Ampoule Washing Machine - New

7/25/2019 Ampoule Washing Machine - New

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User Requirement Specification

Client Name,Location

Ampoule washing machine

Revision:

Project No. !ormulations !acilit"

Project:


For


Author

Name: Initials: Date: Signature:

Reviewer


Reviewer


Approver


Table of Contents

$oc. No.: -PS)-nternational

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!ntro"uction##########################################################################################################$

%.% Responsiilit"................................................................................................../

%. Statutor" Regulation......................................................................................../

%.0 1quipment rief #escription.............................................................................&

% Process &escription############################################################################################'

.% -nput 2 C3arging.............................................................................................&

. *rief Process Steps.........................................................................................4

.0 +utput 2 $isc3arging......................................................................................5

( Pro"ucti)it* Requirement###################################################################################+

0.% $esire#6 suggeste# capacit"...........................................................................5

0. Stan#ar# atc3 si7e.........................................................................................5

0.0 C3ange +ver 8ime 9if applicale....................................................................5

0./ Cleaning..........................................................................................................5

0.& +t3er Pro#uctivit" Requirement......................................................................5$ ,perational Requirements##################################################################################-

/.% Process Control...............................................................................................(

/. !ailure ;o#e $etection...................................................................................(

/.0 -nProcess control...........................................................................................(

/./ Level of instrumentation..................................................................................=

/.& Cleaning requirement......................................................................................=

/.4 ualification Requirement.............................................................................%'

/.5 ;aterial of Construction................................................................................%'

/.( Use of luricants............................................................................................%'

/.= % C!R Part %% compliance..........................................................................%'

/.%' $ata integrit"..............................................................................................%%

/.%% *atc3 #ata #ispla" an# recor# printing.......................................................%%

/.% $esire# #ocuments....................................................................................%%


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/.%0 8raining......................................................................................................%0

/.%/ ?;P requirement 9ot3ers.........................................................................%0

' Safet* Requirement###########################################################################################$

&.% ?eneral..........................................................................................................%/

&. Power failure and recovery...............................................................................%&

&.0 Containment .............................................................................%&

. Technical requirement#######################################################################################.

4.% *asic tec3nical requirement..........................................................................%4

4. Level of automation.......................................................................................%4

4.0 Specific requirements....................................................................................%4

+ /oo" 0ngineering Practices#############################################################################+

5.% ?eneral..........................................................................................................%5

5. -nspection an# testing...................................................................................%5

5.0 Support..........................................................................................................%(- Constraints#########################################################################################################-

(.% 1quipment location an# availale space.......................................................%(

(. @vailale utilit"...............................................................................................%(

(.0 8imelines.......................................................................................................%=

1 Change 2og########################################################################################################1

3 Anne4ure#########################################################################################################1


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!ntro"uction

83e oective of t3is #ocument is to outline scope of suppl", services an# t3e minimum

requirements for a Supplier Standard system forAmpoule Washing Machine A3ic3 s3all e

operational Ait3in t3e of , ,in terms of #esign asis

an# function an# operational requirements. -t inclu#es process an# tec3nical aspects onl". 83e

folloAing requirements liste# in t3is URS are t3e minimumrequirements A3ic3 must e a##resse#

an# are not an ex3austive list.

# Responsibilit*

-t is t3e responsiilit" of BBB to Arite t3is URS.-t is t3e responsiilit" of representatives of engineering, pro#uction 6 operation an# @ of to approve t3is URS.

1.2 Statutor* Regulation

83e equipment s3oul# compl" Ait3 t3e folloAing gui#elines6 stan#ar#:

/5P Regulations

P-C6S gui#elines

D+ ?ui#elines

1U)?;P ?ui#eline Part %, @nnex %, %% 2 %&

Co#e of !e#eral Regulations 9C!R %, Part %': c?;P in ;anufacturing, Processing,

PacEing an# Dol#ing of $rugsF ?eneral

% C!R Part %%: Current ?oo# ;anufacturing Practice for finis3e# P3armaceuticals

F&A /ui"ance for !n"ustr*

Sterile $rug Pro#ucts Pro#uce# " @septic Processing

$ocumentation for Sterili7ation Process Gali#ation

/A5P


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-n)fee# conve"or: s3all e responsile for fee#ing of t3e ampoules to t3e main Aas3ing

mac3ine.

-nfee# star A3eel6 screA: @mpoules s3all e separate# 2 elevate# out of t3e conve"or 2

#elivere# to t3e revolving conve"ing s"stem.

Cleaning station: @mpoules s3all e passe# t3roug3 t3e cleaning station upsi#e #oAn 2 at t3e

in#ivi#ual station t3e spra" tues travel in s"nc3roni7ation. -nternal an# 1xternal Aas3ing of

ampoules is carrie# out Ait3 re)circulate# Aater, Purifie# Aater 2 !res3 !-. @tleast 4 Aas3ing

stations s3all e provi#e# in t3e Aas3ing mac3ine. @fter eac3 Aas3ing, #r"ing s3all e carrie#

out using filtere# compresse# air.

+utfee# star A3eel6 Aorm: @mpoules s3all e reverse# " %('H 2 engage# in t3e slots of an outfee# star A3eel 2 pus3e# acE to t3e #oAnstream tunnel in an uprig3t position.

%Process &escription

%# !nput 6 Charging

a Unwashe" ampoules: 83e ampoule Aas3ing mac3ine requires an infee# station A3ereampoules Aill e manuall" loa#e# from a tra" or conve"e# from #e)cartoning room. -n case of

manual loa#ing, ven#or s3all #esign t3e require# #imension of tra" an# infee# station, so t3at

tra" coul# effectivel" fit to t3e loa#ing station an# optimum numer of ampoules can e

c3arge# at one time.Trays shall be provided by the user.

b) Re-circulated water: !- use# in t3e final rinsing of ampoules s3all e store# an#recirculate# for initial Aas3ing of ampoules. 83e ampoule Aas3ing mac3ine s3oul# 3ave all

arrangement for recirculation of Aater. 83e recirculate# Aater s3oul# pass t3roug3 a


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# Fresh 8ater for injection 78F!9:!- s3all e use# as final Aas3ing me#ia in t3e ampouleAas3ing mac3ine. 83e ampoule Aas3ing mac3ine s3oul# e suitale to collect !- #irectl"

from t3e room suppl" valve of !- #istriution loop. 83e interface location of connecting !-

collection pipe to t3e room suppl" valve is to e #eci#e# #uring #etail engineering stage.

Vendor shall quote for


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c .

#

%#( ,utput 6 &ischarging

83e Aas3e# an# #rie# ampoules s3all e rotate# %('H after t3e final #r"ing " t3e in#ivi#ual grippers

an# place# on t3e outfee# #isc3arge s"stem. 83e Aas3e# ampoules s3all t3en e transfere# from

t3e Aas3ing mac3ine outfee# conve"or to t3e #r"ing 7one of tunnel.

(Pro"ucti)it* Requirement

(#&esire"; suggeste" capacit*83e Aas3ing mac3ine s3all e suitale to pro#uce Aas3e# ampoules at eloA mentione# capacit":

per minute of .

Vendor to quote capacity of other ampoule si&es also.

(#%Stan"ar" batch si


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$,perational Requirements

$#Process Control

a 83e equipment s3oul# 3ave facilit" for monitoring of pressure an# temperature of !- Ait3

alarm in case of loA or ver" 3ig3 temperature or pressure.

83e equipment s3oul# 3ave facilit" for monitoring of pressure of P Ait3 alarm in case of loA

or ver" 3ig3 pressure.

c 83e Aater recirculation s"stem an# Aater at3 s3all 3ave all arrangement to maintain t3e

Aater temperature more t3an &'IC an# s3all 3ave t3e facilit" for controlling an# monitoring t3e

pressure an# temperature of #eliver" Ait3 alarms in case loA or ver" 3ig3 values.

# 83e compresse# air suppl" pipeline s3oul# e provi#e# Ait3 t3e facilit" to monitor t3e pressure

of #eliver" Ait3 alarm in case of loA or ver" 3ig3 values of pressure.

e 83e equipment control s"stem s3oul# e suitale to a#ust t3e equipment spee#.

f) 83e equipment s3oul# stop in case of infee# conve"or is empt".

$#%Failure 5o"e &etection

1quipment s3all e capale to #etect t3e folloAing failure, notif" t3e operator Ait3 alarm an#

s3ut#oAn t3e process.


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a Pressure of !-6 P e"on# loA63ig3 limit

Pressure of recirculate# Aater e"on# loA6 3ig3 limit.

c 8emperature of recirculate# Aater e"on# loA63ig3 limit

# Pressure of compresse# air e"on# loA63ig3 limit

e Level of recirculation Aater tanE is ver" loA

f Continuous malfunction of Aas3ing process e.g. malfunction of ampoule clamps

g ;otor overloa#

3 -nfee# empt"

i ;aximum outfee# con#ition reac3e# at t3e inlet of tunnel

Sterili7ing tunnel elt stops

E 1mergenc" stop activate#

l Safet" ?uar# opens

m !olloAing con#ition nee# onl" notification to operator for proce#ural control

n ;alfunctioning of vapour ex3aust s"stem

$#( !n=Process control

Sampling valves should be present on the PW, WFI, Compressed air and recirculation water

line before and after filters for inprocess sampling!

4.4 2e)elof instrumentation

Sufficient an# suitale instrumentation for t3e process, safet" an# pro#uctivit" control as

in#icate# in t3e folloAing tale:

T*pe ofcontrol

PurposeRange of

measurement

&esire"2eastCount

04tent of !nstrumentation

!n"ication Alarm Control Recor"ing

8emperature8o monitor t3etemperature of

recirculate# Aater.

') %&'C %C > > N N

8emperature

8o monitor t3e

temperature of

!-.

') %&'C %C > > N N

PressurePressure of !-

suppl"% 4 Kg6cm '.% Kg6cm > > N N

Pressure Pressure of re)

circulate# Aater

% 4 Kg6cm '.% Kg6cm > > N N


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suppl"

Pressure

Pressure of

compresse# air

suppl"

% %' Kg6cm '. Kg6cm > > N N

PressurePressure of P

suppl"% 4 Kg6cm '.% Kg6cm > > N N

Level

Level of Aater in

recirculate# Aater

tanE.

N > > N

Counter

!or counting

numer of 6

ampoules

G8S G8S > N N >

> 'equired( N ot required( G8S Gen#or to specif"

$#'Control S*stem

a 83e @mpoule Aas3ing mac3ine s3oul# e full" automatic an# PLC ase# Ait3 D;- for local

operation.

PLC s3oul# e connecte# to SC@$@ softAare for printing an# to c3ecE an# control t3e real

time status of t3e equipment.

c 1quipment an# softAare s3all 3ave folloAing facilit":

1. Passwor" Polic*>es 7?9;

No 7@9

PassAor#)protecte# in#ivi#ual user accounts

PassAor# an# User -$ polic" 9-n#ivi#ual unique -$ an# PassAor#, minimum

lengt3 an# strengt3 of -$ an# PassAor#

@fter generation of user -$9user creation s"stem s3all asE for passAor# c3angeon first login.

@utomaticall" limit numer of faile# login attempts

@utomaticall" recor# unaut3ori7e# login attempts

1lectronicall" require users to c3ange t3eir passAor#s at regular intervals.

S"stem s3all asE to c3ange t3e passAor# to user perio#icall" 9at settale interval

of time " giving prior notification on eac3 logging. 8ime for prior notification

s3all e settale at user en#@utomaticall" passAor# protects computer6SC@$@ s"stems A3en i#le for s3ort

perio#s.

2. User management s*stem 6 Pri)ileges1nsure t3at t3e user level ase# on functionalit" an# aut3orit" is #efine#.


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!acilit" to create t3e groups suc3 as operator, supervisor, manager,

a#ministrator, maintenance, caliration etc an# allocation of t3eir user privileges

can e #efine# an# can e c3ange# as per requirement at site.1nsure t3at t3e privileges liEe #elete, cop", cut, paste, rename, etc. s3all not e

alloAe# to un)aut3ori7e# user.

3. 0lectronic &ata1lectronic #ata an# report s3oul# e 3uman rea#ale an# suitale for inspection

an# revieA.1nsure t3e content: Performe# " Ait3 #ate an# time stamp, Print " Ait3 #ate

an# time, RevieAe# " Ait3 #ate an# time stamp, s"stem an# anal"sis

parameter relate# information, etc.

4. 0lectronic "ata storage+nl" aut3ori7e# users can access configuration screen an# partitions of 3ar#

#isE

?enerate# #ata s3all not e e#ite# or altere#.

$ata s3oul# e save# automaticall" to pre #efine location

Progressive numer of c"cle or atc3 s3oul# reflect in atc3 or c"cle report.

5. Au"it TrailS"stem s3oul# tracE for all creations, mo#ifications, an# #eletions performe# in

t3e s"stem 9@ll activit" s3oul# e logge# etAeen login an# log out Ait3 time

an# #ate stamp along Ait3 user #etails.@ll critical 3ar#Aare relate# errors an# Aarning s3oul# e logge# in au#it trail

9S"stem au#it trail.;aintain all entere# #ata: $onMt oscure original #ata A3en c3anges are ma#e

9s3all maintain revision 3istor" for t3e c3anges ma#e.8ime an# #ate stamp c3ange automaticall", it s3all e locEe# an# not e#itale

unless performe# " aut3ori7e# user 9s3all e #efine# t3roug3 user rig3ts

#istriutionComputer6SC@$@ s"stem s3all e #esigne# in a Aa" t3at user to recor# reason

for c3ange t3roug3 use of aut3ori7e# login * passAor# to go a3ea# Ait3

c3anges.

@utomaticall" recor# i#entit" of in#ivi#ual A3o ma#e c3ange.

S"stem s3all prevent to mo#if" or #elete au#it trail.

@u#it trail #ocumentation s3all e retaine# for a perio# at least as long as t3at

require# for t3e suect electronic recor#s an# s3all e availale for agenc"revieA if require#. @tleast for & "ears.

6. 0lectronic Signature6.

1

0lectronicall* signature "ocuments ha)e following content 7Automaticall*generate983e printe# name of t3e signer.

83e #ate an# time A3en t3e signature Aas execute#.

83e meaning 9suc3 as revieA, approval, responsiilit", or aut3ors3ip associate#

Ait3 t3e signature.83e items i#entifie# in paragrap3s 4.%.%, 4.%., an# 4.%.0 of t3is section s3all e

suect to t3e same controls as for electronic recor#s an# s3all e inclu#e# as

part of an" 3uman rea#ale form of t3e electronic recor# 9suc3 as electronic


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#ispla" or printout.

6.

283e unique !& an# PassAor# for electronic signature

1lectronic signatures an# 3an#Aritten signatures execute# to electronic recor#s

s3all e linEe# to t3eir respective electronic recor#s to ensure t3at t3e

signatures cannot e excise#, copie#, or ot3erAise transferre# to falsif" an

electronic recor# " or#inar" means83e eac3 process of electronic signature s3oul# e electronicall" logge# in au#it

trail Ait3 time an# #ate stamp an# user -$.Uniqueness to e maintaine# etAeen passAor# an# !& *ot3 are same is notacceptale " s"stem.

7. &ata acBup#SoftAare s3all 3ave facilit" for auto #ata acE)up to an" client or connecte#

central server

8. ,therUser s3all not e ale to save or relocate t3e result files, it s3oul# e controlle#

t3roug3 softAare onl"User s3all not 3ave rig3ts to create fol#ers or proect in softAare t3ese rig3ts

s3all e Ait3 a#ministrator


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$#.Cleaning requirement

a Cleaning s3all e #one manuall". Recommen#e# cleaning agents are mil# alEaline solution of

so#ium 3"#roxi#e or ammonium 3"#roxi#e, 5'O -P@ an# !-.

Vendor to suggest and quote for different possible options of the same.


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$esign of equipment s3oul# en3ance cleaning feasiilit" " provi#ing minimum s3arp corners,

minimum crevices 2 smoot3 finis3e# Ael#s oints.

c Parts, A3ic3 are require# for cleaning, s3oul# e provi#e# Ait3 quicE fixing arrangement.

# @ll gasEets provi#e# to avoi# leaEage s3oul# e amenale for eas" removal 2 re) fixing.

e @ll olts, nuts on t3e exterior part of equipment Aill e Ait3 #ome nut.

f) Gen#or to provi#e suitale arrangement for #raining of Aater from t3e conve"or elt.

$#+ualification Requirement

a @ll equipments s3all e qualifie# Ait3 life c"cle approac3, i.e. $, - 2 +. Gen#or s3all

provi#e all #ocumentation support inclu#ing protocol suect to approval " t3e user.

Gen#or s3all provi#e execution support to t3e user to complete all stages of t3e qualification

report

$#-5aterial of Construction

a @ll metallic critical contact surfaces 2 critical utilit" pipelines s3oul# e constructe# of 0%4

gra#e stainless steel or etter Ait3 internal mirror surface finis3 J '.( m Ra an# external

surface matt finis3.

@ll non pro#uct contact metallic surfaces s3oul# e constructe# of 0'/ gra#e stainless steel or

etter, external surface finis3 J %. m Ra, matte finis3.

c ?asEets, seals an# +)rings coming in #irect 6 in#irect contact surfaces s3oul# e constructe#

of foo# gra#e pol"meric materials onl". -t s3oul# e temperature resistant i.e. >5'IC in case of

recirculate# Aater an# !-.

# Stainless steel farications must e Ael#e# un#er inert gas, an# treate# " picEling an#

passivation to p3armaceuticall" accepte# stan#ar#s, to prevent corrosion.

e @ll Ael#s s3all e cracE an# crevice free an# s3oul# e groun# finis3e# to J %.m Ra.

f -nternal Ael#s an# Ael#s liEel" to e in contact Ait3 t3e cleaning me#ia s3all e groun#

smoot3 an# flus3. @ll ot3er Ael#s s3all e groun# smoot3.

g @ll t3e valves 2 fittings 9if applicale installe# on t3e clean me#ia pipings s3oul# e of

3"gienic #esign. ;+C s3oul# e SS 0%4 or etter.

3 Clean me#ia pipes s3oul# e orital Ael#e#.

i 83e ;+C of safet" cainet s3all e compatile Ait3 t3e #ifferent #isinfectants use#. 83e most

preferre# one is Pol"caronate.

$#1Use of lubricants

@n" luricant, if use# in t3e equipment must e foo# gra#e an# non)toxic. Use# luricants must not

come in contact of t3e potential pro#uct contact surfaces. Lurication s"stem s3all e leaE proof


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$#3 % CFR Part compliance

83e control s"stem s3oul# 3ave a provision to connect to a % C!R part %% compliant SC@$@

softAare in t3e future.

$# &ata integrit*

S"stem securit" s3all e provi#e# to access t3e operation s"stem an# to alter configuraleparameter values t3roug3 access passAor#. S"stem securit" access s3all consist of t3e folloAing 0level passAor# protection Ait3 unique passAor#s:

a +perator= minimum %' nos.

Supervisor minimum '0 nos.

c @#ministrator '% no.

$#% atch "ata "ispla* an" recor" printing

83e D;- s3oul# e ale to #ispla" in#epen#ent atc3 recor#, A3ic3 s3oul# contain t3e folloAing:


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a Nameof Compan"

1quipment i#entification numer

c Pro#uct $etails

# @mpoule si7e

e *atc3 No

f ;ac3ine parameters Ait3 set values an# process values

g @larm ;essages

1ac3 process step of t3e equipment s3all generate online printing of t3e in#epen#ent atc3 recor#,

A3ic3 s3all contain t3e folloAing

3 Name of Compan"

i 1quipment i#entification numer

Process parameters an# operation time as start #ate Ait3 start time, en# #ate Ait3 en# time

an# total c"cle time

E @larms

l Numer of units Aas3e#

m +perator Name an# Co#e

n -#entifie# space to sign for operator 2 supervisor

o 83ere s3oul# e a possiilit" to store an# arc3ive t3e #ata for future retrieval an# anal"sis. 98o

e quote# as optional

$#( &esire" "ocuments

!olloAing #ocuments, ut not limite# to t3ese, are expecte# from t3e ven#or as part of t3e suppl"

pacEage as 3ar# cop" an# electronic e#itale version in 1nglis3 language

a 83e electronic #ocuments s3all e in t3e folloAing formats:

8extual #ocuments or# 9.#oc

$raAings @utoC@$ 9.#Ag or .#xf

!unctional#esign specification6 $esign ualification containing:

1quipment #escriptions

1quipment operation steps

D;- functions Ait3 screen s3ot

List of failure in#ications

List of interlocEs an# locE #iagram Ait3 t3eir functions an# @larms

Critical list of maor component, #evices an# instruments Ait3 t3eir specific

functions, specification #ata s3eet.


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Sc3ematic #iagram of t3e equipment

List of -nput an# +utput signals

c +peration an# maintenance manuals, preventive maintenance sc3e#ule for equipment maor

component as Aell as t3e operating s"stem

# +peration an# maintenance manuals for t3e oug3t out items

e -nstallation instructions6 gui#eline for equipment

f !inal @s)uilt #raAing for equipment

g $etaile# #raAing 9Plan an# minimum one elevation marEing clearl" all t3e necessar"

#imensions an# locations of utilities along Ait3 requirement of utilities on t3e #raAing alongAit3 t3e offer

3 +t3er #raAings 9suc3 as P2-$, electrical, instrumentation etc.

i Spare an#6 or c3ange parts list Ait3 or#ering information

;+C certificates for all #irect6 in#irect pro#uct contact surfaces

E -nstrument caliration certificates Ait3 respect to t3e traceale national reference stan#ar#

instrument an# t3eir caliration proce#ure

l !actor" acceptance test specifications an# reports Ait3 actual test results6 #ata for equipment

m Recommen#e# S+PQs for operation, cleaning an# maintenance of eac3 equipment

n ?uarant"6 Aarrant" certificates for eac3 equipment an# maor oug3t)out items, suc3 as PLC,

printer, recor#ers, instrumentation etc.

o SoftAare installation C$6 flopp" Ait3 acE)up, A3erever applicale.

p SoftAare recover" proce#ures in case of control s"stem reaE#oAn, for equipment control

s"stem.

q S3ipping c3ecElist

r $, - an# + protocols

s 8"pes of Luricant an# Lurication instructions. !oo# gra#e certificate 9if applicale.


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$#$ Training

a @ special training for operators 3as to e inclu#e# in t3e offer.

@ special training for tec3nical staff 3as to e inclu#e# in t3e offer

$#' /5Prequirement 7others9

a 83e infee# conve"or s3oul# 3ave slot for collection of fallen ampoules on t3e conve"or.

Spee# of t3e mac3ine s3oul# e settale t3roug3 t3e D;-.

c 83e connection of !-6 P collection pipe of ampoule Aas3ing mac3ine Ait3 !-6 P suppl"

valve in t3e room s3all e #etac3ale an# sanitar".

# 83e collection pipe s3oul# e provi#e# Ait3 a sampling point efore t3e point of #eliver" at

Aas3ing mac3ine.

e 83e recirculation Aater tanE s3all e completel" #rainale Ait3 #rain valve for #raining t3e

Aater. 83e sloping insi#e t3e tanE s3all e toAar#s t3e #rain point.

f 83e suppl" line s3oul# e compatile Ait3 3ot !- 9> 5'HC.

g 83e !-6 P collection pipe s3oul# 3ave sufficient slope 9minimum %O for complete

#rainage of t3e pipeline.

3 83e !-6 P collection line s3oul# not 3ave an" #ea# leg more t3an times t3e pipe

#iameter.

i 3en Aas3ing mac3ine stops, t3e mac3ine s3oul# 3ave suitale arrangement to prevent

stagnanc" of Aater in t3e collection pipeline, e.g. automaticall" close t3e room suppl" valve of

t3e #istriution pipeline or give alarm for operator intervention.

Gen#or to provi#e './& micron filter on t3e recirculate# Aater line to re#uce contamination an#

iour#en.

E !ilters on utilit" lines s3oul# e equippe# Ait3 ports for integrit" testing.

l Deating arrangement s3all e provi#e# for 3eating an# maintaining t3e temperature of

recirculating Aater aove &'IC. 8emperature sensor s3oul# e provi#e# for monitoring of t3e

same along Ait3 alarm provision.

m Level sensor s3oul# e provi#e# to control t3e level of Aater insi#e t3e recirculating Aater

storage tanE.

n 83e complete transport of t3e @mpoules from t3e last rinsing station of t3e Aas3ing mac3ine

up to t3e infee# part of t3e tunnel s3oul# e eit3er covere# 9if #istance is


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q 83e Aas3ing mac3ine s3oul# e #esigne# to prevent t3e risE of contamination from

con#ensate.

r @mpoule Aas3ing mac3ine s3oul# consistentl" remove t3e solule an# in)solule contaminant

from t3e glass ampoules A3en t3e Aas3ing process is con#ucte# Ait3in operating ranges of

t3e process parameter. as3e# @mpoules s3oul# e essentiall" free from t3e visual

particulate.

s @t t3e en# of Aas3ing c"cle, @mpoules s3oul# e free from an" Aater #roplet or Aetting A3en

c3ecEe# visuall".

t Gen#or to provi#e t3e acceptance criteria for resi#ual moisture content on ampoules after

Aas3ing.

u @ll t3e components s3oul# e laele# properl" along Ait3 proper floA #irection. 83e laelling

must e in 1nglis3 language.

'Safet* Requirement

'#/eneral

!olloAing features s3all e consi#ere# to ensure t3e safet" of personnel, process an# pro#uct.

$esign s3all also ensure no contamination of AorEing area.


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a 1quipment location s3all e appropriate to minimi7e t3e risE of acci#ent 9e.g. material floA,

process floA, personnel floA, etc....

Noise level eloA (' # at a #istance of % m from t3e equipment.

c 1mergenc" stop function on accessile areas.

# 83e outsi#e surface temperature of t3e equipment at places A3ere t3e operator ma" touc3,

s3all not excee# a temperature of /&ICF else it s3all e clearl" marEe# Ait3 safet" signs.

e arning sticEers on all 3ot surfaces an# moving parts.

f @ll electrical Airing s3all e conceale# an# proper eart3ing s3all e provi#e#.

g 83e operator s3all not e expose# to an" moving parts or 3ot surfaces #uring normaloperation.

3 @ll mac3ine #oors, A3ic3 are close# #uring pro#uction for operator safet", 3ave to e

supervise# " securit" sAitc3es. -n case of opening t3e mac3ine must stop imme#iatel".

5.2 Power failure and recovery

a +n poAer failure equipment s3all come to rest, to protect operator, equipment itself an# t3e

pro#uct 9vials.

PoAer restart must not e automatic an# 3uman intervention must e require#.

c +n poAer recover", t3e operational parameters 3ave to e retrieve# " memor" acEup

mec3anism.

5.3 Containment


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.Technical requirement

.#asictechnical requirement

a 83e la"out must e taEen into account A3en #etermining t3e la"outs of t3e units.

@ proposal of a possile installation la"out s3oul# e a##e# to t3e #ocumentation

c 83e manufacturer 3as to give t3e clear #etails on t3e #imension, total Aeig3t an# t3e capacit"

of all equipments of t3e filling line

# 83e 3eat given off " t3e unit must e state#

e 83e construction of t3e complete s"stem s3oul# e #escrie# in t3e #ocumentation in #etail

f Gen#or s3all provi#e special toolsfor assemling, #isassemling an# maintenance.

.#%2e)elof automation

a 83e equipment s3oul# operate Ait3 minimum operator involvement. 83e equipment control

panel must e provi#e# Ait3 a Duman mac3ine interface ase# on 1nglis3 language Ait3

appropriate numer 9a minimum of %' programs of recipe of all process parameters.

83e equipment s3oul# control automaticall" all critical parameter an# #etect failure mo#e

automaticall". Critical process parameters an# failure mo#es are liste# in t3e prece#ing

sections

c Duman mac3ine interface must e use# to enter t3e process #etails, A3ic3 s3oul# appear in

t3e print out. Print out must provi#e results of all critical process parameter an# failure alarms

# 83e PLC real time clocE s3oul# e s"nc3roni7e#.

e ?;P relevant parameters limits s3oul# e #efine# an# alarme#

f 83e D;- s3oul# #ispla" all t3e status parameters #uring eac3 process stage. 83e floA of

process s3all e provi#e# Ait3 t3e 3elp of arroAs. @u#io6 visual alarms s3oul# also e

visuali7e# along Ait3 fault #ispla"e#

g 83e parameter setting in t3e D;- s3oul# e in numeric onl"#

.#(Specific requirementsa -n general t3e equipment 3as to e #esigne# in a Aa" to get eas" an# quicE access to all

necessar" maintenance points e. g. pumps, motors, filters, etc.

@s a special requirement t3e mac3ine must alloA set up " tip sAitc3es Ait3 cale

c D;- s3all e touc3 screen t"pe.

# 83e mac3ine operating 3eig3t s3all e =& & mm an# t3e clearance from t3e ottom s3all

e %'')%&' mm

e 83e maEe of t3e PLC s3all preferal" e Siemens 6 @llen *ra#le"6 ;itsuis3i6 *eier

f @ll setting s3all e user a#ustale an# t3roug3 t3e control panel A3ic3ever is possile.


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g @rrangement of alternative poAer suppl" 9UPS to control an# monitoring s"stem. 9+ptional

3 Gen#or s3all provi#e special tools for maintenance of t3e equipment.

i Suppl" voltage to t3e ampoule Aas3ing mac3ine s3oul# e /%&G, &' D7.

83e Gen#or s3all ensure maintenance parts availailit" for a minimum of %& mont3s from

#eliver".

E Recirculation pump of @-S- SS 0%4L require# for recirculation of !- tanE.

+/oo" 0ngineering Practices

5.%/eneral

a 1quipment must e faricate# folloAing all ?oo# 1ngineering Practices. 83e ven#orQs ualit"

S"stem must folloA applicale national or international stan#ar#s.

Gen#or must generate all applicale #ocuments #uring all p3ases of equipment farication i.e.

#esign, farication, testing an# s3ipment as per applicale stan#ar#s e.g. ?@;P

c @ll sensors, controllers, PLC, transmitters, in#icators an# an" ot3er controller or in#icators to

rea#, print or control an" of t3e parameter, Aill 3ave to e calirate#, traceale to National or

international stan#ar#s. +riginal caliration certificate along Ait3 traceailit" to e sumitte# "

ven#or in t3eir - file.

# @ll material of construction s3oul# 3ave test certificate.

e Gen#or must generate an# provi#e all specifications an# test certificates of softAare use# in

t3e equipment control an#6or monitoring s"stem.

f @ll measuring instruments s3oul# 3ave suitale measuring range an# appropriate accurac".

83e material of sensor s3oul# also resist t3ermal loa#.

g Sensors s3oul# e provi#e# Ait3 mec3anical protection an# positione# properl" so as to

prevent #amage. -t s3oul# e feasile to #ismount, replace or calirate sensors.

3 Re)caliration of sensors s3oul# e possile.

i 83e #ea# legs in t3e pipelines s3oul# e minimi7e# 9preferre# %. an# all t3e utilit" pipelines

s3oul# e incline# toAar#s t3e Aas3ing mac3ine

@ll oints s3oul# e oritall" Ael#e#.

E Strainer s3oul# e provi#e# on t3e #rain line to prevent c3oEing.

l ;ac3ine s3oul# e eas" to maintain. 83e unit must contain necessar" protection #evices to

ensure t3at t3e equipment 2 t3e article remain in a safe con#ition.

+#%!nspection an" testing

a S"stem s3all e inspecte# an# teste# 9!@8 at t3e supplierQs site in t3e presence of userQs

representative efore #eliver".


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Performance test #uring !@8: C3ecEing of t3e %''O reliailit" of t3e mac3ine " performing 0

successful running trials for an" one ampoule si7e.

c Performance test #uring S@8: C3ecEing of t3e %''O reliailit" of t3e mac3ine " performing

t3ree successful runningtrials for all t3e availale ampoule si7es.

+#(Support

a 83e Gen#or s3all provi#e start)up services t3roug3 successful completion of t3e site

acceptance test. 83e site acceptance test Aill e a repeat of t3e factor" integration test

performe# at t3e Gen#orQs facilit".

83e Gen#or s3all provi#e a four 9/ 3our training course to tAelve 9% maintenance people on

troules3ooting an# repair of t3e s"stem.

c 83e Gen#or s3all provi#e a tAent")four 9/ 3our tec3nical support p3one numer Ait3 a

maximum of t3irt" 90' minute response time to calls requesting assistance. Support

personnel for t3is 3otline must e EnoAle#geale an# professional.

-Constraints

-#0quipmentlocation an" a)ailable space

83is equipment Aill e installe# in t3e Sterile formulations facilit".

!loor: ?roun# !loorF Room Name 2 No.: @mpoule as3ing 2 $ep"rogenation 9?!'/&

Room si7e: /4&' mm x &(&' mm 9Room la"out attac3e# as @nnex '%

-#%A)ailable utilit*

a 1lectricit": BBBBBBBBBBBBBB9Report Requirement

ater for inection:BBBBBBBBBBBBBB9Report Requirement

c Purifie# ater:BBBBBBBBBBBBBB9Report Requirement

# Compresse# air: BBBBBBBBBBBBBB9Report Requirement

Note: Gacuum s"stem to e supplie# " t3e Gen#or


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-#(Timelines

a Response to URS: it3in AeeEs of receipt of URS

uotation Sumission: it3in t3ree AeeEs of receipt of URS

c Sumission of #etail functional #esign specification, $esign ualification 9$ an# sc3ematic

#raAings: !our AeeEs after or#er finali7ation

# Sumission of !@86S@8 Specification): !our AeeEs efore !@8

e Sumission of -nstallation ualification 9- an# +perational ualification 9+ protocols ):

8Ao mont3s after or#er finali7ation

f ;ec3anical an# electrical #raAings): 8Ao AeeEs efore !@8.

g Sumission of control s"stem #etails an# control s"stem verification protocol: AeeEs efore

!@8

3 83e Supplier s3all notif" customer tAo AeeEs in a#vance of t3e start of t3e !@8

1Change 2og

&ate !nitial Re)ision Change;Comments

3 Anne4ure

Anne4ureNo#

&escription Ref# &ocument; &rawing No#

'%La"out s3oAing positioning of @mpouleas3ing mac3ine.


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Ampoule Washing Machine - New

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