Tiêu chuẩn iso 14644 2 2015

© ISO 2015 Cleanrooms and associated controlled environments — Part 2 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration Salles propres et env[.]

Cleanrooms and associated c ontrol ed

Part 2:

S le s pro re s et en iro nement maîrisés a p r ntés —

Partie 2: S rveilla c du maintien de s pe f rma ce s de la sale pro r

p ur la pro r té p rticulaire de l’air

COPYRIGHT PROTECTED DOCUMENT

© ISO 201 , P blshed in Sw itz rlan

A ll rig hts r eserved Unles otherw ise spe ified, nopar of this p blc tion ma y be r epr od c d or utilz d otherw ise in an form

or b an me ns, ele tr onic or me hanic l, inclu in p oto opying , or postin on the internet or an intranet , w ithout prior

written permis ion Permis ion c n be req esed from either ISO at the ad r es below or ISO’s member bod y in the c u try of

F reword i v

Introduction v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms and definitio s 1

4 Cr eating, implementing and maintaining a mo itoring plan 2

4.1 Principle 2

4.2 R isk as es ment 2

4.3 Monitoring plan 3

4.4 Calbration 3

4.5 Review an a pr ov l 4

4.6 Response to a deviation d ring monitoring 4

5 Perio ic clas ificatio of air cle nlnes by particle c onc entratio 4

A nne x A (informative)Mat er to c onsider when developing a monitor ing plan 5

A nne x B (informative)Co sideratio s for set ing aler t and actio levels 9

Biblog raphy

.14

ISO (he Int ernational Org nization for Stan ardization) is a worldwidefede ation of national s an ards

b dies (ISO membe b dies) The work of pr p ring Int ernational Stan ards is normaly car ied out

through ISO t ech ical committ ees Each membe b dy int er st ed in a subje t for w hich a t ech ical

committ ee has be n es a lshed has the right t o be r pr sent ed on that committ ee Int ernational

org nizations, g ove nmental an non-g ove nmental, in laison with ISO, also take part in the work

ISO cola orat es closely with the Int ernational Ele trot ech ical C mmis ion (IEC) on al matt ers of

ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www.iso.org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sponsible for identifying any or al such p t ent right Detais of

any p t ent right identified d ring the develo ment of the document wi be in the Introd ction an / r

on the ISO ls of p t ent de larations r c ived ( e www.iso.org p t ent )

Any trade name used in this document is information given for the convenienc of use s an does not

cons itut e an en orsement

F or an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lat ed t o conformity

as es ment, as wel as information a out ISO’ s adhe enc t o the WTO principles in the Te h ical

Bar ie s t o Trade (TBT) se the fol owing URL: F or word - Sup lementary information

The committ ee r sp nsible for this document is ISO/TC 2 9, Clea ro ms a d as s oc iated c ontroled

env iro ments

This se on edition canc ls an r plac s the firs edition (ISO 14644- 2:2 0 ), w hich has be n

t ech icaly r vised throughout

ISO 1464 consis s of the fol owing p rt , un e the g ene al title Clea ro ms a d as soc iated c ontroled

env iro ments:

— Part 1: Clas s ific atio  o air clea lnes s b  p rticle c onc entratio

— Part 2 : Mo itorin  to prov ide evidenc e o clea ro m pe frma c e r lated to air clea lnes s b  p rticle 

c onc entratio

— Part 3 : Tes t meth ds

— Part 4 : Des ig ,c ons truc tio a d s tart-u

— Part 5: Ope atio s

— Part 7: Sep rati ve dev ic es (clea  air h ods, glo eb xes , i s olators a d minienv iro ments)

— Part 8: Clas s ific atio  o air clea lnes s by chemic al c onc entratio  (AC )

— Part 9: Clas s ific atio  o  s urf c e clea lnes s b  p rticle c onc entratio

— Part 10: Clas s ific atio  o  s urf c e clea lnes s b  chemic al c onc entratio

A tt ention is also drawn t o ISO 146 8, Clea ro ms a d as s oc iated c ontroled env iro ments — B

io-c ontamin tio c ontrol:

— Part 1: G ene al princ iples a d meth ds

— Part 2 : Ev lu tio  a d inte pr tatio  o bio-c ontamin tio  data

This r vision of ISO 14644- 2 emphasiz s the ne d t o conside a monit oring s rat eg in ad ition t o

the initial or pe iodic ex ecution of the clas if ication of a cleanro m or clean zone in ac ordanc with

ISO 1464 -1:2 1 , 5.1 The monit oring activity pro ides a contin ing flow of data o e time, the eb

pro iding a mor detaied view of the pe formanc of the ins alation

Pot ential benef it g ined from monit oring ar

— fast er r sponse t o adve se event an conditions,

— a i ity t o develo tr n s from data o e time,

— int egration of data from multiple ins rument ,

— enhanc d k owledge of ins alation an proc s , which alow s for mor efe tive risk as es ment, an

— improved control of o e ational cos s an prod ct los es

ISO 1464 - 2 spe ifies the r q ir ment of a monit oring plan, b sed on risk as es ment ofthe int en ed

use The data o tained pro ide evidenc of cleanro m or clean zone pe formanc r lat ed t o air

cleanl nes b p rticle conc ntration

In some cir ums anc s, r lev nt r gulat ory ag encies ma imp se sup lementary polcies, r q ir ment

or r s rictions In such situations, a pro riat e ada tations of the monit oring proc d r s ma be

r q ir d Aft er a monit oring plan is initialy es a l shed an implement ed, it ma be ne es ary t o

r vise the plan w hen signif icant chang es ar made t o the ins alation or proc s r q ir ment It is also

pru ent t o con uct pe iodic r view s of a monit oring plan b sed on data o tained an ex e ienc in use

Cleanrooms and associated c ontrol ed environments —

Part 2:

This p rt of ISO 14644 spe if ies minimum r q ir ment for a monit oring plan for cleanro m or clean

zone pe formanc r lat ed t o air cleanlnes b p rticle conc ntration, b sed up n paramet ers that

measur or afe t airb rne p rticle conc ntration

This part of ISO 14644 does not ad r s con ition monit oring of aspe t such as vibration or g ene al

maint enanc of the engine ring sy st ems It does not pro ide for monit oring of particle p pulations

that ar out ide the spe if ied lower thr shold p rticle-siz rang e, 0,1 µm t o 5 µm Conc ntrations of

ultraf ine p rticles (p rticlessmale than 0,1µm) wi l be ad r s ed in a separat e s andard

2 Normati ve r eferences

The folowing document , in w hole or in p rt, ar normatively r fe enc d in this document an ar

in ispensa le for it a pl cation F or dat ed r fe enc s, only the edition cit ed a pl es F or u dat ed

r fe enc s, the lat es edition of the r fe enc d document ( inclu ing any amen ment )a pl es

ISO 14644-1:2 1 , Clea ro ms a d as s oc iated c ontroled env iro ments  — Part 1: Clas s ific atio  o  air 

clea lnes s by p rticle c onc entratio

3 Terms and definitions

For the purp ses ofthis document, the terms an definitions given in ISO 1 464 -1 an the folowing a pply :

3.1

test

proc d r un e taken in ac ordanc with a defined method t o det ermine the pe formanc of an

ins al ation or an element the eof

3.2

mo itoring

o se v tions made b measur ment in ac ordanc with a def ined method an plan t o pro ide evidenc

of the pe formanc of an ins alation

Note 1 t o entry: Monit oring may b contin ous, seq ential or periodic; an if periodic, the freq ency shal b

specif ied

Not e 2 t o entry: T is information may b used t o det ect tren s in operational stat e an t o provide proces su port

3.3

actio level

level of a paramet er set b the use w hich, w hen ex ce ded, r q ir s immediat e int ervention, inclu ing

inves ig tion of ca use, an cor e tive action

alert level

level of a paramet er set b the use giving early warning of a drif from normal con itions, w hich, w hen

ex ce ded, should r sult in inc eased att ention or cor e tive action

4 Creating, implementing and maintaining a monitoring plan

4.1 Pr inciple

In orde t o g in as uranc that a cleanro m or clean zone is pe forming adeq at ely b delve ing

the r q ir d control of air cleanlnes b p rticle conc ntration, a monit oring plan shal be c eat ed,

implement ed an maintained

A monitoring plan shal take into a ccou t the level of air cleanlnes r q ir d, c itical locations an

pe formanc at ributes of the cleanro m or clean zone that afe t the pe formanc of the ins alation The

folowing steps shal be inclu ed in the c eation, implementation an maintenanc of the monitoring plan:

— use a pro riat e risk as es ment t ools t o u de s an , ev luat e an document the risk of adve se

contamination event ;

— develo a writt en monit oring plan;

— r view an a pro ethe plan;

— implement the plan b pe forming the monit oring;

— analy se the data de ived from the monit oring activity, u de take tr n analy sis w he e a pro riat e

an r p rt pe formanc ;

— implement and document actionsor cor e tiveactions r q ir d;

— un e take pe iodic r view of the monit oring plan

The conc ntration of airb rne particles measur d un e a monit oring plan ma be highe than the

conc ntration o se ved d ring at-r s clas if ication The o se ved v lues ma fluctuat e conside a ly

d e t o fact ors such as, but not lmit ed t o, the n mbe of pe sonnel pr sent, the airflow rat e, ventiation

efe tivenes , the o e ation of ins rument or machine y, an activities in adjac nt pac s

F or proc s es that in e ently prod c particles as p rt of the proc s an w he e these p rticles ar

not a thr at t o the proc s or prod ct, it ma be a pro riat e t o r ly on pe iodic at-r s clas if ication,

or o e ational clas if ication of simulat ed o e ations, rathe than monit oring of airb rne p rticles in

o e ation Othe pe formanc an cleanl nes at ribut es ma s i l be r q ir d t o be monit or d

4.2 Risk as es ment

Risk as es ment is a sy st ematic proc s of identification of hazards and the analy sis an ev luation of

risks as ociat ed with ex osur t o those hazards

A risk as es ment shal be u de taken in orde t o

— develo a monit oring plan b det ermining fact ors that ma afe t the a i ty t o maintain the a r ed

air cleanlnes b particle conc ntration of the cleanro m or clean zone, an

— det erminethe monit oring r q ir ment t o pro ide evidenc of pe formanc

F or guidanc on w hat t o conside w hen un e taking a risk as es ment, se informative An ex A

4.3 Monitor ing plan

4.3.1 T e monitoring plan shal take into ac ou t the output fr om the risk as es ment

When develo ing the monit oring plan, the fact ors desc ibed in 4.3.2 t o 4.3.1 shal be inclu ed as a

minimum

4.3.2 Lis ing an jus ification of al the paramete s to be monitor ed, inclu ing those that ma y afe t the

air bornep rticle conc ntration

4.3.3 Desc iption and justification of measurement methods For furthe g uidanc on considerations

when develo ing a monitoring plan, se informative A nnex A

4.3.4 Accuracy, maintenanc an calbr ation of monitoring instrumentation

4.3.5 Identification an jus ification ofsele ted monitoring locations Monitoring locations shal be

defined in three dimensions

4.3.6 Identification an jus ification of monitoring ac eptanc c ite ia or lmit , inclu ing

es a lshment of a single alarm level, or a d al alarm a pr oach of ale t and action levels T e minimum

r eq ir ement is that a single alarm action level is es a lshed A dditionaly, an alarm ale t level can be

es a lshed to pr ovide ear ly warning of pe formanc deviation For furthe g uidanc on setting ale t an

action levels, se informative A nnex B

4.3.7 Spe ification of the r esp nse r eq ir ed should the data fal outside the spe ified lmit

4.3.8 T e ne d for an fr eq ency of pe iodic cleanr oom or clean zone air cleanlnes clas ification b

p rticle conc ntration in ac or danc w ith ISO 14644-1:2 1 , 5.1

4.3.9 T e format for recor ding data

4.3.10 T e methods, inclu ing statis ical methods to be used for data tr en ing or othe a pr opriate

analysis

4.3.11 T e r ep rting r eq ir ements

4.3.12 T e p lcy and media to be used for record retention

4.3.13 T e fr eq ency of r eview of the monitoring plan

NOTE Monit oring plans are reviewed periodicaly; an b sed on the k owledg g ined a out the cle nro m

or cle n zone, the monitoring pro ramme is revised

4.4 Cal bration

Ins rumentation used for monit oring shal be adeq at e t o pe form the monit oring o e ations r q ir d,

shal ha e a v ld calbration c rtificat e, an shal me t cur ent ac ept ed practic s for the fr q ency

an method of calbration

In p rticular for airb rne p rticle cou t ers, the fr q ency an method ofcalbration should be b sed

up n cur ent ac ept ed practic as spe if ied in ISO 2 5 1-4

NOTE S me particle cou ter can ot b calibrated to al of the req ired tests in ISO 2 5 1-4 If this is the

case, record the decision t o use the cou ter in the monitoring plan

4.5 Review and approval

The complet ed plan shal be r viewed an a pro ed

4.6 Response to a deviation during monitoring

If monit oring r sult ex ce d the spe ified lmit (s), an inves ig tion shal be con uct ed t o det ermine

cause, an r medial action taken as r q ir d

If the r medial action r q ir s significant chang es t o the ins alation an / r it o e ation, then the

clas if ication t es ac ording t o ISO 14644-1 shal be un e taken The monit oring plan shal also be

r viewed as a r sult of the chang es t o the ins al ation an / r it o e ation

When the desir d clas ification has be n achieved, monit oring ma be r sumed

5 P er iodic clas ification of air cleanl nes by particle c oncentration

Pe iodic clas ification t es ing shal be u de taken ann aly in ac ordanc with ISO 14644-1 This

fr q ency can be ext en ed b sed on risk as es ment, the ext ent of the monit oring syst em, an data

that ar consist ently in complanc with ac eptanc lmit or levels def ined in the monit oring plan

NOTE ISO 14 4 -3 specif ies ancil ary tests relat ed to other aspects of cle nro m performance such as

pres ure diference, airflow, et c

A nne x A

A 1 Risk as es ment c onsiderations

A 1.1 S lection ofan appr opr iate risk as es ment tool

Risk as es ment can be u de taken using a n mbe of t ools – sep rat ely or in combination – inclu ing

but not lmit ed t o

These can be fact ors such as

— un e s an ing the contamination sour es an their impact on the activity in the cleanro m or clean

zone at c itical locations or at locations r pr sentative of the g ene al air cleanlnes in a cleanro m

or clean zone,

— pe formanc of the ins alation that might afe t he cleanlnes levels such as pr s ur dife ential,

airflow uniformity, airflow v lume, venti ation efe tivenes , t empe atur , r lative h midity,

— normal an ene g -sa ing set-b ck mode,

A 2.2 T e measur ement te h iq e, inclu ing the sele tion of manual an / r automated monitoring

A 2.3 T e r esolution, ac ur acy an calbr ation req irement of the measur ement sys em inclu ing , in

the case of air borne p rticle cou te s, the eficiency an lmitations of the cole tion sys em

A 2.4 T e location of monitoring sys em comp nent , inclu ing r eq irement for ac es for

maintenanc an calbration