1116 MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING

ENVIRONMENTS
HIGHLIGHTS of 1116
In any environmen !"ere "#man o$eraor% are $re%en& mi'ro(ia) 'onaminaion a %ome )eve) i%
inevia()e* Even "e mo% 'a#io#% ')ean+room environmen ,e%i-n an, o$eraion !i)) no e)iminae "e
%"e,,in- of mi'roor-ani%m% if "#man o$eraor% are $re%en* T"#%& an e.$e'aion of /ero 'onaminaion
a a)) )o'aion% ,#rin- every a%e$i' $ro'e%%in- o$eraion i% e'"ni'a))y no $o%%i()e an, "#% i%
#nrea)i%i'* T"ere are no mean% o ,emon%rae "a an a%e$i' $ro'e%%in- environmen an, "e $ro,#'+
'ona' %#rfa'e% !i"in "a environmen are %eri)e* Moniorin- )o'aion% %"o#), (e ,eermine, (a%e,
#$on a a%%e%%men of ri%0* A)"o#-" man#fa'#rer% %"o#), revie! environmena) moniorin- re%#)%
fre1#en)y o en%#re "a "e fa'i)iy o$erae% in a va)i,ae, %ae of 'onro)& moniorin- re%#)% 'an nei"er
$rove nor ,i%$rove %eri)iy* Be'a#%e of "e )imiaion% of moniorin-& man#fa'#rer% 'anno re)y ,ire')y
on moniorin-& %ai%i'%& or $erio,i' a%e$i'+$ro'e%%in- %im#)aion% o en%#re a %eri)iy a%%#ran'e )eve)*
Environmena) moniorin- i% #%#a))y $erforme, (y $er%onne) an, "#% re1#ire% o$eraor inervenion* A% a
re%#)& environmena) moniorin- 'an (o" in'rea%e "e ri%0 of 'onaminaion an, a)%o -ive fa)%e+$o%iive
re%#)%* T"#%& inen%ive moniorin- i% #n!arrane,& $ari'#)ar)y in "e ISO 2 environmen% "a are #%e, in
"e mo% 'rii'a) /one% of a%e$i' $ro'e%%in-*
T"e ,e%i-n an, 'on%r#'ion of ')ean room% an, 'onro))e, environmen% are 'overe, in ISO 13633 %erie%*
T"i% %an,ar, ,efine% "e $erforman'e of a ')ean environmen !i" re%$e' o "e 'on'enraion of oa)
$ari'#)ae% $er #ni vo)#me* ISO 13633+1 %i$#)ae% "e oa) $ari'#)ae 'o#n% a))o!e, for a ')ean
environmen o mee "e ,efine, air 1#a)iy ')a%%ifi'aion%* T"e rea,er i% referre, o "i% %an,ar,
re-ar,in- "e ,e%i-n '"ara'eri%i'% an, 'erifi'aion of ')ean environmen%*
Ta()e 1* Air(orne Toa) Pari'#)ae C)ean)ine%% C)a%%e%
a

ISO Class
b
Particles 0.5 m/m3
ISO 2 4256
ISO 6 42&566
ISO 7 425&666
ISO 8 4&256&666
a Ta0en from ISO Inernaiona) San,ar, 13633 Par 1& $#()i%"e, (y "e Inernaiona) Or-ani/aion for
San,ar,i/aion& May 1999*
( T"e fo#r ISO 13633+1 ')a%%e% 'orre%$on, ')o%e)y o former :*S* Fe,era) San,ar, 569E ')a%%ifi'aion%*
T"e re)aion%"i$% are
ISO 2;C)a%% 166& ISO 6;C)a%% 1666& ISO 7;C)a%% 16&666& an,
ISO 8;C)a%% 166&666*
S$e'ifi'aion% for air '"an-e% $er "o#r an, air ve)o'iie% are no in')#,e, in ISO 13633& nor !ere "ey
in')#,e, in Fe,era) San,ar, 569E* Ty$i'a))y& ISO C)a%% 8;C)a%% 166&666 room% are ,e%i-ne, o $rovi,e a
minim#m of 56 air '"an-e% $er "o#r< ISO C)a%% 7;C)a%% 16&666 room% are ,e%i-ne, o $rovi,e more "an
26 air '"an-e% $er "o#r< an, ISO C)a%% 2;C)a%% 166 ')ean room% $rovi,e more "an 166 air '"an-e% $er
"o#r* T"e ,e%i-n of %ome fa'i)iy 'rieria may ,iffer* By ,i)#in- an, removin- 'onaminan%& )ar-e
vo)#me% of air are )i0e)y o re,#'e air(orne 'onaminaion in a%e$i' $ro,#'ion*
Man#fa'#rer% %"o#), mainain a $re,ominan)y #ni,ire'iona) f)o! of air =ei"er veri'a) or "ori/ona)> in
a %affe, C)a%% 2 ')ean room environmen& $ari'#)ar)y !"en $ro,#'%& $ro,#' 'onainer%& an, ')o%#re%
are e.$o%e,* In "e eva)#aion of air movemen !i"in a ')ean room& %#,yin- airf)o! vi%#a))y (y %mo0e
%#,ie% or o"er %#ia()e mean% i% $ro(a()y more #%ef#) "an #%in- a(%o)#e mea%#re% of airf)o! ve)o'iy
an, '"an-e rae%*
Air ve)o'iy an, '"an-e rae% are far )e%% im$oran in i%o)aor% or ')o%e, RABS "an in ')ean room%
(e'a#%e $er%onne) are more 'aref#))y %e$arae, from "e $ro,#'& $ro,#' 'onainer%& an, ')o%#re%*
IMPORTANCE OF A MICROBIOLOICAL E!AL"ATION PRORAM FOR CONTROLLE#
EN!IRONMENTS
In a%e$i' $ro'e%%in- environmen% an, $ari'#)ar)y in ISO C)a%% 2 environmen%& 'onaminaion i%
infre1#en)y o(%erve,* In i%o)aor en')o%#re%& 'onaminaion i% rarer %i)) (e'a#%e of %#$erior e.')#%ion of
"#man+(orne 'onaminaion* Be'a#%e of "e 'rii'a)iy of "e%e environmen%& even minor '"an-e% in "e
'onaminaion in'i,en rae% may (e %i-nifi'an& an, man#fa'#rer% %"o#), fre1#en)y an, 'aref#))y
revie! moniorin- ,aa* In )e%% 'rii'a) environmen%& mi'ro(ia) 'onaminaion may (e "i-"er& (#
'"an-e% in re'overy rae% %"o#), (e noe,& inve%i-ae,& an, 'orre'e,* I%o)ae, re'overie% of
mi'roor-ani%m% %"o#), (e 'on%i,ere, a norma) $"enomenon in 'onveniona) ')ean room%& an, "e%e
in'i,en% -enera))y ,o no re1#ire %$e'ifi' 'orre'ive a'ion& (e'a#%e i i% a)mo% 'erain "a
inve%i-aion% !i)) fai) o yie), a %'ienifi'a))y verifia()e 'a#%e* Be'a#%e %am$)in- i%e)f re1#ire% an
a%e$i' inervenion in 'onveniona) ')ean room%& any %in-)e #n'orre)ae, 'onaminaion even 'o#), (e a
fa)%e $o%iive*
P$%SICAL E!AL"ATION OF CONTAMINATION CONTROL EFFECTI!ENESS
T"e ,e%i-n& 'on%r#'ion& an, o$eraion of ')ean room% vary -rea)y& %o i i% ,iffi'#) o -enera)i/e
re1#iremen% for $arameer% %#'" a% fi)er ine-riy& air ve)o'iy& air $aern%& air '"an-e%& an, $re%%#re
,ifferenia)* In $ari'#)ar)y 'rii'a) a$$)i'aion% %#'" a% a%e$i' $ro'e%%in-& a %r#'#re, a$$roa'" o
$"y%i'a) ri%0 a%%e%%men may (e a$$ro$riae*
One %#'" me"o, "a% (een ,eve)o$e, (y L?#n,1vi% an, Reinm@))er* T"i% me"o,& 0no!n a% "e L+R
me"o,& '"a))en-e% "e air veni)aion %y%em (y eva)#ain- (o" airf)o! an, "e a(i)iy of an environmen
o ,i)#e an, remove air(orne $ari')e%* In "e L+R me"o,& a %mo0e -eneraor a))o!% ana)y%% o vi%#a)i/e
"e air movemen% "ro#-"o# a ')ean room or a 'onro))e, environmen& in')#,in- vori'e% or #r(#)en
/one%& an, "e airf)o! $aern 'an (e fine+#ne, o minimi/e "e%e #n,e%ira()e effe'%* Fo))o!in- vi%#a)
o$imi/aion of airf)o!& $ari'#)ae maer i% -enerae, ')o%e o "e 'rii'a) /one an, %eri)e fie),* T"i%
eva)#aion i% ,one #n,er %im#)ae, $ro,#'ion 'on,iion% (# !i" e1#i$men an, $er%onne) in $)a'e* T"i%
y$e of e% 'an a)%o (e #%e, o eva)#ae "e a(i)iy of RABS an, i%o)aor %y%em%& $ari'#)ar)y aro#n,
$ro,#' e.i $or% in "e%e %y%em%& o re%i% "e effe'% of 'onaminaion*
Vi%#a) eva)#aion of air movemen !i"in ')ean room% i% a %#(?e'ive $ro'e%%* Com$)ee e)iminaion of
#r(#)en'e or vori'e% i% no $o%%i()e in o$eraionin- ')ean room% "a 'onain $er%onne) an, e1#i$men*
Air vi%#a)i/aion i% %im$)y one %e$ in "e effor o o$imi/e ')ean room o$eraion% an, i% no a ,efiniive
$a%%;fai) e%& (e'a#%e a''e$a()e or #na''e$a()e 'on,iion% are no rea,i)y ,efina()e*
Trai&i&' () *ers(&&el
Trainin- of a)) $er%onne) !or0in- in 'onro))e, environmen% i% 'rii'a)* T"i% rainin- i% e1#a))y im$oran
for $er%onne) re%$on%i()e for "e mi'ro(ia) moniorin- $ro-ram& (e'a#%e 'onaminaion of "e ')ean
!or0in- area 'o#), ina,veren)y o''#r ,#rin- mi'ro(ia) %am$)in-* In "i-")y a#omae, o$eraion%&
moniorin- $er%onne) may (e "e em$)oyee% !"o "ave "e mo% ,ire' 'ona' !i" "e 'rii'a) %#rfa'e%
an, /one% !i"in "e $ro'e%%in- area* Mi'ro(io)o-i'a) %am$)in- "a% "e $oenia) o 'onri(#e o
mi'ro(ia) 'onaminaion 'a#%e, (y ina$$ro$riae %am$)in- e'"ni1#e% or (y $)a'in- $er%onne) in or near
"e 'rii'a) /one* A forma) rainin- $ro-ram i% re1#ire, o minimi/e "i% ri%0* T"i% rainin- %"o#), (e
,o'#mene, for a)) $er%onne) !"o ener 'onro))e, environmen%* Inervenion% %"o#), a)!ay% (e
minimi/e,& in')#,in- "o%e re1#ire, for moniorin- a'iviie%< (# !"en inervenion% 'anno (e avoi,e,&
"ey m#% (e 'on,#'e, !i" a%e$i' e'"ni1#e "a a$$roa'"e% $erfe'ion a% ')o%e)y a% $o%%i()e*
T"e rainin- %"o#), in')#,e in%r#'ion a(o# "e (a%i' $rin'i$)e% of a%e$i' e'"ni1#e an, %"o#),
em$"a%i/e "e re)aion%"i$ of man#fa'#rin- an, "an,)in- $ro'e,#re% o $oenia) %o#r'e% of $ro,#'
'onaminaion* T"o%e %#$ervi%in-& a#,iin-& or in%$e'in- mi'ro(io)o-i'a) 'onro) an, moniorin-
a'iviie% %"o#), (e 0no!)e,-ea()e a(o# "e (a%i' $rin'i$)e% of mi'ro(io)o-y& mi'ro(ia) $"y%io)o-y&
,i%infe'ion an, %aniaion& me,ia %e)e'ion an, $re$araion& a.onomy& an, %eri)i/aion* T"e %aff
re%$on%i()e for %#$ervi%ion an, e%in- %"o#), "ave a'a,emi' rainin- in me,i'a) or environmena)
mi'ro(io)o-y*
Sam$)in- $er%onne) a% !e)) a% in,ivi,#a)% !or0in- in ')ean room% %"o#), (e 0no!)e,-ea()e a(o# "eir
re%$on%i(i)iie% in minimi/in- "e re)ea%e of mi'ro(ia) 'onaminaion* Per%onne) invo)ve, in mi'ro(ia)
i,enifi'aion re1#ire %$e'ia)i/e, rainin- a(o# re1#ire, )a(oraory me"o,%* A,,iiona) rainin- a(o#
"e mana-emen of 'o))e'e, ,aa m#% (e $rovi,e,* Ano!)e,-e an, #n,er%an,in- of a$$)i'a()e %an,ar,
o$erain- $ro'e,#re% are 'rii'a)& e%$e'ia))y "o%e $ro'e,#re% re)ain- o 'orre'ive mea%#re% a0en !"en
environmena) 'on,iion% re1#ire* :n,er%an,in- of 'onaminaion 'onro) $rin'i$)e% an, ea'"
in,ivi,#a)B% re%$on%i(i)iie% !i" re%$e' o -oo, man#fa'#rin- $ra'i'e% =GMP%> %"o#), (e an ine-ra)
$ar of "e rainin- $ro-ram& a)on- !i" rainin- in 'on,#'in- inve%i-aion% an, in ana)y/in- ,aa*
A%e$i' $ro'e%%in- environmen% re1#ire "e #%e of %eri)i/e, -o!n% !i" "e (e% avai)a()e fi)raion
$ro$erie%* T"e f#))e% $o%%i()e %0in 'overa-e i% ,e%ira()e& an, %)eeve 'over% or a$e %"o#), (e 'on%i,ere,
o minimi/e )ea0% a "e 'rii'a) -)oveC%)eeve ?#n'ion* E.$o%e, %0in %"o#), never (e vi%i()e in
'onveniona) ')ean room% #n,er any 'on,iion%*
CRITICAL FACTORS IN T$E #ESIN AN# IMPLEMENTATION OF A MICROBIOLOICAL
EN!IRONMENTAL MONITORIN PRORAM
A -enera) mi'ro(io)o-i'a) -ro!" me,i#m %#'" a% %oy(eanC'a%ein ,i-e% me,i#m =SCDM> i% %#ia()e for
environmena) moniorin- in mo% 'a%e% (e'a#%e i %#$$or% "e -ro!" of a !i,e ran-e of (a'eria& yea%&
an, mo),%* T"i% me,i#m 'an (e %#$$)emene, !i" a,,iive% o over'ome or o minimi/e "e effe'% of
%anii/in- a-en% or of ani(ioi'%*
T"e a(i)iy of any me,ia #%e, in environmena) moniorin-& in')#,in- "o%e %e)e'e, o re'over %$e'ifi'
y$e% of or-ani%m%& m#% (e eva)#ae, for "eir a(i)iy o %#$$or -ro!"& a% in,i'ae, in 71 *
mi'ro(io)o-i%% may in'#(ae a %in-)e $)ae a (o" a )o! an, a "i-"er em$era#re* In'#(ain- a "e
)o!er em$era#re fir% may 'om$romi%e "e re'overy of Gram+$o%iive 'o''i "a are im$oran (e'a#%e
"ey are ofen a%%o'iae, !i" "#man%*
Conaminaion %"o#), no (e inro,#'e, ino a man#fa'#rin- ')ean room a% a re%#) of #%in-
'onaminae, %am$)in- me,ia or e1#i$men *If a%e$i'a))y $re$are, me,ia m#% (e #%e,& ana)y%% m#%
'arry o# $rein'#(aion an, vi%#a) in%$e'ion of a)) %am$)in- me,ia (efore inro,#'ion ino "e ')ean
room*
ESTABLIS$MENT OF SAMPLIN PLAN AN# SITES
D#rin- iniia) %ar#$ or 'ommi%%ionin- of a ')ean room or o"er 'onro))e, environmen& %$e'ifi'
)o'aion% for air an, %#rfa'e %am$)in- %"o#), (e ,eermine,* Lo'aion% 'on%i,ere, %"o#), in')#,e "o%e in
$ro.imiy of "e e.$o%e, $ro,#'& 'onainer%& ')o%#re%& an, $ro,#' 'ona' %#rfa'e%*
T"e fre1#en'y of %am$)in- ,e$en,% on "e man#fa'#rin- $ro'e%% 'on,#'e, !i"in an environmen*
C)a%%ifie, environmen% "a are #%e, on)y o $rovi,e a )o!er overa)) )eve) of (io(#r,en in non%eri)e
$ro,#' man#fa'#rin- area% re1#ire re)aive)y infre1#en environmena) moniorin-* C)a%%ifie,
environmen% in !"i'" ')o%e, man#fa'#rin- o$eraion% are 'on,#'e,& in')#,in- fermenaion& %eri)e
API $ro'e%%in-& an, '"emi'a) $ro'e%%e%& re1#ire fe!er moniorin- %ie% an, )e%% fre1#en moniorin-
(e'a#%e "e ri%0 of mi'ro(ia) 'onaminaion from "e %#rro#n,in- environmen i% 'om$araive)y )o!*
Mi'ro(io)o-i'a) moniorin- of environmen% in !"i'" $ro,#'% are fi))e, (efore ermina) %eri)i/aion i%
-enera))y )e%% 'rii'a) "an "e moniorin- of a%e$i' $ro'e%%in- area%* T"e amo#n of moniorin- re1#ire,
in fi))in- o$eraion% for ermina) %eri)i/aion ,e$en,% on "e %#%'e$i(i)iy of "e $ro,#' %#rviva) an, "e
$oenia) for $ro)iferaion of mi'ro(ia) 'onaminaion* T"e i,enifi'aion an, e%imae, n#m(er of
mi'roor-ani%m% "a are re%i%an o "e %#(%e1#en %eri)i/aion may (e more 'rii'a) "an "e
mi'ro(io)o-i'a) moniorin- of "e %#rro#n,in- man#fa'#rin- environmen%*
I i% no $o%%i()e o re'ommen, mi'ro(ia) 'onro) )eve)% for ea'" y$e of man#fa'#rin- environmen* T"e
)eve)% e%a()i%"e, for one ISO C)a%% 7 environmen& for e.am$)e& may (e ina$$ro$riae for ano"er ISO
C)a%% 7 environmen& ,e$en,in- on "e $ro,#'ion a'iviie% #n,era0en in ea'"* T"e #%er %"o#), 'on,#'
a $ro%$e'ive ri%0 ana)y%i% an, ,eve)o$ a raiona)e for "e %am$)in- )o'aion% an, fre1#en'ie% for ea'"
'onro))e, environmen* T"e ')a%%ifi'aion of a ')ean room "e)$% e%a()i%" 'onro) )eve)%& (# "a ,oe% no
im$)y "a a)) room% of "e %ame ')a%%ifi'aion %"o#), "ave "e %ame 'onro) )eve)% an, "e %ame
fre1#en'y of moniorin-* Moniorin- %"o#), ref)e' "e mi'ro(io)o-i'a) 'onro) re1#iremen% of
man#fa'#rin- or $ro'e%%in- a'iviie%* Forma) ri%0 a%%e%%men e'"ni1#e% 'an re%#) in a %'ienifi'a))y
va)i, 'onaminaion 'onro) $ro-ram*
Ta()e 5 %#--e%% fre1#en'ie% of %am$)in- in ,e'rea%in- or,er of fre1#en'y an, in re)aion o "e 'rii'a)iy
or $ro,#' ri%0 of "e area (ein- %am$)e,* T"i% a()e ,i%in-#i%"e% (e!een a%e$i' $ro'e%%in- !"ere
$er%onne) are a%e$i'a))y -o!ne, an, "o%e !"ere a )e%%er -o!nin- i% a$$ro$riae* Environmena)
moniorin- %am$)in- $)an% %"o#), (e f)e.i()e !i" re%$e' o moniorin- fre1#en'ie%& an, %am$)e $)an
)o'aion% %"o#), (e a,?#%e, on "e (a%i% of "e o(%erve, rae of 'onaminaion an, on-oin- ri%0 ana)y%i%*
On "e (a%i% of )on-+erm o(%ervaion%& man#fa'#rer% may in'rea%e or ,e'rea%e %am$)in- a a -iven
)o'aion or e)iminae a %am$)in- )o'aion a)o-e"er* Over%am$)in- 'an (e a% ,e)eerio#% o 'onaminaion
'onro) a% #n,er%am$)in-& an, 'aref#) 'on%i,eraion of ri%0 an, re,#'ion of 'onaminaion %o#r'e% 'an
-#i,e "e %am$)in- inen%iy*
Ta()e 5* S#--e%e, Fre1#en'y of Sam$)in- for A%e$i'
Pro'e%%in- Area%
a

Sam*li&' Area/L(cati(&
Fre+,e&c- ()
Sam*li&'
C)ean Room;RABS
Crii'a) /one =ISO 2 or (eer>
A'ive air %am$)in- Ea'" o$eraiona) %"if
S#rfa'e moniorin- A "e en, of "e o$eraion
Sam*li&' Area/L(cati(&
Fre+,e&c- ()
Sam*li&'
A%e$i' area a,?a'en 'rii'a) /one
A)) %am$)in- Ea'" o$erain- %"if
O"er nona,?a'en a%e$i' area%
A)) %am$)in- On'e $er ,ay
SELECTION OF SAMPLE SITES DITHIN CLEAN ROOMS AND ASEPTIC PROCESSING AREAS
SO 13633 %#--e%% a -ri, a$$roa'" for "e oa) $ari'#)ae air ')a%%ifi'aion of ')ean room%* T"i% a$$roa'"
i% a$$ro$riae for 'erifyin- "e oa) $ari'#)ae air 1#a)iy $erforman'e a-ain% i% ,e%i-n o(?e'ive* Gri,%
may a)%o "ave va)#e in ana)y/in- ri%0 from mi'ro(ia) 'onaminaion& a)"o#-" in -enera)& -ri,% "a "ave
no $er%onne) a'iviy are )i0e)y o "ave )o! ri%0 of 'onaminaion* Mi'ro(ia) 'onaminaion i% %ron-)y
a%%o'iae, !i" $er%onne)& %o mi'ro(io)o-i'a) moniorin- of #n%affe, environmen% i% of )imie, va)#e*
Mi'ro(io)o-i'a) %am$)in- %ie% are (e% %e)e'e, !i" 'on%i,eraion of "#man a'iviy ,#rin- man#fa'#rin-
o$eraion%* Caref#) o(%ervaion an, ma$$in- of "e ')ean room ,#rin- "e 1#a)ifi'aion $"a%e 'an $rovi,e
#%ef#) informaion 'on'ernin- "e movemen an, $o%iionin- of $er%onne)* S#'" o(%ervaion 'an a)%o
yie), im$oran informaion a(o# "e mo% fre1#en)y 'on,#'e, mani$#)aion% an, inervenion%*
SINIFICANT E.C"RSIONS
E.'#r%ion% (eyon, a$$ro.imae)y 12 'f# re'overe, from a %in-)e ISO 2 %am$)e& !"e"er from air(orne&
%#rfa'e& or $er%onne) %o#r'e%& %"o#), "a$$en very infre1#en)y* D"en %#'" ISO 2 e.'#r%ion% ,o o''#r&
"ey may (e in,i'aive of a %i-nifi'an )o%% of 'onro) !"en "ey o''#r !i"in "e ISO 2 'rii'a) /one in
')o%e $ro.imiy o $ro,#' an, 'om$onen%* T"#%& any ISO 2 e.'#r%ion E12 'f# %"o#), $rom$ a 'aref#)
an, "oro#-" inve%i-aion*
Mi'ro(io)o-i%% %"o#), revie! re'overy rae% for a )ea% !o !ee0% (efore "e in'i,en of a(norma))y
"i-" re'overy %o "a "ey 'an (e a!are of o"er re'overie% "a mi-" in,i'ae an #n#%#a) $aern*
Mi'ro(io)o-i%% %"o#), 'aref#))y 'on%i,er a)) re'overie%& in')#,in- "o%e "a are in "e more y$i'a) ran-e
of 1C2 'f#* T"e i,eniy of "e or-ani%m% re'overe, i% an im$oran fa'or in "e 'on,#' of "i%
inve%i-aion*
n "e 'a%e of an i%o)ae, %in-)e e.'#r%ion& e%a()i%"in- a ,efiniive 'a#%e $ro(a()y !i)) no (e $o%%i()e&
an, on)y -enera) 'orre'ive mea%#re% 'an (e 'on%i,ere,* I i% never !i%e o %#--e% a roo 'a#%e for !"i'"
"ere i% no %o)i, %'ienifi' evi,en'e*
In "e "i-"+1#a)iy environmen% re1#ire, for a%e$i' $ro'e%%in-& ,ee'ion fre1#en'y y$i'a))y i% )o!* A%
'an (e %een from "e rae% re'ommen,e, in Ta()e 4& "e ma?oriy of %am$)e% a0en in an a%e$i'
$ro'e%%in- area !i)) yie), a re'overy of /ero 'onaminaion* In "e mo% 'rii'a) area% !i"in an a%e$i'
$ro'e%%in- o$eraion& i i% e.$e'e, "a )e%% "an 1F of "e %am$)e% !i)) yie), any re'overa()e
'onaminaion*
Se)in- P)ae%GT"i% me"o, i% %i)) !i,e)y #%e, a% a %im$)e an, ine.$en%ive !ay o 1#a)iaive)y a%%e%%
"e environmen% over $ro)on-e, e.$o%#re ime%* P#()i%"e, ,aa in,i'ae "a %e)in- $)ae%& !"en
e.$o%e, for 3+ o 2+"o#r $erio,%& 'an $rovi,e a )imi of ,ee'ion for a %#ia()e eva)#aion of "e a%e$i'
environmen* Se)in- $)ae% may (e $ari'#)ar)y #%ef#) in 'rii'a) area% !"ere a'ive %am$)in- 'o#), (e
inr#%ive an, a "a/ar, o "e a%e$i' o$eraion*
One of "e ma?or ,ra!(a'0% of me'"ani'a) air %am$)er% i% "e )imie, %am$)e %i/e of air (ein- e%e,* D"en
"e mi'ro(ia) )eve) in "e air of a 'onro))e, environmen i% e.$e'e, o 'onain e.reme)y )o! )eve)% of
'onaminaion $er #ni vo)#me& a )ea% 1 '#(i' meer of air %"o#), (e e%e, in or,er o ma.imi/e
%en%iiviy* Ty$i'a))y& %)i+o+a-ar ,evi'e% "ave an 86+L;min %am$)in- 'a$a'iy ="e 'a$a'iy of "e %#rfa'e
air %y%em i% %ome!"a "i-"er>* If 1 '#(i' meer of air !ere e%e,& "en i !o#), re1#ire an e.$o%#re ime
of 12 min* I may (e ne'e%%ary o #%e %am$)in- ime% in e.'e%% of 12 min o o(ain a re$re%enaive
environmena) %am$)e* A)"o#-" %ome %am$)er% are re$ore, o "ave "i-" %am$)in- vo)#me%&
'on%i,eraion %"o#), (e -iven o "e $oenia) for ,i%r#$ion of "e airf)o! $aern% in any 'rii'a) area an,
o "e 'reaion of #r(#)en'e*
Cona' $)ae% fi))e, !i" n#rien a-ar are #%e, for %am$)in- re-#)ar or f)a %#rfa'e% an, are ,ire')y
in'#(ae, for "e a$$ro$riae ime an, em$era#re for re'overy of via()e or-ani%m%* S$e'ia)i/e, a-ar 'an
(e #%e, for "e re'overy of or-ani%m% "a "ave %$e'ifi' -ro!" re1#iremen%* Mi'ro(ia) e%imae% are
re$ore, $er 'ona' $)ae*
T"e %!a((in- me"o, 'an (e #%e, o %#$$)emen 'ona' $)ae% for %am$)in- of irre-#)ar %#rfa'e%&
e%$e'ia))y irre-#)ar %#rfa'e% of e1#i$men* T"e area "a !i)) (e %!a((e, i% ,efine, !i" a %eri)e em$)ae
of a$$ro$riae %i/e* In -enera)& i i% in "e ran-e of 53C46 'm5* Afer %am$)e 'o))e'ion "e %!a( i% $)a'e,
in an a$$ro$riae ,i)#en or ran%$or me,i#m an, i% $)ae, ono "e ,e%ire, n#rien a-ar* T"e mi'ro(ia)
e%imae% are re$ore, $er %!a( of ,efine, %am$)in- area*