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SB Pharma
USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
EQUIREMENTS USER R R EQUIREMENTS for a SATURATED STEAM AUTOCLAVE CEPHALOSPORIN BLOCK
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SB Pharma
USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
NOTES for use of the User Reu!reme"ts Tem#$ate% U#o" &om#$et!o" of the tem#$ate' (e$ete th!s #a)e #r!or to u#(at!") the Ta*$e of Co"te"ts a"( #r!"t!")+
1 Ma() area! area! of t*+! t*+! tem,-ate tem,-ate *ave !e-ect+ !e-ect+o(! o(! or ta.-e! ta.-e! t*at *ave *ave .ee( ,re,ared ,re,ared for gu+da(ce a(d ea!e of tem,-ate tem,-ate com,-et+o( Te/t Te/t +( +ta-+c! +! +! +(te(ded to .e u!ed a! (ote! to t*e U!er a(d !*ou-d .e de-eted ,r+or to ,r+(t+(g A() o,t+o(! a(d0or e/am,-e! t*at are (ot a,,-+ca.-e to t*e !,ec+f+c docume(t .e+(g created !*ou-d .e de-eted a! e-- 2 To u,date t*e t*e f+(a- Ta.Ta.-ee of Co(te(t!" Co(te(t!" ,-ace t*e t*e cur!or +(!+de +(!+de t*e !*aded !*aded area" ,re!! t*e R+g*t mou!e e)" e)" a(d !e-ect U,date 3+e-d 4 Item! Item! t*at ca( .e d+rect d+rect-) -) te!ted te!ted are are +de(t+f+ +de(t+f+ed ed +t* +t* a ∇ $ 5*ere ,o!!+.,o!!+.-e" e" t*e U!er !*ou-d !*ou-d +de(t+f) +de(t+f) t*e !ource !ource 6eg !tud+e!" !tud+e!" !ta(dard! !ta(dard!"" etc7 for t*e acce,ta.-e ra(ge! of var+a.-e! or ot*er cr+t+ca- re8u+reme(t! t*at *ave .ee( der+ved
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SB Pharma
USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
REVISION HISTOR, Re-+
Date
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Re-!s!o" Summar.
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A2
#010#1
A4
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Va-+dat+o( Rev+e
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SB Pharma
USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
TABLE OF CONTENTS /+0
INTRODUCTION++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++1
2+0
OVERVIE3++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++4
5+0 OPERATIONAL REQUIREMENTS+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++6 5+/ CAPACIT, 5+2 PROCESS R EQUIREMENTS 5+5 PROCESS CONTROL; 5+7 FUNCTIONS; 5+1 DATA AND SECURIT,12 5+4 ENVIRONMENT 1$ 7+0 CONSTRAINTS+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++/6 7+/ MILESTONES AND TIMELINES1 7+2 EQUIPMENT CONSTRAINTS 1; 7+5 COMPATIBILIT, AND SUPPORT1; 7+7 AVAILABILIT, 21 7+1 PROCEDURAL CONSTRAINTS 21 7+4 MAINTENANCE 22 1+0 LIFE8C,CLE++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++25 1+/ DEVELOPMENT24 1+2 TESTIN924 1+5 DELIVER,2$ 1+7 SUPPORT2 4+0
9LOSSAR,++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++24
6+0
REFERENCES+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++26
:+0
APPROVAL+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++2:
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SB Pharma
USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
Pro;e&t No+% I(!ert t*e u(+8ue ,ro=ect (um.er a!!oc+ated +t* t*+! ,art+cu-ar URS Do&ume"t No+% I(!ert t*e Docume(t Ide(t+f+cat+o( &um.er a(d Rev+!+o( Do&ume"t Des&r!#t!o"% I(!ert de!cr+,t+o( of docume(t" eg Saturated Steam Autoc-ave for Ster+-e Ma(ufactur+(g Su,,ort
/+0INTRODUCTION T*+! docume(t a! ge(erated u(der t*e aut*or+t) of t*e S> Pharma Va-+dat+o( Docume(t! Co(tro- for t*e ,ur,o!e of !,ec+f)+(g t*e u!er re8u+reme(t for a !aturated !team autoc-ave t*at +-- !ter+-+?e a +de ra(ge of ,roduct! +(c-ud+(g .u(g!" f+--+(g c*a(ge ,art! a(d co(tact ,art! of a do!+(g mac*+(e +( a ,*armaceut+ca- e(v+ro(me(t T*e U!er Re8u+reme(t! S,ec+f+cat+o( 6URS7 +! ,rov+ded to a+d t*e u!er t*roug* t*e +m,orta(t com,o(e(t!" var+a.-e! a(d o,t+o(! (ece!!ar) to ,rocure a fu(ct+o(a- Autoc-ave !)!tem t*at meet! t*e u!er@! (eed! +( t*e mo!t co!teffect+ve met*od ,o!!+.-e T*e URS +! t*e( ,rov+ded to t*e Su,,-+er to ,rov+de a ,r+ce 8uote for t*e !team !ter+-+?er !u,,-) +(c-ud+(g t*e de!+g( a(d ma(ufacture of t*e e8u+,me(t T*+! URS +-- .e recog(+?ed a! a( +(tegra- ,art of t*e ,rocureme(t agreeme(t +t* t*e !e-ected e8u+,me(t ve(dor T*e e8u+,me(t !u,,-+er or ve(dor +-a.+de .) t*e +(format+o( a(d co(d+t+o(! !et fort* .) t*+! docume(t a! e-- a! t*e !ta(dard ,urc*a!+(g term a(d co(d+t+o(! of t*e S> Pharma. T*e !team !ter+-+?er +-- .e +(terfaced to t*e out,ut of a v+a- a!*er a(d t*e +(,ut to a f+--+(g !)!tem T*e !team !ter+-+?er +-- .e -ocated +( a c-a!! > o,erat+(g area +t*+( a cBMP ,acag+(g o,erat+o( A( e8u+,me(t va-+dat+o( ,-a( *a! .ee( deve-o,ed to out-+(e t*e ,-a((ed ta!! a(d e/,ectat+o(! for va-+dat+o( of t*e !team !ter+-+?er T*+! ,-a( *a! .ee( +(c-uded a! Attac*me(t T*e e8u+,me(t !u,,-+er or ve(dor *a! !,ec+f+c re!,o(!+.+-+t+e! a! out-+(ed .) t*e Va-+dat+o( P-a( a(d t*+! docume(t
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SB Pharma
USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
2+0OVERVIE3 T*e +(format+o( are t*e fo--o+(g: • •
•
U!e: T*e autoc-ave +-- u!e !aturated !team to !ter+-+?e ,roduct co(tact a(d cr+t+ca- e8u+,me(t u!ed +( t*e a!e,t+c formu-at+o( a(d f+--+(g of ,are(tera- drug! Ca,ac+t) a(d0or Cr+t+ca- Attr+.ute!: Actua- c*am.er !+?e (eeded or (um.er of !,ec+f+c com,o(e(t! to ,ro,er-) !+?e t*e c*am.er 1## L T*e !)!tem mu!t ,rov+de" at m+(+mum" t*e fo--o+(g .a!+c c)c-e!: Ve(ted Saturated Steam C)c-e 17 eat+(g P*a!e 27 E/,o!ure P*a!e 47 Coo-+(g P*a!e 3orced A+r Remova- C)c-e 17 A+r Remova- P*a!e 27 eat+(g P*a!e 47 E/,o!ure P*a!e $7 E/*au!t P*a!e
7 Vacuum Dr)+(g P*a!e <7 Vacuum Re-+ef P*a!e
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SB Pharma
USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
5+0OPERATIONAL REQUIREMENTS 5+/
Ca#a&!t. •
•
Ra(ge of mater+a-!" ,roduct! or e8u+,me(t to .e !ter+-+?ed - >u(g! - SS ,art! - 3+--+(g auger! - P-a!t+c tu.+(g - B-a!! are! 1## L
3or e/am,-e for mater+a-!: -a. g-a!!are" ,-a!t+c tu.+(g" -+8u+d! +( !ea-ed g-a!! co(ta+(er!" a(d -+8u+d! +( !ea-ed ,-a!t+c co(ta+(er! 5+2
Pro&ess Reu!reme"ts
De!cr+.e t*e (um.er of door! a(d -oad+(g a(d u(-oad+(g re8u+reme(t! for t*e autoc-ave Def+(e +f t*e e8u+,me(t +-- .e f-oor or ,+t mou(ted a(d *o t*+! +-- +m,act t*e -oad+(g re8u+reme(t! De!cr+.e +( deta+- t*e re8u+reme(t! for t*e var+ou! !te,!0,*a!e! t*at are re8u+red I( eac* ,*a!e +de(t+f) t*e cr+t+ca- co(tro- re8u+reme(t! a(d var+a.-e! t*at are (eeded 3or e/am,-e: A+r Remova- P*a!e 6+f re8u+red7 - Ra(ge of vacuum 6or grav+t) o(-)7 - &um.er of vacuum ,u-!e! - T+me to atta+( vacuum - Ra(ge of vacuum *o-d t+me - Vacuum -eve3or t*e fo--o+(g ,*a!e! a-!o ,rov+de cr+t+ca- co(tro- re8u+reme(t! a(d var+a.-e!: C*arge P*a!e • E/,o!ure P*a!e • • E/*au!t P*a!e •
• •
Dr)+(g P*a!e 6+f re8u+red7 Vacuum Re-+ef P*a!e 6+f re8u+red7
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USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
Def+(e door !ea- med+um 6eg c-ea( !team or ,*armaceut+ca- a+r7 re8u+reme(t! Def+(e +f .acu, door !ea-+(g +! re8u+red
5+5
A"&!$$ar. Eu!#me"t
De!cr+.e a(c+--ar) !u,,-+ed e8u+,me(t for e/am,-e" -oad+(g cart!0tra(!fer carr+age re8u+reme(t! 5+7
Pro&ess Co"tro$
Ide(t+f) t*e cr+t+ca- ,roce!! mea!ureme(t! !uc* a! tem,erature a(d ,re!!ure 3or eac* cr+t+ca- mea!ureme(t or co(tro- dev+ce -+!t t*e: • Mea!ureme(t Ra(ge • Set,o+(t Ra(ge Parameter Co(tro- To-era(ce • If )ou de!+re !,ec+a- mo(+tor+(g !uc* a! mo(+tor+(g at !,ec+f+c -ocat+o(! +( t*e c*am.er or ,+,+(g or redu(da(t ,roce!! mea!ureme(t! +(c-ude +t +( t*+! -+!t 6for e/am,-e +(c-ude c*am.er dra+(" c*am.er -oad ,ro.e 6a(d (um.er of ,ro.e! re8u+red7" c*art recorder ,ro.e7 If t*ere are !ta(dard+?ed te!t! )ou a(t t*e !u,,-+er to ru( t*at *ave g+ve( to-era(ce! 6eg Euro,ea( &orm 2;7 -+!t t*e a,,-+ca.-e te!t! If )ou are u(!ure *at t*e !u,,-+er ,rov+de! +( t*e+r !ta(dard mode-!" *ave t*em ,rov+de t*at +(format+o( to )ou +( t*e+r re8ue!t for !u.m+tta- Note: At a minimum, list the critical, process parameters. Consider documenting how/where each of the parameter requirements was determined. 5+1
Fu"&t!o"s
41
O,erat+o( E(ter )our !,ec+f+c o,erat+o(a- re8u+reme(t! *ere • •
>a!+c co(f+gura.-e c)c-e! or ,*a!e! re8u+red &um.er of C)c-e!
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USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
•
Rec+,e ca,a.+-+t+e! 6L+(+(g of c)c-e! or ,*a!e! !e8ue(t+a--)7 Consider providing a recipe that the system must be capable of running.
•
O,erator +(teract+o( +t* t*e !)!tem De!cr+.e )our e/,ectat+o(! for e).oard" mou!e or touc* !cree( +(teract+o(
T*e fo--o+(g are e/am,-e!: T*e !)!tem !*a-- .e a.-e to ru( t*e mu-t+,*a!e c)c-e from !tart to f+(+!* +t* (o o,erator +(teract+o( re8u+red after t*e c)c-e +! ,ro,er-) +(+t+ated T*e !)!tem !*a-- .e o,erated -oca--) at t*e autoc-ave De!cr+.e t*e co(tro- !)!tem re8u+reme(t! +( term! of ma(ua-" !em+automat+c a(d automat+c o,erat+o( >e a! !,ec+f+c a! ,o!!+.-e o( *atF t*e !)!tem !*ou-d do 42
Poer fa+-ure0Recover) Poer 3a+-ure: I(!ert )our !,ec+f+c ,oer fa+-ure0recover) !c*eme *ere 3or e/am,-e: I( t*e eve(t of a ,oer fa+-ure" t*e !)!tem !*a-- ,rotect +( t*e fo--o+(g ,r+or+t): •
Per!o((e-
•
E8u+,me(t
•
Product
I( t*e eve(t of a ,oer fa+-ure t*e autoc-ave co(tro-! !*a-mec*a(+ca--) fa+- to a !tate t*at ,-ace! t*e c*am.er +( a ve(ted !tate at atmo!,*er+c ,re!!ure Recover) Met*od!: I(!ert )our !,ec+f+c ,oer fa+-ure recover) !c*eme *ere 3or e/am,-e: •
Ma(ua--) re!tart .a!ed o( o,erator +(,ut! 6O,erator +(+t+ate! ,oer recover) !e8ue(ce7
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USER REQUIREMENTS SPECIFICATION
Doc ID: Saturated SteamRev1
SATURATED STEAM AUTOCLAVE
Augu!t 19" 2#1$
•
Re!tart .a!ed o( -a!t !tate .efore -o!! of ,oer 6S)!tem ru(! t*roug* ,oer recover) !e8ue(ce *e( o,erator !tart !+g(a- +! g+ve(7
•
If t*ere +! a( automat+c .atc* re,ort+(g !)!tem" t*e +(format+o( !*a-- .e reta+(ed +( t*e eve(t of a ,oer fa+-ure 6A UPS +! re8u+red for automat+c .atc* re,ort+(g !)!tem! for data rete(t+o(7
•
A.ort or re!ume c)c-e .a!ed o( -e(gt* of ,oer fa+-ure or tem,erature dev+at+o( from !et,o+(t
Emerge(c) Sto,F I(!ert )our !,ec+f+c Emerge(c) Sto,F 6ESto,7 !trateg) a(d commu(+cat+o( !c*eme *ere 3or e/am,-e: T*e !)!tem !*a-- *ave a( ESto, mec*a(+!m de!+g(ed to !to, a-- ,*)!+ca- moveme(t of t*e e8u+,me(t +mmed+ate-) T*e ESto, mec*a(+!m6!7 !*a-- .e -ocated +( c-o!e ,ro/+m+t) to t*e autoc-ave -oad+(g a(d u(-oad+(g door!
4$
O,erator A.ortF De!cr+.e t*e re8u+reme(t! for t*e !)!tem re!,o(!e to a( o,erator +(+t+ated c)c-e a.ort De!cr+.e t*e f+(a- !tate t*e autoc-ave (eed! to .e +( at t*e co(c-u!+o( of t*e a.ort !e8ue(ce
4
A-arm! a(d 5ar(+(g!
3or e/am,-e: Cr+t+ca- A-arm! !*a-- tae act+o( automat+ca--) to !*ut t*e e8u+,me(t do( a(d (ot+f) t*e o,erator of t*e co(d+t+o(6!7 T*e o,erator !*a-- .e re8u+red to ac(o-edge t*e a-arm .efore t*e a-arm ca( .e re!et a(d t*e !)!tem re!tarted O(ce t*e a-arm +! re!et" t*e o,erator ma) re!tart t*e !)!tem Note: For a customied equipment application, include an alarm table, li!e the e"ample that follows. 3or e/am,-e:
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