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USER R EQUIREMENTS SPECIFICATIONfor Capsule Filler
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TABLE OF CONTENTS
1 INTRODUCTION......................................................................................................................................
! O"ER"IE#.........................................................................................................................................$
% OPERATIONAL REQUIREMENTS.................................................................................................$.1 F!"C#IO"$.....................................................................................................................................5.2 D%#% & $'C!RI#(..........................................................................................................................8. ' ")IRO"*'"#..............................................................................................................................11
CONSTRAINTS.................................................................................................................................1!+.1 *I'$#O"'$ %"D #I*'I"'$........................................................................................................12+.2 CO*P%#I-II#(.............................................................................................................................1+
+. %)%I%-II#(...............................................................................................................................15+.+ PROC'D!R% CO"$#R%I"#$.........................................................................................................15+.5 *%I"#'"%"C'..............................................................................................................................1
$ LIFE&C'CLE.....................................................................................................................................1(5.1 D')'OP*'"#..............................................................................................................................15.2 #'$#I"/........................................................................................................................................15. D'I)'R(.....................................................................................................................................15.+ $!PPOR#........................................................................................................................................18
( )LOSSAR'........................................................................................................................................!*
+ REFERENCES...................................................................................................................................!1
, APPRO"AL........................................................................................................................................!!
OI"# '!IP*'"# #R%"$I#IO" #'%*
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RE"ISION -ISTOR'
Re. Da/e Approal Reisio0 Suar2
0 1031832005 #/P I4itial Release to '## ebsite for use.
OI"# '!IP*'"# #R%"$I#IO" #'%*
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Pro6ect "o.: 77777777777777777777777
Docue4t "o.: 77777777777777777777 Docue4t Descriptio4: Capsule Filler !ser Re9uiree4ts Descriptio4
1 INTRODUCTION
#is ;ocue4t !R$? is provi;e; to ai; te user troug te iporta4t copo4e4ts, variables a4; optio4s 4ecessar=to procure a fu4ctio4al capsule filler tat eets te user@s 4ee;s i4 te ost costAeffective eto; possible. #e !R$ is te4 provi;e; to te $upplier to provi;e a price 9uote for purcase of te
capsule filler i4clu;i4g te ;esig4 a4; a4ufacture of te e9uipe4t.
#is !R$
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! O"ER"IE#
#e capsule filler is use; to e4capsulate pro;uct >;r=3li9ui;? i4 gelati4 capsules. 'pt= capsules areloa;e; i4to te capsule opper
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.1.1.1 Capsules are to be tra4sferre; troug te capsule filler
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.1.2 Pro;uct Output
#e capsule filler sall ave a aci4e efficie4c= rate of 77777777 , as easure; b= te
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.1. %lars a4; ar4i4gs#e capsule filler sall be e9uippe;
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.2.2.1 I4terface
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.2. I4terface
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• *aci4e rate
• %lars a4; e.g. Goff,H G o4,H Gsta4;b=H states, etc.?
• Oter >specif=?
.2..2 Data Collectio4 a4; $torage Re9uiree4ts
• "o4e
%.% E0iro0e0/
..1 a=out
%llocate; floor space for te capsule filler is 7777777 i4ces specif=?
#is area is classifie; as:
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• "o4AaBar;ous
• Class I, Div II
• Class I, Div I
• Oter >specif=?
#e rati4g re9uiree4ts of te e4closures i4 tis e4viro4e4t are:
• "'*% 1
• "'*% +M
• Oter >specif=?
.. Clea4i4g
#e e9uipe4t
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OI"# '!IP*'"# #R%"$I#IO" #'%*
Date
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.! Copa/i9ili/2
+.2.1 PC Co4trollers
#e $upplier sall utiliBe 7777777777777 a4ufacture; prograable logic co4trollerstat sall i4clu;e a 7777777777777 cou4icatio4s port. #e $upplier sall provi;e;ocue4tatio4 tat te progra >ebe;;e; soft
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.% Aaila9ili/2#e capsule filler is i4te4;e; to be operate;:
• Co4ti4uousl=
• Regularl=
777777777 ours per ;a=
777777777 ours per specif=?
7777777777777777777777777777777777777777777777777777777777777777777777777
777777777777777777777777777777777777777777777777777777777777777777777777
• Operatio4 of te capsule filler sall be sut ;o
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Oter sta4;ar;s are attace;. #e $upplier sall a;ere to te i4;icate; sectio4s o4l=.
I4stallatio4, operatio4, a4; ai4te4a4ce i4structio4 ;ocue4tatio4 for te s=ste sall be;evelope; to a level tat is copree4sible b= a ig scool gra;uate.
.$ Mai0/e0a03e
+.5.1 #e capsule filler sall be ai4tai4e; o4 a sce;ule as i4;icate; b= te supplier. $upplieris to provi;e >at i4iu? te folloai4te4a4ce a4; operatio4 a4ualsof ve4;or e9uipe4t?.
+.5.1.2 % copree4sive lubricatio4 list a4; recoe4;e; lubricatio4 sce;ule.
+.5.1. % copree4sive recoe4;e; ai4te4a4ce >regular recoe4;e; i4spectio4i4tervals,
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#e F%# specificatio4 sall be subitte; to te !ser for revie< a4; approval prior to eecutio4.
% i4iu of 77777777
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• Process a4; I4strue4tatio4 Diagra >P&ID?
• I4strue4t isti4g
• Co4trol $ceatics
• Co4trol Pa4el %ssebl= Dra
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5.+.+ #ec4ical $upport
5.+.+.1 #ec4ical support sall be provi;e; via telepo4e for a perio; of 77777 =earsfollo
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( )LOSSAR'
Ta9le (.* )lossar2
A3ro02 Defi0i/io0
%$*' %erica4 $ociet= of *eca4ical '4gi4eers
CFR Co;e of Fe;eral Regulatio4s
F%# Factor= %ccepta4ce #est
/%*P /oo; %utoate; *a4ufacturi4g Practice
'## oi4t '9uipe4t #ra4sitio4 #ea
"'C "atio4al 'lectrical Co;e
"'*% "atio4al 'lectrical *a4ufacturers %ssociatio4
"FP% "atio4al Fire Protectio4 %ge4c=
OIP Operator I4terface Pa4el
O$N% Occupatio4al $afet= a4; Nealt %;i4istratio4
PC Prograable ogic Co4troller
! !4;er
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+ REFERENCES
Ta9le +.* Refere03es
Do3ue0/ A//a3:e5 /o URS ;'es < No=
'9uipe4t )ali;atio4 Pla4
Curre4t revisio4 of /%*P /ui;eli4es
)e4;or Pipi4g Certificatio4 >if applicable?
Custoer Co44ectio4 Diagra
%pprove; I4strue4tatio4 ist
Process Flo< Diagra21 CFR Part 11
"atio4al 'lectrical Co;e
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, APPRO"AL
#is ;ocue4t as bee4 revie