PQ- 20-25°C incubator- micro biology

Heter o PERFORMANCE QUALIFICATION PROTOCOL Equip quipm ment ent Name

: B O D Inc Incubat ubato or

Equipm Equipment ent Numbe Numberr : OMBI OMBI!" !"# #

Faci$it%: Microbio$o&% Lab ' Unit(I Formu$ation Faci$it%

Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

PERFORMANCE QUALIFICATION PROTOCOL FOR B O D INCUBATOR -MICROBIOLO./ LAB ' UNIT (I FORMULATION FACILIT/0 MA1E: NE2TRONIC

Re+i3ion In,e4 Re+i3ion No5 00

O-QA008/F01-00

Date

CRN No5 NA

Rea3on *or re+i3ion New Document

Page 1 of 16

Heter o PERFORMANCE QUALIFICATION PROTOCOL Equipment Name

: B O D Incubator

Equipment Number : OMBI!"#


Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

TABLE OF CONTENT6 75!

Protoco$ Appro+a$8888888888888888888888888888888888888888888888888888)

95!

Obecti+e88888888888888888888888888888888888888888888888888888888888;

)5!

6cope88888888888888888888888888888888888888888888888888888888888888;

;5!

Equipment De3cription888888888888888888888888888888888888888888888888;

"5!

Re3pon3ibi$itie3 an, I,enti*ication o* E4ecution Team8888888888888888888888"

#5!

Te3t Proce,ure388888888888888888888888888888888888888888888888888888#

<5!

Recor,3 o* ob3er+ation88888888888888888888888888888888888888888888887;

=5!

Di3crepanc% an, Correcti+e Action Report8888888888888888888888888888887"

>5!

Compi$ation? Re+ie@ an, 6ummar% Report8888888888888888888888888888887"

7!5!

Appen,i488888888888888888888888888888888888888888888888888888888887"

75! Protoco$ Appro+a$ O-QA008/F01-00

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Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

Signing of this appo!a" page of potoco" in#icates ageement with the $ua"ification appoach #esci%e# in this #ocument& 'f an( mo#ification in the $ua"ification appoach %ecomes necessa() a e!ision though change conto" sha"" %e pepae#) chec*e# an# appo!e#& +his potoco" cannot %e e,ecute# unti" appo!e# %( fo""owing pesonne"&

Department

Name

De3i&nation

6i&nature  Date

Prepare, b% Qua"it( Assuance Re+ie@e, b% ngineeing/ Po.ects ico%io"og( Appro+e, b% Qua"it( Assuance

95! Obecti+e O-QA008/F01-00

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: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

+he pupose of this potoco" is +o po!i#e #ocumente# e!i#ence that the e$uipment is capa%"e to continuous"( maintaining the #esie# con#itions within the specifie# $ua"it( atti%utes thee%( esta%"ishing its #epen#a%i"it( +o esta%"ish sufficient #ata) to assue that the OD 'ncu%ato 'D&No3 O-'-0465 supp"ie# %( /s Newtonic $uipment ompan( Pi!ate 7imite#& o#e"& No3 N 128+SS' is suita%"e fo maintaining the #efine# specifications when opeate# in acco#ance with the esta%"ishe# stan#a# opeating poce#ue O-066& +o esta%"ish the opeating anges fo the s(stem *e( conto" paametes that po!i#e the means of assessing when the s(stem is opeating outsi#e esta%"ishe# conto" paamete "imits an# %inging the s(stem %ac* to state of conto"&

6cope +his potoco" co!es a"" aspects of Pefomance Qua"ification of OD 'ncu%ato use# in mico%io"og( "a% of 9eeto "a%s 7t#) :nit-;' fomu"ation faci"it()
)5! Equipment De3cription +he OD 'ncu%ato is supp"ie# %( /s N=+ON' Q:'PN+ OPAN> P';A+ 7''+D o#e"& No3 N 128+SS' to incu%ate the mateia" with tempeatue fom 20-24?& $uipment Name

3

OD 'ncu%ato

a*e

3

N=+ON' Q:'PN+ OPAN> P;+&7+D&

o#e"

3

N 128+SS'

S& No&

3

OD/1204

apacit(

3

@68 7it&

Operation  De3i&n *eature:

O-QA008/F01-00

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Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

A OD 'ncu%ato is #esign to maintain the tempeatue themostatica""( at the se"ecte# position& A noma" wo*ing tempeatue 20-24? is o%taine# %( positioning the themostat *no% at the position& +he tempeatue ange of the themostat is 4? to 60?& +he am%ient tempeatue at the "ocation of the OD 'ncu%ato an# the fe$uenc( an# #uation of "i# / #oo opening wi"" ha!e impact on the tempeatue in the OD 'ncu%ato& +he tempeatue conto" *no% shou"# %e a#.uste# so that) it must maintain 20-24? in the OD 'ncu%ato& ;5! Re3pon3ibi$itie3 an, I,enti*ication o* E4ecution Team ;57

Re3pon3ibi$itie3: +he goup compising of epesentati!es fom each of the fo""owing #epatments shown in the ta%"e %e"ow an# the( sha"" %e esponsi%"e fo the o!ea"" comp"iance with this potoco"& Qua$it% A33urance -(a$i,ation0 • • • • •

Pepaation of PQ potoco" Appo!a" of PQ potoco"& ,ecution of PQ potoco" a"ong with the co-o#ination of othe #epatments& e!iew of esu"ts an# compi"ing of epots& Pepaation an# appo!a" of PQ epot

Qua$it% Contro$ • •

e!iew of PQ potoco" an# epot& an powe suppot

En&ineerin& • •

;59

e!iew of PQ potoco" an# epot +echnica" suppot #uing $ua"ification stu#(

I,enti*ication o* E4ecution Team: A"" the i#entifie# e,ecutos in!o"!e# with this potoco" to eco# name) #esignation an# signatue B #ate& ;eif( the taining #etai"s in the especti!e poce#ues in!o"!e# in the potoco" efe anne,ue-1&

"5! Te3t Proce,ure3

O-QA008/F01-00

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: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

"57

: (POMB!))!!

PreRequi3ite3 Pio to con#ucting / e,ecuting the Pefomance $ua"ification potoco" fo""owing con#itions must %e fu"fi""e#3 •

•

"59

"5)

S(stem shou"# %e safe fo e,ecution& Appo!a" of Opeationa" Qua"ification epot&

PreQua$i*ication te3t •

Stan#a# Opeating Poce#ue ;eification

•

a"i%ation of a"" measuing instuments

•

a"i%ation of +est instuments

Qua$i*ication Te3t Pro&ram +he OD 'ncu%ato wi"" %e consi#ee# $ua"ifie# fo consistent an# e"ia%"e pefomance !a"i#ate#5 on successfu" comp"etion of the fo""owing tests

•

+empeatue apping of the cham%e of OD 'ncu%ato

•

Open #oo stu#(

+o $ua"if( these tests the e$uipment shou"# fu"fi" the acceptance citeia #esci%e# in the in#i!i#ua" test poce#ues& Afte comp"etion of the $ua"ification tests a"" the #ata geneate# wi"" %e compi"e# togethe to e!a"uate a%i"it( of the OD 'ncu%ato at the set paametes an# set "oa#ing patten&

O-QA008/F01-00

Page 6 of 16


: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

"5;

: (POMB!))!!

Te3t Matri4 Fo""owing test mati, is pepae# fo the initia" pefomance $ua"ification an# e!a"i#ation of OD 'ncu%ato&

Pre Qua$i*ication Te3t 65 No5

Te3t

Frequenc% 'nitia" !a"i#ation on"( / whene!e thee is an( ma.o changes ma#e

Run3

1&

SOP !eification

NA

2&

a"i%ation of easuing 'nstuments

Quate"( C 1 wee*

One

&

a"i%ation of test instument

Quate"( C 1 wee*

One

1&

+empeatue mapping - mpt( ham%e

'nitia" !a"i#ation on"( / whene!e thee is an( ma.o changes ma#e

+hee

2&

+empeatue mapping - 7oa#e# ham%e

Annua""( C 1 month

+hee

&

Open #oo stu#(

Annua""( C 1 month

One



Pe an# post ca"i%ation of #ata "ogge themocoup"es

efoe an# afte !a"i#ation

One

Qua$i*ication Te3t

Re+a$i,ation Pro&ramme

"5"

1&

+empeatue mapping - 7oa#e# ham%e

Annua""( C 1 month

One

2&

Open #oo stu#(

Annua""( C 1 month

One



Pe an# post ca"i%ation of #ata "ogge themocoup"es

efoe an# afte !a"i#ation

One

Qua$i*ication Te3t Proce,ure

O-QA008/F01-00

Page @ of 16


: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

PreQua$i*ication 6tu,% "5"5757 6tan,ar, Operatin& Proce,ure (eri*ication O%.ecti!e +o !eif( the stan#a#s opeating poce#ues e$uie# in the pefomance $ua"ification of 'ncu%ato sha"" %e of cuent e!ision& 65 No5 1 "5"5759

6OP Tit$e Poce#ue fo opeation) ca"i%ation an# c"eaning of OD incu%ato ;eification of a"i%ation of a"" measuing instuments

O%.ecti!e +o ensue that a"" the measuing instuments "iste# %e"ow ae ca"i%ate#& 65 No5 1

Item De3cription A"" sensos attache# to the instument&

Acceptance citeia3 A"" tempeatue measuing instuments sha"" %e maintaining C 1&0?c with efeence to stan#a# instument tempeatues& 'f #oes not meet the acceptance citeia sha"" %e ep"ace the measuing instument& esu"ts eco# the o%se!ations an# esu"ts in the fomat enc"ose# as Anne,ue-2& "5"575)

;eification of a"i%ation of +est instuments O%.ecti!e +o ensue that a"" the test instuments attache# to the OD 'ncu%ato is to %e ca"i%ate# %efoe an# afte !a"i#ation stu#(& 65 No5

Item De3cription

1&

A"" a##itiona" sensos P+E-100 t(pe sensos5 attache# to the #ata "ogge&

2&

Data 7ogge

Acceptance citeia3 Pe an# post ca"i%ation of a"" a##itiona" sensos P+-100 t(pe sensos5 sha"" agee to C 0&4? with efeence to stan#a# instument& 'n an( test) O-QA008/F01-00

Page 8 of 16


: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

fai"ue of themocoup"e #uing post ca"i%ation #oes not in!a"i#ate the !a"i#ation un/s po!i#e# that thee ae not moe than one themocoup"e fai"s) howe!e if at the time of fai"ue it was in the co"#est "ocation then the same un wi"" %e epeate#& 'f it was not) then accept the #ata an# ep"ace the + %efoe the ne,t un& 'f moe than one themocoup"e fai"s epeat the un) ega#"ess which + the( ae& esu"ts eco# the o%se!ations an# esu"ts in the f omat enc"ose# as Anne,ue- & Qua$i*ication 6tu,% +he fo""owing +est sha"" %e caie# out to esta%"ish the Pefomance Qua"ification of 'ncu%ato&  

"5"5957

+empeatue apping of OD 'ncu%ato Open #oo stu#(

Temperature mappin& o* empt% an, $oa,e, camber 3tu,ie3 O%.ecti!e +he intent of this stu#( is to esta%"ish unifom tempeatue #isti%ution thoughout the empt( cham%e fo the gi!en set paametes that wi"" %e use# fo !a"i#ating "oa#s in the incu%ato an# esta%"ish the sufficient #ata fo the e!i#ence& +est e$uiements  

a"i%ate# #ata "ogge& a"i%ate# P+-100 t(pe sensos&

Te3t Proce,ure3 

Disti%ute at "east 16 pe-ca"i%ate# P+-100 t(pe sensos thoughout the incu%ato cham%e Font) i##"e an# n# potions of the incu%ato cham%e5 though the access pot po!i#e# on the incu%ato as shown in the #iagam an# p"ace one senso outsi#e of the cham%e that wi"" %e monito the oom tempeatue&

O-QA008/F01-00

Page  of 16


: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :



: (POMB!))!!

'f necessa() use +ef"on tapes o an( mean to secue themocoup"es in position& nsue that the tips of themocoup"es) whee the wies ae so"#ee#) #o not touch an( meta""ic suface&



Set the paametes in the themostat is 22&4?



7ogge shou"# %e configue# so that it stats #ata "ogging afte the pesci%e# time&



eco# the tempeatues of a"" themocoup"es insi#e the cham%e thoughout the c(c"e at an inte!a" of 4 minute fo not "ess than 2 hous&



Stop eco#ing the #ata afte comp"etion of the c(c"e&



#own"oa# the "ogge# #ata an# ta*e the pint outs of the #ata an# attach with the $ua"ification epot



'#entif( the coo" an# hot points in incu%ato cham%e i&e& font) mi##"e an# en# potions5&

Locationa$ ,ia&ram o* te temperature 3en3or3

O-QA008/F01-00

Page 10 of 16


: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

12

11 6

7

1

2 15

16 10 3

8

13

14 9

4

5

3 •

,tena" tempeatue senso 3

tempeatue conto""e

LOCATION OF TEMPERATURE 6EN6OR6

O-QA008/F01-00

Page 11 of 16


: B O D Incubator



Protoco$ Number

: (POMB!))!!

E**ecti+e ,ate :

Location5 No

Location Name +op font "eft si#e of the

71

cham%e +op font ight si#e of

72

the cham%e ottom font "eft si#e of

7

the cham%e ottom font ight si#e

7

of the cham%e Font mi##"e of the

74

cham%e +op mi##"e "eft si#e of

76

the cham%e +op mi##"e ight si#e of

7@

the cham%e

Location5 No

Location Name

7

ottom mi##"e ight si#e of the cham%e

710

i##"e of the cham%e

711

+op %ac* "eft si#e of the cham%e

712

+op %ac* ight si#e of the cham%e

71

ottom %ac* "eft si#e of the cham%e

71

ottom %ac* ight si#e of the cham%e

714

%ac* mi##"e of the cham%e

ottom mi##"e "eft si#e 78

of the cham%e an#

716

nea to the conto" +D

Outsi#e of the cham%e i&e& am%ient con#ition5

Acceptance iteia +hee shou"# %e unifom #isti%ution of tempeatue within the ham%e #uing the pefomance $ua"ification stu#( an# the tempeatue at each "ocation po%e shou"# %e within the 20-24? esu"t eco# the o%se!ations an# esu"ts in the f omat enc"ose# as Anne,ue -& Summa( Attach the #ata "ogging epots of tempeatue mapping to the pefomance $ua"ification epot as Anne,ue- "5"5959

Open ,oor 6tu,% o* BOD Incubator O%.ecti!e

O-QA008/F01-00

Page 12 of 16


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Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

+he o%.ecti!e of this test is to i#entif( the impact of the tempeatue f"uctuations once afte the #oo is opene# an# the time ta*ing to attain the #esie# tempeatue in the cham%e to assess an# esta%"ish the sufficient #ata fo the e!i#ence& +est e$uiements 

a"i%ate# #ata "ogges&



a"i%ate# tempeatue sensos&

+est Poce#ues 

P"ace one tempeatue senso P+-100 t(pe sensos5 in incu%ato cham%e whee the ma,imum tempeatue eco#e# in tempeatue mapping of "oa#e# cham%e stu#ies&



P"ace one themocoup"e in outsi#e of the cham%e oom5 to monito the oom tempeatue&



'f necessa() use +ef"on tapes o an( mean to secue themocoup"es in position& nsue that the tips of themocoup"es) whee the wies ae so"#ee#) #o not touch an( meta""ic suface&



Set the paametes in the themostat is 22&4?&



Open the incu%ato #oo unti" the cham%e tempeatue senso attains fo not "ess than 24?&

 

A""ow the instument to get the #esie# tempeatue in the cham%e& "ose the incu%ato #oo afte cham%e tempeatue senso attaine# %( moe than 24?&



eco# the tempeatue senso insi#e the cham%e at an inte!a" of 1 minute unti" ma,imum tempeatue eco#e# in "oa#e# cham%e stu#(&



Stop eco#ing the #ata afte comp"etion of the c(c"e&



Down"oa# the "ogge# #ata an# ta*e the pint outs of the #ata an# attach with the $ua"ification&

O-QA008/F01-00

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: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :



: (POMB!))!!

Detemine the time ta*en %( the tempeatue senso insi#e the cham%e to attain the #esie# tempeatue an# time ta*en to each ma,imum tempeatue eco#e# in "oa#e# cham%e&





Fo outine opeations set the ma,imum #oo open a""owa%"e time an# c"ose time& Acco#ing"( impact nee# to %e assesse#&

esu"t eco# the o%se!ations an# esu"ts in the f omat enc"ose# as Anne,ue -4& Summa( Attach the #ata "ogging epots of tempeatue mapping to the pefomance $ua"ification epot as Anne,ue G 4& #5! Recor,3 o* ob3er+ation eco# the o%se!ations of afte e,ecution of each test poce#ues) in the anne,ue eco#ing of O%se!ations fo Pefomance Qua"ification5&'f an( specification is not meeting against e$uie# specification / acceptance citeia) wite NoE in the Heeting e$uiementI co"umn) specif( the #iscepanc( un#e HcommentsI an# must %e e,p"aine# in HDiscepanc( an# oecti!e Action epotI #57

Re Qua$i*ication Pefomance Qua"ification of OD 'ncu%ato sha"" %e #one once in a (ea as pe the e-!a"i#ation mati, mentione# a%o!e in this potoco"& +he $ua"ification shou"# a"so %e pefome# a##itiona""( in case of fo""owing •

An( ma.o mo#ification in e$uipment afte the "ast pefomance $ua"ification& +his must %e pope"( #ocumente# though a change conto" s(stem&

A#.ustments ma#e in the instuments) to coect the non-comp"iance of pefomance paametes with espect to specifications& $uipment inten#e# to an( othe set tempeatues& <5! Di3crepanc% an, Correcti+e Action Report •

•

Document an( #iscepancies o%se!e# #uing the pefomance $ua"ification of the e$uipment in the anne,ue& 'nc"u#e the coecti!e actions of the same& =hen a"" the O-QA008/F01-00

Page 1 of 16


: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

#iscepancies ae satisfactoi"( eso"!e# o an appo!e# action p"an is #e!e"ope# which ensues that the #iscepanc( wi"" %e eso"!e#) #ocument that the s(stem is ea#( fo ne,t step in the $ua"ification& =5! Compi$ation? Re+ie@ an, 6ummar% Report ompi"e an# e!iew that a"" test poce#ues ha!e %een comp"ete#) econci"e# an# attache# to this potoco"& ;eif( that the appo!a"s fo #e!iations if an(5 ha!e %een ta*en an# ae eso"!e# appopiate"( to the satisfaction& Pefomance Qua"ification sha"" %e consi#ee# accepta%"e when a"" the con#itions specifie# in the $ua"ification poce#ues ha!e %een met& Pepae the Pefomance Qua"ification epot as pe the SOP No& O-QA008 an# su%mit this fo e!iew an# appo!a" to the ;a"i#ation oe +eam& >5! Appen,i4 >57

Abbre+iation3 an, De*inition3 Abbre+iation

>59

Fu$$ Form

PQ

Pefomance Qua"ification

?

Degee entiga#e

SOP

Stan#a# opeating poce#ue

QA

Qua"it( Assuance

'D

'#entification

/s

esseEs

7t#&

7imite#

No&

Num%e

N

hange e$uest Note

Enc$o3ure Anne,ue 13 i#entification of e,ecution team an# taining #etai"s& Anne,ue 23 ;eification of a"i%ation of a"" measuing instuments

O-QA008/F01-00

Page 14 of 16


: B O D Incubator



Protoco$ Number

E**ecti+e ,ate :

: (POMB!))!!

Anne,ue 3 ;eification of a"i%ation of +est instuments Anne,ue 3 +empeatue mapping of OD 'ncu%ato Anne,ue 43 Open #oo stu#( >5)

Re*erence3 SOP No&3

SOP No&3 O-QA008 'nsta""ation) Opeationa" an# Pefomance Qua"ification of $uipment / 'nstument5

SOP No&3

O-066 Poce#ue fo opeation) ca"i%ation an# c"eaning of OD incu%ato5

O-QA008/F01-00

Page 16 of 16

PQ- 20-25°C incubator- micro biology

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