Bioreactor_URS_A1.doc

JETT

USER REQUIREMENTS SPECIFICATION

BIOREACTOR

Page 1 of 30 Doc ID: BIOREACTOR URS A1 April 2005

EQUIREMENTS TEMPLATE USER R R EQUIREMENTS FOR A FOR A BIOREACTOR SYSTEM

JOINT EUIP!ENT TRANSITION TEA!

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BIOREACTOR


REVISION HISTORY Rev.

A1

Note:

Date

"#5#2005

Developed B!

JE$

Revision Summary

I%i&ial Relea'e ('i%g JETT B)AN* URS TE!P)ATE+Re,3

For an initial release, release, provide a note that the document is being routed routed for initial review/approval.

(Reminder of Page Intentionall !eft "lan#$


JETT


BIOREACTOR


REVISION HISTORY Rev.

A1

Note:

Date

"#5#2005

Developed B!

JE$

Revision Summary

I%i&ial Relea'e ('i%g JETT B)AN* URS TE!P)ATE+Re,3

For an initial release, release, provide a note that the document is being routed routed for initial review/approval.

(Reminder of Page Intentionall !eft "lan#$


JETT


BIOREACTOR


TABLE OF CONTENTS ".#

INTROD INTRODUCT UCTION ION $SCOPE%. $SCOPE%....... ............. .............. .............. ............. ............. .............. ............. ............. ................. ...............................& .....................&

'.#

OVERV OVERVIE(.. IE(........ ............. .............. .............. ............. ............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............... ................) ........)

*.# OPERA OPERAT TIONAL IONAL REQUIR REQUIREME EMENTS. NTS........ ............. ............. .............. .............. ............. ............. .............. ......................... .......................) .....) *." CAPACITY........................................................................................................................) *.' PROCESS R EQUIREMENTS EQUIREMENTS ..............................................................................................+ *.* PROCESS CONTROL........................................................................................................+ *.& FUNCTIONS ......................................................................................................................, *.) DATA ATA AND SECURITY ...................................................................................................."& *.+ ENVIRONMENT .............................................................................................................."&.# CONSTR CONSTRAIN AINTS... TS......... ............. .............. ............. ............. .............. .............. ............. ............. .............. ............. ................. ................................. .......................", .", &." MILESTONES AND TIMELINES......................................................................................", &.' EQUIPMENT CONSTRAINTS ..........................................................................................'# &.* COMPATIBILITY AND SUPPORT....................................................................................'# &.& AVAILABILITY ...............................................................................................................'' &.) PROCEDURAL CONSTRAINTS ........................................................................................'' &.+ MAINTENANCE..............................................................................................................'* ).# LIFECY LIFECYCLE CLE...... ............. .............. .............. ............. ............. .............. ............. ............. .............. .............. ............. ............. .............. ............. ............. ...............'& ........'& )." DEVELOPMENT..............................................................................................................'& ).' TESTIN/.........................................................................................................................'& ).* DELIVERY......................................................................................................................'& ).& SUPPORT........................................................................................................................'+ +.#

/LOSSAR /LO SSARY.. Y......... ............. ............. .............. .............. ............. ............. .............. ............. ............. .............. .............. .................. ................................. .......................'.'-

-.#

REFERE REFERENCE NCES..... S........... ............. .............. ............. ............. .............. .............. ............. ............. .............. ............. ................. ................................. .......................', .',

,.#

APPROVA APPROVAL............................................................ L.................................................................................................................. ..........................................................'0 ....'0

0.#

ATTA ATTACHMENT CHMENTS..................................................... S.......................................................................................................... ........................................................*# ...*#


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BIOREACTOR

Page " of 30 Doc ID: BIOREACTOR URS A1 April 2005

P1o2e3t No.! Insert the uni%ue pro&ect number associated with this particular 'R. Do345e6t No.! Insert the )ocument Identification Number and Revision. Do345e6t De7318pt8o6! "I*R+-*R +0, 1+ +2ample "lan# 'ser Re%uirements pecification emplate Rev. 3.

".#INTRODUCTION $SCOPE% T-i' .oc(/e%& .efi%e' o%l &-e ('er re(ire/e%&' for &-e Bioreac&or S'&e/ Elec&ro%ic Recor.' a%. Elec&ro%ic Sig%a&(re ER#ES4 'ec(ri& a%. o&-er &pe' of co//o% re(ire/e%&' a' 6ell a' ('er re(ire/e%&' of o&-er proce'' cell' are co,ere. el'e6-ere i% &-e S'&e/ )e,el U'er Re(ire/e%&' Specifica&io%' for &-e Proce'' Co% &rol S'&e/ Delega&e fro/ Jaco7' E%gi%eeri%g $ro(p I%c i' &-e a(&-or T-e .oc(/e%& i' &-e fir'& '&ep i% &-e pro8ec& life ccle a%. clarifie' &-e goal' of &-i' pro8ec& T-i' life ccle co%'i'&' of 9e (ali& .eli,era7le' .oc(/e%&i%g &-e .e'ig% .e,elop/e%& a%. i/ple/e%&a&io% of &-e Bioreac&or S'&e/ T-i' .oc(/e%& 6ill o%l co,er &-e &pical ('er proce'' re(ire/e%&' for &-e Bioreac&or S9i. Bioreac&or U&ili& S9i. a%. a%cillar e(ip/e%& Refer &o &-e E(ip/e%& ali.a&io% Pla% &-a& o(&li%e' &-e S(pplier;' re'po%'i7ili&ie' a' a&&ac-e. T-i' i' &o 7e (&ili for &-e e(ip/e%& A..e%.(/' /a 7e ('e. &o ro(%. o(& &-e re(ire/e%&'



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BIOREACTOR


'.#OVERVIE( T-i' .oc(/e%& e%co/pa''e' &-e %or/al ra%ge of &-e Bioreac&or S'&e/ a%. a%cillar e(ip/e%& opera&io%' '."

'.'

U7e! De'cri7e 6-a& applica&io%' &-e e(ip/e%&#''&e/ 6ill 7e ('e. &o '(ppor& I%cl(.e a 7rief e?pla%a&io% of &-e ge%eral f(%c&io%'

211

T-e p(rpo'e of &-e Bioreac&or S'&e/ i' &o perfor/ cell gro6&- i% a co%&rolle. e%,iro%/e%& &o (a%&i& a%. co%ce%&ra&io% '(i&a7le for -ar,e'& T-e Bioreac&or i' loca&e. i% &-e proce'' area a%. 6ill 7e opera&e. i% 7a&c/o.e Pro.(c& 6ill 7e &ra%'ferre. fro/ -ere &o &-e p(rifica&io% '(i&e I& ca% al'o 7e .i'car.e. &o Bio6a'&e

212

Cell' are &ra%'ferre. i%&o &-e /e.ia fille. 7a&c- reac&or ,ia air pre''(re a%. are &-e% c(l&(re. i% &-e 7ioreac&or ''&e/ (%.er clo'e. co%.i&io%' T-e i%oc(l(/ for &-i' reac&or i' gro6% i% &-e 7ioreac&or a%. i' p%e(/a&icall &ra%'ferre. i%&o &-e .o6%'&rea/ proce'' !e.ia ca% 7e '(pplie. &o &-i' reac&or fro/ a% of &-e !e.ia Prepara&io% e''el' &-ro(g- a 'erie' of &ra%'fer pa%el' Ca('&ic A%&ifoa/ a%. %(&rie%&' are '(pplie. fro/ Por&a7le e''el' ('i%g ei&-er peri'&al&ic p(/p' or air pre''(re &o acco/pli'- &-e &ra%'fer

213

T-e /a'' 'pec&ro/e&er a%al
Capa38t: Pro,i.e a 7rief .e'crip&io% of &-e e(ip/e%&#''&e/ capaci& re(ire/e%&'

221

T-e e(ip/e%& '-all 7e capa7le of pro.(ci%g  pro.(c& co%&i%(o('l o,er a% -o(r '-if&

*.#OPERATIONAL REQUIREMENTS T-i' Sec&io% '-all '&a&e &-e opera&io%al re(ire/e%&': ''&e/ f(%c&io%' .a&a a%. i%&erface' I& '-all al'o .efi%e &-e e%,iro%/e%& i% 6-ic- &-e ''&e/ /('& opera&e Cri&ical re(ire/e%&' '-all 7e 'pecificall i.e%&ifie. a' '(c- I%cl(.e proce'' .e'crip&io%' a%. flo6c-ar&' a' appropria&e *."

Capa38t

311 Ra%ge of pro.(c&' 312 Co//o.i&ie' &o 7e ('e. ie ,ial' 7o&&le' &a7le&' e&c4 313 Proce''e. !a&erial' &o 7e ('e. or i%,ol,e. 31" Pro.(c&io% ra&e'


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Page F of 30 Doc ID: BIOREACTOR URS A1 April 2005


BIOREACTOR P1o3e77 Re9481e5e6t7

321

(ali& of pro.(c&' a%. co%ce%&ra&io%'

322

Pro.(c& li/i&a&io%' ie &e/pera&(re -(/i.i& p@ e&c4

P1o3e77 Co6t1ol

331

!ea'(re/e%& Ra%ge

Mea741a:le Va18a:le

Mea741e5e6t Lo3at8o6

Mea741e5e6t Ra6;e < D87pla Re7ol4t8o6

A3341a3

Te/pera&(re

e''el

0 &o 1500 GC

± 025

GC

Te/pera&(re

Jac9e&

0 &o 1500 GC

± 025

GC

Agi&a&or Spee.

Agi&a&or Dri,e

0 &o 00 rp/

± 1

Pre''(re

e''el

0 &o 500 p'ig

± 02

p@+1

e''el

2 &o 130 p@

± 1

HS

p@+2

e''el

2 &o 130 p@

± 1

HS

DO+1

e''el

0 &o 2000 H'a&

± 1

HS

DO+2

e''el

0 &o 2000 H'a&

± 1

HS

CD+1

e''el

0 &o 15 /illio% cell'#/l

± 5

HS

CD+2

e''el

0 &o 15 /illio% cell'#/l

± 5

HS

O,erla Air

Air i%le& gro(p

0 &o 500 'lp/

± 1

HS

O2lo6

Air i%le& gro(p

0 &o 500 'lp/

± 1

HS

Sparge Air

Air i%le& gro(p

0 &o 500 'lp/

± 1

HS

CO2lo6

Air i%le& gro(p

0 &o 1000 'lp/

± 1

HS

!e.ia !a'' lo6

!e.ia ee.

0 &o 50 9g # /i%(&e

± 1

HS

Te/pera&(re

I%oc(l(/ Trap

0 &o 1500 GC

± 03

GC

Te/pera&(re

Re&e%&a&e Trap

0 &o 1500 GC

± 03

GC

Te/pera&(re

Sa/ple Trap

0 &o 1500 GC

± 03

GC

Te/pera&(re

Bioreac&or Seal

0 &o 1500 GC

± 03

GC

Te/pera&(re

Per/ea&e 1 Trap

0 &o 1500 GC

± 03

GC

Te/pera&(re

Per/ea&e 2 Trap

0 &o 1500 GC

± 03

GC

Te/pera&(re

Cell ree )P

0 &o 1500 GC

± 03

GC

Te/pera&(re

-ole Cell )P

0 &o 1500 GC

± 03

GC

332

HS p'ig

Se&poi%& Ra%ge Setpo86t


Te/pera&(re

e''el

Te/pera&(re Agi&a&or Spee.

Jac9e& Agi&a&or Dri,e

Pre''(re

e''el

M868545


Ma=8545

Page K of 30 Doc ID: BIOREACTOR URS A1 April 2005


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BIOREACTOR Setpo86t

p@+1

Mea741e5e6t Lo3at8o6 e''el

p@+2

e''el

O,erla Air

Air i%le& gro(p

O2lo6

Air i%le& gro(p

Sparge Air

Air i%le& gro(p

CO2lo6

Air i%le& gro(p

!e.ia !a'' lo6

!e.ia ee.

Te/pera&(re

I%oc(l(/ Trap

Te/pera&(re

Re&e%&a&e Trap

Te/pera&(re

Sa/ple Trap

Te/pera&(re

Bioreac&or Seal

Te/pera&(re

Per/ea&e 1 Trap

Te/pera&(re

Per/ea&e 2 Trap

Te/pera&(re

Cell ree )P

Te/pera&(re

-ole Cell )P

333

M868545

Ma=8545

Para/e&er Co%&rol Tolera%ce

Note: t a minimum, list the critical, process parameters. -onsider documenting how each of the parameter re%uirements was determined. Pa1a5ete1


Co6t1ol Tole1a63e L 05 oC

Te/pera&(re

e''el

Te/pera&(re Agi&a&or Spee.

Jac9e& Agi&a&or Dri,e

Pre''(re

e''el

L 2 p'i

p@+1

e''el

L 01

p@+2

e''el

L 01

O,erla Air

Air i%le& gro(p

L 01

O2lo6

Air i%le& gro(p

L 01

Sparge Air

Air i%le& gro(p

L 01

CO2lo6

Air i%le& gro(p

L 01

!e.ia !a'' lo6

!e.ia ee.

L 01

Te/pera&(re

I%oc(l(/ Trap

L 05 oC

Te/pera&(re

Re&e%&a&e Trap

L 05 oC

Te/pera&(re

Sa/ple Trap

L 05 oC

Te/pera&(re

Bioreac&or Seal

L 05 oC

Te/pera&(re

Per/ea&e 1 Trap

L 05 oC

Te/pera&(re

Per/ea&e 2 Trap

L 05 oC

Te/pera&(re

Cell ree )P

L 05 oC

Te/pera&(re

-ole Cell )P

L 05 oC


L 05 oC L 10 RP!


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Page  of 30 Doc ID: BIOREACTOR URS A1 April 2005

F463t8o67

3"1

Opera&io% 3"11 T-e ''&e/ '-all opera&e 6i&- a /i%i/(/ of opera&or i%,ol,e/e%& Opera&io% '-all 7e 'afe fro/ a% opera&or a%. e%,iro%/e%&al '&a%.poi%& 3"12 T-e ''&e/ '-all 7e opera&e. locall a& &-e e(ip/e%& i&'elf 7 /ea%' of &-e opera&or i%&erface &er/i%al OIT4

3"2 Co%&rol ''&e/ re(ire/e%&' All co%&rol loop' are i/ple/e%&e. i% &-e P)C ('i%g a,aila7le co%&roller '&r(c&(re' .epe%.i%g (po% &-e &pe of proce'' ,aria7le T-e P)C co%&rol loop 7loc9' ca% 7e co%fig(re. &o perfor/ PID co%&rol Se&poi%& co%&rol !(l&iple4 ca'ca.e co%&rol Ti/er co%&rol a%. co/7i%a&io%' Se&poi%&' alar/ li/i&' a%. /i%i/(/ a%. /a?i/(/ o(&p(& li/i&' are recipe ,aria7le' &-a& ca% 7e .o6%loa.e. fro/ &-e Proce'' Co%&rol S'&e/ 3"2

Co%&rol )oop' 3"21 !e.ia I%i&ial C-arge Ba&c- ee.' T-e ''&e/ ca% 7e fe. 7 a p(/p a& a flo6 ra&e ra%ge of 0 &o 2 lp/ T-e ''&e/ ca% 7e fe. 7 a /ea%' of a pre''(ri

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BIOREACTOR

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3"2K $a' lo6 Ra&e' O,erla ga'e' of air a%. car7o% .io?i.e &o 7e pro,i.e. a& a /ea'(ra7le a%. co%&rolla7le flo6 ra&e ra%ge of 0 &o 10 'lp/ for air a%. 0 &o 2 'lp/ for car7o% .io?i.e Air car7o% .io?i.e o?ge% a%. %i&roge% 6ill 7e pro,i.e. for 'pargi%g a%. flo6 ra&e' 6ill 7e /ea'(ra7le a%. co%&rolle. lo6 ra&e' 6ill 7e 0 &o 5 'lp/ for air 2 'lp/ for car7o% .io?i.e 0 &o 15 'lp/ for o?ge% a%. 0 &o 20 'lp/ for %i&roge% 3"2 Pre''(re Co%&rol T-e ''&e/ 7ac9 pre''(re i' /ea'(ra7le a%. ca% 7e co%&rolle. a& 2 &o 30p'i L 2 p'i 3"2M Pre''(re @ol. T-e ,e''el -a' &-e a7ili& -ol. pre''(re Pre''(ri

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BIOREACTOR 3"212 Se(e%ce of Opera&io%

T-e (%i& i' capa7le of f(ll a(&o/a&io% .(ri%g &-e follo6i%g proce'' '&ep'  No&e: T-e &er/ Proce'' Opera&io% i' &a9e% fro/ &-e Proce'' !o.el of &-e ISA S01 Ba&c- Co%&rol '&a%.ar. T-i' 'ec&io% i' orga%i
CIP Vessel

Pre-SIP Leak Test

SIP Vessel

Cool Equipment and Establish Sterile Blocks

Prep and Transfer Media

Inoculate Bi oreactor

ro!th - "ddition #eeds

Sample Vessel

$ar%est Transfer

&iscard to B'

'#I #lush

'#I #lush

Thermal Inacti%ation

Thermal Inacti%ation

CIP Vessel

CIP Vessel



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3"3 Po6er fail(re#Reco,er 3"31

Po6er ail(re: I%'er& o(r 'pecific po6er fail(re#reco,er 'c-e/e -ere For e2ample: In the event of a power failure, the sstem shall protect in the following priorit: 3"311 Personnel 3"312 +%uipment 3"313 Product

3"32

Reco,er !e&-o.': I%'er& o(r 'pecific reco,er 'c-e/e -ere For e2ample: 3"321 0anuall re4start based on operator inputs (*perator initiates power recover se%uence$. 3"322 Re4start based on last state before loss of power. (stem runs through power recover se%uence when operator start signal is given$ 3"323 If there is an automatic batch reporting sstem, the information shall be retained in the event of a power failure ( 'P is re%uired for automatic batch reporting sstems for data retention$.

3"" =E/erge%c S&op> I%'er& o(r 'pecific =E/erge%c S&op> ES&op4 '&ra&eg a%. co//(%ica&io% 'c-e/e -ere For e2ample: 5.6.6

he sstem shall have an +4top mechanism designed to stop all phsical movement of the e%uipment immediatel. he +4top mechanism(s$ shall be located in easil accessible areas around the e%uipment as re%uired b national and local safet standards.

3"5 Alar/' a%. ar%i%g' 3"51

>C18t83al ala157?  I%'er& o(r 'pecific =Cri&ical Alar/> ac&io% 'c-e/e -ere

For e2ample: 3"511

-ritical larms shall ta#e action via interloc#(s$ and/or operator procedural response to shut the




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BIOREACTOR

e%uipment down and notif the operator of the condition(s$. he operator shall be re%uired to ac#nowledge the alarm before the alarm can be reset and the sstem restarted. *nce the alarm is reset, the operator ma restart the sstem. 3"52

>I6@o15at8o6al Me77a;e7? '-all %o&if &-e opera&or a%. &a9e %o f(r&-er ac&io%

Note: For a customi7ed e%uipment application, include an alarm table, li#e the e2ample that follows. For e2ample: 3"521

he +%uipment shall have the following critical alarms and warnings:

Critical Alarm

Stackpole Light Illuminatio n (color/ash ing)

Information al Message

E/erge%c S&op











Co%&rol Pla&for/ Co//(%ica&io% a&c-.og









Co%&rol Po6er a(l&









!ai% Air a(l&







@ig- e''el )e,el









)o6 e''el )e,el









@ig- Te/pera&(re









)o6 Te/pera&(re









De,ia&io% Te/pera&(re







@ig- Agi&a&io% Spee.









)o6 Agi&a&io% Spee.









De,ia&io% Agi&a&io% Spee.







@ig- DO









)o6 DO









De,ia&io% DO







@ig- p@









)o6 p@









Alarm or Informational Message

Response


Interlock perator (s) !roce"ural



JETT

BIOREACTOR

Alarm or Informational Message

Critical Alarm

Stackpole Light Illuminatio

Information al Message

Response Interlock perator (s) !roce"ural

De,ia&io% p@







@ig- Air lo6









)o6 Air lo6









De,ia&io% Air lo6







@ig- Car7o% Dio?i.e lo6









)o6 Car7o% Dio?i.e lo6









De,ia&io% Car7o% Dio?i.e lo6







@ig- O?ge% lo6









)o6 O?ge% lo6









De,ia&io% O?ge% lo6







@ig- Ni&roge% lo6









)o6 Ni&roge% lo6









De,ia&io% Ni&roge% lo6







R(p&(re Di'c ail(re









!o&or a(l&'







CONTRO) P)ATOR! Ba&&er )o6 ar%i%g

 



T-e li'& of cri&ical alar/' i% &-e &a7le i' %o& i%&e%.e. &o 7e a co/pre-e%'i,e li'& of all alar/' for &-e ''&e/ A co/ple&e alar/ li'& 6ill 7e .e,elope. a%. i%cl(.e. i% &-e (%c&io%al Specifica&io% .oc(/e%& or a '&a%.ar. e(ip/e%& &pe applica&io% re(e'& &-e '(pplier &o '(7/i& &-e co/ple&e alar/ li'& a%. .iffere%&ia&e 7e&6ee% cri&ical a%. %o%cri&ical alar/' Note: -onsider documenting how 8critical and informational message9 criterions were determined.



JETT

*.)

BIOREACTOR

Page 1" of 30 Doc ID: BIOREACTOR URS A1 April 2005

Data a6d Se3418t

-ontrols provided with )ata -ollection sstems intended for use in the manufacture of pharmaceutical products shall be re%uired to meet 6 -FR Part 66 compliance. 351

Safe& T-e follo6i%g 'afe& re(ire/e%&' 6ill 7e i%corpora&e. i%&o &-e ''&e/ .e'ig% a%. i/ple/e%&a&io%: 1 I%p(& fa(l& alar/' ge%era&e. o% o,er#(%.er c(rre%& 'ig%al' o% all a%alog I#O .e,ice' 2 ail'afe 'of&6are co%fig(ra&io% &o /a&c- ''&e/ co/po%e%& fail po'i&io%' S'&e/ re,er&' &o fail'afe po'i&io%' o% po6er lo'' 3 Po6er(p logic &o re'&ore .e,ice' &o po6er(p po'i&io% %o&e  %o& %ece''aril fail'afe po'i&io%'4 " All OIT e%clo'(re' /('& /ee& NE!A " re(ire/e%&'

352

Sec(ri& T-e follo6i%g 'ec(ri& 6ill 7e re(ire. a& a /i%i/(/ o% ''&e/': 1 P)C ca7i%e&' 6ill 7e loc9e. a%. acce'' 6ill 7e re'&ric&e. &o a(&-ori
i%ac&i,i& 353 U'er I%&erface' T-i' 'ec&io% '-o(l. a..re'' &-e follo6i%g i''(e': 3531

U'er i%&erface acce'' le,el'

3532

re(e%c of .a&a poi%& collec&io%

3533

@ar.cop#elec&ro%ic .a&a collec&io% re(ire/e%&'

353"

Co/plia%ce 6i&- 21CR Par& 11 for E(rope  EREC $(i.eli%e'4

3535

Da&a re&e%&io% &i/e o% &-e ''&e/

353F

Da&a '&orage /e.ia Acce'' &o all I%p(&#O(&p(& ,al(e' a%. ''&e/ '&a&(' 7i&' '-all 7e pro,i.e. &-ro(g- a .a&aco//(%ica&io% li%9 Sec(ri& for .a&a a%. opera&or acce'' i' pro,i.e. 7 U'er ID#Pa''6or. Car. Rea.er Bio/e&ric i%gerpri%& ee 'ca% ,oice recog%i&io% e&c4




JETT

BIOREACTOR 35"

U'er I%&erface 6i&- S(per,i'or' a%. Opera&or' I%'er& o(r i%&erface 'c-e/e -ere For e2ample: 6.6

he -*NR*! P!F*R0 sstem shall include interfaces with the *perator and upervisor that ensures eas, safe, and reliable operation.

6.

n operator4interface terminal shall be provided and mounted near the e%uipment or on the e%uipment. his panel shall provide the necessar switches, indicators, and devices to operate the e%uipment.

355 )a%g(age re(ire/e%&' Specif la%g(age &-a& i%for/a&io% 6ill 7e .i'plae. i% ie E%gli'- Spa%i'- $er/a% Bili%g(al e&c4 3551

Di'plae. Re(ire/e%&': S&a&e &-e ''&e/ of /ea'(re/e%& &-a& 6ill 7e ('e. E%gli'- or !e&ric SI44

!arameter

$nit(s) of measurement

#ormat

Te/pera&(re

4 (%i&'

(%i&'



4H

H

35F I%&erface 6i&- O&-er E(ip/e%& T-e co%&rol ''&e/ '-all i%cl(.e &-e i%&erface' %ece''ar &o facili&a&e opera&io% a%. co%fig(ra&io% or e?a/ple: 35F1

A proprie&ar co//(%ica&io%' por& ie D@L !o.7(' e&c4 '-all 7e pro,i.e.

35F2

A% E&-er%e& co//(%ica&io%' por& '-all 7e pro,i.e.

35F3

A -ig-'pee. co%fig(ra&io%#/o%i&ori%g co%%ec&io% '-all 7e pro,i.e.

35K Sec(ri& )e,el' )i'& &-e &o&al %(/7er of .iffere%& acce'' le,el' &-a& 6ill 7e re(ire. Pro,i.e a ge%eral .e'crip&io% of &-e acce'' rig-&' for eac - le,el 'cree% %a,iga&io% opera&io%al co%&rol co%&rol loop ,aria7le /a%ip(la&io% alar/ 'e&poi%& /a%ip(la&io% e&c4


Page 1F of 30 Doc ID: BIOREACTOR URS A1 April 2005


JETT

BIOREACTOR

o & ( A o % & o e i & . a o g i , ! a e c N i % , e e e r D c S e g % a C

f f O r o . % a @ o & e . o ! e c i , e D e g % a C

A33e77 Level

No%e  Opera&or S(per,i'or E%gi%eer # !ai%& A./i%i'&ra&or

    

 

   

. % a 7 . a e D . % a 0 a l e D e / i T 5 ' & % i o p & e S / r a l A e g % a C

 

' / r a l A e l 7 a ' i D # e l 7 a % E

 

' / r a l A e g . e l 6 o % 9 c A

   

e . o ! & ( p & ( O g o l a % A e g % a C

e ( l a : & ( p & ( O g o l a % A e g % a C

 

  

' & % i a r & ' % o C & e ' e R . % a e & a R 5 % i a $ p o o ) D I P e g % a C

' e . o ! . % a ' & % i o p & e S p o o ) D I P e g % a C

  



35 Da&a Collec&io% Co%'i.er a% arc-i,i%g a%. repor&i%g re(ire/e%&' -ere 351

No%e

352

Recor.er

353

Proce'' Pri%&o(&

35"

Elec&ro%ic proce'' pri%&o(& @i'&orical Tre%.i%g

355

Elec&ro%ic proce'' pri%&o(& @i'&orical Tre%.i%g a%. i%&erface &o co/pa% %e&6or9

T-e follo6i%g '-all 7e recor.e.: 35F

Te/pera&(re

35K

Agi&a&or Spee.

35

Di''ol,e. O?ge%

35M

p@

3510 Air lo6 3511 Car7o% Dio?i.e lo6 3512 O?ge% lo6


l o r & % o C e c i , e D e & o / e R

   

Page 1K of 30 Doc ID: BIOREACTOR URS A1 April 2005


JETT

BIOREACTOR 3513 Ni&roge% lo6 351" CIP lo6 3515 CIP Pre''(re 351F SIP Te/pera&(re 351K SIP Ti/e

*.+

E6v81o65e6t

Provide details of the phsical environment in which the "ioreactor will be operated. 3F1 )ao(& For e2ample: 3.;.6.6

llocated floor space for the e%uipment is <<<<< inches b <<<<<<<< inches with at least a <<<<<<
3.;.6.

=ertical clearance is <<<<<<<<< inches.

3F13 3.;.6.5

Floor !oading is

pounds/ft

ee attached drawing ><<<<<<<<<<<<<<<<<<<<<<<< (if applicable$.

!aout is specific to the si7e e%uipment being used and sstem re%uirements of the e%uipment. 3F2 P-'ical Co%.i&io%' 3F21

Roo/ E?plo'io% Cla''ifica&io% )i'& &-e cri&ical e?plo'io% re(ire/e%&' for &-e roo/ 3F211

3F22

Roo/ 6ill 7e %o%-a
E%,iro%/e%&al Cla''ifica&io% )i'& &-e cri&ical air (ali& re(ire/e%&' for &-e e%,iro%/e%& 3F221

ISO Cla'' 5 K or  ISO 1"F""1 a%. ISO 1"F"" 24

3F222

Cla'' A B C or D T-e R(le' $o,er%i%g !e.ici%al Pro.(c&' i% &-e E(ropea% U%io%  A%%e? 14

3F223

Direc&io%al airflo6

3F22"

Airflo6 ,eloci&

3F225

N(/7er of air c-a%ge'



JETT

BIOREACTOR 3F22F 3F23

Page 1 of 30 Doc ID: BIOREACTOR URS A1 April 2005

Par&icle I%gre''

Bio-a
3F2"

3F231

B)1

3F232

B)2

Ra&i%g of e%clo'(re' )i'& &-e ra&i%g re(ire/e%&' for e%clo'(re' i% &-e e%,iro%/e%& 3F2"1

NE!A " a'- .o6% a%. %o%Corro'i,e4

3F3 Clea%i%g Re(ire/e%&' • • • •

A(&o/a&e. CIP or /a%(al clea%i%g U'e e?i'&i%g or ce%&rali
3F" S&erili
A(&o/a&e. SIP '&erili
3F5 I%&e%.e. Opera&i%g E%,iro%/e%&: De'cri7e &-e &pe of opera&i%g e%,iro%/e%& &-a& &-e Bioreac&or 6ill 7e e?po'e. &o follo6i%g i%'&alla&io% For e2ample: 3F51

he "ioreactor shall be mounted in a ?0P environment with a temperature range of 6@ to @ A-, non4condensing humidit.

3.;.@.

=ibration levels in operating environment are BNegligible, light, or evereC

3.;[email protected]

he eismic Done in the operating environment is BDone 6, Done , Done 3, Done 5, or Done 5C.


Page 1M of 30 Doc ID: BIOREACTOR URS A1 April 2005


JETT

BIOREACTOR

&.#CONSTRAINTS &."

M8le7to6e7 a6d T85el86e7

"ased on the model outlined below, establish the pro&ect milestones with a timeline:

JETT EQUIPMENT ACQUISITION MODEL SUPPLIER

USER$CONSULTANT 8@ appl83a:le% Ma7te1 Val8dat8o6 Pla6 E948p5e6t Val8dat8o6 Pla6 R87 A77e775e6t E=pla6at8o6 to S4ppl8e1

U7e1 A4d8t

P. O.

RFQ U7e1 Re9481e5e6t7 Spe38@83at8o6 $L8v86; Do345e6t%

a l p o 7 P 1 o P .O .

P1opo7al A6al787

E6;86ee186; Fea78:8l8t St4d a6d Re74lt7 P1opo7al P1o2e3t Pla6

Q4al8t < Val8dat8o6 Pla6

F463t8o6al Spe38@83at8o6 $t1a3ea:le to URS%

Rev8e F463t8o6al Spe38@83at8o6

App1oval

Deta8led De78;6 Do345e6tat8o6 $t1a3ea:le to F463t8o6al Spe38@83at8o6%

Rev8e Deta8led De78;6

A p p1 ov al

S7te5 A33epta63e Te7t Spe38@83at8o67 $IQOQ% Ha1da1e

Rev8e S7te5 A33epta63e Te7t Spe38@83at8o67

I6te;1ate 8t Val8dat8o6 Do345e6tat8o6 a7 app1op18ate

A p p1 ov a l

So@ta1e

S7te5 A33epta63e Te7t86; a6d Re74lt7 U7e1 (8t6e77 Opt8o6al Ma86te6a63e < S4ppo1t Do345e6tat8o6


JETT

&.'



BIOREACTOR

E948p5e6t Co67t1a86t7

)escribe the operating constraints that the "ioreactor will be re%uired to meet. For e2ample: "21 E%,iro%/e%&al Co%.i&io%' T-e Bioreac&or i' &o 7e ('e. a& &-e follo6i%g e%,iro%/e%&al co%.i&io%': "211

Al&i&(.e ++++++++ f& a7o,e 'ea le,el

"22 @AC E(ip/e%& Co%'&rai%&' "221

Proce'' air e%&er' i% fro/ I%.oor Te/pera&(re:

"222

"223

°C

O(&.oor Te/pera&(re: !i%i/(/:

° C

!a?i/(/:

°C

Cli/a&ic co%.i&io%': i%&er .r 7(l7

°C

i%&er 6e& 7(l7

°C

S(//er .r 7(l7

°C

S(//er 6e& 7(l7

°C

"23 E(ip/e%& $e%era&e. i7ra&io% T-e /a?i/(/ allo6a7le e(ip/e%& ,i7ra&io% ge%era&e. .(ri%g opera&io% i' Q,al(e &.*

Co5pat8:8l8t a6d S4ppo1t

Include an re%uirements for compatibilit with other 'ser sstems. In the e2amples provided below, fill in blan#s with the appropriate information. )elete areas that are not applicable to this application. "31 CONTRO) P)ATOR! Co%&roller' "311

T-e S(pplier '-all (&ili
"312

T-e S(pplier '-all pro,i.e .oc(/e%&a&io% &-a& &-e progra/ e/7e..e. 'of&6are4 6a' .e,elope. a%. co.e. (&ili
"313

T-e '(pplier '-all i%.ica&e &-e ('e of c('&o/ or =7e'po9e> co.e 6i&-i% &-e e(ip/e%& a%. '-all '(ppl lice%'i%g of &-e c('&o/ co.e for &-e life of &-e e(ip/e%&

"31"

A% e'cro6 agree/e%& '-all 7e re(ire. i% &-e e,e%& &-e '(pplier



JETT

BIOREACTOR


ca%%o& '(ppor& &-e '(pplie. c('&o/ 'of&6are a% lo%ger I% '(ci%'&a%ce' &-e 'o(rce co.e a%. all i%for/a&io% regar.i%g &-e 'o(rce co.e '-all 7e gi,e% &o &-e ('er i% a &i/el fa'-io% &o pre,e%& .o6%&i/e of &-e e(ip/e%& "32 Preferre. e%.or )i'& "321

If %ece''ar a&&ac- a% cri&ical preferre. ,e%.or' Refrai% fro/ .ri,i%g &-e '(pplier i%&o c('&o/i
"322

If &-e ,e%.or 6i'-e' &o .e,ia&e fro/ &-e Preferre. I%'&r(/e%&a&io% )i'& a li'&i%g of &-e propo'e. co/po%e%&' a%. i%'&r(/e%&a&io% '(7,e%.or' i%.ica&i%g &pe a%. /o.el %(/7er' '-all 7e '(7/i&&e. 6i&- &-e (o&a&io% alo%g 6i&- a% e?pla%a&io% of 6- &-e .e,ia&io% i' reco//e%.e.

"33 U&ili&ie' "331

T-e (&ili&ie' a%. 'pace i%,ol,e. %ee.' &o 7e .i'c(''e. prior &o p(rc-a'i%g &-e e(ip/e%& O7,io('l &-e ac&(al e(ip/e%& 'i
"332

T-e U'er '-all e%'(re &-a& &-e follo6i%g (&ili&ie' are a,aila7le a%. &-a& &-e (&ili& '(ppl li%e' a%. pipi%g are &er/i%a&e. 6i&- fi&&i%g' or co%%ec&io%' 6-ic- are co/pa&i7le 6i&- &-o'e .e'cri7e. o% &-e C('&o/er Co%%ec&io% Dra6i%g'

"333

T-e S(pplier '-all 'pecif (&ili& .a&a 6-ic- i' /ar9e. 6i&- a &ria%gle U&ili& .a&a 6-ic- are %o& 'pecifie. or /ar9e. 6i&- a &ria%gle '-all 7e 7ro(g-& &o &-e a&&e%&io% of &-e U'er T-e'e .a&a '-all 7e 'pecifie. 7 &-e U'er or &-e S(pplier4 a%. '-all 7e appro,e. 7 7o&- &-e U'er a%. &-e S(pplier 7efore ''&e/ .e'ig% 7egi%' Ba7e Ut8l8t8e7 (o17eet

"33"

"335

Rela&e. Di'c-arge' "33"1

ol(/e

"33"2

p@

"33"3

Te/pera&(re

"33""

!a&erial'

Elec&rici& "3351

++++++ AC ++++ @er&<

"3352

P-a'e'



JETT

BIOREACTOR

"33F


"3353

A/perage

"335"

U%i%&err(p&i7le Po6er S(ppl Defi%e U'e4

Co%&rol Air "33F1

Pre''(re For e2ample: <<<<<<< PI? (must be clean, dr I instrument %ualit air, capacit to be determined b si7e of e%uipment$. Recommend at least E PI? constant air pressure for all e%uipments, unless specified.

"33K

O&-er U&ili& Re(ire/e%&' Pro,i.e .e&ail' regar.i%g a% o&-er (&ili& ''&e/' &-a& are re(ire. &o '(ppor& opera&io% of &-e e(ip/e%&#''&e/

&.&

Ava8la:8l8t

""1 T-e Bioreac&or i' i%&e%.e. &o 7e opera&e. Co%&i%(o('l ++ -o(r' per .a ++ -o(r' per 6ee9 ""2 Opera&io% of &-e Bioreac&or '-all 7e '('pe%.e. a%. &-e ''&e/ '-all 7e a,aila7le for pre,e%&a&i,e /ai%&e%a%ce or ro(&i%e 'er,ice ++ -o(r' per 6ee9 ++ co%&i%(o(' -o(r' per 6ee9 ++ .a' per /o%&- ++ 6ee9' per ear &.)

P1o3ed41al Co67t1a86t7

"51 Pro.(c& Co%&ac& !a&erial' )escribe an local procedural re%uirements such as local standards, which must be adhered to if applicable. "511

All pipi%g 6el.' a%. pro.(c& co%&ac& 6el.' '-all /ee& AS!E a%. 3A 'pecifica&io% re(ire/e%&'

"512

Pro.(c& co%&ac& /e&al &o 7e 31F) S&ai%le'' S&eel 31F S&ai%le'' S&eel 30" S&ai%le'' S&eel e&c4

"513

)i'& cri&ical re(ire/e%&' for '(rface fi%i'- ro(g-%e'' e&c

"51"

O&-er '&a%.ar.' are a&&ac-e.

he upplier shall adhere to the indicated sections onl. "52 Pro.(c& i% Co%&ac& 6i&- !a&erial' ll product contact parts should be considered. "521

T-e Bioreac&or 6ill 7e ('e. for a(eo(' 'ol(&io%' lo6 )E) lo6er e?plo'io% li/i&4 'ol,e%&' -ig- )E) 'ol,e%&' e&c4



JETT

BIOREACTOR


"53 Noi'e )e,el Co%'&rai%&' I%'er& o(r o6% %oi'e le,el co%'&rai%& re(ire/e%&' -ere For e2ample: he noise level generated during operation of the "ioreactor will not e2ceed G@ d" from 3 feet awa. "5" E!I # RI le,el' are: I%'er& o(r o6% elec&rical a%. ra.io %oi'e i//(%i& re(ire/e%&' -ere For e2ample: he "ioreactor will not be used in an area where two4wa radio communication devices are in operation. he "ioreactor shall meet -+ re%uirements for electrical noise immunit and emissions. "55 Co%&ai%/e%& "551

E?plo'io% Pro&ec&io% T-i' 'ec&io% i' o%l ,ali. if &-e pro.(c& 7ei%g ('e. i' -ig-l reac&i,e I%'er& co%&ai%/e%& g(i.eli%e' -ere ie Bar Co%'&r(c&io% 6i&- i'ola&io% a%. '(ppre''io% 10 Bar co%'&r(c&io% 6i&- i'ola&io% o%l Clo'e.)oop Ni&roge% S'&e/ e&c4

"5F )a7eli%g All e(ip/e%& a%. co%&rol 6iri%g '-all 7e la7ele. a%. i.e%&ifie. &.+

Ma86te6a63e

)escribe the e2pected hardware and software maintenance support including: ease of maintenance, e2pansion capabilit (software onl$, li#el enhancements (software onl$, e2pected lifetime and long4term supp ort. "F11

S'&e/ '-all 7e /ai%&ai%e. o% a 'c-e.(le a' i%.ica&e. 7 &-e '(pplier

"F12

S(pplier i' &o pro,i.e a& /i%i/(/4 &-e follo6i%g /ai%&e%a%ce i%'&r(c&io%':

"F13

All '(7''&e/' pro,i.e. !ai%&e%a%ce a%. opera&io% /a%(al' of ,e%.or e(ip/e%&4

"F1"

A co/pre-e%'i,e l(7rica&io% li'& a%. reco//e%.e. l(7rica&io% 'c-e.(le

"F15

A co/pre-e%'i,e reco//e%.e. /ai%&e%a%ce reg(lar reco//e%.e. i%'pec&io% i%&er,al' 6ear poi%&' reco//e%.e. 'pare par&' li'&4

"F1F

S(pplier '-all '(ppl ++++++ Copie' of Opera&io% I%'&alla&io% !ai%&e%a%ce a%. .eco//i''io%i%g /a%(al'



JETT

BIOREACTOR "F1K

Page 2" of 30 Doc ID: BIOREACTOR URS A1 April 2005

Acce''i7ili& for opera&io% a%. /ai%&e%a%ce per'o%%el

).#LIFECYCLE )."

Develop5e6t

If GG is to be applied to the e%uipment being ac%uired, it should be referenced in this section of the document. 511 T-e S(pplier '-all pro,i.e a (ali& a%. Pro8ec& Pla% a' par& of &-eir propo'al T-e S(pplier '-all -a,e a (ali& ''&e/ i% place I%&er%al (ali& proce.(re' '-all 7e a,aila7le for &-e U'er;' re,ie6 512 T-e S(pplier '-all pro,i.e a Pro8ec& !a%ager for &-e pro8ec& &o pro,i.e a 'i%gle co//(%ica&io% poi%& 6i&- &-e U'er 513 T-e pro8ec& '-all (&ili
Te7t86;

)escribe the upplier testing re%uirements. Reference the =alidation est Plan, Factor cceptance est, special tests, etc. his section should also include re%uired amount of demonstrated run time, an special materials necessar to complete testing, integration testing, etc. 521 I% or.er &o ,erif ''&e/ perfor/a%ce &-e U'er '-all 6i&%e'' &-e e?ec(&io% of &-e ac&or Accep&a%ce Te'& proce.(re' T-e S(pplier '-all %o&if &-e U'er +++++++ 6ee9' i% a.,a%ce of &-e '&ar& of &-i' &e'& 522 T-e ac&or Accep&a%ce Te'& Specifica&io% '-all 7e '(7/i&&e. &o &-e U'er for re,ie6 a%. appro,al prior &o e?ec(&io% A /i%i/(/ of +++++++ 6ee9' '-all 7e allo6e. for &-e U'er &o re,ie6 a%. &o co//e%& a%.#or appro,e &-e ac&or Accep&a%ce Te'& Specifica&io% 523 T-e U'er '-all %o&if &-e S(pplier of &-e le%g&- of r(%' re(ire. 'pecial /a&erial' re(ire. a%. a% o&-er (%i(e &e'& re(ire/e%&' +++++++ 6ee9' i% a.,a%ce of &-e '&ar& of &e'&i%g Refer &o &-e E(ip/e%& ali.a&io% Pla% for applica7le proce.(re' ).*

Del8ve1

he "ioreactor, with all options, e%uipment, and the documentation listed below, shall be delivered to the 'serHs receiving doc#. 531 Doc(/e%&a&io% 5311

I%'&alla&io% opera&io% a%. /ai%&e%a%ce i%'&r(c&io% .oc(/e%&a&io% for &-e ''&e/ '-all 7e .e,elope. &o a le,el &-a& i' co/pre-e%'i7le &o a -ig- 'c-ool gra.(a&e

5312

T-e S(pplier '-all ('e &-e for/a&' .e'cri7e. i% &-e $A!P



JETT

BIOREACTOR


S(pplier $(i.e C(rre%& er'io% &o pro.(ce &-e .oc(/e%&a&io% T-e S(pplier '-all pro,i.e &-e .oc(/e%&a&io% for preli/i%ar re,ie6 T-e S(pplier '-all pro,i.e .oc(/e%&a&io% reflec&i%g =a' 7(il&> co%.i&io% 6i&- fi%al .eli,er 5313

All fi%al .oc(/e%&' '-all 7e '-ippe. 6i&- &ra%'/i&&al' &-a& i.e%&if &-e/ a' co%&rac&(all re(ire. .oc(/e%&' All fi%al .oc(/e%&' a%. .ra6i%g' '-all reflec& =a'7(il&> co%.i&io%

531"

All .oc(/e%&' '-all i% &-e la%g(age of &-e .e'&i%a&io% co(%&r a%. '(pplie. 6i&- -ar. copie' a%. elec&ro%ic ,er'io%' '(pplie. i% &-e for/a& i.e%&ifie. for eac- .oc(/e%&:

•

Pro8ec& Pla%

!icro'of& or. 2002 .oc4

•

U'er Re(ire/e%&' Specifica&io%

!icro'of& or. 2002 .oc4

•

(%c&io%al Specifica&io%#Re(ire/e%&

!icro'of& or. 2002 .oc4

•

De'ig% Specifica&io%'

!icro'of& or. 2002 .oc4

•

Co%&rol' Te'&

!icro'of& or. 2002 .oc4

•

@ar.6are I%'&alla&io% Te'&

!icro'of& or. 2002 .oc4

•

Opera&io%al Te'&

!icro'of& or. 2002 .oc4

•

ac&or Accep&a%ce Te'&

!icro'of& or. 2002 .oc4

•

Opera&or !ai%&e%a%ce a%. Ser,ice !a%(al'

!icro'of& or. 2002 .oc4

•

Proce'' a%. I%'&r(/e%&a&io% Diagra/ PVID4

•

I%'&r(/e%& )i'&i%g

•

Co%&rol Sc-e/a&ic'

A(&oCAD ,er'io% 2002 .?f4

•

Co%&rol Pa%el A''e/7l Dra6i%g'

A(&oCAD ,er'io% 2002 .?f4

•

E(ip/e%& A''e/7l Dra6i%g'

A(&oCAD ,er'io% 2002 .?f4

•

Bill of !a&erial'

!icro'of& or. 2002 .oc4 or E?cel 2002 ?l'4

•

Spare Par&' )i'&


•

Co/po%e%& C(& S-ee&'


•

CONTRO) P)ATOR! Progra/ Pri%&o(& a%. Di'9 ile

 Progra/ De,elop/e%& for/a&

•

OIP Co%fig(ra&io% Pri%&o(& a%. Di'9 ile

 Progra/ De,elop/e%& for/a&

A(&oCAD ,er'io% 2002 .?f4 !icro'of& or. 2002 .oc4 or E?cel 2002 ?l'4



JETT

).&

BIOREACTOR

Page 2F of 30 Doc ID: BIOREACTOR URS A1 April 2005

S4ppo1t

)escribe what support activities are re%uired after acceptance. he paragraphs outlined below provide some areas for consideration. 5"1

S&ar&(p S(ppor& li'& a,aila7le op&io%'4 5"11 Trai%i%g li'& &rai%i%g op&io%' a,aila7le4

5"2

Po'& S&ar&(p S(ppor& li'& po'&'&ar&(p '(ppor& a,aila7le4 5"21 Tec-%ical S(ppor& 5"211

Telep-o%e oice or !o.e/4

5"212 Replace/e%& Par&' A,aila7ili& )i'& Nor/al lea. &i/e' '-all 7e li'&e.4 5"22 U'er Si&e S(ppor& 5"221

Pre,e%&a&i,e !ai%&e%a%ce li'& /ai%&e%a%ce co%&rac&' a,aila7le4

5"222

S'&e/ I/pro,e/e%&' '(pplier '-all %o&if ('er of a% i/pro,e/e%&' a,aila7le o% a reg(lar 7a'i'4



JETT

BIOREACTOR

Page 2K of 30 Doc ID: BIOREACTOR URS A1 April 2005

+.#/LOSSARY If %ece''ar a&&ac- a glo''ar 6-ic- i%cl(.e' .efi%i&io%' of &er/' &-a& /a 7e (%fa/iliar &o &-e S(pplier or &er/i%olog &-a& /a -a,e /ea%i%g' 'pecific &o e%&rie' o% &-i' U'er Re(ire/e%&' C-ec9 '-ee& or e?a/ple e2ample list is not intended to be complete4: A31o65 °C

CR .B E!I f&

De@868t8o6

Degree' Cel'i(' Co.e of e.eral Reg(la&io%' Deci7el' Elec&ro!ag%e&ic I%&erfere%ce ee&

$UI @AC ISO

$rap-ic U'er I%&erface @ea&i%g e%&ila&io% a%. Air Co%.i&io%i%g I%&er%a&io%al Orga%i
JETT

Joi%& E(ip/e%& Tra%'i&io% Tea/

)E)

)o6er E?plo'io% )i/i&

NEC

Na&io%al Elec&ric Co.e

OIT

Opera&or I%&erface Ter/i%al

RI

Ra.io re(e%c I%&erfere%ce

URS

U'er Re(ire/e%& Specifica&io%



JETT

BIOREACTOR

Page 2 of 30 Doc ID: BIOREACTOR URS A1 April 2005

-.#REFERENCES )i'& refere%ce' &-a& 6ere ('e. i% prepari%g &-i' .oc(/e%& or &-a& pro,i.e a..i&io%al .e&ail' '(c- a': K1 E(ip/e%& ali.a&io% Pla% K2 C(rre%& re,i'io% of $A!P $(i.eli%e' K3 e%.or Pipi%g Cer&ifica&io% if applica7le4 K" C('&o/er Co%%ec&io% Diagra/ K5 Appro,e. I%'&r(/e%&a&io% )i'& KF Proce'' lo6 Diagra/ KK 21 CR Par& 11 K Na&io%al Elec&ric Co.e KM S



JETT

BIOREACTOR

Page 2M of 30 Doc ID: BIOREACTOR URS A1 April 2005

,.#APPROVAL Insert our companHs standard approval page at the appropriate position in the document or utili7e the sample approvals listed below. he approval process/re%uirements should be outlined in the +%uipment =alidation Plan. T-i' .oc(/e%& -a' 7ee% re,ie6e. 7 &-e U'er Pro8ec& !a%ager a%. appro,e. for ('e 7 &-e S(pplier

P186tedTped Na5e

S8;6at41e

Date

T-i' .oc(/e%& -a' 7ee% re,ie6e. 7 &-e U'er (ali& A''(ra%ce $ro(p a%. appro,e. for ('e 7 &-e S(pplier


S8;6at41e

Date

T-i' .oc(/e%& -a' 7ee% re,ie6e. 7 &-e S(pplier Pro8ec& !a%ager a%. appro,e. for ('e 7 &-e S(pplier Pro8ec& Tea/


S8;6at41e

Date

O&-er appro,al' a' %ece''ar /a 7e i%cl(.e. '(c- a' &-e Tec-%ical Ser,ice' $ro(p' U'er $ro(p' E%gi%eeri%g e&c a' re(ire.


Bioreactor_URS_A1.doc

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