISO-14698-1 Biocontamination: General Principles - 2003
ISO-14698-2 Biocontamination: Eval’n & Interpretation of Data - 2003
Status
WG01
WG01
WG03
2001
2004
SG06
2004
WG08
WG02
WG02
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ISO 14644 & 14698 Standards
ISO Document Title
ISO-14644-1 Classification of Air Cleanliness - 1999
ISO-14644-2 Testing for Continued Compliance to -1 - 1999
ISO-14644-3 Test Methods & Metrology - 2005
ISO-14644-4 Design, Construction & Start Up
ISO-14644-5 Cleanroom Operations
ISO-14644-6 Terminology - 2007
ISO-14644-7 Separative Enclosures
ISO-14644-8 Classification of Airborne Molecular Contamination - 2007
ISO-14698-1 Biocontamination: General Principles - 2003
ISO-14698-2 Biocontamination: Eval’n & Interpretation of Data - 2003
Status
WG01
WG01
WG03
2001
2004
SG06
2004
WG08
WG02
WG022 new standards under development to cover 2 new standards under development to cover
SCP via WG9 & SCP via WG9 & --9 and SCC via WG8 & 9 and SCC via WG8 & --1010
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ISO 14644 TD Proposal
Deals with the role of an ISO 14644 Technical Document as an Overview, Introduction, Explanation and Context in dealing with updates and changes to ISO 14644 & ISO 14698 re airborne and surface cleanliness classification by total particles, viable, chemical and nano particles
Approved in Milan 2011- to be presented to ISO TC 209 in Zurich, September 2012
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ISO 14644 Issues
Historical development and focus on Airborne Particles
New standards deal with surfaces, chemicals and nanoparticles
Need backward compatibility
Where to put the history, context, perspective, objectives, usage & application notes
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Existing definition of cleanroom relates to airborne particles ie total particle concentration in air
New definition needs to address the concept of a controlled environment where the control could be total particles, viables or chemicals in air and/or on a surface
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ISO 14644 Issues
ISO 14664/ 14698 StructureTotal
ParticlesViable
Biocontamination Chemical Nano-particles
ACC
SCC
Airborne
Surface
ACP
SCP
ACN ?
SCN ?
ACV
SCV
TotalParticles
ViableBiocontamination Chemical Nano-
particles14698-1 14698-214698-1 14698-2Surface
Airborne 14644-1
14644-9
14644-8
14644-10
14644-?
14644-?
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ISO Support StandardsStandard
14644-6 Terminology Terminology
14644-7 Separative Devices Separative Devices
Design, Construction & Startup
14644-5 Operations Operations
14644-4 Design, Construction & Startup
Testing for Ongoing Compliance to 14644-1
14644-3 Test Methods Supporting Test Methods
14644-2 Testing for Ongoing Compliance to14644-1
Existing New
14698-? Supporting ?
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ISO DIS 14644 -1 & - 2
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Apply good science and statistics
Remove confusion and inconsistencies
Simplify terms
Use more precision
Use a Table for Classification instead of the
universal formula
ISO DIS 14644 -1 & -2
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DIS Vote May ‘11 – unanimous but > 200 comments
Differences over no of samples for confidence level and maximum area to determine classification
Differences over method of selection of sample locations, application of statistics – random selection
Differences over treatment of 5 micron particles
Differences over normative use of ISO 21501-4
ISO DIS 14644 -1Copenhagen
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DIS Vote May ‘11 – unanimous
Decided to remove classification and keep to
Periodic Testing & Monitoring
Agreed that Classification and Periodic Testing are
NOT the same – amount of testing
Differences over inclusion of Differential Pressure
ISO DIS 14644 -2Copenhagen
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ISO 14698 -1 & -2:2003
- Biocontamination WG 02
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ISO 14698 -1 & -2: 2003
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ISO 14698 not in line with ISO 14644No Tables of ClassificationNot up to date with Risk Assessment & Risk Management techniques (eg ICH Q9 QRM)No Check Lists of “Things to Consider”Not up to date with technology advances in Rapid Microbiological Methods (RMM) & Instantaneous Microbiological Detection (IMD) (eg ATP, Bioluminescence)
ISO 14698 Issues
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Cannot “Monitor a process into Control”Not enough clarity on differences, issues and guidance on Aseptic vs Non Sterile applicationsNot enough guidance on Airborne vs Surface biocontamination risks and controlOverall seen as not easy to read & use
ISO 14698 Issues
IS O/TC 2 09 N 187 Re solutions from ISO/ TC 20 9 Mee ting 9-10 Nov em be r 2007 Résolutio ns de l' ISO/T C 209 (19 èm e réu nion, 9 et 10 Novembre 2007) Re solution 1 IS O/TC 209 reso lves th at WG 2 co mmence s work on these two documents :
a. C lassi fication of airb orne bioconta minatio n in c leanroo ms, inc luding metho ds of measure ment a nd their valida tion.
b. C lassi fication of s urf ace biocontaminatio n in c le anroo ms, including method s of measure ment a nd their valida tion.
At t he appropriat e time during the de velopment of these docu ments, t he position of IS O 14 698
Parts 1 a nd 2 sh ould b e cons idered, as wel l as a Risk Manage ment St andard. (All in fa vor)
ISO TC 209Preliminary Work Items WG02
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ISO Standards are NOT industry specific -Bird’s Eye view from 25,000 feetNormative (Must do) & Informative (Should do)Based on good science with clear and
independent guidance Short & concise, easy to read & use
Check Lists, flow charts, suggested methods, options on best practice methods, choices, examples.
ISO Standard Principles
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Working Group is a team of international experts nominated by each member countryTerms of reference set by TC 209Duration varies but typically 2 - 5 yearsAct as Subject Matter Experts (SMEs) in their
field
ISO Working Group Principles
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Capture best science and international expertise“Get all the toys on the table” and play with themEverything on the tableOpen dialogue encouraged until the endLet “good science” prevail
ISO Working Group Principles
Current measurement ‘technologies’ limited to orders of magnitude resolution, especially in low density populationsSpecies recovered using these technologies
limited due to incubation methodology (inc media, temperature, pH, aerobic/anerobic, etc.)“Environmental microbiologists recent research
indicate that some species are inter-dependant & one species will not culture successfully
without the presence of the other”
ISO 14698 Challenges- Limitations of Quantitation
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People are the greatest source of biocontaminationUnpredictability and uncertainty of Human
behaviour“80% of the species found in the human upper
respiratory tract cannot be recovered”
ISO 14698 Challenges- Diversity of People
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Below limit of resolution for current technologies
i.e. 1 cfu recovered may be indicative of 1cfu or perhaps >10cfu, impossible to accurately and repeatably determine
Risk of false positives high due to likelihood of accidental contamination during collection and incubation
ISO 14698 Challenges- Issues in clean spaces
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In some cases, all species are considered harmfulIn some cases there is ‘background counts’ of
cfu of species considered ‘normal and non-harmful’In some cases, some species are considered
‘objectionable’ and are not tolerated at all
ISO 14698 Challenges- Process/ Application Specific
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“In Grade A and B zones, the monitoring of the ≥5.0 μm particle concentration count takes on a particular significance as it is an important diagnostic tool for early detection of failure.”“... consecutive or regular counting of low
levels (of ≥5.0 μm) is an indicator of a possible contamination event and should be investigated.”Particles ≥5.0 μm could be skin particles
carrying biocontamination
Aseptic Processing- 5μm Particles & EU GMPs
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ISO 14698- Proposed New Structure
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New ISO 14698 Flowchart
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New ISO 14698 Flowchart
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New ISO 14698 Flowchart
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Risk Analysis/ Assessment
Risk Management
Establishing (Risk) Control
Proposed New ISO 14698 -1- Establishing Control
Identify ‘typical, non-harmful’ species- typical in cleanroom- not harmful to product or application/customer
Identify ‘objectionable’ species- atypical in cleanroom- harmful to product and/or harmful to customer
ISO 14698- Establishing Control Step 1
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For “normal, non-harmful”:- establish typical ‘background counts’, e.g. <10cfu- establish acceptable incidence of higher than normal counts, where maximum limit is defined- anything above incidence rate or maximum triggers investigation
ISO 14698-Establishing Control Step 2
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For “Objectionable”:- establish acceptable incidence, including maximum number process will tolerate- anything above incidence rate or maximum triggers investigation
ISO 14698- Establishing Control Step 3
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Classify your process/cleanroom:“Normal, non-harmful”- species- by ‘background counts’- by acceptable incidence of ‘higher than normal’ (maximum limit is defined)
“Objectionable”- establish acceptable incidence, including maximum number process will tolerate per incidence
ISO 14698- Establishing Control Step 4
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ISO 14698- Airborne Classification
Class *Airborne limit In Operation
cfu/m3
ACVx 1 <10# ACVx 2 < 100 ACVx 3 < 1000 ACVx 4 < 10000
1. *Combined with an appropriate incidence rate2. ‘x’ is the species of interest3. # still under discussion (added error by air collection
method)4. Intermediate classes are permitted, eg SVCx 3,5
Surface Contamination Class (SCV)
*Surface Count Limit (CFU)
Sampled Area
SVCx 1 <4 1 m2
SVCx 2 <40 1 m2
SVC x3 <40 1 cm2
SVCx 4 <300 1 cm2
SVC x5 >300 1 cm2
1. Numbers are open for further discussion
2. *Combined with an appropriate incidence rate
3. ‘x’ is the species of interest
4. Intermediate classes are permitted, eg SVCx 3,5
ISO 14698- Surface Classification
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Next meeting – Zurich Sept 2012
New Work Item Proposal (NWIP)
Formal Vote required for approval
ISO timetable of CD, DIS FDIS, & IS over 3 years
ISO 14698- WG 02
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Thank You for Your Attention
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