micro-10-qa-002[1][1]

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Surge Laboratories (Pvt.) Ltd. Quality Assurance Department

ASEPTIC PROCESS VALIDATION

PROTOCOL (Dry Powder

Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae ! o" !#

$%ere are !2 nu&bers o" 'aes in t%is Protocol.

(ontrolled w%en in Red Do Not Du'licate

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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae 2 o" !#

)e %ave reviewed t%e Ase'tic Process *alidation Protocol +icro-!0-,A-002 "or t%e Dry

Powder Injectable and "ound it acce'table.

Pre'ared * ++++++++++++++++++++++++++++ Date* +++++++++++++++

&air ubair /+icrobioloist

Revie,ed *++++++++++++++++++++++++++++ Date*+++++++++++++++

1a&ran Ati" /+anaer ,A

A''roved *++++++++++++++++++++++++++++ Date*+++++++++++++++

Asad--a&an /3+ P 4 P

A''roved *++++++++++++++++++++++++++++ Date*+++++++++++++++

+utas&a as&een /6ead o" $ec%nical 7'erations


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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae # o" !#

TALE O- CONTENTS

S. No. TITLE PAE NO.

0! 7bjective

02 nit 7'eration

0# Acce'tance (riteria

08 Re"erence

05 Process low

0 ;

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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae 8 o" !#

/ISTOR0 S1MMAR0 S/EET

S. No Nature o2 C3a4ge Page5Li4e Sig4.


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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae 5 o" !#

!." O6ECTIVE*

!.! $o validate t%at Ase'tic illin o" Dry Powder Injectable &eet all 're-establis%ed

c3+P re

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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae o" !#

9." PROCESS -LO:*


Issuance o" !00 *ials o"

bot% 250& and !000&ca'acity

2000 vials

for 500mg

1950

vials for 1000mg

)as%in 4 ?teriliation o"

*ials.

Autoclavation at 250o( "or 2

%rs

?teriliation o" illin Accessories

e. +ac%ine Parts ni"or&s

Rubber ?to''er ?.3loves 4

Dusters at !2!o( "or !%r

Asse&blin o" +ac%ine Parts

Issuance o" $?@ +edia

/0.958 1

Pre'aration o" &edia.

/#!.> in )I 4 +edia in *essel/(a'acity 50

?teriliation o" &edia at

!2!o( "or !5 &in

Issuance o" P;3 >000Powdersterilied by a&&a radiation

/ A''roCi&ately 8.81

Steri;e Process Si

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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae = o" !#

=." E#1IPMENT*

ist o" +ajor ;

5*ial ?ealin

+ac%ine08-*?-5>

*ial ?ealin

AreaP,-08-005

." MATERIAL*

+edia: $ry'tic ?oya @rot% F 0.958 1 /#0 'er iter

P;3 >000 F 8.81

3lass *ials:

#050 3lass *ial > &l "or 250& "illin o'eration.

#050 3lass *ial !5&l "or !000& "illin o'eration.

B." PROCED1RE*

Re2ere4ce*@+7-08-00 4 ?+P-08-00

B.! ISS1ANCE O- 1L*

3et issue o" sealed sterile P;3 >000 'owder /?terilied by 3a&&a Radiation "ro&

+aterial +anae&ent 4 non-sterile $?@ &edia "ro& ,( a day in advance as 'er ?7P-


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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae > o" !#

0>-,(-002 and t%en sterilie it at !2!o

( "or !5 &inutes in ?tea& ?terilier /Autoclaveo" Dry Powder Injectable Area.

?e'arately 'er"or& sterility test o" sterile P;3 >000 'owder as 'er &e&brane "iltration&et%od as 'er ?7P-0>-,(-0!8. @ioburden o" Non sterilied @rot% is to be evaluated

beside Gve and Positive /Hve test o" @rot% "or rowt% "or&ation.

B.$ :AS/IN STERILIATION O- VIALS*

)as% lass vials wit% Deionied )ater iltered Distilled )ater (o&'ressed Air /0.85 40.2 +icrons as 'er ?7P-08-005 4 ?7P-08-00> 4 sterilie t%e lass vials as 'er ?7P-08-

009. Deter&ine t%e bioburden o" was%ed vials be"ore steriliation as 'er ?7P-0>-,(-!0. (%ecE t%e sterility o" vials a"ter steriliation as 'er ?7P-0>-,(-!00. +onitor %ot air

oven by usin ?'ore ?tri' bioindicator as 'er ?7P-0>-,(-!02.

B.7 :AS/IN STERILIATION O- MAC/INE PARTS*

)as% 4 ?terilie t%e +ac%ine Parts as 'er ?7P-08-009. +onitor autoclave by usin

A&'oule bioindicatoras 'er ?7P-0>-,(-!0!.

B.8 STERILIATION O- -ILLIN ACCESSORIES*

?terilie t%e rubber 'lus uni"or&s loves 4 dusters as 'er ?7P-08-009. (%ecE t%esterility o" rubber 'lus a"ter steriliation as 'er ?7P-0>-,(-!00.

B.9 STERILIATION O- MEDIA*

Pre'are t%e @rot% as 'er ?7P-0>-,(-002 i.e #!.> "or 000 unitsJvials /5.# &l in eac%

vial in ?? container 4 sterilie it at !2! o( "or !5 &inin ?tea& ?terilier /Autoclave o"

Dry Powder Injectable Area. Per"or& 3rowt% Pro&otion test o" $?@ &ediu& as 'er?7P-0>-,(-02=.

B.= STERILE PROCESS SIM1LATION*

B.=.! All activities are 'er"or&ed under t%e direct su'ervision o" ,uali"ied Person "ro&

,A Production 4 +icrobioloy ?ection.

B.=.$ Per"or& all t%e activities in t%e s'eci"ic classi"ied areas.

B.=.7 Pre'are t%e ase'tic area as 'er ?7P-08-00!.


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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae 9 o" !#

B.=.8 Per"or& &onitorin o" Air (%anes Air *elocity o" a&inar low 6ood /6 4Pressure Di""erential as 'er ?7P-0>-,(-05>and air "low 'attern as 'er ?7P-0>-

,(-!08.

B.=.9 irst adjust Powder illin &ac%ine "or 250 & /225 - 2>>& wei%t 4 "ill

#000vials wit%/P;3 >000'owder and t%en i&&ediately "ill $?@ @rot% 5.# &l ineac% vial t%rou% Auto&atic +edia illin Nole "itted wit% co&'oundin vessel

as 'er ?7P-08-0!2. A"ter @ot% "illin 'lu 4 seal t%e container.

B.=.= Per"or& t%e "illin o" ! on t%e sa&e day a"ter cleanin 4 &o''in o" area wit%stay o" #0 &inutes in t%e 'resence o" +icrobioloist 4 ,A. Now adjust t%e

&ac%ine "or ! /900 G !!50& wei%t to "ill 'owder 4 t%en i&&ediately "ill$?@ @rot% 5.# &l in eac% vial t%rou% Auto&atic +edia illin Nole "itted wit%

co&'oundin vessel as 'er ?7P-08-0!2. A"ter @ot% "illin 'lu 4 seal t%e

container.

B.=. A"ter sealin o" vials t%e vials s%ould be inverted and s%aEe ently to ensure t%at

all internal sur"aces o" t%e vials are t%orou%ly wetted wit% t%e brot% and P;3 isdissolved in @rot% solution.

B.=.B Per"or& sterility testin o" "iltered nitroen and co&'ressed air as 'er ?7P-0>-,(-0#2.

B.=.F (%ecE t%e wei%t o" vials "or 250& and ! vial a"ter every 85&inutes as ?7P-

08-025.

B.=.!" ;C'ose t%e settle 'lates at s'eci"ied location durin "illin as 'er ?7P-0>-,(-09.

B.=.!! Per"or& swab test at rest /be"ore "illin 4 at o'erational /durin "illin as 'er

?7P-0>-,(-0>.

B.=.!$ Per"or& non-viable 'article count at rest /be"ore "illin 4 at o'erational /durin"illin as 'er ?7P-0>-,(-!0#.

B.=.!7 Per"or& viable 'article count by usin centri"ual air sa&'ler at rest /be"ore"illin 4 at o'erational /durin "illin as 'er ?7P-0>-,(-0=.


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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae !0 o" !#

B.=.!8 (%ecE t%e &icrobial status o" "iner o" o'erators a"ter "illin as 'er ?7P-0>-,(-02 t%en disin"ect i&&ediately /=0B IPA inside ??-bowl. $%is activity s%ould be

'er"or&ed outside t%e "illin roo&.

B.=.!9 (%ecE t%e &icrobial status o" clot%in o" o'erator a"ter "illin as 'er ?7P-0>-,(-

098. $%is activity s%ould be 'er"or&ed outside t%e "illin roo&.

B.=.!= $rans"er all "illed vials to ,( "or incubation and ins'ection. Incubate all vials as

in section 9.!.

B.=.! A"ter @rot% ill $rial t%orou%ly was%J clean disin"ect 4 "u&iate "or two

consecutive days as 'er ?7P-08-00! 4 ?7P-08-085

B.=.!B Now 'er"or& swab test as 'er ?7P-0>-,(-0> 4 eC'ose settle 'lates as 'er ?7P-0>-,(-09.

F." INC1ATION INSPECTION*

A"ter illin 4 ?ealin o" *ials "or 250& 4 ! trans"er all units to

+icrobioloy ?ection "or Incubation 4 Ins'ection.

irst invert t%e vials t%en incubate in strai%t 'osition.

Incubation (onditions /irst incubate at #0-#5o( "or = days and t%en incubate at

20-25o( "or neCt 0= days

re

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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae !! o" !#

Per"or& Identi"ication test "or conta&ination observed 4 t%orou% investiation"or t%e "ailure o" run as 'er ?7P "or 6andlin o" 7ut o" ?'eci"ication /77?

K?7P-0>-,A-02=L.


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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae !2 o" !#

!"." Deviatio4 C3a4ge Co4tro;*

Any Deviation /s 4 (%ane (ontrol "ro& t%e 're a''roved Protocol &ust be recordedinvestiated 4 justi"ied as 'er ?7P-0>-,A-022.

!!." Data A4a;sis *

(ollect t%e data durin eCecution o" Protocol "or all listed critical 'ara&eters 4 t%en

evaluate t%e data in t%e li%t o" acce'table criteria to conclude w%et%er t%e 'rocess isvalidated or not related "or&ats "or data collection as under:-

Sr. 4o. -or< Tit;e -or< No.

! Ase'tic *alidation Re'ort -0>-02>

2 +aterial J Product ?terility $est Re'ort -0>-00>

# +icrobial @ioburden Re'ort -0>-02

8 ?terility $estin o" Nitroen J (o&'ressed air -0>-02!

5 ;""icacy $estin o" Disin"ectants -0>-0!9

7'erators @reat%in $est -0>-022

> Pressure Di""erential +onitorin -05-0>

9 (+ +onitorin -0>-00!

!0 *ial )as%in Record -08-!!

!! ?teriliation (ycle o -08-2#

!2 InProcess (ontrol Record -08-!=

!# InProcess (ontrol Record /*ial )as%in -0>-,A-22

!8 (%ecE ist "or Dry Powder Injectable illin Area -0>-,A-058

!5 InProcess (ontrol Record /7'tical c%ecEin -0>-,A-2#! InProcess (ontrol Record /)ei%t -0>-,A-!0

!= ?ur"ace ?wab test re'ort -0>-0#=

!> ?ur"ace area &onitorin o" vial "illin area -0>-#

!9 Air "low 'attern re'ort -0>-0#0

20 Air 'article count -0>-002


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Injectable Area)

Micro!"#A""$

Revision No.: - %"&

Issue Date: 25-09-2009 Pae !# o" !#

2! A&'oule &onitorin usin a&'oule indicator -0>-02=

22 $e&' 4 6u&idity Record -0>-,A-0#!

2# @ioburden (%ecE "or A&'oules and *ials a"ter )as%in R3-,(-2

28 ?terility testin o" e&'ty vialsJa&'oulesJrubber sto''ers a"ter ?teriliation R3-,(-2>

25 +onitorin o" Dry 6eat 7ven usin ?'ore ?tri' @ioindicator R3-,(-20

2 3rowt% Pro&otion $est R3-,(-!9

2= ?terility $estin o" Nitroen and (o&'ressed Air R3-,(-29

!$." REVALIADTION

!2.! Re-validation includes:

7n 3oin ?i&ulation will be 'er"or&ed a"ter eac% siC /0 &ont%s.

A"ter +ajor (%anes in &anu"acturin 'rocedure

A"ter +ajor (%anes in t%e AreaJ6*A( ?yste&.

!7. CONCL1SION ISS1ANCE O- CERTI-ICATE

In t%e li%t o" above acce'tance criteria conclude t%at w%et%er Ase'tic illin Process is

?atis"actory or need so&e a&end&ents . ,A will issue (erti"icate o" ?uccess"ul Ase'tic

Process *alidation "or Dry Powder Injectables.

micro-10-qa-002[1][1]

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