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Establish

ingof

sterility

validation

Deterio

ratio

nof

thecontaine

rs?

Prod

uct’s

change

inthenature

?

EBSterilizatio

nforp

lasticvialcontaine

rs

Effectsinthesolutio

n

Req

uire

d K

ill ra

te

Issu

es

Lyop

Lyop

Layout

ofvialfillin

gprocess

combine

dwith

EBsterilizatio

n

Filling

area

EBAirw

ashing

Containe

rsupp

ly

Isolator(VHP

decontam

ination)

EBtunn

elisinstalledbefore

thefillingprocess.

Vialsc

leaned

byairspray

forb

eing

transferredto

EBVialsa

redirectlysterilizedby

the3u

nitsEbe

ams

Filledwith

theliquidprod

uct,then

willbe

conveyed

tothe

lyop

hilizer

Pharam

aProcess20

15AirexCo

.,Ltd.

Out

view

offillin

gprocess

combine

dwith

vialEB

sterilizatio

n

VTR

Pharam

aProcess20

15AirexCo

.,Ltd.

Summeryof

theresults

UtilizingEB

Sterilizatio

nforV

ialCon

tainers

1.System

canguaran

teethedo

serate

levelo

f“

25kG

y”on

who

lesurfaceof

vialcontaine

rs2.

Anyinflu

ence

oftheEBe

amirrad

iatio

nto

the

vialcontaine

rs3.

Tokeep

Grad

eAdu

ringsterilizing

4.Speedof

vialsterilizatio

nis20

0vials/min

5.FD

Aap

proved

Pharam

aProcess20

15AirexCo

.,Ltd.

1.Th

epa

rameterstocontrolthe

EBdo

seissimply

show

nas

inbe

low

Eelectronacceleratin

gvolta

geEelectrontube

current

Obstacle’sm

ovingspeed

Obstacle’sd

istance

Lesson

sLearned

2.Lowvolta

gean

dlowcurren

tEBha

smany

advantages

asinbe

low

Inlineprocessisd

evelop

edUniform

dose

mapping

LowOzone

gene

ratio

nEasy

keep

unidire

ctionalflowandGradeA

Lead

coverisu

nnecessary

Pharam

aProcess20

15AirexCo

.,Ltd.

Evalua

tionof

tubsurface

decontam

inationto

introd

uceit

into

anasep

ticfillin

gisolator

Pharam

aProcess20

15AirexCo

.,Ltd.

Summary1

1.ThesePFSprod

uctio

nscanbe

expe

cted

togrow

upinthe

future

2.Itisacrucialissue

howto

introd

ucene

stsyrin

getubs

into

aniso

lator

3.Ithasb

eenclearn

owthat

contam

inationriskisinvolved

inifintrod

ucingthetubs

throughmou

seho

leinto

theiso

lator

with

debagging,Then

, you

need

totake

areallycareful

attentioninusingthismetho

d.4.

Ontheothe

rhand,thebe

stsolutio

nforintrodu

cing

tubs

into

aniso

latorw

ouldbe

tousetheLowvolta

geEbe

amsterilizatio

nsystem

that

canpe

rfectlydisin

fecttheou

ter

surfaceof

thetubs.

Summary2

5.Thelowvolta

geEbe

amsterilizatio

nsystem

caneasily

shieldXray,andadditio

nally

that

haslotsof

advantages

such

asthepriceandthelifetim

e.6.

Inthesedays,thisE

beam

system

hasb

eeninitiated

toapplyforthe

sterilizatio

nof

containe

rssuch

asforv

ials,

Inadditio

n,ne

wapplications

ofthissystem

forn

ewtechno

logies

likeRe

gene

rativ

emed

icine,Nan

ofilm

and

Microne

edlesa

restarted,itwou

ldbe

comeakey

techno

logy

forthe

pharmaceu

ticalmanufacturin

ginthe

future.

Para

digm

shi

ft

Ifyouha

vean

yqu

estio

ns,

please

contactm

eby

email

kawasaki@

airexx.co.jp

Than

kyouvery

much

fory

oura

tten

tion