URS Barrier Isolator v0904

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CL Tech.

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USER REQUIREMENTS

SPECIFICATION

Barrier Isolator and HVAC System

Page 1 of 33

Doc ID: Barrier

Isolator_URS_

November 26, 2002

USER R EQUIREMENTS TEMPLATE

for !ARRIER ISOLATOR AN" #$AC S%STEM

RE$ISION #ISTOR%

Rev. "&e A''rov( Rev)*)on S+mmr

A1 11!"!1 T. Pe&ro Draft

A# 1!1$!# T. Pe&ro Incor%orated content and c&anges from re'ie( )y *+,,

)rea-.o/t gro/% on 11!1$!10

B1 3!1!# M C*e Validation re'ie(

C1 11!#!# M R)ver ormat Re'ie(

C# 11!#"!# T. Pe&ro inal re'ie( of content and format )y a/t&or

11!#"!# T. Pe&ro A%%ro'ed for Initial Release

,o &a'e any doc/ment %re%ared2 contact C ,ec&0 Inc0 )y emailing info45/alityleader0com or 'isiting

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Doc ID: Barrier

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TA!LE OF CONTENTS

-.0 INTRO"UCTION..............................................................................................

2.0 O$ER$IE/........................................................................................................

.0 OPERATIONAL REQUIREMENTS...............................................................6

.- CAPACIT%000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000"

.2 PROCESS R EQUIREMENTS0000000000000000000000000000000000000000000000000000000000000000000000000000000"

. PROCESS CONTROL00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000"

.1 FUNCTIONS00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000006

. "ATA AN" SECURIT%0000000000000000000000000000000000000000000000000000000000000000000000000000000000000007

.6 EN$IRONMENT0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000011

1.0 CONSTRAINTS...............................................................................................-1

1.- MILESTONES AN" TIMELINES0000000000000000000000000000000000000000000000000000000000000000000000018

1.2 EQUIPMENT CONSTRAINTS0000000000000000000000000000000000000000000000000000000000000000000000000001$

1. COMPATI!ILIT% AN" SUPPORT0000000000000000000000000000000000000000000000000000000000000000000001$

1.1 A$AILA!ILIT%00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000016

1. PROCE"URAL CONSTRAINTS000000000000000000000000000000000000000000000000000000000000000000000000016

1.6 MAINTENANCE0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000017

.0 LIFEC%CLE....................................................................................................-3

.- "E$ELOPMENT0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000017

.2 TESTIN4000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000017

. "ELI$ER%0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000#.1 SUPPORT000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000#1

6.0 4LOSSAR%......................................................................................................22

5.0 REFERENCES.................................................................................................2

.0 APPRO$AL.......................................................................................................21















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Doc ID: Barrier

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November 26, 2002

Pro7ec& No.8

Insert t&e /ni5/e %ro9ect n/m)er associated (it& t&is %artic/lar URS0

"oc+men& No.8

Insert t&e Doc/ment Identification /m)er and Re'ision0

"oc+men& "e*cr)'&)on8

Insert descri%tion of doc/ment2 e0g0 PUR+ S,+A; <++RA,=R2 +>am%le User

Re5/irements S%ecification0

-.0INTRO"UCTION

Note: Insert your own description and introduction. You may wish to include

your own requirements and specifics to allow the inexperienced reader,contractors, and suppliers adequate explanation to understand the scope of the

equipment.

Descri)e (&o %rod/ced t&e doc/ment2 /nder (&at a/t&ority2 and for (&at %/r%ose0

Descri)e t&e contract/al stat/s of t&e doc/ment0 Incl/de or reference as an

attac&ment t&e ?legal@ %aragra%& t&at comm/nicates %/rc&asing terms and

conditions in t&is section0

Descri)e t&e relations&i% of t&is doc/ment to ot&er doc/ments0 ,&is isim%ortant for e5/i%ment t&at is %art of an integrated %rocess or line and (ill

&el% t&e S/%%lier to /nderstand and as- 5/estions t&at may ot&er(ise )eo'erloo-ed0

Refer to t&e +5/i%ment Validation Plan t&at o/tlines t&e S/%%liersres%onsi)ilities is attac&ed0

Remo'e any o%tions t&at are not a%%lica)le for t&is %ro9ect2 if ot&er /ses (ill

a%%ly list eac& se%arately0

,&is is to )e /tilied as a g/ide for t&e /ser to ans(er t&e ma9ority of 5/estionsin'ol'ed in s%ecifying t&e ?(&at@ for t&e e5/i%ment0 Addend/ms may )e /sed

to ro/nd o/t t&e re5/irements0

2.0O$ER$IE/

The Barrier Isolator and HVAC System provides a mechanical separationbetween the controlled room environment, and the interior environment inwhich the pharmaceutical product is processed. The barrier isolator ismanufactured in such a manner that the materials are resistant to corrosion, donot allow poolin of the cleanin materials, and allow access to the interior as















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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 (ide 6 Chlorine 7ioide 6 Vapori8ed Hydroen 'eroide 6 (thers















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Isolator_URS_

November 26, 2002

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

•%nlish

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

• Bilinual; <es = +o

.0OPERATIONAL REQUIREMENTS

301 '%4-(4*A+C% 4%)$I4%*%+TS

3.1.1 Capacity

Add capacities and details concerning equipment capacity here. Identify the type anddimensions of the equipment that will fit inside of the barrier.

2." -$+CTI(+S

The Barrier Isolator and HVAC System is divided into two main portions& Thebarrier isolator, and the HVAC system.

30#01 Barrier Isolator Operation

The barrier isolator is an enclosure that provides isolation between the

operator=outside environment and the interior of the barrier where thepharmaceutical processin is done. The barrier isolator provides the followinfunctions&

• Isolation between the operator and the process

• Safety Barrier to separate the operator from e!uipment ha8ards

• A non/corrosive, drainable, and easily cleaned enclosure.

• 7oors to provide access to the e!uipment durin cleanin and

chaneover

• 3loveports to allow access to machinery and product durin

production

• Transfer ports to introduce commodities and e!uipment to theenvironment

• Infeed openin to introduce commodities to the system.

• %it openin to allow finished commodities to eit the system.















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November 26, 2002

30#0# 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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Doc ID: Barrier

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November 26, 2002

?. %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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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.

30#03 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

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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.

30#0301 'ressure 7ifferential between 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

30#030# Temperature Control is maintained at =/ #.>°C of setpoint within the full

temperature control rane of ?.> °C minimum to ?>°C maimum.

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

30#0303 Humidity Control durin production is maintained at =/ #.>°C dew point

within the full humidity rane of ?.> °C minimum to "?°C maimum. 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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30#0308 Air Circulation is provided by a variable speed fan circulatin the airthrouh heatin, coolin, dehumidification, and filter systems. The airis 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 second minimum to E> feet per second maimum. 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

30#030$ H%'A=$'A filtration of the recirculated air is provided by two pairs offilters in series. The filters are EE.EEJ efficient at removin particlesreater than >.2 microns in si8e. The fresh air inlet uses a rouhinfilter and a E>J efficient ASH4A% filter prior to the H%'A=$'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 cleanedout 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.















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

surfaces of the barrier isolator.

#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 runsthrouh power recovery se!uence when operator start sinal isiven1

• If there is an automatic batch reportin system, the information shall

be 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 all

environmental 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 fanwill 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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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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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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2.2 7ATA A+7 S%C$4IT<

3.3.% Inter&aes

Insert your interface scheme here. For example:

The 'rorammable oic Controller = (perator/Interface 'anel system0hereafter referred to as the K'C=(I' system@1 shall include interfaces with the(perator, Supervisors, eternal e!uipment, and the $serFs control system toensure safe, reliable, continuous, and automatic operation and easy, safe, andreliable confiuration.

Access to all Input=(utput values and system status bits shall beprovided throuh a data/communication lin. Security for dataand operator access is provided by 0Chec all that apply1&

• $ser I7='assword

• Card 4eader

• Biometric 0-inerprint, eye scan, voice reconition, etc.1

3.3.2 Interace !it" S#per$isors an% &perators

Insert your interface scheme here. For example:The 'C=(I' system shall include interfaces with the (perator that ensureseasy, safe, and reliable operation.

An operator/interface panel shall be provided and mounted on the machine.This panel shall provide the necessary switches, indicators, and devices tooperate the barrier isolator HVAC system. The followin shall be displayed&

• System Status 0e.., Kstate@ the system currently is in1

• 'ressure 7ifferential

• Temperature

• Humidity

• HVAC -an Speed

• $tility Controls

• Alarms and 5arnins.

• (ther 0specify1.

2.2.".# The followin shall be accessible only to Supervisors&

Security Confiurations

Control loop variables 0i.e., K'I7 terms@1.















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Ability to force system to a different state.

Alarm setpoints.

(ther :::::::::::: 0specify1.















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3.3.3 Interace !it" &t"er E'#ipment

Insert your interface scheme here. #escribe$ define or give details where possible. For example:

The control system shall include the interfaces necessary to facilitateoperation and confiuration.

Interface to other e!uipment may include&

• 'rocessin e!uipment interior to the barrier isolator HVAC system

• Commodity infeed systems

• Commodity outfeed systems

•%terior HVAC system

• Cleanin and saniti8ation systems

• *%S or SCA7A systems

• (thers&

For example: "n %!&'& communications port shall be provided. " (odem communications port shall be provided. " highspeed configuration/monitoring connection shall be provided.

3.3.( Data Collection• +one

• 4ecorder

• 'rocess 'rintout

• %lectronic process printout, Historical Trendin

• %lectronic process printout, Historical Trendin and interface to

company networ

The followin shall be recorded&

• 7ifferential 'ressure

• Temperature

• Humidity

• 'ressure ea Test 4ates

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















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2.9 %+VI4(+*%+T

In the followin section, provide details of the physical environment in whiche!uipment will be operated.

3.(.1 )ayo#t

-or eample& Allocated floor space for the barrier isolator is ::::::: inches wide by :::::::: inches in lenth, with at least a 2 inch corridor around theperiphery for the e!uipment. Vertical clearance is ::::::::: inches.

Allocated floor space for the HVAC pacae is ::::::: inches by :::::::: inches with at least a 2 inch corridor around the periphery for

the e!uipment. Vertical clearance is ::::::::: inches.

The HVAC pacae will be&

• *ounted directly to the top of the barrier isolator.

• *ounted alon side 0at the same level1 as the barrier isolator.

• *ounted indirectly above the barrier isolator.

• (ther

See attached drawin G:::::::::::::::::::::::: 0if applicable1.

)ote: *ayout is specific to the si+e equipment being used and system

requirements of the equipment.















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3.(.2 *"ysical Con%itions

-or %ample0s1&The barrier isolator and HVAC system will be used for 0Chec all that apply,insert your e!uipment re!uirements here1&

• A!ueous

• ow % 0ower %plosion imit1 Solvents

• Hih % Solvents

• (ther

4oom Classification&

• 4oom will be non/ha8ardous 0Lone >1

• 4oom will be Class I 7iv II 0Lone #1 0eplosive atmospherepresent at nown times1

• 4oom will be Class I 7iv I 0Lone "1 0eplosive atmosphere

present at all times1

Clean 4oom Classification&

• Class A

• Class B

• Class C

• (ther

Bioha8ard evel&

• B/#

• B/"

• %tc.

+%*A 4atin of enclosures&+%*A #" 0(il tiht1+%*A 9 05ash down1+%*A 9M 05ash down and non/Corrosive1















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2.9.".# Intended (peratin %nvironment&

The Equipment shall be mounted in a 3*' environment with a temperaturerane of #? to "? NC, non/condensin humidity.

Vibration levels are&

• +eliible

• Sliht

• Severe

Seismic Lone&

• +eliible

• Sliht

• Severe

+oise Constraints& 0+ote& 'lace in Constraint section1D? 7B from 2 feet

%*I = 4-I levels are&

• +eliible.

• (ther 0specify1 :::::::::.

The e!uipment is to be used at the followin environmental conditions& Altitude :::::::: ft above sea level.

The followin is applicable for HVAC %!uipment&'rocess air enters in from&

• Indoor Temperature :::::: °C

• (utdoor Temperature& *inimum& :::::: ° C, *aimum& :::::: °C

Climatic conditions&

5inter dry bulb :::::: °C

5inter wet bulb :::::: °C

Summer dry bulb ::::: °C

Summer wet bulb ::::: °C0If these values are not nown, state location to be installed& 1

:::::::::::::::::::::::::::::::::::















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2.9."." Containment 0move to constraints1

2.9.".".# %plosion 'rotection

+ote& This section is only valid if processin products with a ris ofeplosion. Select one choice.

• " Bar Construction with isolation and suppression

• #> Bar construction with isolation only

• Closed/oop +itroen System

2.9."."." Containment of 'roduct

+ote& This section is only valid if the product bein used is hihlyreactive.

Insert containment guidelines here.















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1.0CONSTRAINTS

1.- M)(e*&one* n9 T)me()ne*

Based on t&e model o/tlined )elo(2 esta)lis& t&e %ro9ect milestones (it& a

timeline:

In&e:r&e ;)&h $()9&)on

"oc+men&&)on <* ''ro'r)&e=

>!ASELINE? EQUIPMENT ACQUISITION MO"EL

SUPPLIER

F+nc&)on( S'ec)f)c&)on<Trceb(e &o URS=

USER@<CONSULTANT )f ''()cb(e=

M*&er $()9&)on P(n

R F Q

U*er A+9)& of S+''()erD U*er In)&)&e*

Pro'o*(

D Q+()&, P(nD Pro7ec& P(n

E+)'men& $()9&)on P(nD EB'(n&)on &o S+''()er

<L)v)n: "oc+men&=

U*er Re+)remen&* S'ec)f)c&)on <URS=

<L)v)n: "oc+men&=

Pro'o*( An(,*)*

P r o '

o * (

P .O .

"e&)(e9 "e*):n

"oc+men&&)on<&rceb(e &o F+nc&)on( S'ec)f)c&)on=

Rev)e; F+nc&)on( S'ec)f)c&)on

Rev)e; "e&)(e9 "e*):n S,*&em Acce'&nce Te*&

S'ec)f)c&)on* <IQ@OQ=D #r9;reD Sof&;re

Rev)e; S,*&em

Acce'&nce Te*& S'ec)f)c&)on* S,*&em Acce'&nce

Te*&)n: n9 Re*+(&*

<U*er /)&ne** O'&)on(=

M)n&ennce S+''or&

"oc+men&&)on

A''rov(

A ' 'r ov (

A ' 'r o v (

R F Q















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Page ## of 33

Doc ID: Barrier

Isolator_URS_

November 26, 2002

1.2 Com'&)b)()& n9 S+''or&

Incl/de any re5/irements for com%ati)ility (it& ot&er User systems0 Int&e e>am%les %ro'ided )elo(2 fill in )lan-s (it& t&e a%%ro%riate

information0 Delete areas t&at are not a%%lica)le to t&is a%%lication0

80#01 C=,R= PA,=R; Controllers

,&e S/%%lier s&all /tilie Control Platform

Controllers t&at s&all incl/de a comm/nications %ort0

,&e S/%%lier s&all %ro'ide doc/mentation t&at t&e %rogramEem)edded soft(areF (as de'elo%ed and coded /tiliing

%rogram de'elo%ment and doc/mentation soft(are0

,&e s/%%lier s&all indicate t&e /se of c/stom or ?)es%o-e@ code

(it&in t&e e5/i%ment2 and s&all s/%%ly licensing of t&e c/stomcode for t&e life of t&e e5/i%ment0

An escro( agreement s&all )e re5/ired in t&e e'ent t&e s/%%lier

cannot s/%%ort t&e s/%%lied c/stom soft(are any longer0 In s/c&

instances2 t&e so/rce code and all information regarding t&e so/rcecode s&all )e gi'en to t&e /ser in a timely fas&ion to %re'ent

do(ntime of t&e e5/i%ment0

80#0# Preferred Vendor ist

If necessary attac& any critical %referred 'endors0 Refrain fromdri'ing t&e s/%%lier into c/stomiing &is e5/i%ment %ac-age0

If t&e 'endor (is&es to de'iate from t&e Preferred Instr/mentation

ist2 a listing of t&e %ro%osed com%onents and instr/mentation s/).

'endors indicating ty%e and model n/m)ers s&all )e s/)mitted(it& t&e 5/otation2 along (it& an e>%lanation of (&y t&e de'iation

is recommended0

80#03 Utilities

,&e /tilities and s%ace in'ol'ed needs to )e disc/ssed %rior to

%/rc&asing t&e e5/i%ment0 =)'io/sly2 t&e act/al e5/i%ment sie is )/t a small %art of t&e entire sco%e of (or- necessary to im%lement

a larger system0 ,&e /nit and its s/%%ort e5/i%ment m/st )e a)le to

)e installed in c/rrent )/ilding facilities0

,&e User s&all ens/re t&at t&e follo(ing /tilities are a'aila)le andt&at t&e /tility s/%%ly lines and %i%ing are terminated (it& fittings















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Doc ID: Barrier

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November 26, 2002

or connections2 (&ic& are com%ati)le (it& t&ose descri)ed on t&e

C/stomer Connection Dra(ings0

,&e S/%%lier s&all s%ecify /tility data2 (&ic& is mar-ed (it& a

triangle0 Utility data2 (&ic& are not s%ecified or mar-ed (it& atriangle2 s&all )e )ro/g&t to t&e attention of t&e User0 ,&ese data

s&all )e s%ecified E)y 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

)egins0















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Doc ID: Barrier

Isolator_URS_

November 26, 2002

Base +tilities Wor,s"eet

∇Electricity

:::::: VAC :::: Hert8

• Sinle 'hase

• Three 'hase

∇$ninterruptible 'ower Supply 4e!uired; <es = +o

To 'ower& %ntire System = Controls (nly

∇Instr#ment Air ::::::: 'SI3 0*ust be clean, dry ISA instrument !uality air, capacity tobe determined by si8e of e!uipment1 4ecommend at least E> '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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Doc ID: Barrier

Isolator_URS_

November 26, 2002

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 of the 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.

1. Av)(b)()&

,&e Gequipment/system is intended to )e o%erated Gontinuously,

!egularly, "" hours per day, "" hours per wee# 0

=%eration of t&e Gequipment/system s&all )e s/s%ended2 and t&e system

s&all )e a'aila)le for %re'entati'e maintenance or ro/tine ser'ice G ""hours per wee#, "" continuous hours per wee#, "" days per month, ""

wee#s per year 0

1.1 Proce9+r( Con*&r)n&*

80801 Prod/ct Contact ;aterials

Descri)e any local %roced/ral re5/irements s/c& as localstandards2 (&ic& m/st )e ad&ered to if a%%lica)le0

All %i%ing (elds and %rod/ct contact (elds s&all meet AS;+ and

3A s%ecification re5/irements0 Prod/ct contact metal to )e E31"

Stainless Steel2 31" Stainless Steel2 38 Stainless Steel2 etc0F

ist critical re5/irements for s/rface finis&2 ro/g&ness2 etc00

=t&er standards are attac&ed0 ,&e S/%%lier s&all ad&ere to t&e

indicated sections only0















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Doc ID: Barrier

Isolator_URS_

November 26, 2002

8080# Prod/ct in Contact (it& ;aterials

All %rod/ct contact %arts s&o/ld )e considered0 ,&eGe5/i%ment!system (ill )e /sed for Ea5/eo/s sol/tions2 lo( +

Elo(er e>%losion limitF sol'ents2 &ig& + sol'ents2 etc0F0red/ndant see 3080#

&at is t&e difference )et(een t&is section and 80801J

80803 oise e'el Constraints

Insert yo/r o(n noise le'el constraint re5/irements &ere0

or e>am%le:

,&e noise le'el generated d/ring o%eration of t&eGequipment/system (ill not e>ceed $ dB from 3 feet a(ay0

80808 +;I ! RI le'els are:

Insert yo/r o(n electrical and radio noise imm/nity re5/irements

&ere0

or e>am%le:

,&e Ge5/i%ment!system G(ill!(ill not )e /sed in an area (&eret(o.(ay radio comm/nication de'ices are in o%eration0 ,&e

Ge5/i%ment!system s&all meet C+ re5/irements for electrical noiseimm/nity and emissions0

8080$ Containment

8080$01 +>%losion Protection

,&is section is only 'alid if t&e %rod/ct )eing /sed is

&ig&ly reacti'e0 Insert containment g/idelines &ere Ei0e0

Bar Constr/ction (it& isolation and s/%%ression2 1 Bar

constr/ction (it& isolation only2 Closed.oo% itrogen

System2 etc0F0

8080" a)eling

All e5/i%ment and control (iring s&all )e la)eled and identified0















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Doc ID: Barrier

Isolator_URS_

November 26, 2002

1. M)n&ennce

Descri)e t&e e>%ected &ard(are and soft(are maintenance s/%%ortincl/ding: ease of maintenance2 e>%ansion ca%a)ility Esoft(are onlyF2

li-ely en&ancements Esoft(are onlyF2 e>%ected lifetime and long.terms/%%ort0

System s&all )e maintained on a sc&ed/le as indicated )y t&e s/%%lier0

S/%%lier is to %ro'ide Eat minim/mF t&e follo(ing maintenanceinstr/ctions:

10 All s/).systems %ro'ided E;aintenance and o%eration man/als

of 'endor e5/i%mentF#0 A com%re&ensi'e l/)rication list and recommended l/)rication

sc&ed/le30 A com%re&ensi'e recommended maintenance Ereg/lar

recommended ins%ection inter'als2 (ear %oints2 recommended

s%are %arts listF80 S/%%lier s&all s/%%ly ______ Co%ies of =%eration2 Installation2

;aintenance and de.commissioning man/als

.0LIFEC%CLE

.- "eve(o'men&

If S is to )e a%%lied to t&e e5/i%ment )eing ac5/ired2 it s&o/ld )e

referenced in t&is section of t&e doc/ment0

,&e S/%%lier s&all %ro'ide a K/ality and Pro9ect Plan as %art of t&eir

%ro%osal0 ,&e S/%%lier s&all &a'e a 5/ality system in %lace0 Internal5/ality %roced/res s&all )e a'aila)le for t&e Users re'ie(0

,&e S/%%lier s&all %ro'ide a Pro9ect ;anager for t&e %ro9ect to %ro'ide a

single comm/nication %oint (it& t&e User0

,&e %ro9ect s&all /tilie t&e <A;P met&odology (&en de'elo%ing t&e

system and doc/mentation0

.2 Te*&)n:

Descri)e t&e S/%%lier testing re5/irements0 Reference t&e Validation ,est

Plan2 actory Acce%tance ,est2 s%ecial tests2 etc0 ,&is section s&o/ld alsoincl/de re5/ired amo/nt of demonstrated r/n time2 any s%ecial materials

necessary to com%lete testing2 integration testing2 etc0















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Doc ID: Barrier

Isolator_URS_

November 26, 2002

In order to 'erify system %erformance2 t&e User s&all (itness t&e

e>ec/tion of t&e actory Acce%tance ,est %roced/res0 ,&e S/%%lier s&all

notify t&e User _______ (ee-s in ad'ance of t&e start of t&is test0

,&e actory Acce%tance ,est S%ecification s&all )e s/)mitted to t&e Userfor re'ie( and a%%ro'al %rior to e>ec/tion0 A minim/m of _______

(ee-s s&all )e allo(ed for t&e User to re'ie( and to comment and!or

a%%ro'e t&e actory Acce%tance ,est S%ecification0

Refer to t&e +5/i%ment Validation Plan for a%%lica)le %roced/res0

. "e()ver

,&e Ge5/i%ment!system2 (it& all o%tions2 e5/i%ment2 and t&e

doc/mentation listed )elo(2 s&all )e deli'ered to t&e Users recei'ingdoc-0

$0301 Doc/mentation

Installation2 o%eration2 and maintenance instr/ction doc/mentationfor t&e system s&all )e de'elo%ed to a le'el t&at is com%re&ensi)le

to a &ig& sc&ool grad/ate0

,&e S/%%lier s&all /se t&e formats descri)ed in t&e $A%&

'upplier $uide, urrent (ersion, to %rod/ce t&e doc/mentation0,&e S/%%lier s&all %ro'ide t&e doc/mentation for %reliminary

re'ie(0 ,&e S/%%lier s&all %ro'ide doc/mentation reflecting ?as. )/ilt@ condition (it& final deli'ery0

All final doc/ments s&all )e s&i%%ed (it& transmittals t&at identifyt&em as contract/ally re5/ired doc/ments0 All final doc/ments

and dra(ings s&all reflect ?as.)/ilt@ condition0

All doc/ments s&all in t&e lang/age of t&e destination co/ntry and

s/%%lied (it& &ard co%ies and electronic 'ersions s/%%lied in t&eformat identified for eac& doc/ment:

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

-elow is an example:

•Pro9ect Plan ;icrosoft ord 76 EL0docF

•User Re5/irements S%ecification ;icrosoft ord 76 EL0docF

•/nctional S%ecification!Re5/irements ;icrosoft ord 76 EL0docF

•Design S%ecifications ;icrosoft ord 76 EL0docF















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November 26, 2002

•Controls ,est ;icrosoft ord 76 EL0docF

•Hard(are Installation ,est ;icrosoft ord 76 EL0docF

•=%erational ,est ;icrosoft ord 76 EL0docF

•actory Acce%tance ,est ;icrosoft ord 76 EL0docF

•=%erator2 ;aintenance and Ser'ice ;an/als ;icrosoft ord 76 EL0docF

•Process and Instr/mentation Diagram EPMIDF A/toCAD 'ersion 1#0 EL0d>fF

•Instr/ment isting ;icrosoft ord 76 EL0docF or +>cel 76 EL0>lsF

•Control Sc&ematics A/toCAD 'ersion 1#0 EL0d>fF

•Control Panel Assem)ly Dra(ings A/toCAD 'ersion 1#0 EL0d>fF•+5/i%ment Assem)ly Dra(ings A/toCAD 'ersion 1#0 EL0d>fF

•Bill of ;aterials ;icrosoft ord 76 EL0docF or +>cel 76 EL0>lsF

•S%are Parts ist ;icrosoft ord 76 EL0docF or +>cel 76 EL0>lsF

•Com%onent C/t S&eets ;icrosoft ord 76 EL0docF or +>cel 76 EL0>lsF

•C=,R= PA,=R; Program

Printo/t and Dis- ile NNN Program De'elo%ment format

•=IP Config/ration Printo/t and Dis- ile NNN Program De'elo%ment format

.1 S+''or&

Descri)e (&at s/%%ort acti'ities are re5/ired after acce%tance0 ,&e

%aragra%&s o/tlined )elo( %ro'ide some areas for consideration0

$0801 Start./% S/%%ort Elist a'aila)le o%tionsF

$080101 ,raining Elist training o%tions a'aila)leF

$080# Post Start./% S/%%ort Elist %ost.start/% s/%%ort a'aila)leF

$080#01 ,ec&nical S/%%ort

,ele%&one EVoice or ;odemF

Re%lacement Parts A'aila)ility ist Eormal lead times

s&all )e listedF















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Doc ID: Barrier

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November 26, 2002

$080#0# User Site S/%%ort

Pre'entati'e ;aintenance Elist maintenance contractsa'aila)leF

System Im%ro'ements Es/%%lier s&all notify /ser of any

im%ro'ements a'aila)le on a reg/lar )asisF















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Doc ID: Barrier

Isolator_URS_

November 26, 2002

6.04LOSSAR%

If necessary2 attac& a glossary2 (&ic& incl/des 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 Re5/irements C&ec- s&eet0

or e>am%le Eexample list is not intended to be completeF:

Acronm "ef)n)&)on

°C Degrees Celsi/s

B Bio&aard e'el

CR Code of ederal Reg/lations

dB Deci)els

+;I +lectro.;agnetic Interference

ft eet

<UI <ra%&ic User Interface

H;I H/man O ;ac&ine Interface

HVAC Heating2 Ventilation2 and Air Conditioning

IS= International =rganiation for Standardiation+ o(er +>%losion imit

=IP =%erator Interface Panel

RI Radio re5/ency Interference

URS User Re5/irement S%ecification

,a)le is incom%lete















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Doc ID: Barrier

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November 26, 2002

5.0REFERENCES

ist references t&at (ere /sed in %re%aring t&is doc/ment or t&at %ro'ide

additional details2 s/c& as:

o +5/i%ment Validation Plan

o C/rrent re'ision of <A;P </idelines

o Vendor Pi%ing Certification Eif a%%lica)leF

o C/stomer Connection Diagram

o A%%ro'ed Instr/mentation ist

o

Process lo( Diagramo #1 CR Part 11

o ational +lectric Code

o S















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November 26, 2002

.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 doc/ment &as )een re'ie(ed )y t&e User Pro9ect ;anager and a%%ro'ed for /se )y t&e

S/%%lier0

Pr)n&e9@T'e9 Nme S):n&+re "&e

,&is doc/ment &as )een re'ie(ed )y t&e User K/ality Ass/rance <ro/% and a%%ro'ed for

/se )y t&e S/%%lier0


,&is doc/ment &as )een re'ie(ed )y t&e S/%%lier Pro9ect ;anager and a%%ro'ed for /se )yt&e S/%%lier Pro9ect ,eam0


=t&er a%%ro'als as necessary may )e incl/ded2 s/c& as t&e ,ec&nical Ser'ices <ro/%s2

User <ro/%s2 +ngineering2 etc0 as re5/ired0





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