Design and Construction of USP Purified Water Systems

William V. Collentro

Feed Water Analysis

USP Purified Water System Feed Water Analysis

Official Monograph
United States EPA NPDWR Equivalent European Regulations Equivalent Japanese Regulations World ealth Organi!ation Reference

USP Purified Water System Feed Water Analysis

United States EPA National Primary Drinking Water Regulations (NPDWR Regulated !tems "otal #ia$le %acteria &Pri'ate( Water Su))lies

USP Purified Water System Feed Water Analysis

Regulated !tems * +icroorganisms Cry)tos)oridium
,iardia lam$lia -egionella "otal Coliform "ur$idity #iruses

USP Purified Water System Feed Water Analysis

Regulated !tems Disinfection %y)roducts

%romate C.lorite /aloacetic Acids (/AA0 "otal "ri.alomet.anes (""/+s

USP Purified Water System Feed Water Analysis

Regulated !tems Disinfectants

C.lorine C.loramines C.lorine Dio1ide

USP Purified Water System Feed Water Analysis

Regulated !tems !norganic C.emicals
Antimony Arsenic As$estos %arium %eryllium Cadmium "otal C.romium Co))er

USP Purified Water System Feed Water Analysis

Regulated !tems !norganic C.emicals
Cyanide Fluoride -ead +ercury Nitrate Nitrite Selenium ".allium

USP Purified Water System Feed Water Analysis

Regulated !tems 2rganic C.emicals (03 "otal
Se4age5Waste4ater "reatment /er$icides -andfill -eac.ates C.emical5!ndustrial Facility Waste Fumigants Petroleum 5Refinery Waste !nsecticides

USP Purified Water System Feed Water Analysis

Regulated !tem Radionuclides
Al).a Particles %eta Particles and P.oton Emitters Radium 667 Uranium

USP Purified Water System Feed Water Analysis

Total Viable Bacteria
No limit in NPDWR Total Coliform (Confirmed as Fecal Coliform or E. coli, sed as indicator! "Action #imit$ of %&& cf 'ml in non enforceable General Information (ection of )(P TVB may only indicate a fraction of *iable or+anisms ,resent

USP Purified Water System Feed Water Analysis

Re+ lated -tems . Testin+ / nici,ality0 P1armace tical Facility0 Com,liance0 2bli+ation0 Conse3 ences0

Periodic +onitoring

USP Purified Water System Periodic +onitoring

4eneral /onitorin+ 5 (tora+e and Distrib tion (ystem
Point.of.)se TVB 2nline Cond cti*ity 2nline T2C

USP Purified Water System Periodic +onitoring

4eneral /onitorin+ 5 Water P rification (ystem
Final TVB -nline R2 Feed Water and Prod ct Water Cond cti*ity ,l s 6 Re7ection of -ons -nline Post R2 Polis1in+ Cond cti*ity

USP Purified Water System Periodic +onitoring

Fre3 ent /onitorin+ 5 Water P rification (ystem
(ilt Density -nde8 (Test 9it! Total :ardness (Test 9it! C1lorine (Test 9it!

USP Purified Water System Periodic +onitoring

#ess Fre3 ent /onitorin+ 5 Water P rification (ystem
-nline 2RP for Red cin+ A+ent -n7ection /onitorin+ -nline Total :ardness /onitor -nline C1lorine /onitor

USP Purified Water System Pretreatment Periodic +onitoring

Ra4 Water Post +ultimedia Post Acti'ated Car$on Post U# Post -ead Water Softener Post Polis. Water Softener Post Cartridge Filter NPDWR Tests TVB BET C1lorine T2C T(( Total :ardness Total -ron T rbidity (D-

8 8 8 8 8 8 8 8 8 *

* 8 * 8 8 8 * 8 8 *

* 8 8 8 8 8 8 8 * *

* 8 * * * * * * * *

* 8 * * * 8 8 8 * *

* 8 * * * 8 8 8 * *

* 8 8 * * * * * * 8

USP Purified Water System R25Polis.ing Periodic +onitoring

Post R2 %reak "ank TVB BET ,: T2C Carbon Dio8ide Post R2 Post CED! Post U# Post Final Filter

8 8 8 8 8

8 8 8 8 8

8 * * 8 *

8 * * 8 *

8 * * 8 *

USP Purified Water System Periodic +onitoring

( mmary
/onitorin+ of Pretreatment and -on Remo*al ste,s identifies a ,roblem before it effects ,oint.of. se *al es. Fre3 ency of t1e monitorin+ ,ro+ram establis1ed for eac1 a,,lication Re+ latory concerns

(aniti;ation Pro*isions

USP Purified Water System Saniti9ation Pro'isions

Fre3 ency
Determined by microbial monitorin+ / st incl de stora+e, distrib tion, ion remo*al, and ,retreatment Em,loys c1emical and t1ermal met1ods -neffecti*eness of (team Biofilm re3 ires c1emical saniti;in+ a+ent

USP Purified Water System Saniti9ation Pro'isions

F ndamentals
TVB destr ction a f nction of concentration and time for c1emical saniti;ation TVB destr ction a f nction of tem,erat re and time for 1ot <ater <it1 =%>C lo<est tem,erat re Dead #e+ for t1ermal saniti;ation Dead le+ for c1emical saniti;ation

USP Purified Water System Saniti9ation Pro'isions

F ndamentals
Remo*al of Biofilm Acti*ated Carbon -ss es R2 Waste Recirc lation -ss es Pretreatment and -on remo*al Recirc lation -ss es :ot <ater saniti;able ion remo*al systems Pretreatment m st be incl ded

USP Purified Water System Saniti9ation Pro'isions

E8ec tion . Pretreatment
:ot Water (aniti;able Acti*ated Carbon C1emical (aniti;ation <it1 ?6 sol tion of :ydro+en Pero8ide and Peracidic Acid (e8ce,t acti*ated carbon nit! Re,lace acti*ated carbon media e*ery =.?@ mont1s Dynamic.(ta+nant.Dynamic Proced re

USP Purified Water System Saniti9ation Pro'isions

E8ec tion 5 -on Remo*al
Contin o s o,eration (maAe. , and recirc lation! :ot Water (aniti;ation Pro*isions (entire system! R2 membrane rotation e*ery = mont1s C1emical (aniti;ation <it1 ?6 sol tion of :ydro+en Pero8ide and Peracidic Acid ann ally Dynamic.(ta+nant.Dynamic Proced re

USP Purified Water System Saniti9ation Pro'isions

E8ec tion 5 (tora+e B Distrib tion
2;onation Periodic :ot Water /embrane Filtration disco ra+ed C1emical (aniti;ation <it1 ?6 sol tion of :ydro+en Pero8ide and Peracidic Acid ann ally Dynamic.(ta+nant.Dynamic Proced re

Validation Criteria

Validation Criteria
Commissionin+ Doc mentation
Reference in -C and 2C "Credit$ for ins,ection and testin+ Factory Acce,tance Test (FAT! Doc mentation T rno*er PacAa+es (T2P! Coordination -nterface

Validation Criteria
-C Format
)nit o,eration based <it1 all s ,,ort doc mentation for com,onents and accessories *erified. ( ,,ort doc ments in doc ment or as an a,,endi8'attac1ment. Pro*ides nderstandin+ of com,onent by indi*id als ,re,arin+, re*ie<in+, and e8ec tin+ -C Com,onent based ,ro+ram for items s c1 as *al*es, +a +es, , m,s, etc. Poor tool for indi*id als to nderstand t1e system.

Validation Criteria
-C -nformation
#imits on material0 T1e more information a*ailable, t1e better. -f a accessory breaAs, it m st be re,laced. T1e model n mber, serial n mber, and'or man fact rer may c1an+e or no lon+er e8ists. "C t s1eets$ of accessories ,ro*ide an e8cellent *e1icle for identifyin+ a "liAe.for.liAe$ re,lacement <1ic1 si+nificantly red ces t1e "C1an+e Control$ effort.

Validation Criteria
-C -nformation
All s ,,ort information s1o ld reference t1e ori+inal man fact rerDs ,art n mber. Pro7ect s,ecifications s1o ld clearly state t1at t1e name of t1e man fact rer as <ell as t1e ,art n mber be ,ro*ided. T1e *ast ma7ority of t1is information is "coded$ to t1e <ater , rification e3 i,ment man fact rerDs model n mber, seless for re,lacement on a "liAe.for.liAe$ basis.

Validation Criteria
2C -nformation
Pre,ared and e8ec ted in an inte+rated basis. -ndi*id al )nit 2,eration <ill im,act t1e o,eration of ot1er com,onents. E8ec tion m st ,ro*ide e8act o,eratin+ condition. As an e8am,le, if media is not installed in a ,retreatment com,onent d rin+ e8ec tion of a FAT, e8ec tion (,artial! may be re3 ired after installation and start. ,.

Validation Criteria
2C -nformation 5 Considerations
Fi8ed alarm and o,eratin+ set ,oints *ers s ad7 stable set ,oints Processor access le*els Alarm set ,oints and time delays Control set ,oints and time delays Vie< screen na*i+ation "A#ER/$ banner dis,lay "2PERAT2R 2VERR-DE$ banner dis,lay

Validation Criteria
PC Criteria
Post start. , and commissionin+ E& day sam,le ,eriod (am,lin+ ,lan to d ,licate <ater se
"WorAin+ days$ Attem,t to d ,licate <ater demand Attem,t to d ,licate act al conditions at indi*id al ,oints.of. se

Validation Criteria
PC Criteria
E*ery ,oint.of. se e*ery day if ,ractical T2C "+rab$ sam,les from eac1 ,oints.of. se Cond cti*ity "+rab$ sam,les from ,oints.of. se ( ++est transition for abo t E&.=& days after s ccessf l e8ec tion Contin es for one year ,eriod /onitorin+ ne*er sto,s

Validation Criteria
PC /icrobial /onitorin+
D ,licate sam,lin+ sc1ed le o*er len+t1 of intense monitorin+ ,ro+ram and less fre3 ently t1ereafter Different a+ar (PCA *ers s R@A! Different inc bation tem,erat res (@@>C and E&.E%>C! E8tended inc bation time ,eriod (E, %, F, and ?& days!

Validation Criteria
PC /icrobial /onitorin+
EP /ono+ra,1 Reference Verify en meration ,arameters Bacteria identification
/-( Ribo,rinter

4ram (tain 2b7ectionable or+anisms ( mmary Re,ort

2,eratin+ Proced res

(tandard 2,eratin+ Proced res

4eneral Considerations
Pre,ared, re*ie<ed, and acce,ted before 2C e8ec tion Verbatim com,liance 9ee, as concise as ,ossible Do not incl de maintenance ,roced res "Control$ of co,ies im,ortant Formal trainin+

(tandard 2,eratin+ Proced res

4eneral Considerations
Video ta,e trainin+ sessions Trainin+ /an als (ystem PB-Ds mo nted in <ater system area Doc mentation of indi*id al attendin+ trainin+ sessions Periodic retrainin+ Personnel incident'e8c rsion retrainin+

Pre*entati*e /aintenance Pro+ram

Pre*entati*e /aintenance Pro+ram

2b7ecti*e . Proacti*e not reacti*e . (1 tdo<n Considerations 5 fre3 ency . Cost of lost ,rod ction time . Cost of 3 arantine of ,rod ct . Cost of lost ,rod ct . "/icro delay$

Pre*entati*e /aintenance Pro+ram

Pretreatment Com,onent E8am,le 5 Acti*ated Carbon )nit
!tem /edia Re,lacement (aniti;e Col mn -nternals Re,lace 4asAets Access 4asAets Clean'Re,lace Distrib tors -nstr ment Calibration Re,lace Val*e Dia,1ra+ms Suggested Fre:uency (i8 /ont1s (i8 /ont1s T<o Gears (i8 /ont1s 2ne Gear 2ne Gear T<o Gears Conse:uences T2C and'or C1loramine BreaAt1ro +1 /icrobial E8c rsion #eaA'(1 tdo<n #eaA'(1 tdo<n Fail re 5 /edia in Prod ct Water -m,ro,er (ystem 2,eration By,ass'Cross Contamination

Pre*entati*e /aintenance Pro+ram

-on Remo*al Com,onent E8am,le 5 Re*erse 2smosis )nit
!tem "Rotate R2 /embranes$ Contract Clean Rotated /embranes C1emical (aniti;ation -nterconnector 2. Rin+s End Fittin+ 2.Rin+s -nstr ment Calibration Suggested Fre:uency (i8 /ont1s (i8 /ont1s Conse:uences #oss in Prod ct Water Flo< Rate and C ality (C1emical and TVB! #oss in Prod ct Water Flo< Rate and C ality (C1emical and TVB! TVB E8c rsions Waste.to.Prod ct #eaA Waste.to.Prod ct #eaA #oss of (ystem Control

(i8 /ont1s (i8 /ont1s (i8 /ont1s 2ne Gear

Pre*entati*e /aintenance Pro+ram

-on Remo*al Com,onent E8am,le 5 Re*erse 2smosis )nit
!tem Re,lace Feed Water P m, (eals Vale (eals'Dia,1ra+ms (aniti;e Press re Vessels C1an+e Prefilters :ot Water (aniti;e (if e3 i,,ed! Re,lace "Rotated /embranes$ Suggested Fre:uency T<o Gears T<o Gears (i8 /ont1s 2ne WeeA T<o WeeAs T1ree Gears Conse:uences P m, #eaA 5 -ntrod ction of Air'Water 5 TVB -ncrease By,ass TVB E8c rsions Fo lant -ncrease Res ltin+ in TVB -ncrease TVB E8c rsions #oss in Prod ct Water Flo< Rate and C ality (C1emical and TVB!

Pre*entati*e /aintenance Pro+ram

(tora+e B Distrib tion #oo, E8am,le 5 )(P P rified Water (tora+e TanA (No 2;one! !tem Suggested Conse:uences
Fre:uency 2ne Gear (i8 /ont1s 2ne Gear (i8 /ont1s (i8 /ont1s 2ne Gear -nstr ment Calibration -ns,ect R ,t re Disc Re,lace R ,t re Disc Re,lace :ydro,1obic Vent Filter Cartrid+e -ns,ect TanA -nterior Re,lace /an<ay 4asAet #oss of #e*el Control TVB E8c rsion TVB E8c rsions TVB E8c rsion Ro +in+'Biofilm TVB E8c rsion'#eaA

Pre*entati*e /aintenance Pro+ram

-on Remo*al Com,onent E8am,le 5 Re*erse 2smosis )nit
!tem Re,assi*ate Dero +e B Re,assi*ate :ot Water (aniti;ation C1emical (aniti;ation Suggested Fre:uency 2ne .T<o Gears T<o .T1ree Gears 2ne WeeA 5 2ne /ont1 (i8 /ont1s Conse:uences Ro +in+ 5 Biofilm 5 TVB -ncrease Ro +in+ 5 Biofilm 5 TVB -ncrease TVB E8c rsions Biofilm 5 TVB E8c rsion

T1anA yo H
C estions0