ISPE Water Article

8/13/2019 ISPE Water Article

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3. WATER OPTIONS AND SYSTEM PLANNING

3.1 INTRODUCTION

This chapter ot!i"es #asic $ater s%ste& 'esi(" criteria a"') a!o"( $ith s#se*e"t

chapters) ai&s to pro+i'e a #etter "'ersta"'i"( o, phar&acetica! $ater) ho$ it is se'

a"' ho$ it ca" #e pro+i'e'. The pri&ar% (oa! o, this chapter is to pro+i'e the ser $ith a

&etho'o!o(% ,or -

E+a!ati"( $ater *a!it% optio"s ,or pro'ct &a",actri"(

E+a!ati"( #asic s%ste& co",i(ratio"s a+ai!a#!e to pro+i'e the $ater

Detai!e' i",or&atio" o" "it operatio" 'esi(") &ai"te"a"ce a"' cost ,actors is a''resse'

i" !ater chapters

The chapters a!so ot!i"es the s%ste& p!a""i"( e,,ort ,or phar&acetica! $ater s%ste&s.

This p!a""i"( starts $ith the se!ectio" o, $ater *a!it% #ase' po" pro'ct re*ire&e"t)

processi"( operatio"s) a"' e"' se. A 'ecisio" tree co"cept is i"c!'e' to assist i"

se!ectio" o, co&pe"'ia! a"' "o" co&pe"'ia! $aters ,or pro'ctio") c!ea"i"( a"'

spport. The pro(ra& the" pro+i'es steps to (i'e the ser thro(h a se poi"t a"'

s%ste& a"a!%sis) to setp the $ater s%ste& 'istri#tio" strate(%. /i"a!!%) e+a!atio"

poi"ts are pro+i'e' ,or this se!ectio" o, the pri&ar% s%ste& co",i(ratio"s

3.0 WATER UALITY OPTIONS

a!it% re*ire&e"t ,or $ater se' i" phar&acetica! &a",actri"( a"' pro'ct

'e+e!op&e"t are 'ri+e" #% the pro'ct characteristics) &a",actri"( processes) a"' the

i"te"'e' se the pro'ct. To ai' i" the $ater se!ectio" process) the USP &o"o(raphs

'e,i"e &i"i&& re*ire&e"ts ,or (e"era! t%pes o, phar&acetica! $ater se' i" a!&ost

e+er% phar&acetica! app!icatio".

2o$e+er) there is a!so the opport"it% ,or a &a",actrer to 'eter&i"e $ater *a!it%

re*ire&e"ts) 'i,,ere"t ,ro& those i" the USP) #ase' o" speci,ic pro'ct characteristics

a"' processi"( operatio"s. I, this optio" is tae") the pro'ct &a",actrer is respo"si#!e

,or assri"( that $ater se' to &a",actre the pro'ct is appropriate) to re!ia#!% pro'ce

sa,e pro'ct.



Tho(h $ater *a!it% re*ire&e"ts are pro'ct speci,ic) it is i&practica! to re!ia#!%

pro'ce specia! $ater that is speci,ic to each sitatio". Ma",actri"( operatio"s

t%pica!!% (e"erate a"' 'istri#te o"!% a ,e$) or perhaps 4st o"e) *a!it% $ater. There,ore)

pro'cts a"' operatio"s re*iri"( si&i!ar $ater *a!ities are co&&o"!% (rope'. The

&ost co&&o" se(&e"tatio" is that 'e,i"e' i" the USP

Ma",actrers a(ree that i" &a"% i, "ot &ost cases) the re*ire&e"ts 'e,i"e' i" the USP

are a'e*ate ,or pro'ctio" o, sa,e pro'ct. More stri"(e"t $ater *a!it% speci,icatio"s

&a% #e appropriate ,or so&e pro'cts a"' processes. Other &a% #e appropriate!% !ess

stri"(e"t. T%pica!!% &ore stri"(e"t re*ire&e"ts &a% app!% to so&e processi"(

operatio"s i"+o!+i"( si("i,ica"t co"ce"tratio" steps or pro'cts co&prise' oh hi(h $ater

co"te"t) $hich &a% #e app!ie' i" !ar(e +o!&e 'oses) !ie$ise) process i"+o!+i"( re!ia#!e

steri!i5atio" a"' pri,icatio" steps $hich re&o+e i&prities &a%) i" so&e cases) "ot

re*ire $ater *a!ities as strict as those 'e,i"e' i" the USP. Other process characteristics

ca" a,,ect $ater *a!it% re*ire&e"ts as $e!!

I" &a",actri"( operatio"s $ith o"!% o"e *a!it% o, $ater) the $ater s%ste& &st #e

'esi("e' to &eet the &ost stri"(e"t re*ire&e"ts o, the &ost 'e&a"'i"( pro'ct o,

process. With &ore tha" o"e *a!it% o, $ater) pro'ct a"' processes are o,te"

cate(ori5e' a"' ,e' #% the &ost appropriate s%ste&. The "&#er o, t%pes o, $ater

(e"erate' is &ost o,te" a ,"ctio" o, +o!&e o, $ater co"s&e' a"' +ariatio" o, *a!it%.

Lar(e co"s&ers &a% ,i"' it eco"o&ica! to (e"erate a"' 'istri#te &!tip!e (ra'es o,

$ater) $hi!e s&a!! sers o,te" $i!! (e"erate o"!% o"e *a!it% o, $ater.



Phar&acetica! $ater *a!it% Decisio" Tree

Note - co&&it&e"ts &a'e i" 'r( app!icatio"s o+erri'e s((estio"s o, this 'ecisio" tree

C!ea"i"(

/i"a!

ri"sePare"tera!

Steri!e

#! Research

No"

pare"tera!6!

CGMP7 No" GMP

Ma",actri"(

Water Use'

,or8.

W/I

La#orator%

Wash

stepA"a!%tica!

USP Pri,ie'

Sita#!e No"

Co&pe"'ia!



/i"a! treat&e"t Optio"s - Water /or I"4ectio" 9W/I:

;.1 I"tro'ctio"

This chapter a''resses the USP appro+e' ,i"a! treat&e"t &etho's ,or the pro'ctio" o,

co&pe"'ia! W/I.

W/I is the prest (ra'e o, #! $ater &o"o(raphe' #% the USP a"' $o!' #e e<pecte' to

#e se' ,or the &a",actre o, pare"tera!) so&e ophtha!&ic a"' i"ha!atio" pro'cts a"'

,or ,i"ishi"( steps o, pare"tera! (ra'e acti+e phar&acetica! i"(re'ie"ts 9API=s:

Reco&&e"'e' s%ste&s i"c!'e either 'isti!!atio" or RO as the ,i"a! processi"( step) #t

&a% a!so i"c!'e !tra,i!tratio" 9U/:) 'eio"i5atio" 9DI: a"' 7 or io" e<cha"(e 9I>: to

co&p!i&e"t the RO or 'isti!!atio" "it operatio"

The tech"o!o(%) operatio") &ai"te"a"ce a"' re!ati+e cost isses ,or the appro+e' process

&etho's are 'iscsse'. This chapter i"c!'es USP &o"o(raph i",or&atio") re(!ator%

isses a"' s#sectio"s that co+er the "it operatio"s -

Si"(!e e,,ect 9SE: 'isti!!atio"

M!ti e,,ect 9ME: 'isti!!atio"

?apor co&pressio" 9?C: 'isti!!atio"

Re+erse os&osis 9RO:

/ee' $ater pretreat&e"t is co+ere' a!o"( $ith eco"o&ic ,actor sch as co"strctio"

&ateria!s) sr,ace ,i"ishes a"' i"str&e"tatio" a"' co"tro!s. A co&pariso" ta#!e o" USP

@ W/I ,i"a! treat&e"t optio"s a"' re!ati+e attri#tes pro+i'e'

;.0 US P2ARMACOPOEIA ISSUES

The "ite' states phar&acopoeia 9USP: a!!o$s W/I to #e pri,ie' #% 'isti!!atio" or #%

RO) this state&e"t 'oes "ot i&p!% that the re(!ate' process step is the o"!% process step)

#t the USP a'+isor% sectio" that it is the ,i"a! step i" the process

O"!% 'isti!!atio" &a% #e se' to pro'ce W/I "'er crre"t Eropea" re(!atio"s

Disti!!atio") RO a"' U/ are a!!o$a#!e &etho's to pro'ce W/I "'er the apa"ese

re(!atio"s

There are ,e$ re(!atio"s) $hich (o+er" the 'esi(" a"' co"strctio" o, phar&acetica!

$ater pri,icatio" s%ste&s. There are "o e<isti"( re(!atio"s (o+er"i"( &ateria!s o,



co"strctio"s. T%pe) or !e+e! o, i"str&e"tatio") sr,ace ,i"ish or operati"( te&peratres.

Most practices co&&o"!% ,o!!o$e' $ith respect to these a"' other isses) ha+e #ee"

a'opte' #ase' o" &a"% ,actors.

A&o"( US (o+er"&e"t p#!icatio"s i"c!'i"( the co'e o, ,e'era! re(!atio"s 9C/R: a"'

the /DA Gi'e to i"spectio" o, 2i(h Prit% Water S%ste&s) there are ,e$ stip!atio"s

re!ate' to 'esi(" a"' co"strctio" o, W/I processi"( e*ip&e"t. T$o "ota#!e

stip!atio"s are -

2eat e<cha"(ers) other tha" the 'o#!e co"ce"tric t#e t%pe or 'o#!e t#e sheet

t%pe) &st e&p!o% a pressre 'i,,ere"tia! a"' a &ea"s ,or &o"itori"( the 'i,,ere"tia!

A!! sti!!s a"' ta"s ho!'i"( !i*i' re*iri"( &icro#ia! co"tro! sha!! ha+e air +e"ts $ith

"o" ,i#er re!easi"( steri!i5a#!e ,i!ters capa#!e o, pre+e"ti"( &icro#ia! co"ta&i"atio"

o, the co"te"t

;.3 DISTILLATION

The phar&acetica! sti!! che&ica!!% a"' &icro#io!o(ica!!% pri,ies $ater #% phase

cha"(es a"' e"trai"&e"t separatio". I" this process $ater is e+aporate') pro'ci"( stea&.

The stea& 'ise"(a(es ,ro& the $ater !ea+i"( #ehi"' 'isso!+e' so!i's) "o" +o!ati!es a"'

hi(h &o!ec!ar $ei(ht i&prities. 2o$e+er) !o$ &o!ec!ar $ei(ht i&prities are carrie'

$ith the $ater &ist7'rop!ets) $hich are e"trai"e' i" the stea&.A separator re&o+es ,i"e &ist a"' e"trai"e' i&prities) i"c!'i"( e"'oto<i"s. The

pri,ie' stea& is co"'e"se' i"to W/I. Disti!!atio" s%ste&s are a+ai!a#!e to pro+i'e a

&i"i&& o, 3!o(1B 9. : re'ctio" i" e"'oto<i" co"ce"tratio". Speci,ic e"'oto<i"

!oa'i"( !i&its sho!' #e re+ie$e' $ith the &a",actrer

A +ariet% o, 'i,,ere"t 'esi("s are a+ai!a#!e i"c!'i"( si"(!e e,,ect 9SE:) &!tie,,ect

9ME:) a"' +apor co&pressio" 9?C:. The 'isti!!e' $ater *a!it% e<pecte' ,ro& a" SE sti!!

is e*i+a!e"t to a" ME 'esi(") #% +irte o, the ,act that $ater is 'isti!!e' o"!% o"ce i"

#oth s%ste&s. The #e"e,it to the ser o, ME +erss SE 'isti!!atio" are the si("i,ica"t!%

!o$er operati"( costs associate' $ith ti!ities.

I" a" ME s%ste&) pri,ie' stea& pro'ce' #% each is ti!i5e' to heat $ater a"' (e"erate

&ore stea& i" the s#se*e"t e,,ect. De to this sta(e' e+aporatio" a"' co"'e"satio"



process) o"!% the ,irst e,,ect re*ires heat ,ro& a" e<ter"a! sorce) a"' o"!% the pri,ie'

stea& pro'ce' #% the ,i"a! e,,ect is co"'e"se') si"( a" e<ter"a! coo!i"( &e'i&.

?C sti!!s ca" pro'ce si&i!ar *a!it% $ater si"( a 'i,,ere"t tech"i*e. E"er(% i&parte'

to the (e"erate' stea&) #% a &echa"ica! co&pressor) res!t i" co&presse' stea& $ith

i"crease' pressre a"' te&peratre. The hi(her e"er(% stea& is the" 'ischar(e' #ac i"to

the e+aporator 7 co"'e"ser +esse! to (e"erate &ore stea& i" a co"ti"os &e'i&.

Areas o, co"cer" are carr% o+er o, i&prities) e+aporator ,!oo'i"() sta("a"t $ater) a"'

p&p a"' co&pressor sea! 'esi(". These co"cer"s &a% #e a''resse' si"( &ist

e!i&i"ators) hi(h $ater !e+e! i"'icators) se o, sa"itar% p&ps a"' co&pressor) proper

'rai"a(e) a'e*ate #!o$ 'o$" co"tro!) a"' co"'cti+it%) se"si"( to 'i+ert "accepta#!e

$ater to 'rai".

;. DISTILLATION APPLICATIONS AND CAPACITIES.

The &a4orit% o, USP W/I crre"t!% pro'ce' i" the U"ite' States is pro'ce' #%

'isti!!atio". W/I pro'ctio" is share' #% #oth ME a"' ?C sti!!s. SE sti!!s are ,o"' i"

areas $here o"!% s&a!! *a"tities o, W/I are re*ire'. 2o$e+er) $here !ar(e a&o"ts o,

W/I are re*ire') eco"o&ics o, operatio" 'ictate the se o, either ME or ?C.

Ta#!e ;1 sho$s t%pica! capacities a"' te&peratres o, W/I pro'ce' #% each process.

Table 6-1 capacities and WFI Temperatures Options

Si"(!e E,,ect M!ti E,,ect ?apor Co&pressio"

CAPACITY RANG IN

GP!1 1BB 0F @ 3)BBB 1BB @ ;)BBB

WFI Temperature ran"e

# options$ CB 1BB 3H @ 1BB

A&#ie"t

B 1BB

Co&#i"atio"

A&#ie"t72ot

FINA% TRAT&NT OPTION' ( WATR FOR IN)CTION * WFI +

6, PROCC' AN. 'Y'T& .'CRIP'ION

6,,1 'in"le //ect .istillation * ' +



SE s%ste&s i"corporate a si"(!e e+aporator heat e<cha"(er) separator &echa"is&) a"' a

co"'e"ser.

SE s%ste&s are a+ai!a#!e i" e!ectrica!!% or stea& po$ere' +ersio"s) a!tho(h e!ectrica!

"its are !i&ite' to +er% s&a!! pro'ctio" rates 9 3B (a!!o"s per hor :.

Stea& po$ere' "its t%pica!!% re*ire 3B @ ;B psi( p!a"t stea&. Coo!i"( ,!i' is re*ire'

,or #oth stea& a"' e!ectric po$ere' +ersio"s. Whe" $ater is the coo!a"t) the rate is

appro<i&ate!% @ 1B (a!!o"s per (a!!o" o, W/I pro'ce') #ase' o" a spp!% te&peratre

o, @ 1;°C) a"' te&peratre rise o, ;H°C.

SE s%ste&s t%pica!!% operate at at&ospheric a"' 1BB°C) a"' i"corporate "o" @ ASME

co'e +esse!s.

W/I is 'e!i+ere' at at&ospheric pressre a"' B @ 1BB°CJ ths a 'isti!!ate tra"s,er p&p

is re*ire') "!ess the W/I ta" is at a !o$er e!e+atio" tha" the sti!!.

6,,0 &ulti //ect .istillation * & +

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