tema renrum 2021
TRANSCRIPT
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EN/ISO Cleanroom Standards –Application to Projects and Operations
A Route-MapGordon FarquharsonNovember 2021President CCN; Chair UK BSI LBI/030; Chair CEN TC243; UK HoD ISO TC209
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EN/ISO Cleanroom Standards –Application to Projects and
Operations
Did you know there are 18 current EN ISO Cleanroom Standards?
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Agenda todayn The BS EN ISO family of International Cleanroom Standardsn Are my standards up to date?n The links to Industry sector Guidance & Regulationsn The links to other trade and profession best practices such as
commissioning of engineering systemsn Choosing the relevant standards
¨ Life sciences project¨ Other cleanroom project¨ Life sciences operations – maintaining compliance
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BS, EN & ISOn There is an important mechanism to prevent ISO & CEN from
having conflicting standards in the same subject = the Vienna Agreement (VA)¨ All the work of ISO TC209 has been carried out under the VA ¨ For ‘cleanroom standards’, ISO leads, CEN follows¨ Nations parallel vote in CEN and ISO¨ CEN is a European institution not an EU one
n EN Standards must be published as national standards in CEN member nations (UK is one)¨ Hence the EN ISO Cleanroom Standards are truly international ¨ In the UK, published as BS EN ISO 14644-xx:xxxx
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Is my standards library up to date?Are my standards current?
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ISO Standards are Generic- apply to all sectors and all aspects from design concept, through construction & testing, to routine operation.
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List of (18) standards & status September 2021n ISO Standardsn 14644-1&2:2015 – (Classification) SR confirmedn 14644-2:2015 – (Monitoring) SR confirmedn 14644-3:2020 – (Testing)n 14644-4:2001 – (Design/Construction) In rev DIS vote.n 14644-5:2004 – (Operations) Rev due to startn 14644-6:2007 – (Terminology) Withdrawnn 14644-7:2004 – (Separative Devices) Rev due to startn 14644-8:2013 - (Air chem cleanliness) Rev in progressn 14644-9:2012 - (Surface part cleanliness) Rev in
progressn 14644-10:2012 - (Surface chem cleanliness) Rev in
progressn 14644-11 – Void number
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n 14644-12:2018 (Air cleanliness nano)n 14644-13:2017 (Cleaning surfaces)n 14644-14:2016 (Equpt suitability particles) SRn 14644-15:2017 (Equpt suitability chem)n 14644-16:2018 (Energy)n 14644-17:2020 (Particle deposition)n 14644-18 (WD) (Consumable suitability)n 14698-1:2003 (Bio-contam Principles)
Replacement due to startn 14698-2:2003 (Bio-contam Evaluation data)
Replacement due to startn CEN Standardsn 17141:2020 (Bio-contam control) Replaced
EN14698-1&2 which are withdrawn)08/11/2021
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ISO WD14644-18 Consumable Suitability
ISO 14644-16 Energy
The evolving family of ISO Cleanroom Standards
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Horizontal standards – Design, Testing, Applications, Devices
Vert
ical
Sta
ndar
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lean
lines
s A
ttrib
utes
ISO 14644-3 Testing
ISO 14644-4 Design/Construction
ISO 14644-5 Operations
ISO 14644-17 Particle Deposition
ISO 14644-7 Separative Devices
ISO
1464
4-8 A
ir Che
m Cl
eanli
ness
ISO
1464
4-9 S
urfac
e Par
t Clea
nline
ss
ISO
1464
4-10
Sur
face C
hem
Clea
nline
ss
ISO
1464
4-12
Air N
ano C
leanli
ness
ISO
1464
4-13
Ass
essm
ent C
leanin
g
ISO
1464
4-14
Equ
ptSu
itabil
ity P
artic
les
ISO
1464
4-15
Equ
ptSu
itabil
ity C
hem
ISO
1464
4-1&
2 Clas
sifica
tion
ISO
1469
8-1&
2 Bio-
conta
mCo
ntrol
EN 1
7141
Bio-
conta
mco
ntrol
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Links to Regulations & Guidelines
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A logical hierarchy – The cleanroom context
Product
GMPs & Mandated Standards
Regulatory GuidanceFDA Aseptic Guide: USP<1116>:
Annex 1: PIC/S Guides
Industry MonographsISPE Baseline ®: PDA, PHSS Monographs:
Education, Training, Expertise, Competence, GEPFurther Education: Training: Publications
Technical StandardsEN/ISO 14644/series
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Critical Quality AttributesCritical Process Parameters
Performance Requirements
More detailed Performance Requirements
Operational & Test Requirements
Best Practices
Good Engineering Practices
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Applying appropriate ISO Cleanroom Standards in a logical way
Using the project stages in the new ISO DIS 14644-4:2021 ‘Design, Construction & Start-up’ standard as my RouteMap
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Part 4 – Design, Construction & Start-upn Sets a framework
strategyn Can be adapted to
small & large projects
n New build or refurbishment
n Flexible – can link to GMP Qualification practices
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Current version
Revision in progress
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ISO 14644-4:2001 (current version)
n Text describes all stages of a project
n More detailed informative guidance covers “Review and Approval stages”
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ISO 14644-4 Revision (in progress 2021)
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Using ISO CD 14644-4:2020 as a logical RouteMapIncluding GMP requirements and Qualification practices
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ISO 14644-4 Route-Map
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Business caseObjective
Budget & Timeline
GMPs Needs of Product/Process
Cleanliness AttributeISO 14644-1,8,9,10,12
ISO 14644-7
GMPs compliance requirements – Flow/Press
ISO 14644-4ISO 14644-16 Energy
Cleanliness AttributeISO 14644-17 Deposition
GMP QualificationGEP + Engineering Stds
ISO 14644-3
1,2 or 3 steps depends on complexity
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ISO 14644-4 Route-Map
ISO 14644-4
GMP Qualification
ISO 14644-5
ISO 14644-4
Engineering Commissioning &
Qualification Guides NEBB, ASHRAE,
CIBSE, ISPE, PDA
ISO 14644-5
ISO 14644-3
ISO 14644-1,2,3,8,9,10,12EN 17141
ISO 14644-1,2,8,9,10,12
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Requirements Phase standards
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Horizontal standards – Design, Testing, Applications, Devices
Vert
ical
Sta
ndar
dsC
lean
lines
s A
ttrib
utes
ISO 14644-17 Particle Deposition
ISO
1464
4-8 A
ir Che
m Cl
eanli
ness
ISO
1464
4-9 S
urfac
e Par
t Clea
nline
ss
ISO
1464
4-10
Sur
face C
hem
Clea
nline
ss
ISO
1464
4-12
Air N
ano C
leanli
ness
ISO
1464
4-14
Equ
ptSu
itabil
ity P
artic
les
ISO
1464
4-15
Equ
ptSu
itabil
ity C
hem
ISO
1464
4-1&
2 Clas
sifica
tion
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ISO 14644-16 Energy
Design Phase standards
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Horizontal standards – Design, Testing, Applications, Devices
Vert
ical
Sta
ndar
dsC
lean
lines
s A
ttrib
utes
ISO 14644-3 Testing
ISO 14644-4 Design/Construction
ISO 14644-7 Separative Devices
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Construction Phase standards
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Horizontal standards – Design, Testing, Applications, Devices
Vert
ical
Sta
ndar
dsC
lean
lines
s A
ttrib
utes ISO 14644-4 Design/Construction
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Commissioning, Start-up Phase standards
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Horizontal standards – Design, Testing, Applications, Devices
Vert
ical
Sta
ndar
dsC
lean
lines
s A
ttrib
utes
ISO 14644-3 Testing
ISO 14644-4 Design/Construction
ISO
1464
4-8 A
ir Che
m Cl
eanli
ness
ISO
1464
4-9 S
urfac
e Par
t Clea
nline
ss
ISO
1464
4-10
Sur
face C
hem
Clea
nline
ss
ISO
1464
4-12
Air N
onoC
leanli
ness
ISO
1464
4-13
Ass
essm
ent C
leanin
g
ISO
1464
4-1&
2 Clas
sifica
tion
ISO
1469
8-1&
2 Bio-
conta
mCo
ntrol
EN 1
7141
Bio-
conta
mco
ntrol
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Operational Phase standards
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Horizontal standards – Design, Testing, Applications, Devices
Vert
ical
Sta
ndar
dsC
lean
lines
s A
ttrib
utes
ISO 14644-3 Testing
ISO 14644-5 Operations
ISO 14644-17 Particle Deposition
ISO
1464
4-8 A
ir Che
m Cl
eanli
ness
ISO
1464
4-9 S
urfac
e Par
t Clea
nline
ss
ISO
1464
4-10
Sur
face C
hem
Clea
nline
ss
ISO
1464
4-12
Air N
onoC
leanli
ness
ISO
1464
4-1&
2 Clas
sifica
tion
ISO
1469
8-1&
2 Bio-
conta
mCo
ntrol
EN 1
7141
Bio-
conta
mco
ntrol
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Summary & Conclusionsn We can see how the Cleanroom Standard ISO 14644-4:2001 and
revised version establish a structure for a project.n Helps us apply appropriate standards at virtually every stage.n Business and regulatory requirements can be meshed in.n Good Engineering Practices are an essential foundation.
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This presentation has been preparedand delivered by:-
Gordon J FarquharsonPrincipal
Critical Systems LtdConsulting in Safety & Quality Critical Systems
Guildford, Surrey, GU1 2SY, UKtel +44 (0)1252 703 663
© CCN 2021
CRI ICAL
SYSTEMS
CRI ICAL
SYSTEMS
08/11/2021
Contact the Contamination Control Networkwww.theCCNetwork.org
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