Tablet Coater Urs

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USER REQUIREMENTS SPECIFICATION

Tablet Coater System

Page 1 of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

EQUIREMENTS TEMPLATE USER R R EQUIREMENTS FOR A FOR A TABLET COATER S SYSTEM

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REVISION HISTORY Re!

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I*t*al *ssuace of t-e URS for *ustry use.


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Page / of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

TABLE OF CONTENTS '!(

INTRO"UCTION!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!)

*!( OVERVIE+!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!, *!' USE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!, *!* PRO"UCT CLASSIFICATION!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!, *!INTEN"E" USE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!, *!) CAPACITY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!. *!, PRO"UCTION!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!. -!( OPERATIONAL REQUIREMENTS!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!. -!' CAPACITY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!. -!* PROCESS R EQUIREMENTS !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!. -!PROCESS CONTROL!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!. -!) FUNCTIONS!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!/ -!, "ATA AN" SECURITY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!0 -!. ENVIRONMENT !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!'* )!( CONSTRAINTS!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!', )!' MILESTONES AN" TIMELINES!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!', )!* EQUIPMENT CONSTRAINTS !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!'. )!COMPATIBILITY AN" SUPPORT!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!'. )!) AVAILABILITY !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!'1 )!, PROCE"URAL CONSTRAINTS !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!'1 )!. MAINTENANCE !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*( ,!( LIFE2CYCLE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*( ,!' "EVELOPMENT!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*( ,!* TESTIN3!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*( ,!"ELIVERY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*' ,!) SUPPORT!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!** .!(

3LOSSARY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*-

/!(

REFERENCES!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*,

1!(

APPROVAL!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!*.



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Page ! of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

Pro4e5t No!6 Isert t-e u*ue roect umber assoc*ate 3*t- t-*s art*cular URS. "o5&me%t No!6 Isert t-e Documet Iet*f*cat*o #umber a Rev*s*o. "o5&me%t "es5r$#t$o%6 Isert escr*t*o of ocumet4 e.g. PUR$ ST$'& 5$#$R'T"R4 J$TT $amle User Reu*remets Sec*f*cat*o.

'!(INTRO"UCTION Tablet coat*g systems vary * fuct*o a urose. T-ere are several uses of coaters: • • • • • • •

Stregt-e*g coat De(ust7flavor mas8 Color a elegace 'ct*ve rug coats Protect*ve T*me Release Sugar coat

T-ese systems rage from a s*mle aueous +3ater base, coat4 to rug layers4 a solvet base coat*g systems. 'ueous systems ty*cally -ave less comle*ty4 3-ereas act*ve rug coat*g layers -ave a ee for more *strumetat*o a cotrols4 a lastly solvet base systems emloy eve more *strumetat*o a cotrols reu*re r*mar*ly for safety reasos +elos*o rotect*o,. 'lso4 t-e rouct *tself may ose ev*rometal a eosure -a9ars t-at ee to be ealt 3*t- to *mlemet t-e *stallat*o of t-e coat*g system. astly4 t-e ut*l*t*es a sace *volve ees to be *scusse r*or to urc-as*g t-e eu*met. "bv*ously4 t-e actual eu*met s*9e *s but a small art of t-e et*re scoe of 3or8 ecessary to *mlemet a larger coat*g oerat*o. Small coaters ca be self(cota*e4 ee*g uo t-e al*cat*o. T-e u*t a *ts suort eu*met must be able to be *stalle * curret bu*l*g fac*l*t*es. T-*s ocumet ecomasses t-e ormal rage of coater oerat*os. Tec-ology *mrovemets a e3 al*cat*os may reu*re ev*at*o from t-*s temlate. T-*s *s to be ut*l*9e as a gu*e for t-e user to as3er t-e maor*ty of uest*os *volve * sec*fy*g a us*g t-e eu*met. 'eums may be use to rou out t-e reu*remets. ' ty*cal 'ueous Process *volves t-e follo3*g stes:



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Page ; of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

Deust7Pre-eat +blo3ers o4 a * og moe4 -eat al*e4 solut*o rec*rculat*g, 'fter reac-*g a reset e-aust temerature **cat*g tablet b e • *s 3arm: • Sray Solut*o to Tablets +Pa * ru moe, 'fter reac-*g es*re 3e*g-t ga* o tablets: • Coolo3 +
*!(OVERVIE+ T-*s ocumet ecomasses t-e ormal rage of eu*met oerat*os.

2.1 Use T-e coater s-all be use r*mar*ly for: • • • • • • •

Stregt-e*g coat De(ust7flavor mas8 Color a elegace 'ct*ve rug coats Protect*ve T*me Release Sugar coat

2.2 Product Classifcation T-e roucts be*g use o t-e mac-*e are of: • • • •

o3 act*ve +v*tam*s4 sulemets, &e*um act*ve +eg. 'sr*, <*g-ly act*ve +eg. &or-*e, $clus*ve +eg. Pe*c*ll*,

2.3 Intended use T-e coater 3*ll be use for +C-ec8 all t-at aly,: • • • •

'ueous o3 $ +o3er $los*o *m*t, Solvets <*g- $ Solvets Sugar coat



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2.4 Capacity T-e caac*ty of t-e mac-*e *s to be: $tremely small +1 l*ter to 6 l*ters, Small += l*ters to /0 l*ters, &e*um +/0 l*ters to 60 l*ters, arge +60 to 100 l*ters, arger +100 to 1;0 l*ters, argest +1;04 1=04 a above,

• • • • • •

2.5 Production T-e coater s-all be caable of rouc*g er >(-our s-*ft.

+u*t,of coate tablets

-!(OPERATIONAL REQUIREMENTS 3.1 Capacity Rage of roucts Commo*t*es to be use +*.e.4 tablets4 etc., Processe &ater*als to be use or *volve Prouct*o rates

• • • •

3.2 Process Requirements %ual*ty of roucts a cocetrat*os Prouct l*m*tat*os +*.e. temerature4 -um**ty4 <4 etc.,

• •

3.3 Process Control &easuremet Rage +'ccuracy of *strumetat*o es*re,

•

Temerature: •

?7( 2°C +Staar,

•

?7( 1°C +Sec*al,

•

?7( 0.;°C +Custom,

'*rflo3: •

?7( ;@ of Aull Scale +Staar,



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Page = of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

?7( 2.;@ "f Aull Scale +Sec*al,

•

Pa Pressure: ?7( 10@ of Aull Scale +Staar B #egat*ve a ressure ma*ta*e,

•

Solut*o Alo3rate: •

?7( ;@ of Aull Scale o feebac8 +Staar Per*stalt*c,

•

?7( ;@ of Aull Scale 3*t- feebac8 +Per*stalt*c 3*tflo3meter,

•

?7( 2@ of Aull Scale o feebac8 +Staar 5ear Pum,

•

?7( 2@ of Aull Scale 3*t- feebac8 +5ear um 3*tflo3meter,

•

?7( 1@ of Aull Scale 3*t- feebac8 +5ear um 3*t- 3e*gscale,

Ilet '*r
#ot cr*t*cal

•

Dry at least to

•

*t-*

°C

to

°C

De3 o*t

°C

De3 o*t

3.4 Functions /.!.1

"erat*o

T-e system s-all oerate 3*t- a m**mum of oerator *volvemet +loa*g4 uloa*g4 gu cal*brat*o4 mo*tor*g of co*t*os,. "erat*o s-all be safe bot- from a oerator a ev*rometal stao*t. T-e system s-all be oerate locally at t-e Coater mac-*e *tself. Cotrol system reu*remets •

&aual oly

•

&aual7automat*c

Clea*g reu*remets



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Tablet Coater System •

•

'uto(as-

•

Sec*al Reu*remets:

/.!.2

Page > of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

Po3er fa*lure7Recovery

I t-e evet of a o3er fa*lure4 t-e system s-all rotect rouct aga*st amage. T-e system 3*ll sto automat*cally uo loss of electr*c*ty4 a*r4 or ot-er maor ut*l*ty a 3*ll reu*re oerator *tervet*o to re(start. Dee*g uo t-e ot*os c-ose * t-e overv*e3 sect*o4 t-e system 3*ll: •

&aually re(start base o oerator *uts. +"erator **t*ates o3er recovery seuece,

•

Re(start base o last state before loss of o3er. +System rus t-roug- o3er recovery seuece 3-e oerator start s*gal *s g*ve,

•

If t-ere *s a automat*c batc- reort*g system4 t-e *format*o s-all be reta*e * t-e evet of a o3er fa*lure +' UPS *s reu*re for automat*c batc- reort*g systems,.

/.!./

$mergecy Sto

T-e system s-all -ave a emergecy sto +$(Sto, fuct*o es*ge to sto all -ys*cal movemet of t-e mac-*ery *mme*ately. T-e $(Sto buttos s-all be locate * eas*ly access*ble areas arou t-e mac-*e as reu*re by local safety staars. /.!.!

'larms a ar*gs

7Cr$t$5al alarms8 s-all ta8e act*o v*a *terloc8+s, a7or oerator roceural resose to s-ut t-e eu*met o3 a ot*fy t-e oerator of t-e co*t*o+s,. T-e oerator s-all be reu*re to ac8o3lege t-e alarm before t-e alarm ca be reset a t-e system restarte. "ce t-e alarm *s reset4 t-e oerator may restart t-e system. 7I%9ormat$o%al Messa:es8 s-all ot*fy t-e oerator a ta8e o furt-er act*o.

T-e $u*met s-all -ave t-e follo3*g cr*t*cal alarms4 3ar*gs a *format*oal messages:


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Doc ID: Tablet Coater System URS Rev.0 Jue 200!


Alarm or Informational essa!e $mergecy Sto

Critical Alarm

"on# Critical Alarm

Response Information 'perator Interloc$ al essa!e Procedur %s& al

E

E

+FProgrammable Log*c Cotroller −O erator( Iterface Term*alG,

E

E

Cotrol Po3er Aault

E

E

&a* '*r Aault

E

E

Ilet '*r Temerature <*g- Aault

E

E

Ilet '*r Temerature o3 Aault

E

E

Ilet '*rflo3 o3 Aault

E

E

Plugge 5u +lo3 flo3 or solut*o ressure -*g-,

E

E

#o99le '*rflo3 o3 Aault

E

E

Ilet De3o*t <*g- Aault

E

E

PC−"IT Commu*cat*o atc-og

Ilet De3o*t o3 ar*g &otor Aaults

E

E

E

E

Pa Pressure <*g- ar*g

E

E

Pa Pressure o3 ar*g

E

E

PC Hattery o3 ar*g

E

T-e l*st of cr*t*cal alarms * t-e table *s ot *tee to be a comre-es*ve l*st of all alarms for t-e system. ' comlete alarm l*st 3*ll be eveloe a *clue * t-e Auct*oal Sec*f*cat*o ocumet. Aor a staar eu*met tye al*cat*o4 reuest t-e sul*er to subm*t t-e comlete alarm l*st a *fferet*ate bet3ee cr*t*cal a o(cr*t*cal alarms. Note: Consider documenting how “critical and non-critical” criteria were determined.

3.5 (ata and )ecurity Cotrols rov*e 3*t- Data Collect*o systems *tee for use * t-e maufacture of -armaceut*cal roucts s-all be reu*re to comly 3*t-


E


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21 CAR Part 11 . T-e sul*er s-all st*ulate t-e met-os by 3-*c- t-*s cr*ter*o *s met. /.;.1

User Iterfaces

'ccess to all Iut7"utut values a system status b*ts s-all be rov*e t-roug- a ata(commu*cat*o l*8. Secur*ty for ata a oerator access *s rov*e by +User ID7Pass3or4 Car Reaer4 H*ometr*c +A*gerr*t4 eye sca4 vo*ce recog*t*o4 etc.,4 etc.,. *st t-e al*cat*o t-at rov*es secur*ty fuct*os to t-e system4 e*t-er *teral v*a t-e local "IP or eteral v*a a SC'D' system4 etc. /.;.2

User Iterface 3*t- Suerv*sors a "erators

T-e C"#TR" P'TA"R& system s-all *clue *terfaces 3*tt-e "erator a Suerv*sor t-at esure easy4 safe4 a rel*able oerat*o. ' oerator(*terface ael s-all be rov*e a moute ear t-e eu*met or o t-e eu*met. T-*s ael s-all rov*e t-e ecessary s3*tc-es4 **cators4 a ev*ces to oerate t-e eu*met. /.;.2.1

aguage reu*remets Sec*fy laguage * 3-*c- *format*o 3*ll be *slaye +*.e. $gl*s-4 Sa*s-4 5erma4 H*l*gual4 etc.,

/.;.2.2

D*slay Reu*remets: State t-e system of measuremet t-at 3*ll be use +$gl*s- or &etr*c +S.I.,,.

Parameter

Unit%s& of measurement

Format

Ilet Temerature

+., u*ts

Def*e t-e u*ts

$-aust Temerature

+., u*ts


Ilet '*rflo3

+., u*ts


Pa Pressure

+., u*ts


Solut*o Alo3rate

+., u*ts


Total7Seto*t Sray 'mout

+., u*ts


#o99le '*rflo3

+., u*ts


'larms a ar*gs

#7'

#7'


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Tablet Coater System Parameter

Unit%s& of measurement

Format

System Status

#7'

#7'

Prouct Temerature

+., u*ts


Ilet De3o*t

+., u*ts


"t-er +Sec*fy,

+., u*ts


/.;./

Iterface 3*t- "t-er $u*met

T-e cotrol system s-all *clue t-e *terfaces ecessary to fac*l*tate oerat*o a cof*gurat*o. Aor eamle: •

' RS(2/2 commu*cat*os ort

s-all be rov*e. •

' &oem commu*cat*os ort

s-all be rov*e. ' -*g-(see cof*gurat*o7mo*tor*g coect*o s-all be rov*e. •

T-e ort s-all be caable of be*g cof*gure to commu*cate t-e follo3*g ata to a suerv*sory cotrol a ata acu*s*t*o +SC'D', oe +#ote: t-e SC'D' system s-all be sul*e a *stalle by t-e User,: •

'll rocess var*ables

•

'larms a ar*gs.

•

System Status +e.g. Foff4G F o4G

FstabyG states4 etc.,. •

/.;.!

"t-er

+sec*fy,

Secur*ty evels

*st t-e total umber of *fferet access levels t-at 3*ll be reu*re. Prov*e a geeral escr*t*o of t-e access r*g-ts for eac- level +scree av*gat*o4 oerat*oal cotrol4 cotrol loo var*able ma*ulat*o4 alarm seto*t ma*ulat*o4 etc.,. /.;.;

Data Collect*o

Cos*er ay arc-*v*g a reort*g reu*remets -ere. • •

#oe Recorer


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Process Pr*tout

•

$lectro*c rocess r*tout4

<*stor*cal Tre*g $lectro*c rocess r*tout4 <*stor*cal Tre*g a *terface to comay et3or8 •

T-e follo3*g s-all be recore: •

Ilet Temerature

•

$-aust Temerature

•

Ilet '*rflo3

•

Pa Pressure

•

Solut*o Alo3rate

•

Total7Seto*t Sray amout

•

#o99le '*rflo3

•

'larms a 3ar*gs

•

System Status +reay4 ru*g4

etc.,

-!.

•

Prouct Temerature

•

Ilet De3o*t

•

"t-er:

+Sec*fy,

E%$ro%me%t

Prov*e eta*ls of t-e -ys*cal ev*romet * 3-*c- t-e Tablet Coater System 3*ll be oerate. /.6.1

ayout

'llocate floor sace for t-e eu*met *s  *c-es by  *c-es 3*t- at least a *c- corr*or arou t-e er*-ery for t-e eu*met. )ert*cal clearace *s  *c-es. See attac-e ra3*g  +*f al*cable,. ayout *s sec*f*c to t-e s*9e eu*met be*g use a system reu*remets of t-e eu*met.



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Tablet Coater System /.6.2 •

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P-ys*cal Co*t*os Room $los*o Class*f*cat*o *st t-e cr*t*cal elos*o reu*remets for t-e room. 

Room 3*ll be o(-a9arous



Room 3*ll be Class I D*v II +Koe 2, +elos*ve atmos-ere reset at 8o3 t*mes, 

Room 3*ll be Class I D*v I +Koe 1, +elos*ve atmos-ere reset at all t*mes, •

$v*rometal Class*f*cat*o *st t-e cr*t*cal a*r ual*ty reu*remets for t-e ev*romet. 

Class 1004 1040004 or 1004000 + Federal Standard

209E , 

IS" Class ;4 =4 or > +IS" 1!6!!(1 a IS" 1!6!!(2, 

Class '4 H4 C4 or D +T-e Rules 5over*g &e*c*al Proucts * t-e $uroea U*o B 'e 1, 

D*rect*oal a*rflo3



'*rflo3 veloc*ty

  •

#umber of a*r c-ages Part*cle Igress

H*o-a9ar evel *st t-e cr*t*cal b*o-a9ar level reu*remets for t-e ev*romet.

•



H(1



H(2

Rat*g of eclosures *st t-e rat*g reu*remets for eclosures * t-e ev*romet. 

#$&' 1 +"e,



#$&' 12 +"*l t*g-t,



#$&' ! +as- o3,



#$&' !E +as- o3 a o(Corros*ve,



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Tablet Coater System /.6./

Clea*g Reu*remets

•

•

'uto(as-

•

Steam Clea

/.6.!

Page 1! of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

Ster*l*9at*o Reu*remets

Descr*be t-e tye of ster*l*9at*o t-at 3*ll be erforme o or 3*t-* t-e Tablet Coater System a t-e urat*o t-e Tablet Coater System 3*ll be eose. /.6.;

Itee "erat*g $v*romet:

Descr*be t-e tye of oerat*g ev*romet t-at t-e Tablet Coater System 3*ll be eose to follo3*g *stallat*o. Aor eamle: T-e Tablet Coater System s-all be locate * a 5&P ev*romet 3*t- a temerature rage of 1; to 2; LC4 o(coes*g -um**ty. )*brat*o levels * oerat*g ev*romet are M#egl*g*ble4 Sl*g-t4 or SevereN T-e Se*sm*c Koe * t-e oerat*g ev*romet *s MKoe 14 Koe 24 Koe /4 Koe !4 or Koe !'N.

(emainder o! "age #ntentionall$ %e!t &lan'


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)!(CONSTRAINTS 4.1 ilestones and *imelines Hase o t-e moel outl*e belo34 establ*s- t-e roect m*lestoes 3*t- a t*mel*e:

7BASELINE8 EQUIPMENT ACQUISITION MO"EL SUPPLIER

USER@>CONSULTANT $9 a##l$5able?

User A&=$t o9 S&##l$er

Master Val$=at$o% Pla% E&$#me%t Val$=at$o% Pla% O

O

R FQ

E#la%at$o% to S&##l$er

>L$$%: "o5&me%t?

User Re&$reme%ts S #e5$9$5at$o% >URS? >L$$%: "o5&me%t?

User I%$t$ates

Pro#osal

R F Q

O

s a l o o # P r P !O

!

O

Q&al$ty Pla% Pro4e5t Pla%

F&%5t$o%al S#e5$9$5at$o% >Tra5eable to URS?

Pro#osal A%alys$s A##roal

"eta$le= "es$:% "o5&me%tat$o%

Re$e; F&%5t$o%al S#e5$9$5at$o%

>tra5eable to F&%5t$o%al S#e5$9$5at$o%?

Re$e; "eta$le= "es$:%

A # #r o al

System A55e#ta%5e Test S#e5$9$5at$o%s >IQ@OQ? O O

Re$e; System A55e#ta%5e Test S#e5$9$5at$o%s

I%te:rate ;$t< Val$=at$o% "o5&me%tat$o% >as a##ro#r$ate?

A # #r o  al

Har=;are So9t;are

System A55e#ta%5e Test$%: a%= Res<s >User +$t%ess O#t$o%al? Ma$%te%a%5e  S&##ort "o5&me%tat$o%


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4.2 +quipment Constraints Descr*be t-e oerat*g costra*ts t-at t-e eu*met7systemQ 3*ll be reu*re to meet. Aor eamle: !.2.1

$v*rometal Co*t*os

T-e Tablet Coater System *s to be use at t-e follo3*g ev*rometal co*t*os: 'lt*tue  ft above sea level !.2.2

Process a*r eters * from Ioor Temerature:

°C

"utoor Temerature: &**mum:

° C

&a*mum:

°C

Cl*mat*c co*t*os:

!.2./

*ter ry bulb

°C

*ter 3et bulb

°C

Summer ry bulb

°C

Summer 3et bulb

°C

$u*met 5eerate )*brat*o

T-e ma*mum allo3able eu*met v*brat*o geerate ur*g oerat*o *s M)alueN.

4.3 Compati,ility and )upport Iclue ay reu*remets for comat*b*l*ty 3*t- ot-er User systems. I t-e eamles rov*e belo34 f*ll * bla8s 3*t- t-e aror*ate *format*o. Delete areas t-at are ot al*cable to t-*s al*cat*o. !./.1

C"#TR" P'TA"R& Cotrollers

T-e Sul*er s-all ut*l*9e Cotrol Platform Cotrollers t-at s-all *clue a commu*cat*os ort. T-e Sul*er s-all rov*e ocumetat*o t-at t-e rogram +embee soft3are, 3as eveloe a coe ut*l*9*g rogram evelomet a ocumetat*o soft3are.



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T-e sul*er s-all **cate t-e use of custom or Fbeso8eG coe 3*t-* t-e eu*met4 a s-all suly l*ces*g of t-e custom coe for t-e l*fe of t-e eu*met. ' escro3 agreemet s-all be reu*re * t-e evet t-e sul*er caot suort t-e sul*e custom soft3are ay loger. I suc*staces4 t-e source coe a all *format*o regar*g t-e source coe s-all be g*ve to t-e user * a t*mely fas-*o to revet o3t*me of t-e eu*met. !./.2

Preferre )eor *st

If ecessary attac- ay cr*t*cal referre veors. Refra* from r*v*g t-e sul*er *to custom*9*g -*s eu*met ac8age. If t-e veor 3*s-es to ev*ate from t-e Preferre Istrumetat*o *st4 a l*st*g of t-e roose comoets a *strumetat*o sub(veors **cat*g tye a moel umbers s-all be subm*tte 3*t- t-e uotat*o4 alog 3*t- a elaat*o of 3-y t-e ev*at*o *s recommee. !././

Ut*l*t*es

T-e ut*l*t*es a sace *volve ees to be *scusse r*or to urc-as*g t-e eu*met. "bv*ously4 t-e actual eu*met s*9e *s but a small art of t-e et*re scoe of 3or8 ecessary to *mlemet a larger system. T-e u*t a *ts suort eu*met must be able to be *stalle * curret bu*l*g fac*l*t*es. T-e User s-all esure t-at t-e follo3*g ut*l*t*es are ava*lable a t-at t-e ut*l*ty suly l*es a **g are term*ate 3*t- f*tt*gs or coect*os4 3-*c- are comat*ble 3*t- t-ose escr*be o t-e Customer Coect*o Dra3*gs. T-e Sul*er s-all sec*fy ut*l*ty ata4 3-*c- *s mar8e 3*t- a tr*agle. Ut*l*ty ata4 3-*c- are ot sec*f*e or mar8e 3*t- a tr*agle4 s-all be broug-t to t-e attet*o of t-e User. T-ese ata s-all be sec*f*e +by t-e User or t-e Sul*er, a s-all be arove by bot- t-e User a t-e Sul*er before system es*g beg*s. Hase Ut*l*t*es or8s-eet

∇Relate D*sc-arges • • •

)olume < Temerature



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Page 1> of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

&ater*als

∇$lectr*c*ty •

 )'C 
•

P-ases

•

'merage

•

U*terrut*ble Po3er Suly +Def*e Use,

∇Cotrol '*r •

Pressure Aor eamle:  PSI5 +must be clea4 ry IS' *strumet ual*ty a*r4 caac*ty to be eterm*e by s*9e of eu*met,. Recomme at least 0 PSI5 costat a*r ressure for all eu*met4 uless sec*f*e.

∇"t-er Ut*l*ty Reu*remets Prov*e eta*ls regar*g ay ot-er ut*l*ty systems t-at are reu*re to suort oerat*o of t-e eu*met7system.

4.4 A-aila,ility T-e Tablet Coater System *s *tee to be oerate Cot*uously4 Regularly4  -ours er ay4  -ours er 3ee8Q. "erat*o of t-e Tablet Coater System s-all be susee4 a t-e system s-all be ava*lable for revetat*ve ma*teace or rout*e serv*ce  -ours er 3ee84  cot*uous -ours er 3ee84  ays er mot-4  3ee8s er yearQ.

4.5 Procedural Constraints !.;.1

Prouct Cotact &ater*als

Descr*be ay local roceural reu*remets suc- as local staars4 3-*c- must be a-ere to *f al*cable. 'll **g 3els a rouct cotact 3els s-all meet 'S&$ a /' sec*f*cat*o reu*remets. Prouct cotact metal to be +/16 Sta*less Steel4 /16 Sta*less Steel4 /0! Sta*less Steel4 etc.,



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*st cr*t*cal reu*remets for surface f**s-4 roug-ess4 etc.. "t-er staars are attac-e. T-e Sul*er s-all a-ere to t-e **cate sect*os oly. !.;.2

Prouct * Cotact 3*t- &ater*als

'll rouct cotact arts s-oul be cos*ere. T-e Tablet Coater System 3*ll be use for +aueous solut*os4 lo3 $ +lo3er elos*o l*m*t, solvets4 -*g- $ solvets4 etc.,. !.;./

#o*se evel Costra*ts

Isert your o3 o*se level costra*t reu*remets -ere. Aor eamle: T-e o*se level geerate ur*g oerat*o of t-e Tablet Coater System 3*ll ot ecee >; H from / feet a3ay. !.;.!

$&I 7 RAI levels are:

Isert your o3 electr*cal a ra*o freuecy o*se *mmu*ty a em*ss*o reu*remets -ere. Aor eamle: T-e Tablet Coater System 3*ll73*ll otQ be use * a area 3-ere t3o(3ay ra*o commu*cat*o ev*ces are * oerat*o. T-e Tablet Coater System s-all meet C$ reu*remets for electr*cal o*se *mmu*ty a em*ss*os. !.;.;

Cota*met

!.;.;.1

$los*o Protect*o T-*s sect*o *s oly val* *f t-e rouct be*g use *s -*g-ly react*ve. Isert cota*met gu*el*es -ere +*.e. Har Costruct*o 3*t- *solat*o a suress*o4 10 Har costruct*o 3*t- *solat*o oly4 Close(oo #*troge System4 etc.,.

!.;.;.2

Prouct T-*s sect*o *s oly val* *f t-e rouct be*g use *s -*g-ly react*ve. T-e system comes staar 3*t- *let ref*lters a <$P' ref*lters. Isert cota*met of rouct gu*el*es -ere +*.e. <$P' f*ltrat*o of e-aust4 <$P' f*ltrat*o 3*t- bag *(bag out *solat*o of e-aust4 scrubber system4 cycloe searator system4 t-ermal o**9er system4 evaorator4 etc.,.



JETT

Tablet Coater System !.;.6


abel*g

'll eu*met a cotrol 3*r*g s-all be labele a *et*f*e.

4. aintenance Descr*be t-e eecte -ar3are a soft3are ma*teace suort *clu*g: ease of ma*teace4 eas*o caab*l*ty +soft3are oly,4 l*8ely e-acemets +soft3are oly,4 eecte l*fet*me a log(term suort. System s-all be ma*ta*e o a sc-eule as **cate by t-e sul*er. Sul*er *s to rov*e +at m**mum, t-e follo3*g ma*teace *struct*os: 1. 2. /.

!.

'll sub(systems rov*e +&a*teace a oerat*o mauals of veor eu*met, ' comre-es*ve lubr*cat*o l*st a recommee lubr*cat*o sc-eule ' comre-es*ve recommee ma*teace +regular recommee *sect*o *tervals4 3ear o*ts4 recommee sare arts l*st, Sul*er s-all suly  Co*es of "erat*o4 Istallat*o4 &a*teace a e(comm*ss*o*g mauals

,!(LIFE2CYCLE 5.1 (e-elopment If S>> *s to be al*e to t-e eu*met be*g acu*re4 *t s-oul be referece * t-*s sect*o of t-e ocumet. T-e Sul*er s-all rov*e a %ual*ty a Proect Pla as art of t-e*r roosal. T-e Sul*er s-all -ave a ual*ty system * lace. Iteral ual*ty roceures s-all be ava*lable for t-e Users rev*e3. T-e Sul*er s-all rov*e a Proect &aager for t-e roect to rov*e a s*gle commu*cat*o o*t 3*t- t-e User. T-e roect s-all ut*l*9e t-e 5'&P met-oology 3-e evelo*g t-e system a ocumetat*o.

5.2 *estin! Descr*be t-e Sul*er test*g reu*remets. Referece t-e )al*at*o Test Pla4 Aactory 'ccetace Test4 sec*al tests4 etc. T-*s sect*o s-oul also *clue reu*re amout of emostrate ru t*me4 a y sec*al mater*als ecessary to comlete test*g4 *tegrat*o test*g4 etc.



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I orer to ver*fy system erformace4 t-e User s-all 3*tess t-e eecut*o of t-e Aactory 'ccetace Test roceures. T-e Sul*er s-all ot*fy t-e User  3ee8s * avace of t-e start of t-*s test. T-e Aactory 'ccetace Test Sec*f*cat*o s-all be subm*tte to t-e User for rev*e3 a aroval r*or to eecut*o. ' m**mum of  3ee8s s-all be allo3e for t-e User to rev*e3 a to commet a7or arove t-e Aactory 'ccetace Test Sec*f*cat*o. Refer to t-e $u*met )al*at*o Pla for al*cable roceures.

5.3 (eli-ery T-e eu*met7systemQ4 3*t- all ot*os4 eu*met4 a t-e ocumetat*o l*ste belo34 s-all be el*vere to t-e Users rece*v*g oc8. ;./.1

Documetat*o

Istallat*o4 oerat*o4 a ma*teace *struct*o ocumetat*o for t-e system s-all be eveloe to a level t-at *s comre-es*ble to a -*g- sc-ool grauate. T-e Sul*er s-all use t-e formats escr*be * t-e *+," Sulier *uide Current /ersion to rouce t-e ocumetat*o. T-e Sul*er s-all rov*e t-e ocumetat*o for rel*m*ary rev*e3. T-e Sul*er s-all rov*e ocumetat*o reflect*g Fas( bu*ltG co*t*o 3*t- f*al el*very. 'll f*al ocumets s-all be s-*e 3*t- trasm*ttals t-at *et*fy t-em as cotractually reu*re ocumets. 'll f*al ocumets a ra3*gs s-all reflect Fas(bu*ltG co*t*o. 'll ocumets s-all be 3r*tte * t-e laguage of t-e est*at*o coutry a sul*e 3*t- -ar co*es a electro*c vers*os * t-e format *et*f*e for eac- ocumet: •

Proect Pla

&*crosoft or = +.oc,

•

User Reu*remets Sec*f*cat*o


•

Auct*oal Sec*f*cat*o7Reu*remet


•

Des*g Sec*f*cat*os


•

Cotrols Test


•


•

"erat*oal Test



Page 22 of 26


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•

Aactory 'ccetace Test


•

"erator4 &a*teace a Serv*ce &auals


•

Process a Istrumetat*o D*agram +PID,

'utoC'D vers*o 12.0 +.f,

•

Istrumet *st*g

&*crosoft or = +.oc, or $cel = +.ls,

•

Cotrol Sc-emat*cs

'utoC'D vers*o 12.0 +.f,

•

Cotrol Pael 'ssembly Dra3*gs

'utoC'D vers*o 12.0 +.f,

•

$u*met 'ssembly Dra3*gs

'utoC'D vers*o 12.0 +.f,

•

H*ll of &ater*als


•

Sare Parts *st


•

Comoet Cut S-eets


•

C"#TR" P'TA"R& Program Pr*tout a D*s8 A*le

EEE Program Develomet format

•

"IP Cof*gurat*o Pr*tout a D*s8 A*le

EEE Program Develomet format

5.4 )upport Descr*be 3-at suort act*v*t*es are reu*re after accetace. T-e aragra-s outl*e belo3 rov*e some areas for cos*erat*o. ;.!.1

Start(u Suort +l*st ava*lable ot*os,

;.!.1.1

Tra**g +l*st tra**g ot*os ava*lable,

;.!.2

Post Start(u Suort +l*st ost(startu suort ava*lable,

;.!.2.1

Tec-*cal Suort Tele-oe +)o*ce or &oem, Relacemet Parts 'va*lab*l*ty *st +#ormal lea t*mes s-all be l*ste,

;.!.2.2

User S*te Suort Prevetat*ve &a*teace +l*st ma*teace cotracts ava*lable, System Imrovemets +sul*er s-all ot*fy user of ay *mrovemets ava*lable o a regular bas*s,


Page 2/ of 26


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.!(3LOSSARY If ecessary4 attac- a glossary4 3-*c- *clues ef**t*os of terms t-at may be ufam*l*ar to t-e Sul*er or term*ology t-at may -ave mea*gs sec*f*c to etr*es o t-*s User Reu*remets C-ec8 s-eet. Aor eamle +eamle list is not intended to 1e comlete,: A5ro%ym

SC'D' S.I. #$&' RA%

"e9$%$t$o%

Suerv*sory Cotrol a Data 'cu*s*t*o Iterat*oal System of U*ts +&etr*c, #at*oal $lectr*c &aufacturers 'ssoc*at*o Reuest for %uote

P"

Purc-ase "rer

I%

Istallat*o %ual*f*cat*o

"%

"erat*oal %ual*f*cat*o

IS'

Iterat*oal Soc*ety for &easuremet a Cotrol

PSI5

Pous er suare *c- gauge

'S&$

'mer*ca Soc*ety of &ec-a*cal $g*eers

<$P'

<*g- $ff*c*ecy Part*cle 'rrestace <$P' f*ltere a*r *s .=@ free of all art*culate o3 to 0./ m*cros +*clu*g bacter*a4 fugal a ot-er oortu*st*c m*crob*olog*cal,.

°C

Degrees Cels*us

H

H*o-a9ar evel

CAR H $&I ft

Coe of Aeeral Regulat*os Dec*bels $lectro(&aget*c Iterferece Aeet

5UI

5ra-*c User Iterface

<&I

<)'C IS"


Page 2! of 26


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A5ro%ym

"e9$%$t$o%

J$TT

Jo*t $u*met Tras*t*o Team

$

o3er $los*o *m*t

"IP

"erator Iterface Pael

RAI

Ra*o Areuecy Iterferece

URS

User Reu*remet Sec*f*cat*o

)'C

)oltage 'lterat*g Curret



JETT


Page 2; of 26 Doc ID: Tablet Coater System URS Rev.0 Jue 200!

/!(REFERENCES *st refereces t-at 3ere use * rear*g t-*s ocumet or t-at rov*e a*t*oal eta*ls4 suc- as: •

$u*met )al*at*o Pla

•

Curret rev*s*o of 5'&P 5u*el*es

•

)eor P**g Cert*f*cat*o +*f al*cable,

•

Customer Coect*o D*agram

•

'rove Istrumetat*o *st

•

Process Alo3 D*agram

•

21 CAR Part 11

• •

#at*oal $lectr*c Coe S>>



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1!(APPROVAL #nsert $our coman$s standard aro)al age at the aroriate osition in the document or utili3e the samle aro)als listed 1elow. 4he aro)al rocess5re6uirements should 1e outlined in the E6uiment /alidation "lan. T-*s ocumet -as bee rev*e3e by t-e User Proect &aager a arove for use by t-e Sul*er.

Pr$%te=@Ty#e= Name

S$:%at&re

"ate

T-*s ocumet -as bee rev*e3e by t-e User %ual*ty 'ssurace 5rou a arove for use by t-e Sul*er.

Pr$%te=@Ty#e= Name

S$:%at&re

"ate

T-*s ocumet -as bee rev*e3e by t-e Sul*er Proect &aager a arove for use by t-e Sul*er Proect Team.

Pr$%te=@Ty#e= Name

S$:%at&re

"ate

"t-er arovals as ecessary may be *clue4 suc- as t-e Tec-*cal Serv*ces 5rous4 User 5rous4 $g*eer*g4 etc. as reu*re.


Tablet Coater Urs

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