Document no: DQ-01/PW/13, Revision 0.

0 September, 2013

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Revision # Reason Date

0.0

Original Document

12 Sept 2013

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#PPR(.#$ P# E
Pre approval of this URS will e the !oint responsi ilit" of the following functional areas. %"!&'I(!#$ #RE# #ualit" $ssurance Pro%uction &ngineering #ualit" 'ontrol !#,E SI !#'"RE D#'E

Post approval of this URS will e the !oint responsi ilit" of the following functional areas. %"!&'I(!#$ #RE# #ualit" $ssurance Pro%uction &ngineering #ualit" 'ontrol !#,E SI !#'"RE D#'E

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

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!o

&ontent

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1. I!'R(D"&'I(! 1.1.

ener/1
(en%or shall provi%e a complete purifie% water pro%uction an% %istri ution s"stem. )he (en%or is full" responsi le for suppl"* commissioning an% the start up e+ecution on site. )he $ll construction materials which are in contact with the en% pro%uct* that is the purifie% water must compl" with ,-P re.uirements an% certifie%. operation of the purifie% water s"stem must follow the regulation of USP* &uropean Pharmacopoeia* ,-P gui%elines /SP& engineering gui%eline* 0D$ 1 P/'2S. )he e+ecution of the %esign* pro%uction an% %istri ution s"stem have to e consi%ere% following gui%elines an% regulations 3 - 'urrent ,oo% -anufacturing Practice 4',-P5 - /SP& engineering gui%eline - ,$-P 6 goo% automate% manufacturing practice - 0D$ regulations an% gui%es - Regulations &uropean Pharmacopoeia - 'urrent USP - ,-P gui%eline - P/'2S gui%eline - 'o%e of 0e%eral Regulation 6 US 0oo% an% Drug $%ministration* 21 Part 211 - S"stem vali%ation an% .ualification

1.2. Process Description o2 t3e Puri2ie4 W/ter 1.2.1. E5uipment Pre-'re/tment Soften 7ater )an8 90ee% )an8: )his tan8 receives two flows; a. Softener fee% water . Re<circulating permeate

ener/tion

)he Soften 7ater =automaticall"> fee% into the tan8 %epen%ing on the water level. )he measurements of level* service pressure are controlle% locall". )he reverse osmosis is fee% " a group of varia le spee% electropumps* pump rate eing %epen%ent on whether the reverse osmosis or re circulation is eing fee% 1.2.2. %in/1 're/tment Reverse Osmosis $t present* RO units with a capacit" ?00 liter2hour. $n" suspen%e% resi%ue is retaine% " micro filter cartri%ges. )he single stage reverse osmosis unit fe% " one high pressure pump. )he permeate an% concentrate capacities are controlle% " the panel as well as all parameters of pressure or an% temperature. )he panel stop the high pressure pumps when the 'on%uctivit" 1 pressure value are out of setting value setting value Page 1 of 12

&D/ Polishing Reverse Osmosis Permeate flows into the &lectro Deioni@ation unit. /n this unit water will e polishe%2%e<minerali@e% to ensure the water con%uctivit" appro+imatel" less than 1*3AS 2cm. $t present* &lectro Deioni@ation units with a capacit" B00 liter2hour. UC/) complete% " the automatic %ivert that will %irect the pro%uct water to the %ownstream e.uipment provi%e% that pro%uct water .ualit" is a ove the low pro%uct water con%uctivit" 2 resistivit" set point alarm. Pro%uct water will e sent to %rain or %emin water when the s"stem is in stan% " or if there is a low pro%uct water con%uctivit" 2 resistivit" alarm. 1.2.3. Saniti@ation 9purifie% water generation s"stem: 0or the saniti@ation of the Demin water* the fee% pumps* micro filters* the Reverse Osmosis* &lectro Deioni@ation an% recirculation piping* the '/P mo%ule using !ac8ete% tan8 pro%uces hot water at ?0<?B o' will e use% or chemical s"stem. 1.3. Puri2ie4 W/ter Stor/0e /n4 Distribution S6stem Pro%uce% Purifie% 7ater shall e intro%uce% into the Storage )an8 through the non< return valve. 0rom the Storage tan8 purifie% water will e %istri ute% to the point of use an% %istillation unit. )o maintain the velocit" of the return purifie% water from this looping* analog or %igital input2output flow meter shall e installe% in the return loop. &ach looping 4Da Room* 'uci $lat Pro%u8si EPharmaE Room* Process S"rup Room* Process 'ream Room* -i+ing Room* $"a8 Room* 'uci Fotol Room 1 'uci $lat E-in"a8 anginE Room5 will %istri ute the water to the point of use " the following mechanism3 Facteria in the purifie% water shall e %estructe% using 2BG nm wave length U( light s"stem efore %istri ute to the point of use )o maintain the specifie% velocit"* %igital input2output flow meter shall e installe% on the return pipe. )he s"stem shall e capa le of continuousl" operation un%er all loa% con%ition ase% on Purifie% 7ater Deman%. )he 0ee% water level shall e controlle% so that the level in storage tan8 remain etween 2B<B0H.

See the attache% process flow %iagram 2. S+S'E, DESI ! &(!SIDER#'I(!S )he Storage an% Distri ution S"stem shoul% e constructe% as a loop s"stem with all function an% control components inclu%e%. $ll rigi% pro%uct contact surfaces 4e.g. piping* vessel walls* pump* valve* sensors* etc5 shall e constructe% of 31ID stainless steel * mechanical<polishe% finishe% an% passivate%. $ll fle+i le an% semi fle+i le pro%uct contact surfaces 4e.g.* Diaphragm valves* gas8ets etc5 shall e constructe% of pharmaceutical gra%e P)0& or &PD-. 2.1.

ener/1
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)he pipewor8s material for final treatment an% %istri ution s"stem must e SS 1.GG3B or $/S/ 31I D with internal roughness .ualit" Ra J 0*? Am. Or ital 7el%ing must e e+ecute% whenever possi le with tri<clamp<t"pe coupling where %ismantlea le !oints are re.uire%. -anuall" wel%e% seams must we chec8e% 20 H picture or vi%eo have to %elivere%. " oroscope* if necessar" a still

)he wel%ers must e .ualifie% an% vali% .ualification certificates must e provi%e%. Or ital wel%ing machine 4%epen% on con%ition5 must have a vali% .ualification certificate. $ll automatic valves shall e pneumaticall" wor8s 4%epen% on con%ition5 with automatic actuators spring clo%es operation mo%us. 7herever possi le* %ea%<legs shoul% e eliminate%. Kowever* where %ea% legs are unavoi%a le in the pipewor8 %esign* the" must not e+cee% 1*G times internal ranch pipe Diameter 4L1*G<DM5* with e+cess tolerance permitte% in e+ceptional circumstances up to 1*G 4 Lg<DM rule 5. -easurement sensor %evices have to e merge% with )ri<'lamp fittings to the pipelines in the s8i%. )he L1*G<DM rule has to e consi%ere% an% 8ept. $ll user points shall e e.uippe% with L)<t"pe valve to minimi@e the %ea% leg. )he flow rate shall e a%!uste% to fit the consumption. 2.2. ,icrobi/1 &ontro1 Desi0n &onsi4er/tions Doop velocit"3 3<B ft2sec 4return velocit" not less than 3 ft2sec5 Pressure3 $lwa"s maintain positive $ll wette% part or surface contacts with pro%ucts using Stainless Steel 31I D have a surface finishe% Ra 20 or other suita le material that approve% " 0D$ Pipe slope not less than 2H Storage )an83 )ight an% protecte% from contamination* using spra" all to ensure that tur ulence flow was o taine% insi%e the tan8* 0.2 m air venting. Dea% leg3 ma+ 1*G times of insi%e pipe %iameter 2.3. Steri1i7/tion /n4 S/niti7/tion Desi0n &onsi4er/tion $ll materials contacts with hot water shall e use% Stainless Steel 31ID * )eflon* &PD-* Silicone or others materials that compati le with hot water Storage )an8 %esign3 o Spra" all on return loop o 'onnection on the top hea% shall e %esigne% as close to the hea% of tan8* accept for air venting 8. EQ"IP,E!' DESI ! *#SIS SPE&I%I&#'I(!S )he %escri e% components un%erstan% themselves as suppl" inclu%ing assem l". )he s"stem has to e complete% as s"stem rea%" for operation* inclu%ing all necessar" components. Page 3 of 12

8.1. Reverse (smosis S6stem 8.1.1.

Sin01e P/sse4 Reverse (smosis

-em rane t"pe /onic re!ection rate Recover" 0ee% 7ater 0low rate Permeate 0low Kousing -aterial Pre 0ilter Operation -o%e Operation temperature (alves 0ee% water pump Piping materials /nstrumentation 1 'ontrol Description
-aterials Pressure )ransmitter 0low -eter &lectrical enclosure 'on%uctivit" -onitoring 'ontroller 9PD':

3 )hin 0ilm 'omposite Pol"ami%e 3 NB 6 N?H 3 O0H < OBH 3 -inimum 1.000 liter2hr 3 ?00 liter2hour 41st S)$,&5 3 SS 30G 3 Bm* Pleate% -em rane 3 $utomatic 0lushing 3 1B<2Bo' 3 Cee%le (alve 3 -ulti Stage* 'entrifugal* SS 30G Shell 3 SS 30G Sanitar" 1 SS 31ID Sanitar" 3 Re5uirements

SS 30G Sanitar" 4/nlet RO5 1 SS 31ID Sanitar" 4Outlet RO5.

/n Dine C&-$ G Protection /n Dine C&-$ G Protection C&-$ 12 'ontinuousl" anal"sis 7ith output signal )ouch screen with all controller function capa le of monitoring an% controlling all in an% output signals -eets C&-$ G water resistance stan%ar%s -in switch to shut%own the unit Devel in%icator analog2 inar"

o 'ontrol S"stem 3 0ee% 7ater Pressure monitoring 0ee% 7ater 'on%uctivit" monitoring 0ee% 7ater 0low monitoring 'oncentrate 0low monitoring 'oncentrate Pressure monitoring Pro%uct Outlet Pressure monitoring Pro%uct Outlet 0low monitoring Pro%uct Outlet 'on%uctivit" monitoring -onitoring an% 'ontrol the Purifie% water tan8 level Recirculation via tan8 Page 4 of 12

o $larm3 S"stem &+cee% the operational Pressure &rror Operation (t3ers 4esi0n Ro ust stainless<steel frame Sample e+traction points in inlet an% outlet for ever" process component BAm cartri%ges filter with pre an% post pressure in%icator Pressure in%icator for pre an% post cartri%ge 8.1.2. E1ectro Deioni7/tion 0ee% 7ater #ualit" 0ee% 7ater 0low rate Pro%uct 0low Piping materials 3 -ust e RO permeate 3 -inimum ?00 liter2hr 3 B00 liter2hr 3 SS 31I D Sanitar" $S-& FP& -echanical Polish /nstrumentation 1 'ontrol 3 Description
-aterials

Re5uirements
Output Pro%uct materials contact with pro%uce% water shoul% e SS 31I D -echanical Polishe% with roughness * J 0.? Am.

&ontro1 S6stem 3 o 0ee% 7ater Pressure 'on%uctivit" o Pro%uct Outlet 'on%uctivit" o -onitoring an% 'ontrol the Purifie% water tan8 level o Recirculation via tan8 B00 liter2hour 2G hours 2.0 ar 0.B ar 1*0 -32h -ono Disperse Resin 0oo% ,ra%e SS 31ID* -anual Diaphragm (alve 100 mm Dial* 0 I 8g2cm2 Sample valve Rectifier 0low -eter

Cormal 'apacit" '"cle time 9service time: -in /nlet pressure -a+ Pressure %rop across unit -a+ s"stem flow &D/ me%ia use% -O' an% t"pe of valves Pressure gauge si@e* range $ccessories components

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Operation

/ntegrate% control ca inet on the s8i% $utomatic with manual overri%e

're/te4 W/ter Qu/1it6 9E1ectro Deioni7/tion Perme/te: the pro%uct water shall have an e+pecte% con4uctivit6 ; 1,3 <s/cm

8.2. Stor/0e /n4 Distribution 8.2.1. Puri2ie4 W/ter Stor/0e '/n= -aterial 3 'ontact with pro%uct* SS 31I D /nternal finish 3 Kigh mechanical polishe% with less than 0.?Am surface finishe% 'apacit" 3 1.000 D $ir venting pipe 3 0errule* 1M $ir (enting filter 3 K"%ropho ic 0.2Am Shape 3 '"lin%rical* (ertical Support 3 Stainless Steel 3 or G Deg support Design pressure 3 3 ar )hic8ness 3 2 mm #ccessories Spra" all 3I0 Rotar" Pressure 'ontrol (alve Devel Switch 425* Kigh 1 Dow level with %igital signal output G<20 ma an% sanitar" %esigne% Sanitar" Distri ution Pump* full %raina le with SS 31I D shell with automatic pressure switch* Kori@ontal orientation Pressure gauge 4Sanitar" t"pe5 0low2(elocit" meter 4Sanitar" t"pe5 )an8 with %ome cover an% the following connection shall e provi%e o 1 /nlet o 1 Outlet o 1 Return line o 1 Devel o 1 )emperature pro e o 1 Spare )an8 with lifting e"es 'onnection pieces an% tan8 with factor" certificate Spra" all for re circulating line an% fee% line 8.2.2. Disin2ection ". $/mp 0low Rate Ra%iation 7ave length U( Damp -aterial 3 -in 2 -32hr 3 2BG nm 3 -e%ium Pressure 3 7ette% parts SS 31I D* 'a inet SS 30G Page 6 of 12

/nlet<Outlet 'onnection 3 )riclover Operating pressure 3 3<B ar Dight /ntensit" sensor 3 %igital output 4G<20 m$5* Sanitar" t"pe )ransmission 3 $t least N?H at the en% of lamp life time -ounting 3 (erticall" Protection 'lass 3 C&-$ B or G #1/rm U( Damp Replacement &rror operation inclu%e electrical s"stem

8.2.3. Pipin0 components G.2.3.1. Piping2)u ing Stainless Steel 31ID* -echanical Polishe%* with surface roughness less than J0.? Am. Shoul% e supplie% with material certification sheet for material construction an% rugosit" an% pre<cleane% an% cape%. Kan%le material in such a wa" as to prevent intro%uction of contaminants into the piping s"stem. G.2.3.2. )ri<'lamp 0errules -aterials* tolerances* wall thic8ness an% finishing as specifie% for tu ing in wel%ing t"pe with one en% for clamp connection. ,as8et )eflon envelope with &PD- insert* steam resistant* insi%e %iameter as specifie% for tu ing. 'lamps )"pe 30G Stainless Steel. 'onnection $utomatic Or ital 7el%ing 4 Depen% on 'on%ition 5 or Sanitar" 'lamp as per approval* SS 31I D material with surface finishe% Ra. 20 Point of Use (alve )he o%" shall e constructe% of 31I D stainless steel an% have a 20 Ra finish* an% %iaphragm shall e constructe% of &PD- or P)0&. )he onnet* actuator an% han%le shall e %esigne% an% constructe% to manufacturer>s specification. )he connection shall e sanitar" clamp2fitting. Pressure ,auge Diaphragm Seal 3 'onstructe% of SS 31ID* have a surface finishe% Ra. 20 Pipe Support SS 30G support

G.2.3.3.

G.2.3.G.

G.2.3.B.

G.2.3.I.

8.2.8. E1ectric/1 &ontro1 &/binet Page 7 of 12

-onitoring an% control of the purifie% water tan8 level* re<circulation via tan8* pressure ooster pump* flow meter* con%uctivit" meter* on the s8i%. )he unit operation shall overri%e e automatic with manual

PD' control s"stem )ouch Screen user interfaces $ll operations an% faults are shown on the touch panel ,eneral alarm potential free -ain switch to shut %own the unit Devel /n%icator analog2 inar"

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