cleaning validation to be developed from this article on metformin tablets

8/17/2019 Cleaning Validation to Be Developed From This Article on Metformin Tablets

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E. Gopinath et al., ARPB, 2014; Vol 4 (I) ISSN 2250ISSN 2250ISSN 2250ISSN 2250----04040404(RESEAR!"(RESEAR!"(RESEAR!"(RESEAR!" AR#I!$E)AR#I!$E)AR#I!$E)AR#I!$E)

626 | P a g e w w w . a r p b . i n f o

%EVE$&P'EN# AN% !%EVE$&P'EN# AN% !%EVE$&P'EN# AN% !%EVE$&P'EN# AN% !$EANING VA$I%A#I&N & 'E#&R'IN$EANING VA$I%A#I&N & 'E#&R'IN$EANING VA$I%A#I&N & 'E#&R'IN$EANING VA$I%A#I&N & 'E#&R'IN "!$ #AB$E# B S*AP #E!"NI+E"!$ #AB$E# B S*AP #E!"NI+E"!$ #AB$E# B S*AP #E!"NI+E"!$ #AB$E# B S*AP #E!"NI+E

E.E.E.E. GopinathGopinathGopinathGopinath1111 anananan P.P.P.P.Bha/aaBha/aaBha/aaBha/aa2222 Sn/Sn/Sn/Sn/i3e nie/3it, Ala/, Ra6a3thani3e nie/3it, Ala/, Ra6a3thani3e nie/3it, Ala/, Ra6a3thani3e nie/3it, Ala/, Ra6a3than---- 701070, Inia.701070, Inia.701070, Inia.701070, Inia.

2222 Sh/inath6i In3titte o8 Pha/9a:Sh/inath6i In3titte o8 Pha/9a:Sh/inath6i In3titte o8 Pha/9a:Sh/inath6i In3titte o8 Pha/9a:, Natha/a Ra6a3than, Natha/a Ra6a3than, Natha/a Ra6a3than, Natha/a Ra6a3than----717701, Inia717701, Inia717701, Inia717701, Inia

Re:eie Re:eie Re:eie Re:eie 00001111een p/oie to o hat it p/po3e to o/ i3/ep/e3ente to o. #he p/oo8 o8 aliation i3 o>taineth/oh the :olle:tion an ealation o8 ata,

p/e8e/a>l, >einnin 8/o9 the p/o:e33 eelop9entpha3e an :ontine th/oh into the p/o:tion pha3e.Valiation ne:e33a/il in:le3 p/o:e33 ?ali8i:ation >tit al3o in:le3 the :ont/ol o8 the enti/e p/o:e33 8o/

/epeate >at:he3 o/ /n31

.F!/o33-:onta9ination i3 a 3ini8i:ant /i3= to patient3.#hi3 i3 t/e hethe/ th/oh i/e:t a9ini3t/ation to apatient3 o/ in the :a3e o8 in it/o iano3ti:3 th/ohthe pe/8o/9an:e3 o8 a te3t on a patient 3a9ple3.!leanin an :leanin aliation a/e to a:tiitie3 thathae the la/e3t oppo/tnit to p/eent patient /i3= >a33/in that no :/o33 :onta9ination :an o::/.!leanin aliation i3 >e:o9in 9o/e an 9o/ei9po/tant a3 e o/= ith in:/ea3inl potent,in:/ea3inl :o9pli:ate / 3>3tan:e3 anin:/ea3inl :o9ple >iote:hnolo p/o:t3. &/p/o:t3 hae /eate/ an /eate/ /i3=3 o8 inte/a:tion

ith one anothe/ /e3ltin in ha/98l e88e:t3 topatient3. #o t/l li9it thi3 /i3=, 3:ienti8i: app/oa:he393t >e ta=en in all a3pe:t3 o8 the :leanin an :leaninaliation p/o/a92.

!leanin P/o:e/e3!leanin P/o:e/e3!leanin P/o:e/e3!leanin P/o:e/e3*/itten :leanin p/o:e/e3 8o/ ea:h pie:e o8e?ip9ent an p/o:e33 93t >e p/epa/e. It i3 ital thatthe e?ip9ent e3in i3 ealate in etail in

:on6n:tion ith the p/o:t /e3ie3 to >e /e9oe,the aaila>le :leanin aent3 an :leanin te:hni?e3hen ete/9inin the opti99 :leanin p/o:e/e 8o/the e?ip9ent 7 ,4.Rea3on 8o/ !leanin ValiationRea3on 8o/ !leanin ValiationRea3on 8o/ !leanin ValiationRea3on 8o/ !leanin Valiation#he o>6e:tie3 o8 e?ip9ent :leanin an :leaninaliation in an A:tie Pha/9a:eti:al In/eient (API)a/ea a/e 3a9e a3 tho3e in pha/9a:eti:al p/o:tiona/ea. In >oth the3e a/ea3 e88o/t3 a/e ne:e33a/ top/eent :onta9ination o8 a 8t/e >at:h ith thep/eio3 >at:h 9ate/ial.#he :leanin o8 Hi88i:lt to /ea:hH 3/8a:e i3 one o8 the9o3t i9po/tant :on3ie/ation in e?ip9ent :leanin

!o//e3ponin Atho/!o//e3ponin Atho/!o//e3ponin Atho/!o//e3ponin Atho/'/.'/.'/.'/. E. GopinathE. GopinathE. GopinathE. GopinathSn/i3e nie/3it,

Ala/, Ra6a3than- 701070, Inia.'o>. J1-J5J152E9ail opi9pha/9K9ail.:o9


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aliation. E?ip9ent :leanin aliation in an API8a:ilit i3 et/e9el i9po/tant a3 :/o33 :onta9inationin one o8 the pha/9a:eti:al o3ae 8o/93, ill 9ltipl

the p/o>le9. #he/e8o/e, it i3 i9po/tant to o a 3tep->-3tep ealation o8 API p/o:e33 to ete/9ine the 9o3tp/a:ti:al an e88i:ient a to 9onito/ the e88e:tiene33o8 the :leanin p/o:e33.

It i3 ne:e33a/ to aliate :leanin p/o:e/e3 8o/ the8olloin /ea3on31. It i3 a p/i9e :3to9e/ /e?i/e9ent 3in:e it en3/e3the p/it an 3a8et o8 the p/o:t.2. It i3 a /elato/ /e?i/e9ent in A:tiePha/9a:eti:al In/eient p/o:t 9an8a:t/e.7. It al3o a33/e3 the ?alit o8 the p/o:e33 th/oh aninte/nal :ont/ol an :o9plian:e5.

#pe3 o#pe3 o#pe3 o#pe3 o8 !onta9ination38 !onta9ination38 !onta9ination38 !onta9ination31. !/o33 :onta9ination ith a:tie in/eient31. !/o33 :onta9ination ith a:tie in/eient31. !/o33 :onta9ination ith a:tie in/eient31. !/o33 :onta9ination ith a:tie in/eient3!onta9ination o8 one >at:h o8 p/o:t ith 3ini8i:antleel3 o8 /e3ial a:tie in/eient3 8/o9 a p/eio3>at:h :annot >e tole/ate. In aition to the o>io3p/o>le93 po3e > 3>6e:tin :on39e/3 o/ patient3 tonintene :onta9inant3, potential :lini:all 3ini8i:ant

3ne/i3ti: inte/a:tion3 >eteen pha/9a:oloi:alla:tie :he9i:al3 a/e a /eal :on:e/n.2. !on2. !on2. !on2. !onta9ination ith nintene 9ate/ial3 o/ta9ination ith nintene 9ate/ial3 o/ta9ination ith nintene 9ate/ial3 o/ta9ination ith nintene 9ate/ial3 o/:o9pon3:o9pon3:o9pon3:o9pon3 *hile ine/t in/eient3 3e in /p/o:t3 a/e ene/all /e:oni@e a3 3a8e o/ hae >een3hon to >e 3a8e 8o/ h9an :on39ption, the /otine

3e, 9aintenan:e an :leanin o8 e?ip9ent3 p/oiethe potential :onta9ination ith 3:h ite93 a3e?ip9ent pa/t3, l>/i:ant3, :he9i:al :leanin aent3an pie:e3 o8 :leanin tool3 3:h a3 >/3he3 an /a3.7. 'i:/o>ioloi:al :onta9ination7. 'i:/o>ioloi:al :onta9ination7. 'i:/o>ioloi:al :onta9ination7. 'i:/o>ioloi:al :onta9ination 'aintenan:e, :leaninan 3to/ae :onition3 9a p/oie aentitio3 9i:/oo/ani393 ith the oppo/tnit to p/oli8e/ate ithinthe p/o:e33in e?ip9ent .Sa9plin #e:hni?eSa9plin #e:hni?eSa9plin #e:hni?eSa9plin #e:hni?e

Gene/all the/e a/e to tpe3 o8 3a9plin that a/ea::epte. #he 9o3t e3i/a>le i3 the i/e:t 9etho o83a9plin the 3/8a:e o8 the e?ip9ent, anothe/ 9etho

>ein the 3e o8 /in3e 3a9plin.1. %i/e:t 3/8a:e 3a9plin1. %i/e:t 3/8a:e 3a9plin1. %i/e:t 3/8a:e 3a9plin1. %i/e:t 3/8a:e 3a9plin It inole3 the ete/9inationo8 the tpe o8 3a9plin 9ate/ial 3e an it3 i9pa:t onthe te3t ata to :he:= the inte/8e/en:e o8 the 3a9plin9ate/ial ith the te3t. #he/e8o/e, ea/l in the aliationp/o/a99e, it i3 :/:ial to a33/e the 3a9plin 9ei9an 3olent i8 the a/e 3ati38a:to/ an >e /eail 3e.Aantae3 o8 i/e:t 3a9plin a/e that, a/ea3 ha/e3t to

:lean an hi:h a/e /ea3ona>l a::e33i>le :an >eealate, leain to e3ta>li3hin a leel o8:onta9ination o/ /e3ie pe/ ien 3/8a:e a/ea.

Aitionall, /e3ie3 that a/e L/ie otL o/ a/ein3ol>le :an >e 3a9ple > ph3i:al /e9oal.2. Sa> 3a9plin2. Sa> 3a9plin2. Sa> 3a9plin2. Sa> 3a9plin A8te/ :leanin the e?ip9ent, p/o:t

:onta:t 3/8a:e3 :ol >e 3a>>e to ealate 3/8a:e:leanline33. Sa>3 3e 3hol >e :o9pati>le ith thea:tie in/eient3 an 3hol not inte/8e/e ith thea33a. #he 3hol not :a3e an e/aation o8 the

:o9pon. #he 3olent 3e 8o/ 3a>>in 3holp/oie oo 3ol>ilit 8o/ the :o9pon an 3holnot en:o/ae e/aation.7. Rin3e 3a9plin7. Rin3e 3a9plin7. Rin3e 3a9plin7. Rin3e 3a9plin Sa9plin an te3tin o8 /in3e 3a9ple38o/ /e3ial a:tie in/eient i3 a :o99onl aopte9etho to ealate :leanline33. #hi3 i3 a 8ai/l:onenient 9etho in 9an :a3e3 an /e?i/e3 :ont/oloe/ the 3olent 3e 8o/ /in3in, the :onta:t ti9e an

the 9iin inole. #he 3olent 3e 3hol >e3ele:te >a3e on the 3ol>ilit o8 the a:tie in/eientan 3hol eithe/ 3i9late a 3>3e?ent >at:h o8p/o:t o/ at lea3t p/oie ae?ate 3ol>ilit.A i3aantae o8 /in3e 3a9ple3 i3 that the /e3ie o/:onta9inant 9a not >e 3ol>le o/ 9a >e ph3i:allo::le in the e?ip9ent. An analo that :an >e 3e

i3 the Li/t pot.L In the ealation o8 :leanin o8 a i/tpot, pa/ti:la/l ith /ie ot /e3ie, one oe3 notloo= at the /in3e ate/ to 3ee that it i3 :lean; one loo=3at the pot -17.

'A#ERIA$S AN% 'E#"&%S'A#ERIA$S AN% 'E#"&%S'A#ERIA$S AN% 'E#"&%S'A#ERIA$S AN% 'E#"&%SA::eptan:e !/iA::eptan:e !/iA::eptan:e !/iA::eptan:e !/itetetete/ia/ia/ia/ia

'etho o8 :al:latin A::eptan:e !/ite/ia'etho o8 :al:latin A::eptan:e !/ite/ia'etho o8 :al:latin A::eptan:e !/ite/ia'etho o8 :al:latin A::eptan:e !/ite/iai) Ba3e on #he/apeti: %ail %o3ei) Ba3e on #he/apeti: %ail %o3ei) Ba3e on #he/apeti: %ail %o3ei) Ba3e on #he/apeti: %ail %o3e #he p/in:iple 8o/ the/e?i/e9ent i3 that the 3tana/ #he/apeti: %ail%o3e (#%%) o8 the 8olloin 3>3tan:e (:onta9inate3>3tan:e, in thi3 :alle netF) 9a >e :onta9inate> no 9o/e than a :e/tain p/opo/tion (3all 13tan:e ine3tiate in the:leanin aliation (:onta9inatin 3>3tan:e, in thi3:a3e :alle P/eio3F). #hi3 9etho onl applie3 henthe the/apeti: ail o3e i3 =non.It ene/all 3e 8o/ 8inal p/o:t :haneoe/ APIP/o:e33 AF to API p/o:e33 BF.

P/o:e/eP/o:e/eP/o:e/eP/o:e/eE3ta>li3h the li9it 8o/ 'ai99 Alloa>le !a//oe/('A!&) a::o/in to the 8olloin E?ation

'A!&'A!&'A!&'A!& 'ai99 Alloa>le !a//oe/ a::epta>let/an38e//e a9ont 8/o9 the ine3tiation p/o:t(P/eio3F)#%%#%%#%%#%% PPPP/eio3/eio3/eio3/eio3 Stana/ the/apeti: o3e o8 theine3tiate p/o:t (in the 3a9e o3ae 8o/9 a3 #%%


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#%% net#%% net#%% net#%% net Stana/ the/apeti: o3e o8 the ail o3e8o/ the net p/o:t.'BS'BS'BS'BS 'ini99 >at:h 3i@e 8o/ the net p/o:t(3)

(he/e 'A!& :an en p)SSSS Sa8et 8a:to/ (no/9all 1000 i3 3e in :al:lation3>a3e on #%%).ii)ii)ii)ii) Ba3e on #oi:olo %ataBa3e on #oi:olo %ataBa3e on #oi:olo %ataBa3e on #oi:olo %ata

In :a3e3 in hi:h a the/apeti: o3e i3 not =non (e..8o/ inte/9eiate3 an ete/ent3), toi:it ata 9a >e3e 8o/ :al:latin 'A!&.P/o:e/eP/o:e/eP/o:e/eP/o:e/e!al:late the 3o :alle N&E$ n9>e/ (No &>3e/a>leE88e:t $eel) a::o/in to the 8olloin e?ation an3e the /e3lt 8o/ the e3ta>li3h9ent o8 'A!&.

/o9 the N&E$ n9>e/ a 'A!& :an then >e :al:latea::o/in to

'A!&'A!&'A!&'A!& 'ai99 Alloa>le !a// oe/ a::epta>let/an38e//e a9ont 8/o9 the ine3tiate p/o:t(p/eio3F).

N&E$N&E$N&E$N&E$ No &>3e/e E88e:t $eel$%50$%50$%50$%50 $ethal %o3e 50 e a9ini3te/e in o/alo3ae 8o/93. S :an a/ epenin on3>3tan:ea3e on the/apeti: o3e3o/ toi:oloi:al ata /e3lt in na::epta>l hih o/i//eleant :a//oe/ 8i/e3, o/ toi:oloi:al ata 8o/inte/9eiate3 a/e not =no, the app/oa:h o8 a ene/alli9it 9a >e 3ita>le. !o9panie3 9a :hoo3e to hae3:h an ppe/ li9it a3 a poli:. #he ene/al li9it i3 o8ten3et a3 an ppe/ li9it 8o/ the 9ai99 :on:ent/ation

('AM!&N!) o8 a :onta9inatin 3>3tan:e in a3>3e?ent >at:h.#he :on:ent/ation (!&N!) o8 the ine3tiate 3>3tan:e

hi:h :an >e a::epte in the net >at:h, a::o/in too3e /elate :al:lation3, i3

'A!&'A!&'A!&'A!& 'ai99 Alloa>le !a//oe/ a::epta>let/an38e//e a9ont 8/o9 the ine3tiate p/o:t(p/eio3F). !al:late 8/o9 the/apeti: o3e3 an at:h.'BS'BS'BS'BS 'ini99 >at:h 3i@e 8i/ the net p/o:t(3)

(he/e 'A!& :an en p) A ene/al ppe/ li9it 8o/ the9ai99 :on:ent/ation o8 a :onta9inatin 3>3tan:ein a 3>3e?ent >at:h ('AM!&N!) i3 o8ten 3et to pp9epenin on the nat/e o8 p/o:t3 p/o:e 8/o9 the

iniial :o9pan (e.. toi:it, pha/9a:oloi:ala:tiit,) pp9 in API3 i3 e/ 8/e?ent).NoteNoteNoteNote I8 o e:ie to e9plo the :on:ept o8 leel3 o8:leanin 9a >e 3e 8o/ i88e/ent leel3. E3pe:iall i8the p/o:t :leane ot i3 ithin the 3a9e 3ntheti::hain an :oe/e > the 3pe:i8i:ation o8 the API, 9:hhihe/ (?ali8ie) leel3 a/e a::epta>le.I8 the :al:late :on:ent/ation (!&N!) o8 the p/eio3

(>a3e on 'A!& :al:lation 8/o9 the/apeti: o3e3e li9it.Sa> $i9it3Sa> $i9it3Sa> $i9it3Sa> $i9it3I8 ho9oeno3 i3t/i>tion i3 a339e on all 3/8a:e3, a/e:o99ene ale :an >e 3et 8o/ the :ontent in a3a>. #hi3 :an >e 3e a3 >a3i: in8o/9ation 8o/

p/epa/ation o8 a 9etho o8 anal3i3 an ete:tion li9it.P/o:e/eP/o:e/eP/o:e/eP/o:e/eE3ta>li3h the ta/et ale 8o/ 3a> li9it 8o/ the holee?ip9ent t/ain, 3in the 8olloin e?ation

Al3o othe/ 9etho3 ith i88e/ent 3a> li9it3 8o/i88e/ent 3/8a:e3 in a pie:e o8 e?ip9ent ane 3e. 3in thi3 app/oa:h, the


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total a9ont 8on on the e?ip9ent t/ain ha3 to >e>elo the 'A!&.

Sa>>in i3 the 9o3t iel 3e 3a9plin

te:hni?e. Sa>3 9a >e 3at/ate ith 3olent 3:ha3 ate/ o/ al:ohol, 8a:ilitatin the 3ol>ili@ation an

ph3i:al /e9oal o8 3/8a:e /e3ie3 (Sa9plin a/ea

70:92)14.!$EANING VA$I%A#I&N IN %ISPENSING B&"!$EANING VA$I%A#I&N IN %ISPENSING B&"!$EANING VA$I%A#I&N IN %ISPENSING B&"!$EANING VA$I%A#I&N IN %ISPENSING B&"%i3pen3in >ooth i3 3e to pe/8o/9 i3pen3inope/ation3 in pha/9a:eti:al in3t/ie3. #hee?ip9ent3 3e/e a3 3a8et e?ip9ent to ope/ato/oin the i3pen3in ope/ation. In i3pen3in >ooth >ipa:=in o8 ane/o3 :he9i:al3 a/e i3pen3e to 39allpa:=in > ope/ato/ ne/ :la33 100 eni/on9ent3 an10O eha3t 33te9 aopte. %i3pen3in nit i3 ala3

a neatie p/e33/e nit an ai/ i3 :i/:late 8/o9ot3ie to in3ie o8 the e?ip9ent. "en:e /ini3pen3in ope/ation poe/ i3 ala3 3:=e at p/e8ilte/ ien at the >otto9 o8 the :a>inet 3o that:he9i:al3 o not a88e:t the ope/ato/.#a>le. 1#a>le. 1#a>le. 1#a>le. 1 !leanin aliation in i3pen3in >ooth

S.NoS.NoS.NoS.No Na9e o8 a9e o8 Na9e o8 a9e o8 t tt thehehehe!o9ponent !o9ponent !o9ponent !o9ponent

%e3:/iption%e3:/iption%e3:/iption%e3:/iption

1 !a>inet Bo i3 9ae p o8 SS 704 3heet3 hai/ line 8i

i3h o8 /it 10 an thi:=ne33 1.0 99

2 Sie 8/a9e P8 8ille 3ani:h panel o8 SS 704 3heet3

7 oto/ R4e-225-:: 01-027p: 9ae in e/9an

Bloe/ %na9i:all >alan:e al >loe/

ith hih 3tati: p/e33/e lo i>/ation leel

5 Sit:h Ele:t/i: 3it:h 9ae in :hina -07no3

>e liht Philip3 9a=e -70 att3:8l-2no3

aneheli:ae

%e/ 9a=e 9aneheli: ae a/e 3e toea3/e the

/e33/e /op a:/o33 hepa 8ilte/ 0-500pa

/ont oo/ /ont oo/ 8lei>le :/tain(nle)

799 thi:=ne33-01no3

%i3pen3in ill ene/ate 8ine 3t. #hat 9ihteentall :a3e /i3= to ope/ato/3 an al3o p/o:t3.&ne 3hol hae a :leanin p/o:e33 to p/eent an :/o33:onta9ination an p/o:t epo3/e. %i3pen3in tool393t >e 3epa/ate. *e :annot hae a 3epa/ate $A >t

3:oop3 an othe/ ten3il3 93t >e 3epa/ate. ItC3

e33ential to :lean i3pen3in a/ea an aliate.P/o:e/eP/o:e/eP/o:e/eP/o:e/e#he 9ain o>6e:tie o8 thi3 p/o:e/e i3 to e3ta>li3h ap/o:e/e 8o/ 3a> 3a9plin 8o/ aliation o8 te3t3/8a:e to ealate :leanin e88i:a:.'a=in o8 3ap 3ti:= 'a=in o8 3ap 3ti:= 'a=in o8 3ap 3ti:= 'a=in o8 3ap 3ti:= 3ap 3ti:=3 a/e p/epa/e > 3in3te/ile :otton.#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/ !appe te3t t>e3 9ae o8 la33.Sa9plin 3olent *ate/< a3 9entione in thealiation p/oto:ol o8 analti:al 9etho 3e 8o/anal3i3 o8 3a> 3a9ple3 o8 /e3pe:tie a:tiein/eient3.

In3t/9ent 8o/ 9ea3/in a>3o/>In3t/9ent 8o/ 9ea3/in a>3o/>In3t/9ent 8o/ 9ea3/in a>3o/>In3t/9ent 8o/ 9ea3/in a>3o/>an:e lt/a Violetan:e lt/a Violetan:e lt/a Violetan:e lt/a Violet3pe:t/o3:op3pe:t/o3:op3pe:t/o3:op3pe:t/o3:op Pipette ot 109l o8 3a9plin 3olent int/an3po/t :ontaine/. Re9oe a 3a> 8/o9 it3 p/ote:tie

>a 3in a :lean late han loe. Aoi to:hin the3a> hea to p/eent it3 :onta9ination. #/an38e/ the3a> in t/an3po/t :ontaine/ (te3t t>e) :ontainin 109lo8 3a9plin 3olent an allo the 3a> to 3oa=

:o9pletel. #a=e ot the 3a> 8/o9 3a9plin 3olentan 3?ee@e the tip aain3t inne/ 3/8a:e o8 te3t t>e to/e9oe e:e33 3olent in 3:h a 9anne/ that e:e333a9plin 3olent /ip3 in3ie the te3t t>e."ol the 3te9 o8 3a> ithot to:hin the hea o8 the3a>. 3in 9oi3tene 3a> ipe the te3t 3/8a:e o870:92. (ho/i@ontal 3t/o=e3). At the en o8 ea:h 3t/o=e,li8t the 3a> :a/e8ll. #/n the 3a> oe/ to it3 othe/

3ie, ipe the te3t 3/8a:e 70:92

(e/ti:al). At the eno8 ea:h 3t/o=e, li8t the 3a> :a/e8ll. "ol the 3tea9 o8the 3a> ithot to:hin the hea o8 the 3a> an letthe 3a> /op into the t/an3po/t :ontaine/. !ap thet/an3po/t :ontaine/ an 3en 8o/ anal3i3 a8te/ la>elinthe 3a9e. !al:late the :ontent o8 !4"11N5,"!l ta=inJ a3 the ale o8 A(1O, 1 :9) at the 9ai99 at

a>ot 272 n9.

#a>le. 2#a>le. 2#a>le. 2#a>le. 2 Stana/ a9ont o8 10pp9 in 0.001O i3 19.S.NS.NS.NS.Noooo Sa9pleSa9pleSa9pleSa9ple StStStSt

a>3o/>an:ea>3o/>an:ea>3o/>an:ea>3o/>an:e

#e3te3t#e3te3t


!on:ent/ation in!on:ent/ation in!on:ent/ation in!on:ent/ation in

70:970:970:970:92222 (9)(9)(9)(9)

1 I 0.52 0.241 0.22

2 II 0.11 0.212

7 III 0.101 0.11


5/9



!$EANING VA$I%A#I&N IN %ISPENSING BA$A!$EANING VA$I%A#I&N IN %ISPENSING BA$A!$EANING VA$I%A#I&N IN %ISPENSING BA$A!$EANING VA$I%A#I&N IN %ISPENSING BA$AN!EN!EN!EN!E'a=e'a=e'a=e'a=e o9ea'oel'oel'oel'oel &P*

!apa:it!apa:it!apa:it!apa:it 500=Re3oltionRe3oltionRe3oltionRe3oltion 100P/o:e/eP/o:e/eP/o:e/eP/o:e/e 'a=in o8 3ap 3ti:='a=in o8 3ap 3ti:='a=in o8 3ap 3ti:='a=in o8 3ap 3ti:= Sap 3ti:=3 a/e p/epa/e > 3in

3te/ile :otton.#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/ !appe te3t t>e3 9ae o8 la33....Sa9plinSa9plinSa9plinSa9plin 3olent3olent3olent3olent *ate/an:eIn3t/9ent 8o/ 9ea3/in a>3o/>an:eIn3t/9ent 8o/ 9ea3/in a>3o/>an:eIn3t/9ent 8o/ 9ea3/in a>3o/>an:e lt/a Violetlt/a Violetlt/a Violetlt/a Violet3pe:t/o3:op3pe:t/o3:op3pe:t/o3:op3pe:t/o3:op!he:= an en3/e the :leanne33 o8 the i3pen3in

>alan:e >e8o/e 3ta/t aliation p/o:e33. Sele:t te3t3/8a:e a/ea 70:92 in i3pen3in >alan:e. Re9oe a3a> 8/o9 it3 p/ote:tie >a 3in a :lean late hanloe. Pipette ot 109l o8 3a9plin o8 ate/ int/an3po/t :ontaine/. #/an38e/ the 3a> in t/an3po/t:ontaine/ (te3t t>e) :ontainin 109l o8 3a9plin3olent an allo the 3a> to 3oa= :o9pletel. 3in

9oi3tene 3a> ipe the te3t 3/8a:e o8 i3pen3in>alan:e 70:92. (ho/i@ontal 3t/o=e3). #/n the 3a>oe/ to it3 othe/ 3ie; ipe the te3t 3/8a:e 70:92 (e/ti:al). "ol the 3tea9 o8 the 3a> ithot to:hin

the hea o8 the 3a> an let the 3a> /op into thet/an3po/t :ontaine/. !ap the t/an3po/t :ontaine/ an

3en 8o/ anal3i3 a8te/ la>elin the 3a9e. !al:late the:ontent o8 !4"11N5,"!l ta=in J a3 the ale o8 A(1O,1 :9) at the 9ai99 at a>ot 272 n9.#a>le. 7#a>le. 7#a>le. 7#a>le. 7 !leanin aliation in i3pen3in >alan:eSSSS.... NNNNoooo.... Sa9plea9pleSa9plea9ple StStStSt


#e3te3t#e3te3t



70:970:970:970:92222 (9)(9)(9)(9)

10.52

0.1J 0.221

2 I 0.201 0.27J

7 II 0.0 0.0J1

!$EANING VA$I%A#I&N IN SI#ER!$EANING VA$I%A#I&N IN SI#ER!$EANING VA$I%A#I&N IN SI#ER!$EANING VA$I%A#I&N IN SI#ER'a=in o8 3ap 3'a=in o8 3ap 3'a=in o8 3ap 3'a=in o8 3ap 3ti:=ti:=ti:=ti:= 3ap 3ti:=3 a/e p/epa/e > 3in3te/ile :otton

#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/ !appe te3t t>e3 9ae o8 la33.Sa9plinSa9plinSa9plinSa9plin 3olent3olent3olent3olent *ate/< a3 9entione in thealiation p/oto:ol o8 analti:al 9etho 3e 8o/anal3i3 o8 3a> 3a9ple3 o8 /e3pe:tie a:tie

in/eient3.In3t/9ent 8o/ 9ea3/in a>3o/>an:e lt/a VioletIn3t/9ent 8o/ 9ea3/in a>3o/>an:e lt/a VioletIn3t/9ent 8o/ 9ea3/in a>3o/>an:e lt/a VioletIn3t/9ent 8o/ 9ea3/in a>3o/>an:e lt/a Violet3pe:t/o3:op3pe:t/o3:op3pe:t/o3:op3pe:t/o3:op!he:= an /e:o/ the te9pe/at/e an /elatieh9iit in p/o:e33in a/ea te9pe/at/e, 3hol >e 25Q2! R" 45Q5O. !he:= an en3/e i3all all thee?ip9ent an e?ip9ent pa/t3 a/e :leane. Re9oe a3a> 8/o9 it3 p/ote:tie >a 3in a :lean late han

loe. Pipette ot 109l o8 3a9plin o8 ate/ int/an3po/t :ontaine/. #/an38e/ the 3a> in t/an3po/t:ontaine/ (te3t t>e) :ontainin 109l o8 ate/ anallo the 3a> to 3oa= :o9pletel. 3in 9oi3tene3a> ipe the te3t 3/8a:e o8 3i8te/ 70:92. (ho/i@ontal3t/o=e3). #/n the 3a> oe/ to it3 othe/ 3ie; ipe thete3t 3/8a:e 70:92 (e/ti:al). "ol the 3tea9 o8 the

3a> ithot to:hin the hea o8 the 3a> an let the3a> /op into the t/an3po/t :ontaine/. !ap thet/an3po/t :ontaine/ an 3en 8o/ anal3i3 a8te/ la>elinthe 3a9e. !al:late the :ontent o8 !4"11N5,"!l ta=inJ a3 the ale o8 A(1O, 1 :9) at the 9ai99 ata>ot 272 n9.

#a>le. 4#a>le. 4#a>le. 4#a>le. 4 !leanin aliation in 3i8te/SSSS.... NNNNoooo Sa9pleSa9pleSa9pleSa9ple St a>3o/>an:eSt a>3o/>an:eSt a>3o/>an:eSt a>3o/>an:e #e3t#e3t#e3t#e3t



70:970:970:970:92222 (9)(9)(9)(9)

1 I0.52

0.115 0.1

2 II 0.22 0.2

7 III 0.02 0.04


6/9



!$EANING VA$I%A#I&N IN!$EANING VA$I%A#I&N IN!$EANING VA$I%A#I&N IN!$EANING VA$I%A#I&N IN RIBB&N 'IMERRIBB&N 'IMERRIBB&N 'IMERRIBB&N 'IMER'oel'oel'oel'oel- G-0 %o>le Spi/al Ri>>on Blene/,G/o33G/o33G/o33G/o33 :apa:it:apa:it:apa:it:apa:it ---22 allon3 (5 lite/3),

Net Net Net Net :apa:it:apa:it:apa:it:apa:it -14 allon3 (0 lite/3),SpeeSpeeSpeeSpee -70 /p9,.A8te/ nloain o8 the 3ele:te aliation p/o:tion>at:h o8 9et8o/9in "!l ta>let the 9ie/ i3 a3he a3

pe/ it3 /e3pe:tie app/oe :leanin p/o:e/e. #he3pe:ial etene 3a9plin 3hol >e ee:te 8/o9i88e/ent lo:ation38/o9 it3 p/ote:tie >a 3in a :lean late han loe.Pipette ot 109l o8 3a9plin o8 ate/ in t/an3po/t:ontaine/. #/an38e/ the 3a> in t/an3po/t :ontaine/(te3t t>e) :ontainin 109l o8 ate/ an allo the 3a>to 3oa= :o9pletel. 3in 9oi3tene 3a> ipe the te3t

3/8a:e o8 9ie/ 70:92

. (ho/i@ontal 3t/o=e3). #/n the3a> oe/ to it3 othe/ 3ie; ipe the te3t 3/8a:e 70:9 2 (e/ti:al). "ol the 3tea9 o8 the 3a> ithot to:hinthe hea o8 the 3a> an let the 3a> /op into thet/an3po/t :ontaine/. !ap the t/an3po/t :ontaine/ an3en 8o/ anal3i3 a8te/ la>elin the 3a9e. !al:late the:ontent o8 !4"11N5, "!l ta=in J a3 the ale o8 A

(1O, 1 :9) at the 9ai99 at a>ot 272 n9.####a>le. 5a>le. 5a>le. 5a>le. 5 !leanin aliation in /i>>on 9ie/

SSSS.... NNNNoooo.... Sa9pleSa9pleSa9pleSa9ple StStStSt


#e3t#e3t#e3t#e3t

a>3o/>an:e>3o/>an:ea>3o/>an:e>3o/>an:e

!on:ent/ation inon:ent/ation in!on:ent/ation inon:ent/ation in

70:90:970:90:92222 (9)(9)(9)(9)

1 I0.52

0.1J2 .205

2 II 0.15 .0J1

7 III 0.201 .275

!$EANING VA$I%A#I&N IN #RA %RER!$EANING VA$I%A#I&N IN #RA %RER!$EANING VA$I%A#I&N IN #RA %RER!$EANING VA$I%A#I&N IN #RA %RER!leanin p/o:e/e 8o/ t/a /e/!leanin p/o:e/e 8o/ t/a /e/!leanin p/o:e/e 8o/ t/a /e/!leanin p/o:e/e 8o/ t/a /e/Sit:h o88 the ele:t/i:al 9ain o8 t/a /e/. Re9oe

ne/ 3e la>el an pt to >e :leane la>el. Re9oe the3t 8/o9 the >o ith / 3te/. &pen the oo/,/e9oe all the t/a3 an ta=e it in a3hin /oo9. !leanea:h t/a > pota>le ate/ 8olloe > 0.1O %ete/ent

3oltion 3in nlon 3:/>>e/. !lean ea:h t/a ithpota>le ate/ 8olloe > p/i8ie ate/. Re9oeate/ ith the help o8 :o9p/e33e ai/; / all the t/a3ith a :lean lint 8/ee :loth.Re9oe a 3a> 8/o9 it3 p/ote:tie >a 3in a :leanlate han loe. Pipette ot 109l o8 3a9plin o8 ate/in t/an3po/t :ontaine/. #/an38e/ the 3a> in t/an3po/t:ontaine/ (te3t t>e) :ontainin 109l o8 ate/ an

allo the 3a> to 3oa= :o9pletel. 3in 9oi3tene3a> ipe the te3t 3/8a:e o8 t/a /e/ 70:92.(ho/i@ontal 3t/o=e3). #/n the 3a> oe/ to it3 othe/3ie, ipe the te3t 3/8a:e 70:92 (e/ti:al). "ol the3tea9 o8 the 3a> ithot to:hin the hea o8 the3a> an let the 3a> /op into the t/an3po/t:ontaine/. !ap the t/an3po/t :ontaine/ an 3en 8o/

anal3i3 a8te/ la>elin the 3a9e. !al:late the :ontent o8!4"11N5, "!l ta=in J a3 the ale o8 A (1O, 1 :9) atthe 9ai99 at a>ot 272 n9.#a>le. #a>le. #a>le. #a>le. !leanin aliation in t/a /e/

SSSS.... NNNNoooo.... Sa9pleSa9pleSa9pleSa9ple StStStSt

>3o/>an:e>3o/>an:e>3o/>an:e>3o/>an:e

#e3t#e3t#e3t#e3t


!on:ent/ation!on:ent/ation!on:ent/ation!on:ent/ation inininin

70:970:970:970:92222 (9)(9)(9)(9)

1 I0.52

0.75 0.4202 II 0.752 0.417

7 III 0.152 0.1


7/9



!$EANING VA$I%A#I&N IN !A%'I$$!$EANING VA$I%A#I&N IN !A%'I$$!$EANING VA$I%A#I&N IN !A%'I$$!$EANING VA$I%A#I&N IN !A%'I$$Pt & the ele:t/i:al 3ppl an :oe/ 9oto/, 3ta/te/,ith polthene >a. Re9oe hoppe/, >lae :ha9>e/,

3:/een an >lae3 :lean ith pota>le ate/. /the/:lean ith 2.5O #eepol 3oltion 3in 3:/>>e/. Rin3eith pota>le ate/ tho/ohl.Appl 20 lit o8 hot ate/ to all the :leane ite93 an

allo the ate/ to /in=. inall /in3e ith a>ot 70litp/i8ie ate/. *ipe ot ith / :lean lint 8/ee :lothan ith 0O IPA. A33e9>le the pa/t3 an a88i :leane.Re9oe a 3a> 8/o9 it3 p/ote:tie >a 3in a :leanlate han loe. Pipette ot 109l o8 3a9plin o8 ate/in t/an3po/t :ontaine/. #/an38e/ the 3a> in t/an3po/t:ontaine/ (te3t t>e) :ontainin 109l o8 ate/ anallo the 3a> to 3oa= :o9pletel. 3in 9oi3tene

3a> ipe the te3t 3/8a:e o8 :a9ill 70:92

. (ho/i@ontal3t/o=e3). #/n the 3a> oe/ to it3 othe/ 3ie, ipe thete3t 3/8a:e 70:92 (e/ti:al). "ol the 3tea9 o8 the3a> ithot to:hin the hea o8 the 3a> an let the3a> /op into the t/an3po/t :ontaine/. !ap thet/an3po/t :ontaine/ an 3en 8o/ anal3i3 a8te/ la>elinthe 3a9e. !al:late the :ontent o8 !4"11N5, "!l ta=in

J a3 the ale o8 A (1O, 1 :9) at the 9ai99 ata>ot 272 n9.#a>le. #a>le. #a>le. #a>le. !leanin aliation in :a9ill SSSS.... NNNNoooo.... Sa9pleSa9pleSa9pleSa9ple StStStSt

a>3o/>an:ea>3o/>an:ea>3o/>an:ea>3o/>an:e#e3t#e3t#e3t#e3ta>3o/>an:ea>3o/>an:ea>3o/>an:ea>3o/>an:e

!on:ent/ation!on:ent/ation!on:ent/ation!on:ent/ationin 70:9in 70:9in 70:9in 70:92222 (9)(9)(9)(9)

1 I

0.52

0.701 0.757

2 II 0.75J 0.4217 III 0.112 0.171

!$EANING VA$I%A#I&N IN %&B$E !&NE B$EN%ER!$EANING VA$I%A#I&N IN %&B$E !&NE B$EN%ER!$EANING VA$I%A#I&N IN %&B$E !&NE B$EN%ER!$EANING VA$I%A#I&N IN %&B$E !&NE B$EN%ER!leanin aen!leanin aen!leanin aen!leanin aent3t3t3t3 #ap ate/

!leanin e?ip9ent3!leanin e?ip9ent3!leanin e?ip9ent3!leanin e?ip9ent3 %/ 3te/, 0.1O #eepol%i39antle the 3a8et a/ o8 the >lene/, :i/:la/ lian a3=et > n:la9pin the in nt3

!lean the ot3ie o8 the >lene/ ith / 3te/8olloe > 9oi3t 3te/ an then ith / 3te/.Deep the >tte/l ale :lo3e an =eep an SS :ontaine/>elo it. *a3h in3ie the >lene/ ith ta> ne/ an

/ain it th/oh >tte/8l ale. !lean in3ie 3/8a:eith a/9 ate/ 40! to 50! 8olloe > 0.1O teepol3oltion. #hen a3h ith plent o8 ate/ to /e9oe theteepol :o9pletel, an then /in3e ith ate/.*ipe the i88e/ent pa/t3 o8 the >lene/ ith :lean lint8/ee 3te/. #hen a33e9>le the i39antle pa/t3. %/:lean the >lene/ li3 ith lint 8/ee 3te/ an e3tthe ete/nal 3/8a:e ith :lean lint 8/ee 3te/.

'a=in o8 3ap 3ti:= 'a=in o8 3ap 3ti:= 'a=in o8 3ap 3ti:= 'a=in o8 3ap 3ti:= 3ap 3ti:=3 a/e p/epa/e > 3in3te/ile :otton.#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/#/an3po/t :ontaine/ !appe te3t t>e3 9ae o8 la33.Sa9plinSa9plinSa9plinSa9plin 3olent 3olent 3olent 3olent ate/< a3 9entione in thealiation p/oto:ol o8 analti:al 9etho 3e 8o/anal3i3 o8 3a> 3a9ple3 o8 /e3pe:tie a:tiein/eient3.

In3t/9ent 8o/ 9ea3/in a>3o/>an:e VIn3t/9ent 8o/ 9ea3/in a>3o/>an:e VIn3t/9ent 8o/ 9ea3/in a>3o/>an:e VIn3t/9ent 8o/ 9ea3/in a>3o/>an:e VPipette ot 109l o8 3a9plin 3olent in t/an3po/t:ontaine/. Re9oe a 3a> 8/o9 it3 p/ote:tie >a 3ina :lean late han loe. Aoi to:hin the 3a> heato p/eent it3 :onta9ination. #/an38e/ the 3a> int/an3po/t :ontaine/ (te3t t>e) :ontainin 109l o8

3a9plin 3olent an allo the 3a> to 3oa=:o9pletel. #a=e ot the 3a> 8/o9 3a9plin 3olentan 3?ee@e the tip aain3t inne/ 3/8a:e o8 te3t t>e to/e9oe e:e33 3olent in 3:h a 9anne/ that e:e333a9plin 3olent /ip3 in3ie the te3t t>e. "ol the3te9 o8 3a> ithot to:hin the hea o8 the 3a>.3in 9oi3tene 3a> ipe the te3t 3/8a:e o8 70:92.(ho/i@ontal 3t/o=e3). At the en o8 ea:h 3t/o=e, li8t the3a> :a/e8ll. #/n the 3a> oe/ to it3 othe/ 3ie,

ipe the te3t 3/8a:e 70:92 (e/ti:al). At the en o8ea:h 3t/o=e, li8t the 3a> :a/e8ll. "ol the 3tea9 o8the 3a> ithot to:hin the hea o8 the 3a> an let

the 3a> /op into the t/an3po/t :ontaine/. !ap thet/an3po/t :ontaine/ an 3en 8o/ anal3i3 a8te/ la>elinthe 3a9e. !al:late the :ontent o8 !4"11N5, "!l ta=inJ a3 the ale o8 A (1O, 1 :9) at the 9ai99 ata>ot 272 n9.#a>le. #a>le. #a>le. #a>le. !leanin aliation in o>le :one >lene/SSSS.... NNNNoooo Sa9pleSa9pleSa9pleSa9ple St a>3o/>an:eSt a>3o/>an:eSt a>3o/>an:eSt a>3o/>an:e #e3t#e3t#e3t#e3t



70:970:970:970:92222 (9)(9)(9)(9)

1 I

0.52

0.221 0.25J

2 II 0.727 0.7J

7 III 0.742 0.401


8/9



VA$I%A#I&N IN !&'PRESSI&N 'A!"INEVA$I%A#I&N IN !&'PRESSI&N 'A!"INEVA$I%A#I&N IN !&'PRESSI&N 'A!"INEVA$I%A#I&N IN !&'PRESSI&N 'A!"INE

• !lean the pa/t3 3in a>ot 20 = o8 pota>le ate/8olloe > 3:/>>in ith nlon 3:/appe/ ippe

in 0.1O Soi9 $a/l Slphate 3oltion.

• *a3h the pa/t3 ith a>ot 20 = o8 Pota>le ate/an 8inall /in3e ith a>ot 20 = o8 P/i8ie *ate/.

•

Re9oe all the ppe/ pn:he3, an loe/ pn:he3:olle:t the9 in a t/a. !lean all the ppe/ pn:he3ith the help o8 / :lean lint 8/ee :loth. *ipinith a lint 8/ee :loth ippe in 0O I3op/oplal:ohol 8olloe > / lint 8/ee :loth.

• Pla:e the ie3 one a8te/ anothe/ in to the iepo:=et3, initiall p/e33 ith th9> an 8inall 8ithe9 till the ppe/ 3/8a:e o8 the ie3 8l3he3 itht//et 3/8a:e.

• In3e/t the loe/ pn:h into the ie hole. P3h thepn:h to it3 hihe3t po3ition an en3/e it /op38/eel ne/ it3 on eiht. In3e/t the nlon pl

into the loe/ pn:h-lo:=in hole an 8i the antit/nin 3p/in 3t/ip. !a/e8ll /otate the t//et an8i the /e9ainin loe/ pn:he3 in the 3a9e a.

• i >oth the 8ee 8/a9e3 an hoppe/3 p/ope/l an:onne:t the 3t et/a:tion po/t3.

#a>le. J#a>le. J#a>le. J#a>le. J Valiation in :o9p/e33ion 9a:hineSSSS.... NNNNoooo.... Sa9pleSa9pleSa9pleSa9ple StStStSt


#e3t#e3t#e3t#e3t


!on:ent/ation!on:ent/ation!on:ent/ation!on:ent/ation

in 70:9in 70:9in 70:9in 70:92222 (9)(9)(9)(9)

1 I0.52

0.741 0.400

2 II 0.207 0.27

7 III 0.71J 0.74

RES$# AN% %IS!SSI&NRES$# AN% %IS!SSI&NRES$# AN% %IS!SSI&NRES$# AN% %IS!SSI&N#he :leanin aliation 8o/ the e?ip9ent 3e in9an8a:t/in p/o:e33 o8 'et8o/9in ta>let3 a3 :a//ieot to p/oie that o:9ente eien:e ith hihe/ee o8 a33/an:e that the :leanin, hen 8olloe a3

pe/ 3tana/ ope/atin p/o:e/e, iel3 :on://entlan :on3i3tentl the /e3lt3 hi:h ill >e ell ithinthe a::eptan:e :/ite/ia.

#he :leanin aliation i3 :a//ie ot on the e?ip9ent3e 8o/ 9an8a:t/in o8 9et8o/9in ta>let3, a8te/8olloin the :leanin p/o:e/e a3 lai on in3tana/ ope/atin p/o:e/e 8o/ :leanin. Sa9ple3 8o/the anal3i3 e/e o>taine > 3a> 9etho. #hei88e/ent :haneoe/ o8 total /e3ie :a// oe/9et8o/9in in pp9 > 3a> 9etho a3 8on to >e0.211.#a>le. 10#a>le. 10#a>le. 10#a>le. 10 Re3lt3 o8 all the aliation p/o:e/e

S. No.S. No.S. No.S. No. E?ip9ent>on 9ie/ 0.221 0.024J 0.150

5 #/a /e/ 0.77 0.07J 0.052

!a9ill 0.701 0.0105 0.24

%o>le :one

>lene/

0.74 0.077 0.02

!o9p/e33ion

9a:hine

0.77 0.055 0.02


9/9



All the /e3lt3 e/e 8on to >e ell ithin thea::eptan:e :/ite/ia o8 1.52 pp9. #he 3a> 9etho i38on to >e a >ette/ 3a9plin te:hni?e hen

:o9pa/e to a::eptan:e li9it to 3a9plin a9ont iththe 3ati38a:to/ :o9pletion o8 the :leanin aliation. Ita3 :on:le that the :leanin p/o:e/e 8olloe i3app/op/iate an 3ati38a:to/.

!&N!$SI&N!&N!$SI&N!&N!$SI&N!&N!$SI&NIn the p/e3ent o/=, an in3t/ial p/o6e:t ha3 p/o:e/eha3 >een ta=en in !a33el /e3ea/:h la>o/ato/ !hennai.#he p/o6e:t a3 ienti8ie to >e aliate a3 :leaninaliation o8 'et8o/9in ta>let3. #he p/po3e o8 :leaninaliation i3 to e3ta>li3h the o:9ente eien:e ithhih e/ee o8 a33/an:e that the :leanin p/o:e338olloe a3 pe/ 3tana/ ope/atin p/o:e/e 8o/

:leanin the e?ip9ent 3e 8o/ the p/o:e33in o89et8o/9in ta>let3, :on3i3tentl an :on://entl iel3

the /e3lt3 not e:eein p/eete/9ine a::eptan:eli9it o8 the 9et8o/9in ta>let3.All the e?ip9ent3 e/e 3ele:te 8/o9 :/o33

:onta9ination point o8 ie >a3e on the 9at/iapp/oa:h. $i=ei3e, a9on the ta>let3 9an8a:t/in8a:ilit, 9et8o/9in ta>let i3 p/ei:te >a3e on theo/3t :a3e app/oa:h a3 eelope.

#he 3a> 3a9ple3 e/e ta=en 8/o9 all the e?ip9ent3>t othe/ 3a9ple3 e/e ta=en 8/o9 e:lin:o9p/e33ion 9a:hine anal3i3. #he /e3lt3 o8 :leaninaliation e/e 8on to >e oo ithin the a::eptan:eli9it (Ba3e on 3a> li9it an 'A!& app/oa:h) eal3ith the /e3lt3 an i3:33ion ith /ep/e3entation o8ta>let3. /o9 thi3 3t, it 9a >e :on:le that the/e3lt3 o8 :leanin aliation i3 8on to >e ell ithin

the a::eptan:e li9it an hen:e the o>6e:tie o8 the:o9pan to hae an e88e:tie :leanin p/o/a99e i3ell o:9ente an lti9atel the /e3lt3 e/ea:hiee.

REEREN!ESREEREN!ESREEREN!ESREEREN!ES1. Pha/9a:eti:al +alit A33/an:e, B '. A. Pota/

P/aati Boo=3 Pt. $t, Inia, 200, .1.

2. Valiation o8 Pha/9a:eti:al P/o:e33e3, #hi/Eition > /ee/i:= T. !a/leton, Ta9e3 P. Aallo:o,!R! P/e33, 25-Sep-200, pp.4J1.

7. !leanin Valiation in A:tie pha/9a:eti:al

In/eient 9an8a:t/in plant3, API!, Septe9>e/1JJJ.

4.

P. D. Patel, N. '. Patel, P. '. Patel. An &e/ie on!leanin Valiation, ITPBA Vol. 2, I33e, 5 (2011).

5. !leanin Valiation in A:tie Pha/9a:eti:alIn/eient 9an8a:t/in plant3 > A:tiepha/9a:eti:al in/eient3 :o99ittee, Septe9>e/1JJJ.

. S. $. P/a>, #. N. D. S/iap/a=a3h. !leaninValiation an it3 i9po/tan:e in Pha/9a:eti:alIn3t/, Pha/9a #i9e3 - Vol 42 - No. 0 (Tl2010).

. %A, Gie to in3pe:tion o8 aliation o8 :leaninp/o:e33, Tl 1JJ7.

. '. Ten=in3, A. T. Vane/eilen. !leanin aliationAn oe/all pe/3pe:tie, Pha/9 #e:h. 1(4) 0-7

(1JJ4).J. T. '. "e. !leanin aliation 3t/ateie3, ISPE

!IPlane. Rin3e 3a9plin 8o/ :leanin aliation

3tie3, Pha/9 #e:h. 22(5) -4 (1JJ).11. A. Ta9e3. Valiation o8 e?ip9ent :leanin

p/o:e/e3, P%A :on/e33, Ba3el- Sit@e/lan,e>/a/ 1JJ2.

12. A. Ta9e3. Point3 to :on3ie/ in the aliation o8e?ip9ent :leanin p/o:e/e3, T Pa/ental S:i #e:h.4 (5) 17-1 (1JJ2).

17. G. . Phillip3. #he nee 8o/ i9p/it :ont/ol, %ie

Pha/9 In 51(11) 122-12 (1JJ).14. B. S. S. Rao, . S/enh/anath Re, '.

Te>a3=a/an. !leanin aliation o8 al>ena@oleta>let3 400 9, #he Pha/9a innoation, ol. 1 no. 4(2012).

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