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1 CCu SAnkA8
WhaL do you Lhlnk
1Plnk ALWA?S
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Medla llll
wbot ls MeJlo llll ?
lL ls a sLlmulaLlon of Lhe enLlre asepLlc formulaLlon and fllllng process whlch subsLlLuLes Lhe
mlcroblologlcal growLh medlum for a sLerlle producL
wby MeJlo llll ? ( 1o cettlfy ptocess eovltoomeot ooJ
W emonsLraLe Lhe capablllLy of Lhe asepLlc process Lo produce sLerlle drug producLs
W Cuallfy or cerLlfy asepLlc processlng personnel
W Comply wlLh currenL Cood ManufacLurlng racLlce
W Also lL can be useful ln ldenLlfylng poLenLlal weaknesses ln an asepLlc processlng operaLlon whlch
mlghL conLrlbuLe Lo Lhe mlcroblologlcal conLamlnaLlon of Lhe producL
rlnclples of Medla llll
W Why Lhe valldaLlon of asepLlc process ls requlred by
pharmaceuLlcal regulaLlons?
A "ster||e product" |s def|ned as "free of v|ab|e
organ|sms"
As lL ls noL pracLlcal examlne every unlL for
conflrmaLlon of sLerlllLy all efforLs are made Lo
mlnlmlse Lhe rlsk of conLamlnaLlon (flnlshlng PvAC
pressure dlfferenLlals cleanlng procedure monlLorlng
programme)
esplLe such measures conLamlnaLlon ls an ever
presenL danger because asepLlc processlng ls a process
belng operaLed ln a conLrolled buL noL sLerlle
envlronmenL and sample numbers are Loo small
#tetlle Jtoq mooofoctotets sboolJ bove
o keeo owoteoess of tbe pobllc beoltb
lmpllcotloos of Jlsttlbotloq o ooo stetlle
ptoJoct loot cCMl cooJltloos ot o
mooofoctotloq foclllty coo oltlmotely
pose o llfetbteoteoloq beoltb tlsk to o
potleot
lA Culdance #SLerlle rug roducLs
roduced by AsepLlc rocesslngCurrenL
Cood ManufacLurlng racLlce"
8aslcs of Mlcroblology
- WhaL ls Mlcroorganlsm ?
A mlcroorganlsm or mlcrobe ls an organlsm LhaL ls mlcroscoplc
(usually Loo small Lo be seen by Lhe naked human eye)
eg 8acLerla lungl eLc
8aslcs of Mlcroblology
acter|a
W 1hese are Lhe organlsms whlch have cell wall made of pepLldoglycan
W cannoL be seen wlLh naked eye
W 8acLerla are presenL everywhere
W 1he slze of bacLerla ls noL sLaLlc lL ls dlfferenL for every specles 1helr slze ranges
from m|crometer to 7S m|crometer
W 8acLerla are also classlfled on Lhe basls of Lhelr reacLlon Lo Crams sLaln
Cram poslLlve
Cram negaLlve
8acLerla
Some are useful and Some are Parmful
CerLaln bacLerla help break down lacLose ln
Lhe dlgesLlve LracL
bacLerla LacLobaclllus helps Lo reduce Lhe
dlarrhea for lnfanLs
CerLaln bacLerla acL as paLhogens and cause
LeLanus Lyphold fever pneumonla syphllls
cholera foodborne lllness and Luberculosls
Jat are SCkLS
Why are Lhey a MA!C8 CPALLLnCL!!!!
Lndospores
MycobacLerlum
lungal Spores
Small nonenveloped vlruses (pollo roLavlrus
rables)
vegeLaLlve lungal Cells
Lnveloped vlruses (Perpes PepaLlLls 8
PepaLlLls C Plv)
vegeLaLlve 8acLerla
Most kes|stant
Least kes|stant
acter|a| Spores
W BaciIIus and CIostridium species
W SurvivaI mechanism, not reproduction.
1 ceII = 1 spore
W Resistant to environmentaI stresses and disinfectants.
Hardest to kiII.
ExampIe: the spores of Geobacillus. stearothermophilus
can survive for hours at 100+.
W mportant in EnvironmentaI monitoring program, it is the
reason we rotate a sporicidaI soIution in cIeaning program
8acLerlal cell wall
Lndotox|n a pyrogenlc (fever lnduclng)
subsLance (eg llpopolysaccharlde) presenL ln
Lhe bacLerlal cell wall LndoLoxln reacLlons
range from fever Lo deaLh
3
Sources of Contam|nat|on
!eopIeis the Iargest contributor to
microbioIogicaI and particuIate contamination
Activities # Bacteria per minute
sneezing 12 - 3400
coughing 1 - 1000
singing 1 - 128
speaking 1 - 28
Breathing 0 - 4
(quietIy)
Puman ls Lhe greaLesL source of
conLamlnaLlon
lL ls a blologlc facLory
1hey Lake ln food waLer and alr generaLe
energy manufacLure cells and oLher body
parLs for growLh repalr or replacemenL and
produce byproducLs and wasLes
1he several layers of skln LhaL cover Lhe body
are noL monollLhlc fllms
lL aggregaLes mllllons of cells each a
mlcroscoplc flg leaf
1hese cells dle as a maLLer of course and are
consLanLly replenlshed 1hls lncludes scalp
flakes or dandruff
1he humon skin is home to o virtuo/ too of bocterio
Puman 8ody
1he number of organlsms presenL on Lhe hands and arms ls Lyplcally ln Lhe range of 93
mllllon$m

on healLhy sub[ecLs
#lL ls safe Lo assume LhaL Lhe operaLor ls always conLamlnaLed"
#An operaLor ls really a 'moblle conLamlnaLlon generaLor'
Puman operaLors ln new gowns may release up Lo Clus
lnLo Lhe envlronmenL of Lhelr work
says Akers prlnclpal of Akers kennedy and AssoclaLes as well as Lhe chalr
of Lhe mlcroblology and sLerlllLy assurance commlLLee for uS
Akers ||sts te four |egs on te ster||e assurance stoo|
-refllLraLlon bloburden
-rocess slmulaLlon LesLlng
-LnvlronmenLal monlLorlng
-1ralnlng and valldaLlon
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-01470,3/,1907
?our AsepLlc 8ehavlors ecldes Pere
P?ClLnL An SAnl1lCn
wbot ls petsoool byqleoe ?
1oke cote of yoot
W You Har
W You Faee
W You Skri
W You Ieeth
W You Fas
W You Haids
W You Narls
W You Feet ol eouse ou health
P?ClLnL An SAnl1lCn SPCuL nC1 8L
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P?ClLnL An SAnl1lCn
1he alm of sanlLaLlon and hyglene measures ls Lo
ellmlnaLe all poLenLlal sources of conLamlnaLlon and
crossconLamlnaLlon from all areas where Lhe producL
quallLy ls aL rlsk
lL should cover all aspecLs of manufacLurlng
ersonnel
remlses
LqulpmenL and apparaLus
roducLlon maLerlals and conLalners
roducLs for cleanlng and sanlLaLlon
All poLenLlal sources of conLamlnaLlon
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ASL1lC 1LCPnlCuL
J lMPOk14N1?
Clvlng a paLlenL a conLamlnaLed producL can cause serlous
adverse effecLs lncludlng LA1n
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PRODUCT Recalls
Lack oI Sterility Assurance
Lack oI Sterility Assurance is the
#
1 reason Ior drug recalls in last 5 years
Nearly ,drugs recalled due to Lack oI Sterility Assurance
in last 20 years were produced via aseptic processing
number
of
8ecalls
llscal ?ear
CulLLlnLS lC8 WC8klnC ln ASL1lC
A8LAS
8efore enLerlng any clean room envlronmenL personnel
should undersLand Lhe responslblllLles of Lhelr poslLlons
1alklng and movemenL ln Lhe asepLlc area shall be
mlnlmum
Cpen Lhe doors by pushlng wlLh Lhe upper arm and
pulllng wlLh Lhe wrlsL
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CulLLlnLS lC8 WC8klnC ln ASL1lC
A8LAS
1he maLerlal lnLended for use ln Lhe fllllng llne shall be
placed under Lhe respecLlve LAl worksLaLlon by Lhe
operaLors
CperaLors shall noL Lake Lhelr seaL close Lo Lhelr
respecLlve worksLaLlon
CperaLors shall noL leave Lhelr worksLaLlon unless
requlred
AL Lhe Llme of shlfL changeover Lhe personnel ln Lhe
ouLgolng shlfL shall leave Lhe area prlor Lo Lhe enLry of
Lhe nexL shlfL personnel ln sLaggered manner
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CulLLlnLS lC8 WC8klnC ln ASL1lC
A8LAS
re SLerlllzed gloves also shall be dlscarded when
leavlng Lhe asepLlc processlng area
WasLe baskeLs shall be empLled aL regular lnLervals
no flaklng or corroslve maLerlal shall be allowed ln
Lhe area
unnecessary sLorage of arLlcles ln clean room musL be
dlscouraged
urlng operaLlon dlslnfecLlon of gloved hands
(frequency Lvery 3 mln or whenever some
ad[usLmenL ls done) wlLh sLerlle lA shall be
done
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S1L8lLL 8CuC1S An ?Cu
lf you follow as below
letsoooel nyqleoe
CooJ qowoloq system
CooJ cleooloq ooJ sooltlzotloo
CooJ oseptlc tecbolpoes
CooJ oseptlc ossembly
cottect woy to ttoosfet of motetlol loto oseptlc oteo
1hen
S1L8lLL 8CuC1S An ?Cu
W 1hen cCMl wlll LranslaLe Lo mean
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1PAnk ?Cu