AHU_1A

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PERFORMANCE QUALIFICATIONEquipment Name AIR HANDLING UNIT Equipment Number AHU 1A

Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No 1 of 60

!B"E #F $#NEN%

01.0 PROTOCOL APPROVAL..............................................................................................2

02.0 OBJECTIVE...................................................................................................................3

03.0 SCOPE..........................................................................................................................3

04.0 EXECUTION TEA......................................................................................................4

0!.0 EQUIPENT / S"STE DESCRIPTION.....................................................................!

0#.0 ACCEPTANCE AND REVALIDATION CRITERIA.......................................................$

0$.0 TEST PROCEDURE....................................................................................................8

C%&'(&%)*+,...........................................................................................................................

1. T+)%& A* &+ C............................................................................................................

IPQC 10

IRST LOOR.....................................................................................................................12

RESULT ..........................................................................................................................!!

08.0 DEICIENC" AND CORRECTIVE ACTION REPORT............................................!#

0.0 SUAR" AND EVALUATION O RESULTS .........................................................!$

!8

10.0 INAL REPORT APPROVAL......................................................................................!

11.0 APPENDIX................................................................................................................#0

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No & of 60

01'0 P(##$#" !PP(#)!"

01'1 Protocol Prepared by

P5%%)*+, +6 )7* (%&*6*'%)*+, 5&%, * )7 5+,*9*&*): +6 V%&*;%)*+, C++;*,%)+ +6 )7T%< +' II

N!ME *"E %*+N!,(E D!E

. R. S*;7% R;;: D5(): %,%=-V%&*;%)*+,

01'& Protocol c-ecked by

C7'

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No . of 60

0&'0 #B/E$*)E

T7 +9@')*? +6 )7* 5+)+'+& * )+ 5+?*; %, +()&*, 6+ )7 V*6*'%)*+, +6 P6+%,'+6 !ir andling ,nit !,2 1!3 %=%*,) )7 5;)*,; %''5)%,' '*)*% 7,+5%); % 5 )7 ) )%,;%; +5%)*,= 5+';(.

0.'0 %$#PE

T7 '+5 +6 )7* 5+)+'+& * )+ )%9&*7 6*,%&

S)%,;%; O5%)*,= P+';(

S)%,;%; C&%,*,= P+';(

C*)*'%& 5+' '+,)+& '7'

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04'0 E5E$,*#N E!M

Name (eponibility Deignation %ignature

. V*@%: G+,%& T+ 5+?*; E,=*,*,=(55+) 6+ '()*+,

A). %,%=-E,=*,*,=

. A. %%% R%+ T+ 5+?*; 5+)+'+&/;%)%7) %,; +,*)+ )7'()*+,.

S. A*)%,)-Q.A

. N. S*;7% R;;: T+ 56+ %,; 5+?*;%;(%) %,5+ )+'%:+() )7 %')*?*):.

S. E'()*?P+;(')*+,

+ N+ APL/QA/012-00/0#-2001

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07'0 E8,*PMEN 9 %:%EM DE%$(*P*#N

A* 7%,;&*,= (,*) * % '&+ :) 7*'7 -'*'(&%) )7 %* 6 6+ 5%)*'(&%) %)))+ ;*66,) %%. +&&+*,= 5%) % *,)%&&; *, )7 :). D*%=% E,'&+;F

1. P *&)

2. **,= C7%9

3. C++&*,= %,; H%)*,= '+*&

4. C,)*6(=%& B&+ S(55&:F

!. *'+? %,; HEPA *&)

#. S(55&: A* P&,(

$. V+&( %,; * C+,)+& D%5

8. S(55&: %,; R)(, A* =*&& / ;*66(

. R)(, A* P&,(

10. C,)*6(=%& B&+ R)(,F

T7* * % '&+ 9+ ):5 '+,)(')*+, 7%?*,= % C7%9 6+ **,= )7 7 %,; )7

R)(, %*. T7 67 %* * %; )+ 5% )7+(=7 )7 10 6*&). T7 C++&*,= %,;

H%)*,= '+*& % 6*; *, )7 '7%9. T7 % 2 + '7%9 +, 6+C,)*6(=%& B&+ S(55&:F %,; %,+)7 +, 6+ C,)*6(=%& B&+ R)(,F.

T7 AHU '+,,'); )+ )7 L?& II %% * 5+?*;; *)7 0 &%< ;%5 6+ 67 %*%,; )(, %* + )7%) )7 :) '%, 9'+ %()+%)*'%&&: +,' )7+(=7 (5+,;)')*+, +6 7*=7 &?& +6 +&?,) '+,',)%)*+, 9: +&?,) ,+ 5+?*;; *,'+,;*)*+,; 5%'.

Filter

T7 P-6*&) * %; +6 S:,)7)*' ,+,-+?, ;*% (55+)*,= 9: HDPE 7%?*,=

%, 66*'*,': +6 0 %) 10.

T7 *'+? *&) * %; +6 S:,)7)*' ,+,-+?, ;*% (55+)*,= 9: HDPE

7%?*,= %, 66*'*,': +6 %) !..

T7 HEPA 6*&) * %; +6 *'+ 6*9=&% 7%?*,= %, 66*'*,': +6 .$ %) 0.3.

+ N+ APL/QA/012-00/0#-2001

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07'0 E8,*PMEN 9 %:%EM DE%$(*P*#N $ontinued3

T7 )+)%& ?+&( +6 %* * (55&*; )+ )7 ;*66,) %% *)7 )7 7&5 +6 (55&: ;(')7*'7 * %;-(5 +6 G.I. )%& %,; )7 %* )(, )+ )7 )(, %* 5&,( %,;7%();.

Damper )olume and Fire $ontrol3

A) )7 @(,')*+, +6 %'7 9%,'7 ;(') *)7 %*, ;(') %,; 5&*) +6 %*, ;(') V+&('+,)+& ;%5 % 5+?*;;.

* ;%5 % +6 %()+%)*' ):5. T7 %()+%)*' 6* ;%5 7%&& 9 '%5%9& +6+5%)*,= %()+%)*'%&&: +, '*?*,= *=,%& 6+ % 6* %&% 5%,&. * ;%5 %'+,,'); )+ % 5%%) 5%,& '+,,'); *)7 +) '+,)+& )+ %'7*? %(;*+ ?*;+%&% *, '% +6 ;%5 '&+(.

A&& (55&: %,; )(, %* ;(') *, %* 7%,;&*,= (,*) %,; %*, 9%,'7 7%&& 95+?*;; *)7 %55+?; 6* ;%5 +6 %) &%) 2 7+( 6* %)*,=. * ;%5 9&%;7%&& 9 +, 5*' 6+&;; 7*=7 ),=)7 =%&?%,*; )& '+,)(')*+,. I, ,+%&5+*)*+, )7 9&%; 7%&& 9 =%)7; %,; )%'

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No A of 60

0;'0 E% P(#$ED,(E

0;'1 !*( )E"#$*: !ND !*( $!N+E% E%

a3 Purpoe

To demonstrate that the air system is balanced and capable of delivering sufficientair volume to maintain a minimum cross sectional velocity under the absolute filter

b3 Equipment and *ntrumentAnemometer Mae Model

c3 Procedure

0$.1.1 T7 )) % '(); *, ?: ++ 7 %, ;*66( * *,)%&&;.

0$.1.2 5 )7 A,+) %,= % 0 - 1!00 P.

0$.1.3 5 )7 5+9 %) 1.! )+ 2 9&+ )7 D*66( / =*&& %,; ?&+'*): '+;*,= )+9 ,+);.

0$.1.4 E%'7 ;*66( / =*&& (* *,*( 4 )) 5+). %( )7 %* ?&+'*): %) 4'+, +6 )7 ;*66(/=*&&.

0$.1.! A&&+ ,+ +9@') *)7*, 10 6) +6 )7 A,+). *,** )7 ,+ +6 5+5& ;(*,=%) ) ))*,=.

0$.1.# %(,) 7+(&; 9 )%

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No < of 60

d3 !cceptance $riteriaThe air changes per hour should be as per the !esign "ualification.

N#E

10% variation of actual CFM with r!"ct to th #!i$n CFM i! acc"tal at

ach outlt& 'ut th Total CFM in a roo( !houl) not l!! than th #!i$n

CFM&

All #a("r "o!ition! ar (ar*) "r(anntl+ aftr air alancin$&

)1 )&

). )4$alculation

1' otal !ir Flo $FM

P A% +6 D*66(/G*&& #here$ F%M is Feet per minute&FM is &ubic Feet per minute

&' !ir $-ange

T+)%& C T* #0 *,()F

CCCCCCCCCCCCCCCCCCCCCCCCCC V+&( +6 R++ 6)3F

+ N+ APL/QA/012-00/0#-2001

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!*( )E"#$*: !ND !*( $!N+E% E% (E%,"%

(oom NameDiffuer9+rill

%ie" B3

8ty ofDiffuer9 grill

Diffuer9+rill!rea Ft&3

Filter ie 8ty3

(oom )olumeFt.3

" B 3

$!N+E (##M

$#((*D#(

#FF*$E

*P8$

P!(M!$EN(*F,+E !(E!

(E!$#( #)E(!N+*N+ !(E!

E$N*$!"$EN(*F,+E !(E!

%P!("E( F*"E(9G!% !(E!

(!: D(:E(9M*""*N+ !(E!

*NE(MED*!E(E!$#(% !(E!

$(:%!""*HE(!(E!

('M %#(!+E

!(E!GE*+*N+ 9B!"!N$*N+ !(E!

('M D*%PEN%*N+!(E!

+ N+ APL/QA/012-00/0#-2001

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+(#,ND F"##(@

(oom Name

Diffuer9+rill

No'

!ir )elocity !verage)elocity

FPM

otal!ir flo

$FM

No' #f!ir

$-ange)1 )& ). )4

$-ange (oom

$orridor

#ffice !rea

*P8$ !rea

P-arma$entrifuge

!rea

(eactor #ver-anging area

ec-'$entrifuge

!rea

(oom Name Diffuer !ir )elocity !verage otal No' #f

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No 1& of 60

9+rillNo'

)elocityFPM

!ir flo$FM

!ir$-ange

)1 )& ). )4

%parklerFilter9Ga-

!rea

ray Dryer 9Milling !rea

F*(% F"##(

(oom Name

Diffuer9+rill

No'

!ir )elocity !verage)elocity

FPM

otal!ir flo

$FM

No' #f!ir

$-ange)1 )& ). )4

*ntermediate(eactor !rea

$rytallier!rea

(a material

%torage area

Geig-ing 9Balance area

(a Materialdipene area

!cceptance $riteria

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No 1. of 60

M 10 +6 ?%*%)*+, +6 %')(%& C *)7 5') )+ )7 ;*=, C * %''5)%9& %) %'7+()&) 9() )7 )+)%& C *, % ++ 7+(&; ,+) 9 & )7%, )7 ;*; C.

(E%,"T7 C %,; %* '7%,= +6 )7 %% meet/ doe not meet*)7 )7 ;*=,; '*)*% +%% P!%%E% 9 F!*"%*, )7 %9+? ,)*+,; )).

Name Department %ignature Date

$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

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0;'& F*"E( *NE+(*: E%

a3 Purpoe

To ensure that the H'%A filters installed are not damaged during transit$installation or operation and ( or fi)ed properly in the appropriate place$ such thatthere is no leaage from the filter media and the other *oint gasets$ frames etc+

b3 Equipment and *ntrument

A++& G,%)++;& N+ %

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0$.2.# I, '% +6 &%,= ):5 HEPA 6*&) )7 '%,,*,= * )+ 9 ;+, %) *,*( !9&+ )7 HEPA 6*&) )+ %?+*; )7 '+,6(*+, '%); 9: + ?%&( +6%++& 5,)%)*+, %) )7 ;%; %% *. 6&%,= (6%'F

0$.2.$ I6 %,: &%< * +9?; )7, )%

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EP! F*"E( *NE+(*: E% (E%,"%

"ocation @ !ir -andling ,nit ouing

et @ D#P

Equipment ued @

Date of tet @

%' NoEP!

Filter No

,ptreamPenetration

I3

Don treamPenetration

I3

EfficiencyI3

(emark

(E%,"E66*'*,': +6 6*&) * % 5 )7 &**) / +() +6 )7 &**) %,; )7 * ,+ &%

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No 1; of 60

0;'. EMPE(!,(EJ (E"!*)E ,M*D*: !ND P(E%%,(E D*FFE(EN*!"M#N*#(*N+

a3 Purpoe

To demonstrate that the H3A& system is capable of achieving the desired set ofenvironmental conditions 4Temperature$ /H %ressure differentials in the sub*ected

area ( room.+

1F O*,= )+ '*)*'%&*): +6 5+;(') /5+' 7%,;&*,= $orridorJ Drying9MillingJ%ifter roomJ Blender roomJ Packing area and F'+ 8uarantine area %5+?*;; *)7 5+9 %,; *,;*'%)+ 6+ T5%)( R&%)*? H(*;*): %,;P( ;*66,)*%&. T7 %% *&& 9 +,*)+; *, =!t ret> %,; =*n#peration>'+,;*)*+, ;(*,= 56+%,' (%&*6*'%)*+, )(;*.

2F T5%)( ,+ +,&: 6+ PQ )(;*F % 5&%'; *, )7 6+&&+*,=

area' T7 ,+ % )5+%: %,; %,) +,&: 6+ )7 %9+? )(;*.A&& )7 %% /++ % *;,)*6*; % ,+,-'*)*'%& 7,' T5%)(*&&

9 +,*)+; +,&: *, =!t ret>'+,;*)*+,. T5%)( +,*)+*,= ;(*,=+5%)*+, * '&(;; 6+ )7 '+5 +6 )7* )(;:.+(#,ND F"##( F*(% F"##(

1. C7%,= R++ . I,);*%) R%')+ A%2. O66*' A% 10. C:)%&&* A%3. IPQC A% 11. R% %)*%& S)+%= A%4. C:)%&* A% 12. *=7*,= / B%&%,'*,= A%!. R%')+ O? H%,= A% 13. R% %)*%& ;*5,*,= A%#. T'7,*'%& C,)*6(= A% 14. E(*5,) %7 %%$. S5% %7 A% 1!. %)*%& A*&+'< %%8. T%: D:/*&&*,= %% 1#. C&%, E(*5,) %%


D%)% L+==

%

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No 1A of 60

T5%)( S,+

%

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No 1< of 60

Trn) chart! !hall nclo!) in Ann,ur .

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No &0 of 60

able No @ 1 Environmental control recording c-art for =!t ret> $ondition

ime r3

$-ange (oom #ffice !rea *P8$ !reaP-arma $entrifuge

!rea

empK$3

empK$3

empK$3

empK$3


+ N+ APL/QA/012-00/0#-2001

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ime r3


!rea

empK$3

empK$3

empK$3

empK$3


ime r3$-ange (oom #ffice !rea *P8$ !rea

P-arma $entrifuge!rea

emp emp emp emp

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No && of 60

K$3 K$3 K$3 K$3

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No &. of 60


ime r3


!rea

empK$3

empK$3

empK$3

empK$3

!cceptance $riteria

T5%)( 21 )+ 2!C


$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

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ime r3

(eactor #veranging !rea

ec-' $entrifuge!rea

%parkler Filter 9Ga- !rea

ray Dryer9 Milling!rea

empK$3

empK$3

empK$3

empK$3

+ N+ APL/QA/012-00/0#-2001

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ime r3


ec-' $entrifuge!rea



empK$3

empK$3

empK$3

empK$3

+ N+ APL/QA/012-00/0#-2001

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ime r3


ec-' $entrifuge!rea



empK$3

empK$3

empK$3

empK$3

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No &; of 60


ime r3


ec-' $entrifuge!rea



empK$3

empK$3

empK$3

empK$3

!cceptance $riteria

T5%)( 21 )+ 2!C


$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No &A of 60


ime r3


$rytallier !rea (a materialtorage !rea

Geig-ing 9 Balance!rea

empK$3

empK$3

empK$3

empK$3

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No &< of 60


ime r3




empK$3

empK$3

empK$3

empK$3

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No .0 of 60


ime r3




empK$3

empK$3

empK$3

empK$3

+ N+ APL/QA/012-00/0#-2001

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ime r3




empK$3

empK$3

empK$3

empK$3

!cceptance $riteria

T5%)( 21 )+ 2!C


$-ecked by

(evieed by


ime r3 (a material $orridor

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No .& of 60

Dipening !rea

empK$3

empK$3

(I3

PDmm G$3


ime r3

(a materialDipening !rea

$orridor

empK$3

empK$3

(I3

PDmm G$3

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No .. of 60

+ N+ APL/QA/012-00/0#-2001

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ime r3


$orridor

empK$3

empK$3

(I3

PDmm G$3

+ N+ APL/QA/012-00/0#-2001

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ime r3


$orridor

empK$3

empK$3

(I3

PDmm G$3

!cceptance $riteria

T5%)( 21 )+ 2!C

R&%)*? H(*;*): N+) + T7%, #0P( D*66,)*%& 0.! C.


$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

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able No @ & Environmental control recording c-art for =*n #peration> $ondition

ime r3

$orridor

empK$3

(I3

PDmm G$3

+ N+ APL/QA/012-00/0#-2001

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No .; of 60


ime r3

$orridor

empK$3

(I3

PDmm G$3

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No .A of 60


ime r3

$orridor

empK$3

(I3

PDmm G$3

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

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Protocol Number PQ/CP/028/01 Effective Date 24.10.2001Facility UNIT-I Block C Module I Page No .< of 60

able No @ &Environmental control recording c-art for =*n #peration> $ondition

ime r3

$orridor

empK$3

(I3

PDmm G$3

!cceptance $riteria

T5%)( 21 )+ 2!C

R&%)*? H(*;*): N+) + T7%, #0P( D*66,)*%& 0.! C.


$-ecked by

(evieed by

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0;'4 N#N )*!B"E !*( B#(NE P!(*$,"!E $#,N E% !t (et $ondition3

a3 PurpoeTo demonstrate that the clean rooms and critical wor locations within the cleanrooms comply with the design 5ualification during the At R!t Con)ition2 and asper the Federal standard ,6'


L% P%)*'& C+(,)

c3 Procedure

0$.4.1 A6) )7 E,?*+,,)%& '+,)+& T) '&%, )7 ,)* R++ %,; %&&+ )7 A*C+,;*)*+,*,= :) )+ (, 6+ %) &%) $-8 7+( *)7 ,+ %, + %)*%&+?,) *,*; )7 ++.

0$.4.2 *)7 )7 7&5 +6 L% P%)*'& '+(,) '+(,) )7 ,+,-?*%9& %*9+, 5%)*'& %)

+

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,$" Factor for

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N#N )*!B"E !*(B#(NE P!(*$"E $#,N (E%,"% *N =! (E%> $#ND**#N

1' $!N+E (##M

(oomName

"ocation

Non O viable air borne particle count per$u' Ft3

!verage $ount ateac- location a3

0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7

Mean of t-e average M3

%tandard Deviation of t-e average %D3

%tandard error of t-e mean of t-e average %EM3

b3 $alculation

U""r Confi)nc li(it 5UCL0&367 U""r Confi)nc li(it 5UCL3&067

UCL UCL %')+ X SEF UCL UCL %')+ X SEF

UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%

Name Department %ignature Date$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

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&' $#((*D#( !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7




b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

.' #FF*$E !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

44/60






b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

4' *P8$ !(E!

(oomName

"ocation



0'7 7'00'7 7'01 & . 4 7 1 & . 4 7




+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

45/60



b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

7' P!(M! $EN(*F,+E !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7


%tandard Deviation of t-e average %D3%tandard error of t-e mean of t-e average %EM3

b3 $alculation



+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

46/60



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by(evieed by

6' (E!$#( #)E( !N+*N+ !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7




b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

47/60



$-ecked by

(evieed by

;' E$' $EN(*F,+E !(E!

(oomName

"ocation



0'7 7'00'7 7'01 & . 4 7 1 & . 4 7




b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

A' %P!("E( F*"E( 9 G!% !(E!

(oomName

"ocation Non O viable air borne particle count per$u' Ft3


0'7 7'0 0'7 7'0

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

48/60



1 & . 4 7 1 & . 4 7


%tandard Deviation of t-e average %D3%tandard error of t-e mean of t-e average %EM3

b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

8/13/2019 AHU_1A

49/60




b3 $alculation


UCL UCL %')+ X SEF UCL UCL %')+ X SEFUCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

10' $(:%!""*HE( !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7




b3 $alculation

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

50/60





UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

11' *NE(MED*!E (E!$#(% !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7




b3 $alculation



UCL ,$" L UCL ,$" L

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

51/60



c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

1&' (!G M!E(*!" %#(!+E !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7




b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

52/60



1.' GE*+*N+ 9 B!"N$E !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7




b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% ))7 %''5)%,' '*)*% 6+ '&%


$-ecked by(evieed by

14' (!G M!E(*!" D*%PEN%*N+ !(E!

(oomName

"ocation



0'7 7'00'7 7'0

1 & . 4 7 1 & . 4 7

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

53/60






b3 $alculation



UCL ,$" L UCL ,$" L

c3 (E%,"

T7 %?%= 5%)*'& '+,',)%)*+, % & )7%, / + )7 %9+? ;%)% )

)7 %''5)%,' '*)*% 6+ '&%


$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

54/60



0;'7 %#,ND "E)E" E%

a3 Purpoe

To measure the air borne sound pressure levels produced by the basic clean roommechanical and electrical systems within the room and in ad*acent e)ternal

occupied areas and to verify that it is in the acceptable range.


c3 Procedure

0$.!.1 D*?*; )7 +< +, ,)%,' 5&%, *,)+ % =*; +6 (%& %% )7 %%7+(&; ,+) '; 430 S.6).

0$.!.2 S(55+) )7 S+(,; &?& ) +, )7 )%,; *)7 )7 *'+57+, A55+.1.! ) %9+? 6&++ %,; 3 ) %%: 6+ )7 (*5,).

0$.!.3 %( %,; '+; )7 +(,; 5( &?& 6+ %'7 +')%? 9%,; #3 )+ 8000HF *, )7 ',) +6 %'7 =*;.

0$.!.4 R'+; %&& %(,) %,; '+5+,;*,= =*; &+'%)*+,.

d3 !cceptance $riteria

7ess than 80 db 9A: at the wor area against an ambient of 00 db 9A: units for 7AF

units.

7ess than ;, db 9A: against the ambient of 00 db 9A: at the wor area of Materialhandling '5uipments.

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

55/60



%ound "evel (eult -eet

(oom Name "ocation %ound "evel )alue indb =!> %cale

CHANGE ROO

CORRIDOR

OICE AREA

IPQC AREA

PHARA CENTRIUGE AREA

REACTOR HANGING AREA

TECH CENTRIUGE AREA

SPARLER ILTER/ASHAREA

TRA" DR"ER/ILLING AREA

INTEREDIATE REACTORSAREA

CR"STALLIER AREA

R. STORAGE AREA

EIGHING BALANCE AREA

DISPENSED R. AREA

!cceptance $riteria

7ess than 80 db 9A: at the wor area against an ambient of 00 db 9A: units for 7AF units.

7ess than ;, db 9A: against the ambient of 00 db 9A: at the wor area of Material handling'5uipments.

(E%,"

T7 S+(,; &?& )) % 6+(,; )+ 9 *)7*, &**) 7,' )7 ++ P!%% 9 F!*"6+ )7)).


$-ecked by

(evieed by

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

56/60



0A'0 DEF*$*EN$: !ND $#((E$*)E !$*#N (EP#(

0A'1 Decription of deficiency and date oberved

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

0A'& Peron reponible for corrective action and date aigned

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

0A'. $orrective action taken and date conducted

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------

%*+N!,(E%$onducted By@ Date@

!pproved By@ Date@

+ N+ APL/QA/012-00/0#-2001

8/13/2019 AHU_1A

57/60



0

8/13/2019 AHU_1A

58/60



0

8/13/2019 AHU_1A

59/60



10'0 F*N!" (EP#( !PP(#)!"

$E$ED B: )!"*D!*#N $#2#(D*N!#(

T7 S*=,%)( +6 '7'

8/13/2019 AHU_1A

60/60



11'0 !PPEND*5

!BB(E)*!*#N%

!, A* H%,;&*,= U,*)

!MP A5

$FM C(9*' ) 5 *,()+'*' G%&?%,*; I+,

FPM ) P *,()

M#$ %)*%& O6 C+,)(')*+,

db D'*9&

*'+,( R&%)*? H(*;*):

%#P S)%,;%; O5%)*,= P+';(

'F T%); * *)%,'

P,F P+&: U)7%, +%

EP! H*=7 E66*'*,': P%)*'(&%) A*

D#P D* O'):& P7)7%&%)

%q'ft S(% 6)

AHU_1A

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