Barrier Isolat or URS Urs

7/25/2019 Barrier Isolat or URS Urs

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JETTUSER REQUIREMENTS

SPECIFICATION

Barrier Isolator and HVAC System

Page 1 of 34

Doc ID: Barrier

Isolator_US_!

November 26, 2002

USERREQUIREMENTSTEMPLATE

for a BARRIER ISOLATOR AND !AC S"STEM

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Isolator_US_!

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RE!ISION ISTOR"

Rev# Da$e A%%rova& Rev'('o) S*mmar+

A1 11*!+*!1 T# Pe$ro Draft

A) !1*1,*!) T# Pe$ro Incor-orated content and c.anges from re/ie0 y "&%%

rea2ot gro- on 11*1,*!15

B1 3*1*!) M Ca(e+ Validation re/ie0

C1 11*)!*!) M R'vera 6ormat e/ie0

C) 11*)+*!) T# Pe$ro 6inal re/ie0 of content and format y at.or

! 11*)+*!) T# Pe$ro A--ro/ed for Initial elease

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SPECIFICATION


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Doc ID: Barrier

Isolator_US_!

November 26, 2002

TABLEOFCONTENTS

#0 INTRODUCTION##############################################################################################-

2#0 O!ER!IE.########################################################################################################-

/#0 OPERATIONAL REQUIREMENTS###############################################################6

/# CAPACIT"555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555+

/#2 PROCESSREQUIREMENTS5555555555555555555555555555555555555555555555555555555555555555555555555555555+

/#/ PROCESSCONTROL55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555+

/# FUNCTIONS55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555557

/#- DATAANDSECURIT"5555555555555555555555555555555555555555555555555555555555555555555555555555555555555558

/#6 EN!IRONMENT5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555511

#0 CONSTRAINTS###############################################################################################

# MILESTONESANDTIMELINES5555555555555555555555555555555555555555555555555555555555555555555555514

#2 EQUIPMENTCONSTRAINTS5555555555555555555555555555555555555555555555555555555555555555555555555551,

#/ COMPATIBILIT"ANDSUPPORT5555555555555555555555555555555555555555555555555555555555555555555551,

# A!AILABILIT"55555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555517

#- PROCEDURALCONSTRAINTS555555555555555555555555555555555555555555555555555555555555555555555555517

#6 MAINTENANCE5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555518

-#0 LIFE1C"CLE####################################################################################################

-# DE!ELOPMENT5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555518

-#2 TESTIN3555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555518

-#/ DELI!ER"5555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555)!-# SUPPORT555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555555)1

6#0 3LOSSAR"######################################################################################################22

4#0 REFERENCES#################################################################################################2/

5#0 APPRO!AL#######################################################################################################2

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SPECIFICATION


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Doc ID: Barrier

Isolator_US_!

November 26, 2002

Proe7$ No#8

Insert t.e ni9e -roect nmer associated 0it. t.is -articlar US5

Do7*me)$ No#8

Insert t.e Docment Identification $mer and e/ision5

Do7*me)$ De(7r'%$'o)8

Insert descri-tion of docment; e5g5 PU& S%&A(


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SPECIFICATION


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Isolator_US_!

November 26, 2002

re!uired by the e!uipment and products. The environment inside the barrierisolator is controlled in a manner to allow the pharmaceutical product to be

processed in accordance with the purpose and product re!uirements.

".# $S%

The e!uipment shall be used primarily for&

Continuous 'roduction

Batch 'roduction

(ther

"." %)$I'*%+T CASSI-ICATI(+-or eample&-or providin an aseptic environment for&

i!uid fillin of vials with stoppers

'owder fillin of vials with stoppers

i!uid fillin of ampoules with flame/off

i!uid fillin of cartrides with plus

i!uid fillin of syrines

(ther 0define1

Insert your Equipment Classifications here as required using the aboveexample as a guide.

".2 C%A+I+3 4%)$I4%*%+TS

5ipedown

*anual 5ashdown

Clean/In/'lace 0CI'1

Special 4e!uirements&

6 'eracetic Acid

6 %thylene (ide6 Chlorine 7ioide6 Vapori8ed Hydroen 'eroide6 (thers

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".9 A+3$A3% 4%)$I4%*%+TS

%nlish

(ther 0Specify1& ::::::::::::::::::::

Bilinual;


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Isolator_US_!

November 26, 2002

35)5) Barrier Isolator Design

The barrier isolator desin will meet current 3*' for aseptic productmanufacture, alon with wash down and saniti8ation re!uirements.

#. All interior corners will have a minimum of ::>.?@: radius.

". 7rain pans will have a minimum of ::>.?@:: slope per #"@ of run.

2. Hori8ontal surfaces will be minimi8ed to resist poolin. 'oolin ofmore than ::?ml:: of li!uid is not allowed. 'ooled li!uid must notbe more than ::"mm:: deep

9. 7rain pans shall terminate in tan bottom drain valves withmaterials and finish e!uivalent to the rest of the barrier isolatorinterior.

?. Air distribution from the plenum will use ::dual perforatedplates::.

. The air distribution system will be removable for cleanin.

2.".".# Safety of the operator from the machinery or processes within thebarrier isolator must be ensured.

. All doors will have dual/redundant safety switches that willimmediately stop all machinery or processes when the door isopened.

D. 3loveports will be uarded with liht curtains to immediately stopmachinery.

E. All movin machinery eternal to the barrier isolator will be fullyuarded and alarmed.

#>. All hih temperature components eternal to the barrier isolator willbe fully uarded and alarmed.

2."."." *aterials and -inish of the Barrier Isolator will meet current 3*'Fs.

#. 5all thicness of the barrier isolator will be a minimum of::aue: Stainless Steel

". Interior surfaces of the barrier isolator will be manufactured from::2#:::::::: Stainless Steel.

2. %terior surfaces of the barrier isolator and ductwor will bemanufactured from ::2>9 or2#::: Stainless Steel.

9. Interior finish of the barrier isolator will be of :::::::9>: micro/inch 4a finish maimum.

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?. %terior finish of the barrier isolator will be of ::::::#">: micro/inch 4a finish maimum.

. All interior surfaces will be electro/polished redundant; How elsedo you et G9 and G?;.

. All welds will be round and polished to the above finishre!uirements.

D. Air plenums must meet the same materials and finish re!uirementsas the barrier isolator.

E. The completed interior of the barrier isolator will be passivatedprior to shipment to the site.

#>. Components attached to the eterior of the barrier isolator mustmeet current 3*'Fs and be finished to resist corrosion.

2.".".2 7oors and 5indows in the barrier isolator allow visibility and access tothe interior.

#. The window material is manufactured from ::tempered safetylass or polycarbonate::.

". The window sealin material is etruded from ::silicone rubber::.

2. 5indow seals must be desined to prevent poolin.

9. 7oors must hine open to allow access to the interior.

?. 7oors must be removable without tools.

2.".".9 *ousehole (penin0s1 are provided at the eit point to allow the eit ofood vials and of reect vials.

#. *ousehole covers are manufactured to the same re!uirements asthe barrier Isolator.

". *ousehole cover presence is to be sensed and alarmed.

2.".".? 3loveports are provided in the barrier isolator to allow operator accessto the interior without compromisin sterility.

#. 3loves must be replaceable.

". 3loves must be saniti8ed without absorbin sterilant.

2. 3loves will be made from ::fabric reinforced 'VC::.

9. 3loves will be located to access common intervention points.

?. 3loves will be positioned to allow access by operators within thenormal rane of physical si8es.

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Doc ID: Barrier

Isolator_US_!

November 26, 2002

2.".". Transfer 'orts will be provided to allow component and product entryinto the interior of the barrier isolator without compromisin sterility.

#. Transfer ports will be located at the followin locations, and are ofthe followin si8es&ocation G#& :::upstream of filler:: ::2?>mm::ocation G"& :::at stopper entry:::: ::">mm::ocation G2& :::at outfeed:::::::: ::">mm::ocation G9& :::+=A:::::::::::: ::::::::::

". Transfer port manufacture is :::::::::::::::::::::

2. Transfer port saniti8ation process is :::::::::::::::

2.".". Commodity='roduct Infeed to the interior of the barrier isolator will be

provided in the desin.##. Vials enter the barrier isolator from a ::depyroenationtunnel::.

#". 'roduct enters the barrier isolator throuh a ::bulheadfittin::.

#2. Stoppers enter the barrier isolator throuh ::transfer portG"::::.

#9. *iscellaneous 7evices such as&::tools, S*A stands, haners,platforms, instrumentation, test ports, etc.:::

2.".".D 'roduct %it from the interior of the barrier isolator will be provided inthe desin.

#?. Vial path G# transfers vials to a ::flat belt conveyor::.

#. Vial path G" transfers vials to a ::""@ transfer dis::.

#. 7rains in the bottom of the barrier isolator are provided at:::: points to allow for li!uids to be removed durin chaneoverand saniti8ation.

#D. 7rains must be closed durin production.

35)53 HVAC System Operation

The HVAC system controls the environment inside the isolator, and providesthe followin functions&

'ressure differential between the interior and eterior of the isolator

Temperature control of the interior

Humidity Control of the interior

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Doc ID: Barrier

Isolator_US_!

November 26, 2002

Air Circulation throuh the interior

H%'A=$'A filtration of the interior air

Sanitation of the barrier isolator and the e!uipment This seems

incorrect, it may maintain sanitation but not induce it.

35)5351 'ressure 7ifferentialbetween the interior and eterior is maintained atpositive >.#>@H"(, =/ >.>"@H"(. 'ressure balance is to bemaintained within these parameters under all conditions of&

#E. 'roduct infeed doors open or closed

">. 'roduct enterin or not enterin

"#. %it door open or closed

"". 'roduct eitin or not eitin

"2. *ultiple withdrawals of love ports

"9. Transition of transfer ports

"?. -luctuation of outside environment within tolerance

35)535) Temperature Control is maintained at =/ #.>Cof setpoint within the full

temperature control rane of ?.> Cminimum to ?>Cmaimum.

Temperature control is to be maintained within these parameters underall conditions of&

#. Beinnin of the batch". on term continuous run of the batch

2. -luctuation of outside environment within tolerance

35)5353 Humidity Control durin production is maintained at =/ #.>C dew point

within the full humidity rane of ?.> Cminimum to "?Cmaimum. The

system is desined to only lower the dew point. There are noprovisions to raise the dew point above that of the ambientenvironment. Humidity control is to be maintained within these

parameters under all conditions.

9. 7ryin of the barrier isolator after cleanin

?. Beinnin of the batch

. on term continuous run of the batch

. -luctuation of outside environment with tolerance

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Doc ID: Barrier

Isolator_US_!

November 26, 2002

35)5354Air Circulation is provided by a variable speed fan circulatin the airthrouh heatin, coolin, dehumidification, and filter systems. The air

is forced into the barrier isolator throuh a perforated plate to dispersethe air throuhout the interior uniformly. Air is then returned from theinterior throuh the return air ducts. Airflow is measured #" inchesbelow the perforated plates, and must be between ?> feet per secondminimum to E> feet per secondmaimum. Air circulation levels are tobe maintained within these levels under all conditions.

D. Saniti8in cycle of the barrier isolator

E. Beinnin of the batch

#>. on term continuous run of the batch

##. -luctuation of outside environment with tolerance

35)535, H%'A=$'A filtration of the recirculated air is provided by two pairs offilters in series. The filters are EE.EEJefficient at removin particlesreater than >.2 micronsin si8e. The fresh air inlet uses a rouhinfilter and a E>J efficient ASH4A% filterprior to the H%'A=$'A filters.4ecirculated air filtration at all times that the HVAC fan is operatin0frament1.

2.".2. Saniti8ation of the Barrier is provided by the followin processes&

#". The interior of the barrier isolator is manually=automatically cleaned

out of any debris from the previous production. All areas of theinterior that can accumulate debris must be accessible to allow forremoval of debris.

#2. The interior surfaces of the barrier isolator are able to be wipeddown by cleanin personnel easily and efficiently without daner tothe personnel or damae to the materials.

#9. The interior of the barrier isolator can be washed down withcleanin aents and water without poolin or deterioration of theinterior surfaces.

#?. The interior surfaces of the barrier isolator are drainable withoutecessive poolin to allow rapid dryin of the interior.

#. Cleanin aents are introduced by inection into the HVAC systemthrouh a port in the ductwor after the filters.

#. The interior surfaces of the barrier isolator can be saniti8ed by::::::::::::::: cleanin aents without damae to thesurfaces of the barrier isolator.

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Doc ID: Barrier

Isolator_US_!

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#D. All interior surfaces of the barrier isolator are reached by thesaniti8ation aents.

3.2.4 Power Failure and Reo!ery

(n power failure, the system shall fail into a Ksafe state.@ (n power restoration,the system shall not restart without operator or communication/lin input.

Insert your specific power failure / recovery scheme here. For example:In the event of a power failure, the system shall protect in the followinpriority&

'ersonnel

%!uipment 'roduct

4ecovery *ethods&Insert your specific recovery scheme here. For example:

*anually re/start based on operator inputs. 0(perator initiates power

recovery se!uence1

4e/start based on last state before loss of power. 0System runs

throuh power recovery se!uence when operator start sinal isiven1

If there is an automatic batch reportin system, the information shallbe retained in the event of a power failure 0A $'S is re!uired forautomatic batch reportin systems for data retention1.

3.2.5 Emergency Stop

Insert your specific E!top strategy and communication scheme here. Forexample:The system shall have an %/Stop system desined to shut down allenvironmental controls in a safe manner. The %/Stop will be Hard/wired into thefiller %/Stop system so that all machinery within the barrier=isolator will stoppimmediately upon actuation of any %/Stop button. 7etermine if the HVAC fan

will also stop under an emerency stop. The %/Stop button0s1 shall be locatedin easily accessible areas around the e!uipment as re!uired by local safetystandards.

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Isolator_US_!

November 26, 2002

3.2." Alarms And #arnin$s

Insert your "larm scheme here. For example:

2."..# KCritical alarms@ shall tae action automatically to shut the e!uipmentdown and notify the operator. The operator shall be re!uired toacnowlede the alarm before the alarm can be reset and the systemrestarted. (nce the alarm is reset, the operator may restart thesystem.

2.".." K+on/Critical alarms@ shall tae action to shut the e!uipment down atthe end of the cycle, and notify the operator once stopped. The

operator shall be re!uired to acnowlede the alarm before the alarmcan be reset and the system restarted. (nce the alarm is reset, theoperator may restart the system.

2."..2 K(perator Alert@ shall notify the operator and tae no further action.+on/Critical warnins and shall sound the alarm horn, illuminate thealarm indicator but allow the system to continue to operate. Theoperator shall be re!uired to acnowlede the warnin in order tosilence the alarm horn, and the alarm indicator shall be etinuishedwhen the warnin condition disappears.

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Isolator_US_!

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The %!uipment shall have the followin alarms and warnins&

Alarm or Warning Critical Non-Critical

%merency Stop X

Control 'latform Communication 5atchdoX

Control 'ower -ault X

Barrier 7oor (pen X

3love 'ort iht Curtain Interrupted X

*ousehole Cover (pen X

*ousehole Cover Closed X

7rain Valve -ailed to (pen X

7rain Valve -ailed to Close X

iht Curtain Contamination -ault X

4ecirculation -an -ailed to Start X

-ilter 7ifferential 'ressure Alarm X

Barrier Hih 'ressure Alarm X

Barrier ow 'ressure Alarm X

Barrier 7ifferential pressure alarm X

'C Battery ow X

(ther Alarms as 4e!uired

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Isolator_US_!

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2.2 7ATA A+7 S%C$4ITes-o2e? code

0it.in t.e e9i-ment; and s.all s--ly licensing of t.e cstomcode for t.e life of t.e e9i-ment5

An escro0 agreement s.all e re9ired in t.e e/ent t.e s--lier

cannot s--ort t.e s--lied cstom soft0are any longer5 In sc.

instances; t.e sorce code and all information regarding t.e sorcecode s.all e gi/en to t.e ser in a timely fas.ion to -re/ent

do0ntime of t.e e9i-ment5

45)5) Preferred Vendor ist

If necessary attac. any critical -referred /endors5 efrain fromdri/ing t.e s--lier into cstomiing .is e9i-ment -ac2age5

If t.e /endor 0is.es to de/iate from t.e Preferred Instrmentation

ist; a listing of t.e -ro-osed com-onents and instrmentation s

/endors indicating ty-e and model nmers s.all e smitted0it. t.e 9otation; along 0it. an e=-lanation of 0.y t.e de/iation

is recommended5

45)53 Utilities

%.e tilities and s-ace in/ol/ed needs to e discssed -rior to

-rc.asing t.e e9i-ment5 #/iosly; t.e actal e9i-ment sie ist a small -art of t.e entire sco-e of 0or2 necessary to im-lement

a larger system5 %.e nit and its s--ort e9i-ment mst e ale to

e installed in crrent ilding facilities5

%.e User s.all ensre t.at t.e follo0ing tilities are a/ailale andt.at t.e tility s--ly lines and -i-ing are terminated 0it. fittings

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Isolator_US_!

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or connections; 0.ic. are com-atile 0it. t.ose descried on t.e

Cstomer Connection Dra0ings5

%.e S--lier s.all s-ecify tility data; 0.ic. is mar2ed 0it. a

triangle5 Utility data; 0.ic. are not s-ecified or mar2ed 0it. atriangle; s.all e rog.t to t.e attention of t.e User5 %.ese data

s.all e s-ecified Ey t.e User or t.e S--lierF and s.all e

a--ro/ed y ot. t.e User and t.e S--lier efore system design

egins5

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Isolator_US_!

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Base +tilities Wor,s"eet

Electricity:::::: VAC :::: Hert8

Sinle 'hase

Three 'hase

$ninterruptible 'ower Supply 4e!uired; 'SI3constant air pressure for all e!uipment unless specified.

C"ille% Water

:::::::: 3'H, :::::::: 'SI3, ::::::::C Closed loop with

supply and return connections. 0can be provided with additives forcorrosion resistance if re!uired by the facility, not sanitary1

res" Air Inlet:::::::: inch diameter air inlet. 0can enter from technical area1Temperature of inlet air must be within the same rane as re!uired of themachinery.

E/"a#st Air:::::::: inch diameter air ehaust port. 0'rovisions must be made fortreatment of ehausted air dependin on the product and=or sterilant beinused in the system.1

Sanitary Water

:::::::: 3'H, ::::::::: 'SI3, ::::::::C 0$sed for wash down

0CI'1 of the interior of the barrier isolator1

Sterilant

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7efine the method of saniti8ation, the delivery system, and the rate si8edfor the interior volume of the barrier isolator. +ot normally supplied as a

direct connect utility system.

0AC Drain:::::::: inch diameter 0for drainin condensate from the coolin coils ofthe HVAC system1

Barrier Isolator Drain:::::::: inch diameter )uantity of ::::::: drains at various locationsthrouhout the barrier isolator. Tan bottom welded valves that areinstalled with the same specifications as the tan bottoms 0redundant

sentence1.

(ther utility re!uirements shall be discussed as needed.

#/ Ava'&ab'&'$+

%.e Gequipment/system is intended to e o-erated Gontinuously,

!egularly, "" hours per day, "" hours per wee#5

#-eration of t.e Gequipment/system s.all e ss-ended; and t.e system

s.all e a/ailale for -re/entati/e maintenance or rotine ser/ice G""hours per wee#, "" continuous hours per wee#, "" days per month, ""

wee#s per year5

# Pro7e9*ra& Co)($ra')$(

45451 Prodct Contact (aterials

Descrie any local -rocedral re9irements sc. as localstandards; 0.ic. mst e ad.ered to if a--licale5

All -i-ing 0elds and -rodct contact 0elds s.all meet AS(& and

3A s-ecification re9irements5 Prodct contact metal to e E31+

Stainless Steel; 31+ Stainless Steel; 3!4 Stainless Steel; etc5F

ist critical re9irements for srface finis.; rog.ness; etc55

#t.er standards are attac.ed5 %.e S--lier s.all ad.ere to t.e

indicated sections only5

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4545) Prodct in Contact 0it. (aterials

All -rodct contact -arts s.old e considered5 %.eGe9i-ment*system 0ill e sed for Ea9eos soltions; lo0 &

Elo0er e=-losion limitF sol/ents; .ig. & sol/ents; etc5F5redndant see 3545)

.at is t.e difference et0een t.is section and 45451J

45453 $oise e/el Constraints

Insert yor o0n noise le/el constraint re9irements .ere5

6or e=am-le:

%.e noise le/el generated dring o-eration of t.eGequipment/system 0ill not e=ceed , dB from 3 feet a0ay5

45454 &(I * 6I le/els are:

Insert yor o0n electrical and radio noise immnity re9irements

.ere5

6or e=am-le:

%.e Ge9i-ment*system G0ill*0ill not e sed in an area 0.eret0o0ay radio commnication de/ices are in o-eration5 %.e

Ge9i-ment*system s.all meet C& re9irements for electrical noiseimmnity and emissions5

4545, Containment

4545,51 &=-losion Protection

%.is section is only /alid if t.e -rodct eing sed is

.ig.ly reacti/e5 Insert containment gidelines .ere Ei5e5

Bar Constrction 0it. isolation and s--ression; 1! Bar

constrction 0it. isolation only; Closedoo- $itrogen

System; etc5F5

4545+ aeling

All e9i-ment and control 0iring s.all e laeled and identified5

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#- Ma')$e)a)7e

Descrie t.e e=-ected .ard0are and soft0are maintenance s--ortinclding: ease of maintenance; e=-ansion ca-aility Esoft0are onlyF;

li2ely en.ancements Esoft0are onlyF; e=-ected lifetime and longterms--ort5

System s.all e maintained on a sc.edle as indicated y t.e s--lier5

S--lier is to -ro/ide Eat minimmF t.e follo0ing maintenanceinstrctions:

15 All ssystems -ro/ided E(aintenance and o-eration manals

of /endor e9i-mentF)5 A com-re.ensi/e lrication list and recommended lrication

sc.edle35 A com-re.ensi/e recommended maintenance Ereglar

recommended ins-ection inter/als; 0ear -oints; recommended

s-are -arts listF45 S--lier s.all s--ly ______ Co-ies of #-eration; Installation;

(aintenance and decommissioning manals

-#0LIFE1C"CLE

-# Deve&o%me)$

If S is to e a--lied to t.e e9i-ment eing ac9ired; it s.old e

referenced in t.is section of t.e docment5

%.e S--lier s.all -ro/ide a 'ality and Proect Plan as -art of t.eir

-ro-osal5 %.e S--lier s.all .a/e a 9ality system in -lace5 Internal9ality -rocedres s.all e a/ailale for t.e User@s re/ie05

%.e S--lier s.all -ro/ide a Proect (anager for t.e -roect to -ro/ide a

single commnication -oint 0it. t.e User5

%.e -roect s.all tilie t.e


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Doc ID: Barrier

Isolator_US_!

November 26, 2002

In order to /erify system -erformance; t.e User s.all 0itness t.e

e=ection of t.e 6actory Acce-tance %est -rocedres5 %.e S--lier s.all

notify t.e User _______ 0ee2s in ad/ance of t.e start of t.is test5

%.e 6actory Acce-tance %est S-ecification s.all e smitted to t.e Userfor re/ie0 and a--ro/al -rior to e=ection5 A minimm of _______

0ee2s s.all e allo0ed for t.e User to re/ie0 and to comment and*or

a--ro/e t.e 6actory Acce-tance %est S-ecification5

efer to t.e &9i-ment Validation Plan for a--licale -rocedres5

-#/ De&'ver+

%.e Ge9i-ment*system; 0it. all o-tions; e9i-ment; and t.e

docmentation listed elo0; s.all e deli/ered to t.e User@s recei/ingdoc25

,5351 Docmentation

Installation; o-eration; and maintenance instrction docmentationfor t.e system s.all e de/elo-ed to a le/el t.at is com-re.ensile

to a .ig. sc.ool gradate5

%.e S--lier s.all se t.e formats descried in t.e $A%&

'upplier $uide, urrent (ersion,to -rodce t.e docmentation5%.e S--lier s.all -ro/ide t.e docmentation for -reliminary

re/ie05 %.e S--lier s.all -ro/ide docmentation reflecting >asilt? condition 0it. final deli/ery5

All final docments s.all e s.i--ed 0it. transmittals t.at identifyt.em as contractally re9ired docments5 All final docments

and dra0ings s.all reflect >asilt? condition5

All docments s.all in t.e langage of t.e destination contry and

s--lied 0it. .ard co-ies and electronic /ersions s--lied in t.eformat identified for eac. docment:

)ser should define format for document transmission *ie. %' +ord, Autocad, etc.

-elow is an example:

Proect Plan (icrosoft ord 87 EK5docF

User e9irements S-ecification (icrosoft ord 87 EK5docF

6nctional S-ecification*e9irements (icrosoft ord 87 EK5docF

Design S-ecifications (icrosoft ord 87 EK5docF

"#I$% &'UIP(&$% %A$SI%I#$ %&A(


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SPECIFICATION


Page 3! of 34

Doc ID: Barrier

Isolator_US_!

November 26, 2002

Controls %est (icrosoft ord 87 EK5docF

Hard0are Installation %est (icrosoft ord 87 EK5docF

#-erational %est (icrosoft ord 87 EK5docF

6actory Acce-tance %est (icrosoft ord 87 EK5docF

#-erator; (aintenance and Ser/ice (anals (icrosoft ord 87 EK5docF

Process and Instrmentation Diagram EPLIDF AtoCAD /ersion 1)5! EK5d=fF

Instrment isting (icrosoft ord 87 EK5docF or &=cel 87 EK5=lsF

Control Sc.ematics AtoCAD /ersion 1)5! EK5d=fF

Control Panel Assemly Dra0ings AtoCAD /ersion 1)5! EK5d=fF&9i-ment Assemly Dra0ings AtoCAD /ersion 1)5! EK5d=fF

Bill of (aterials (icrosoft ord 87 EK5docF or &=cel 87 EK5=lsF

S-are Parts ist (icrosoft ord 87 EK5docF or &=cel 87 EK5=lsF

Com-onent Ct S.eets (icrosoft ord 87 EK5docF or &=cel 87 EK5=lsF

C#$%# PA%6#( Program

Printot and Dis2 6ile MMM Program De/elo-ment format

#IP Configration Printot and Dis2 6ile MMM Program De/elo-ment format

-# S*%%or$

Descrie 0.at s--ort acti/ities are re9ired after acce-tance5 %.e

-aragra-.s otlined elo0 -ro/ide some areas for consideration5

,5451 Start- S--ort Elist a/ailale o-tionsF

,545151 %raining Elist training o-tions a/ailaleF

,545) Post Start- S--ort Elist -oststart- s--ort a/ailaleF

,545)51 %ec.nical S--ort

%ele-.one EVoice or (odemF

e-lacement Parts A/ailaility ist E$ormal lead times

s.all e listedF

"#I$% &'UIP(&$% %A$SI%I#$ %&A(


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SPECIFICATION


Page 31 of 34

Doc ID: Barrier

Isolator_US_!

November 26, 2002

,545)5) User Site S--ort

Pre/entati/e (aintenance Elist maintenance contractsa/ailaleF

System Im-ro/ements Es--lier s.all notify ser of any

im-ro/ements a/ailale on a reglar asisF

"#I$% &'UIP(&$% %A$SI%I#$ %&A(


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SPECIFICATION


Page 3) of 34

Doc ID: Barrier

Isolator_US_!

November 26, 2002

6#03LOSSAR"

If necessary; attac. a glossary; 0.ic. incldes definitions of terms t.at may e

nfamiliar to t.e S--lier or terminology t.at may .a/e meanings s-ecific to

entries on t.is User e9irements C.ec2 s.eet5

6or e=am-le Eexample list is not intended to be completeF:

A7ro)+m Def')'$'o)

C Degrees Celsis

B Bio.aard e/el

C6 Code of 6ederal eglations

dB Deciels

&(I &lectro(agnetic Interference

ft 6eet


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SPECIFICATION


Page 33 of 34

Doc ID: Barrier

Isolator_US_!

November 26, 2002

4#0REFERENCES

ist references t.at 0ere sed in -re-aring t.is docment or t.at -ro/ide

additional details; sc. as:

o &9i-ment Validation Plan

o Crrent re/ision of


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SPECIFICATION


Page 34 of 34

Doc ID: Barrier

Isolator_US_!

November 26, 2002

5#0APPRO!AL

Insert your companys standard approal page at the appropriate position in the

document or utili0e the sample approals listed below. 1he approal

process/requirements should be outlined in the 2quipment (alidation &lan.

%.is docment .as een re/ie0ed y t.e User Proect (anager and a--ro/ed for se y t.e

S--lier5

Pr')$e9T+%e9 Name S':)a$*re Da$e

%.is docment .as een re/ie0ed y t.e User 'ality Assrance

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