using barrier isolators photo courtesy of nuaire for ... · inner isolator environment from the...
TRANSCRIPT
EARL
IER
THIS
YEA
R,TW
O D
OC
UM
ENTS
WER
E PU
BLIS
HED
TH
AT D
RAM
ATIC
ALL
Yaf
fect
eve
ry c
ompo
undi
ng f
acil
ity
thro
ugho
ut t
he U
nite
d St
ates
. In
Janu
ary,
the
Uni
ted
Stat
es P
harm
acop
eia
publ
ishe
d U
SP C
hapt
er <
797>
,P
harm
aceu
tica
l Com
poun
ding
—St
erile
Pre
para
tion
s, w
hich
det
ails
reg
u-la
tion
s fo
r al
mos
t ev
ery
aspe
ct o
f op
erat
ions
tha
t co
mpo
und
ster
ile
prep
arat
ions
. In
Sep
tem
ber,
the
Nat
iona
l In
stit
ute
for
Occ
upat
iona
lSa
fety
an
d H
ealt
h (N
IOSH
) pu
blis
hed
an
Ale
rt
for
Pre
ven
tin
gO
ccup
atio
nal E
xpos
ures
to
Ant
ineo
plas
tic
and
Oth
er H
azar
dous
Dru
gsin
Hea
lth
Car
e Se
ttin
gs. B
oth
of t
hese
doc
umen
ts c
onta
in e
xcel
lent
gui
d-in
g pr
inci
ples
, but
the
y do
not
con
tain
the
spe
cifi
cs t
hat
wou
ld b
e ne
ces-
sary
for
pha
rmac
ists
, te
chni
cian
s, a
nd a
dmin
istr
ator
s w
ho d
o no
t ha
veex
tens
ive
expe
rien
ce in
suc
h m
atte
rs t
o fu
lly c
ompl
y w
ith
them
. The
bar
-ri
er is
olat
or is
men
tion
ed in
bot
h do
cum
ents
as
a vi
able
eng
inee
ring
con
-tr
ol f
or t
he c
ompo
undi
ng o
f st
eril
e pr
epar
atio
ns.
In o
rder
to
prov
ide
phar
mac
y pr
ofes
sion
als
wit
h th
e kn
owle
dge
they
nee
d to
com
ply
wit
hth
ese
new
reg
ulat
ions
, th
is a
rtic
le w
ill d
iscu
ss b
arri
er i
sola
tors
in
mor
ede
pth
than
Cha
pter
<79
7> o
r th
e N
IOSH
Ale
rt.
Whi
le b
arri
er i
sola
tors
hav
e be
en u
sed
for
som
e ti
me
in t
he U
nite
dK
ingd
om, t
hey
have
onl
y re
cent
ly b
egun
to
see
mor
e w
ides
prea
d us
e he
rein
the
Uni
ted
Stat
es. C
urre
ntly
, the
re a
re n
o fo
rmal
indu
stry
sta
ndar
ds o
rfe
dera
l reg
ulat
ions
con
cern
ing
isol
ator
s. T
he g
uide
lines
tha
t do
exi
st w
ere
wri
tten
for
the
pha
rmac
euti
cal
man
ufac
turi
ng a
nd m
icro
elec
tron
ics
indu
stri
es,
and
do n
ot t
rans
late
to
the
phar
mac
euti
cal
com
poun
ding
indu
stry
ver
y w
ell.
In a
n ef
fort
to
give
som
e gu
idan
ce t
o th
e co
mpo
und-
ing
indu
stry
, th
e C
ontr
olle
d E
nvir
onm
ent
Tes
ting
Ass
ocia
tion
(C
ET
A)
rece
ntly
pos
ted
a do
cum
ent
(CE
TA
App
lica
tion
s G
uide
for
the
Use
of
Bar
rier
Iso
lato
rs i
n C
om
po
un
din
g St
eril
e P
rep
arat
ion
s in
Hea
lth
care
Fac
ilit
ies)
that
is
avai
labl
e on
the
ir w
ebsi
te.
Alt
houg
h th
e do
cum
ent
offe
rs g
uida
nce
for
com
plyi
ng w
ith
USP
Cha
pter
<79
7>, i
t do
es n
ot d
is-
cuss
mea
sure
s fo
r ha
ndlin
g th
e ha
zard
ous
drug
s th
at w
ould
fal
l und
er t
hesc
ope
of t
he N
IOSH
Ale
rt.
Bar
rier
iso
lato
rs d
iffe
rfr
om t
radi
tion
al L
amin
arA
ir-F
low
W
orkb
ench
es(L
AFW
s)
or
Bio
logi
cal
Safe
ty C
abin
ets
(BSC
s) i
nm
any
way
s.
The
m
ost
obvi
ous
diff
eren
ce i
s th
atth
e w
ork
area
in
a ba
rrie
ris
olat
or is
phy
sica
lly s
epa-
rate
d fr
om t
he s
urro
und-
ing
envi
ronm
ent;
co
m-
poun
ders
pe
rfor
m
thei
rta
sks
via
glov
es th
at a
re in
tegr
ated
into
a c
lear
vie
w s
cree
n. In
som
e ca
ses,
barr
ier
isol
ator
s of
fer
tang
ible
adv
anta
ges
over
tra
diti
onal
met
hods
. In
othe
r ca
ses,
the
adv
anta
ges
are
outw
eigh
ed b
y th
e di
sadv
anta
ges.
A c
om-
mon
con
cern
exp
ress
ed b
y th
ose
cons
ider
ing
isol
ator
s is
the
pot
enti
alim
pact
on
prod
ucti
vity
. The
re is
no
doub
t th
at w
orki
ng in
an
isol
ator
iscu
mbe
rsom
e co
mpa
red
to w
orki
ng in
a L
AFW
. Low
-out
put
faci
litie
s w
illpr
obab
ly f
ind
the
inco
nven
ienc
e m
inim
al, b
ut h
igh-
volu
me
user
s sh
ould
incl
ude
the
pote
ntia
l im
pact
on
prod
ucti
vity
in
thei
r de
cisi
on-m
akin
gpr
oces
s. I
do
beli
eve
that
the
for
ced
disc
ipli
ne o
f w
orki
ng t
hrou
gh t
he
glov
es o
f an
iso
lato
r, al
ong
wit
h th
e pr
oces
s of
ins
erti
ng a
nd r
emov
ing
prod
uct
via
the
pass
-thr
ough
, w
ill h
ave
a ve
ry p
osit
ive
effe
ct o
n as
epti
cte
chni
que.
It
is im
port
ant
to c
onsi
der
such
issu
es b
efor
e us
ing
barr
ier
iso-
lato
rs;
they
sho
uld
not
be t
houg
ht o
f as
an
“eas
y w
ay o
ut”
or a
che
apal
tern
ativ
e to
a C
lean
room
.
Mat
eria
l Tra
nsf
erW
hen
plan
ning
you
r en
viro
nmen
tal c
ontr
ols,
the
fir
st t
hing
you
sho
uld
deci
de is
how
you
are
goi
ng t
o m
ove
the
mat
eria
ls in
and
the
pro
duct
out
of th
e is
olat
or. T
radi
tion
ally
, the
re h
ave
been
two
type
s of
ase
ptic
pro
cess
-in
g is
olat
ors:
ope
nan
d cl
osed
. Clo
sed
isol
ator
s em
ploy
con
nect
ions
wit
hau
xilia
ry e
quip
men
t fo
r m
ater
ial
tran
sfer
. T
hese
sea
led
tran
sfer
dev
ices
have
sev
eral
cla
ssifi
catio
ns b
ased
upo
n th
eir
desi
gn, d
egre
e of
con
tain
men
t,ad
apta
bilit
y to
ste
riliz
atio
n, a
nd g
ener
al p
rote
ctiv
e fe
atur
es. T
hey
are
typ-
ical
ly u
sed
in a
man
ufac
turi
ng s
etti
ng. O
pen
isol
ator
s ha
ve o
peni
ngs
to th
esu
rrou
ndin
g en
viro
nmen
t th
at a
re c
aref
ully
eng
inee
red
to s
egre
gate
the
inne
r is
olat
or e
nvir
onm
ent
from
the
sur
roun
ding
roo
m v
ia o
verp
ress
ure.
M
ost
isol
ator
s us
ed f
or s
teri
le c
ompo
undi
ng a
re c
lose
r in
des
ign
toop
en i
sola
tors
in
that
the
y br
ing
prod
uct
in a
nd o
ut t
hrou
gh p
ass-
thro
ughs
ins
tead
of
thro
ugh
seal
ed,
ster
ile a
sept
ic t
rans
fer
devi
ces.
The
purp
ose
of a
pas
s-th
roug
h ch
ambe
r is
to
isol
ate
the
insi
de o
f th
e is
olat
orfr
om t
he r
oom
to
mai
ntai
n th
e in
tegr
ity
of t
he is
olat
or in
teri
or. T
he p
ass-
thro
ugh
cham
ber
desi
gn a
llow
s th
e hi
gher
air
pre
ssur
e in
the
iso
lato
rin
teri
or t
o ca
scad
e th
roug
h th
e pa
ss-t
hrou
gh c
ham
ber
and
then
out
to
the
surr
ound
ing
room
. Pro
duct
is p
lace
d in
to t
he p
ass-
thro
ugh
cham
ber
from
the
roo
m t
hrou
gh t
he o
uter
doo
r, w
hich
is t
hen
seal
ed. W
ith
prod
-uc
t in
the
pas
s-th
roug
h, t
he p
ass-
thro
ugh
spac
e is
now
“co
ntam
inat
ed”
4
Usi
ng
Bar
rier
Iso
lato
rs
for S
teri
le C
om
po
un
din
g
In s
om
e ca
ses,
bar
rier
iso
lato
rs o
ffer
tan
gib
le a
dva
nta
ges
over
tra
dit
ion
al m
eth
od
s.
By
Jam
es T
.Wag
ner
The
Phar
maG
ard
797
is a
pos
itiv
e pr
essu
re b
arri
er is
olat
or.
Photo courtesy of NuAire
5
by
the
amb
ien
t ro
om
air
an
dby
the
out
side
of
the
pack
ages
that
h
ave
bee
n
intr
od
uce
d.
Wip
ing
dow
n th
e pa
ckag
es a
ndpu
rgin
g th
e pa
ss-t
hrou
gh p
rior
to o
pen
ing
the
inte
rio
r d
oo
rw
ill h
elp
redu
ce t
he p
arti
cula
telo
ad t
hat
is t
rans
ferr
ed in
to t
heis
olat
or. I
sola
tor
man
ufac
ture
rssh
ould
pro
vide
doc
umen
tati
onre
gard
ing
the
pro
ced
ure
s an
dp
urg
e ti
mes
nee
ded
fo
r sa
fem
ater
ial t
rans
fer.
Pass
-thr
ough
s ca
n ut
ilize
uni
dire
ctio
nal a
ir, t
urbu
lent
air,
or
stag
nant
airf
low
. Bec
ause
the
pas
s-th
roug
h ca
n im
pact
ove
rall
prod
uct
cont
amin
a-ti
on, p
harm
acis
ts s
houl
d co
nsid
er th
e qu
alit
y of
roo
m a
ir w
here
the
isol
a-to
r is
loca
ted,
how
the
mat
eria
ls w
ill b
e w
iped
dow
n in
the
pas
s-th
roug
h,an
d ho
w e
ffec
tive
the
pur
ge c
ycle
will
be.
Uni
dire
ctio
nal
pass
-thr
ough
desi
gns
offe
r th
e sh
orte
st p
urge
tim
es, a
ffor
ded
by th
e si
ngle
pas
s of
HE
PAfi
lter
ed a
ir. L
onge
r pu
rge
tim
es a
re r
equi
red
for
the
turb
ulen
t fl
ow p
ass-
thro
ughs
bec
ause
con
tam
inan
ts a
re r
emov
ed th
roug
h di
luti
on r
athe
r th
anw
ashe
d aw
ay in
a f
low
of
filt
ered
air.
Sta
gnan
t ai
r pa
ss-t
hrou
ghs
offe
r no
purg
ing
of c
onta
min
atio
n pr
ior
to t
rans
ferr
ing
prod
ucts
to
the
isol
ator
.
Iso
lato
r A
irfl
ow
The
trad
itio
nal t
urbu
lent
flow
isol
ator
is b
asic
ally
a s
eale
d, v
enti
late
d bo
xw
ith
a vi
ew s
cree
n th
at p
rovi
des
acce
ss t
o th
e in
side
thr
ough
glo
ves.
Bot
hin
let
and
reci
rcul
ated
air
are
HE
PA f
ilte
red,
dil
utin
g in
teri
or a
ir w
ith
clea
n, p
arti
cula
te-f
ree
air.
The
am
ount
of
dilu
tion
tha
t ta
kes
plac
e is
dic
-ta
ted
by t
he q
uant
ity
of a
ir t
hat
is r
ecir
cula
ted.
Thi
s is
usu
ally
exp
ress
edas
Air
Cha
nges
per
Hou
r (A
CH
). T
urbu
lent
flo
w i
sola
tors
hav
e be
ende
sign
ed w
ith
as f
ew a
s 40
AC
H t
o w
ell o
ver
150
AC
H.
In a
ddit
ion
to c
onsi
deri
ng h
ow t
o pr
even
t co
ntam
inat
ion
of t
he is
ola-
tor
from
the
outs
ide,
a fu
ndam
enta
l dec
isio
n ne
eds
to b
e m
ade
abou
t how
the
cont
amin
atio
n in
side
the
isol
ator
will
be
man
aged
. An
isol
ator
nee
ds
to b
e op
en f
rom
tim
e to
tim
e fo
r m
aint
enan
ce a
nd c
lean
ing.
At
that
tim
e,th
e ai
r in
side
the
isol
ator
is a
s di
rty
as t
he s
urro
undi
ng e
nvir
onm
ent.
The
isol
ator
mus
t be
abl
e to
elim
inat
e th
is c
onta
min
atio
n. A
ddit
iona
lly, p
ar-
ticu
late
bui
ld-u
p an
d cr
oss-
cont
amin
atio
n th
at w
ill o
ccur
dur
ing
com
-po
undi
ng n
eeds
to
be c
ontr
olle
d. R
elia
nce
on d
iluti
on c
ontr
ol t
o m
anag
eth
ese
task
s is
som
ewha
t ris
ky b
ut th
e ch
ance
s fo
r su
cces
s ca
n be
impr
oved
wit
h hi
gher
air
exc
hang
e ra
tes.
Inc
reas
ing
the
amou
nt o
f H
EPA
-filt
ered
reci
rcul
ated
air
incr
ease
s th
e am
ount
of
part
icle
-lad
en a
ir t
hat
is r
emov
edby
the
air
ret
urn.
Eve
ntua
lly,
the
part
icul
ate
burd
en c
an b
e re
duce
d to
acce
ptab
le le
vels
. How
long
it s
tays
tha
t w
ay is
dep
ende
nt o
n ho
w lo
ng it
is u
ntil
mor
e pr
oduc
ts a
re b
roug
ht i
nto
the
isol
ator
and
how
wel
l th
epr
oduc
t is
cle
aned
pri
or t
o en
try.
B
ecau
se o
f a
turb
ulen
t fl
ow i
sola
tor’
s un
pred
icta
ble
part
icle
rem
oval
char
acte
rist
ics,
the
phar
mac
euti
cal m
anuf
actu
ring
indu
stry
req
uire
s a
val-
idat
ed d
econ
tam
inat
ion
proc
edur
e, t
ypic
ally
Vap
or P
hase
Hyd
roge
nPe
roxi
de (V
HP)
or
som
e ot
her
gase
ous
proc
ess,
to b
e in
pla
ce w
hen
usin
gis
olat
ors
for
ster
ile p
rodu
ctio
n. W
hile
ste
rile
com
poun
ding
isol
ator
s ty
p-ic
ally
do
not
empl
oy t
his
type
of
syst
em, s
ome
valid
ated
met
hod
for
dis-
infe
ctio
n m
ust
be in
pla
ce.
The
USF
DA
has
sho
wn
som
e su
ppor
t for
the
turb
ulen
t-fl
ow-c
ontr
olle
dis
olat
or d
esig
n co
ncep
t; h
owev
er, c
once
rns
have
bee
n ra
ised
abo
ut a
spec
tsof
the
des
ign.
In
thei
r re
cent
ly r
elea
sed
indu
stry
gui
de (
Gu
idan
ce f
or
...c
aref
ul p
lan
nin
g a
nd
str
ict
adh
eren
ce
to d
eco
nta
min
atio
n d
isci
plin
e
is a
mu
st w
hen
usi
ng
an
iso
lato
r
in s
teri
le c
om
po
un
din
g.
Turb
ule
nt
airf
low
Iso
lato
r
Un
idir
ecti
on
al Is
ola
tor
DIL
UTI
ON
CO
NTR
OL
RETU
RN
HEP
A
HEP
A
RETU
RN
FLO
W C
ON
TRO
LRE
TURN
RETU
RN
Turb
ule
nt
airf
low
Iso
lato
r
DIL
UTI
ON
CO
NTR
OL
RETU
RN
HEP
A
RETU
RN
Wit
h un
idir
ecti
onal
air
flow
,the
spe
ed o
f con
tam
inat
ion
rem
oval
is v
ery
high
.C
onta
min
atio
n re
mov
al ta
kes
long
er to
ach
ieve
wit
h tu
rbul
ent a
irflo
w.
Lam
inar
Flo
w G
love
box/
Isol
ator
Photo courtesy of Germfree Laboratories
(Con
tinue
s on
pag
e 6)
Ind
ust
ry—
Ster
ile
Dru
gP
rod
uct
s P
rod
uce
d b
yA
sep
tic
Pro
cess
ing—
Cur
rent
Goo
d M
anuf
ac-
turi
ng
Pra
ctic
e),
they
stat
e: “
Turb
ulen
t flo
w c
anbe
ac
cept
able
w
ithi
ncl
osed
iso
lato
rs,
whi
ch a
reno
rmal
ly c
ompa
ct i
n si
zean
d do
not
hou
se p
roce
ssin
glin
es.
Oth
er a
sept
ic p
roce
ss-
ing
isol
ator
s em
ploy
uni
di-
rect
iona
l air
flow
tha
t sw
eeps
ove
r an
d
away
fr
om
ex
-p
ose
d
ster
ile
mat
eria
ls,
avoi
ding
any
tur
bule
nce
orst
agna
nt a
irfl
ow in
the
are
a of
exp
osed
ste
riliz
ed m
ater
ials
, pro
duct
, and
cont
aine
r cl
osur
es.
In m
ost
soun
d de
sign
s, a
ir s
how
ers
over
the
cri
tica
lar
ea o
nce
an
d t
hen
is
syst
emat
ical
ly e
xh
aust
ed f
rom
th
e en
clo
sure
.”Is
olat
ors
used
for
com
poun
ding
ste
rile
pro
duct
s do
not
bri
ng m
ater
ials
in a
nd
ou
t th
rou
gh s
eale
d s
teri
le t
ran
sfer
dev
ices
, an
d a
re t
her
efo
recl
oser
to
an “
open
” de
sign
. A
s su
ch,
care
ful
plan
ning
and
str
ict
adhe
r-
ence
to
deco
ntam
inat
ion
disc
iplin
e is
a m
ust
whe
n us
ing
an i
sola
tor
inst
erile
com
poun
ding
.R
ecen
t in
tere
st i
n is
olat
ors,
spa
rked
by
USP
Cha
pter
<79
7>,
has
led
to t
he i
nnov
ativ
e m
arri
age
of u
nidi
rect
iona
l ai
rflo
w,
whi
ch h
as b
een
used
in
BSC
s, w
ith
barr
ier
tech
nolo
gy.
Uni
dire
ctio
nal
airf
low
pro
vide
spr
otec
tion
to
the
wor
k ar
ea w
ith
flow
ins
tead
of
dilu
tion
. Pa
rtic
ulat
e-la
den
air
is s
wep
t fr
om t
he w
ork
area
wit
h a
was
h of
HE
PA-f
ilter
ed a
ir.Fi
lter
ed a
ir w
ashe
s ov
er t
he w
ork
area
int
o th
e fr
ont
and
rear
gri
lles
.Pa
rtic
les
that
are
gen
erat
ed b
y th
e w
ork
are
imm
edia
tely
was
hed
into
the
retu
rns
and
out
of t
he w
ork
zone
. Ase
ptic
tec
hniq
ue is
fur
ther
aid
edb
y u
sin
g th
e fl
ow
of
HE
PA-f
ilte
red
air
to
iso
late
th
e w
ork
fro
m t
he
glov
ed h
and
and
to p
reve
nt c
ross
-con
tam
inat
ion
from
wit
hin
the
cham
-
6
The
bu
ffer
roo
m a
nd
th
e p
rim
ary
eng
inee
rin
g c
on
tro
l wo
rk to
get
her
to fa
cilit
ate
go
od
wo
rk p
ract
ice.
Photo courtesy of The Baker Company
The
Che
moS
HIE
LD is
a g
as-t
ight
neg
ativ
epr
essu
re c
onta
inm
ent g
love
box.
ISO
LATO
RS(C
ontin
ued
from
pag
e 5)
Fo
r m
ore
info
rmat
ion,
circ
le #
40 o
n th
e R
ead
er S
ervi
ce C
ard
ber.
The
pha
rmac
ist
can
rely
on
this
uni
dire
ctio
nal a
irfl
ow t
o as
sure
tha
tth
ere
is a
n ar
ea w
ashe
d w
ith
HE
PA-f
ilte
red,
par
ticl
e-fr
ee a
ir t
hat
wil
lre
liabl
y yi
eld
cont
amin
atio
n-fr
ee w
ork.
The
use
of
unid
irec
tion
al a
irfl
ow m
akes
it p
ossi
ble
to u
se t
he s
ame
iso-
lato
r to
com
poun
d di
ffer
ent p
rodu
cts.
Inte
rnal
cro
ss-c
onta
min
atio
n ca
n be
prev
ente
d by
em
ploy
ing
soun
d as
epti
c te
chni
que
wit
h an
und
erst
andi
ng o
f“w
orki
ng u
pstr
eam
.” P
arti
cles
gen
erat
ed b
y th
e co
mpo
undi
ng p
roce
ss a
ndth
e op
erat
or w
ill b
e ca
rrie
d to
the
ret
urns
and
rem
oved
fro
m t
he is
olat
or.
No
sour
ce o
f co
ntam
inat
ion
shou
ld e
ver
be p
lace
d be
twee
n th
e H
EPA
fil-
ter
and
the
prod
uct.
With
an
unde
rsta
ndin
g of
uni
dire
ctio
nal a
irflo
w, p
rod-
ucts
can
be
plac
ed in
an
isol
ator
to
take
adv
anta
ge o
f th
e ai
rflo
w. T
his
isth
e ba
sic
conc
ept
behi
nd w
orki
ng u
pstr
eam
.
Pre
ssu
riza
tio
nIs
olat
ors
used
for
ste
rile
com
poun
ding
are
typ
ical
lyun
der
posi
tive
pre
ssur
e re
lati
ve t
o th
e ro
om u
nles
s th
eyar
e us
ed f
or h
azar
dous
dru
gs.
In t
he e
vent
of
a le
ak i
nth
e sh
ell o
f th
e un
it, a
ir w
ill f
low
out
of
the
isol
ator
, pre
-ve
ntin
g ro
om a
ir f
rom
ent
erin
g it
. Dev
ices
use
d fo
r co
n-ta
inm
ent o
f haz
ards
are
typi
cally
und
er n
egat
ive
pres
sure
rela
tive
to
the
room
. If
the
unit
leak
s, r
oom
air
will
flo
w
7
Qua
draM
ed A
dIs
this
a P
ick-
Up?
The
Mic
roSp
here
is a
thre
e-,f
our-
glov
e,or
cus
tom
des
ign
mic
roen
viro
nmen
t.
Photos courtesy of IsoTech Design
(Con
tinue
s on
pag
e 8)
Fo
r m
ore
info
rmat
ion,
circ
le #
19 o
n th
e R
ead
er S
ervi
ce C
ard
ISO
LATO
RS(C
ontin
ued
from
pag
e 7)
into
it, p
reve
ntin
g w
hat
is in
side
fro
m le
akin
g ou
t.
Isol
ator
s us
ually
ope
rate
som
ewhe
re b
etw
een
0.05
˝ to
1.0
˝w
ater
col
umn
(w.c
.).
Uni
dire
ctio
nal
unit
s w
ill
be n
ear
the
low
er e
nd o
f th
e ra
nge
whi
le d
iluti
on c
ontr
ol u
nits
usu
ally
oper
ate
clos
er t
o th
e up
per
end.
Air
flow
in
a un
idir
ecti
onal
isol
ator
is
the
prim
ary
sepa
rato
r be
twee
n th
e pr
oduc
t an
dth
e ou
tsid
e at
mos
pher
e, t
here
fore
low
er p
ress
ure
is a
ccep
t-ab
le.
In a
tur
bule
nt f
low
uni
t, t
he p
ress
ure
diff
eren
tial
betw
een
the
isol
ator
and
the
roo
m is
the
onl
y m
eans
of
sep-
arat
ion
shou
ld a
pen
etra
tion
in
the
shel
l oc
cur.
The
refo
re,
thes
e un
its
tend
to
use
a hi
gher
pre
ssur
e di
ffer
enti
al.
Is a
bar
rier
iso
lato
r an
alt
ern
ativ
e to
a b
uff
er r
oo
m?
Muc
h ha
s be
en m
ade
of t
he U
SP C
hapt
er <
797>
sta
tem
ent,
“It
is p
re-
ferr
ed, b
ut n
ot n
eces
sary
, to
loca
te b
arri
er is
olat
ors
wit
hin
such
a b
uffe
rai
r qu
alit
y ar
ea.”
Thi
s lo
opho
le w
as le
ft in
the
doc
umen
t to
allo
w s
ome
flex
ibil
ity,
but
not
to
prom
ote
the
isol
ator
as
an a
lter
nati
ve t
o a
wel
lth
ough
t-ou
t fa
cilit
y. H
and
was
hing
, pr
oduc
t fl
ow,
and
faci
lity
clea
ning
mus
t st
ill b
e co
nsid
ered
if y
ou a
re u
sing
an
isol
ator
. The
buf
fer
room
and
the
prim
ary
engi
neer
ing
cont
rol
wor
k to
geth
er t
o fa
cilit
ate
good
wor
kpr
acti
ce. A
n is
olat
or m
ay a
llow
som
e co
nces
sion
s in
buf
fer
room
des
ign,
but
is n
ot a
n al
tern
ativ
e to
a b
uffe
r ro
om. T
he F
DA
is v
ery
clea
r on
thi
ssu
bjec
t in
the
ir g
uide
for
ase
ptic
pro
cess
ing
(Ste
rile
Dru
g P
rod
uct
sP
rodu
ced
by A
sept
ic P
roce
ssin
g—C
urre
nt G
ood
Man
ufac
turi
ng P
ract
ice)
:“A
Cla
ss 1
00,0
00 (
ISO
8)
back
grou
nd is
com
mon
ly u
sed
base
d on
con
-si
dera
tion
of i
sola
tor
desi
gn a
nd m
anuf
actu
ring
sit
uati
ons.
An
asep
tic
pro-
cess
ing
isol
ator
sho
uld
not
be lo
cate
d in
an
uncl
assi
fied
roo
m.”
Sum
mar
yB
arri
er is
olat
ors
can
be a
via
ble
opti
on a
s th
e pr
imar
y en
gine
erin
g co
ntro
lfo
r co
mpo
undi
ng s
teri
le p
rodu
cts.
Whi
le t
hey
shou
ld n
ot b
e us
ed in
stea
dof
a b
uffe
r ro
om, t
hey
may
allo
w s
ome
conc
essi
ons
in b
uffe
r ro
om d
esig
n.M
any
diff
eren
t is
olat
or d
esig
ns a
re n
ow a
vaila
ble.
Whe
n sh
oppi
ng f
or a
nis
olat
or, t
he m
ost c
riti
cal d
ecis
ion
is w
heth
er to
use
turb
ulen
t flo
w o
r un
i-di
rect
iona
l ai
rflo
w.
Com
poun
ding
of
ster
ile p
rodu
cts
is m
ost
com
mon
lyas
soci
ated
wit
h un
idir
ecti
onal
air
flow
. T
he c
riti
cal
natu
re o
f st
erile
com
poun
ding
req
uire
s a
com
mit
men
t to
qual
ity
that
mus
t be
em
brac
ed b
y th
e en
tire
com
poun
ding
sta
ff.
Con
tam
inat
ion
is a
n un
seen
ene
my
that
can
be
cont
rolle
d w
ith
prop
erfa
cilit
ies
and
tech
niqu
e. T
he n
ew e
nvir
onm
enta
l re
quir
emen
ts c
alle
d fo
rby
USP
Cha
pter
<79
7> p
rom
ise
to h
ave
a po
siti
ve e
ffec
t on
ove
rall
qual
-it
y. In
nova
tive
eng
inee
ring
con
trol
s ar
e be
ing
deve
lope
d to
mak
e th
e tr
an-
siti
on t
o m
ore
stri
ngen
t fa
cilit
y re
quir
emen
ts e
asie
r.
Jam
es T
. W
agne
r, p
rinc
ipal
of
Con
trol
led
Env
iron
men
t C
onsu
ltin
g, i
nB
ethl
ehem
, Pen
nsyl
vani
a pr
ovid
es e
xper
tise
in c
riti
cal e
nvir
onm
ents
, wit
hov
er 2
5 ye
ars
expe
rien
ce e
valu
atin
g fa
cilit
ies
used
for
ase
ptic
pro
cess
ing
as w
ell
as l
abor
ator
ies
and
man
ufac
turi
ng f
acili
ties
han
dlin
g ha
zard
ous
subs
tanc
es.
He
has
serv
ed o
n m
any
indu
stry
sta
ndar
ds w
riti
ng c
omm
it-
tees
, am
ong
them
, the
NSF
std
. 49
for
Cla
ss I
I B
iolo
gica
l Saf
ety
Cab
inet
,an
d th
e In
stit
ute
of E
nvir
onm
enta
l Sc
ienc
es a
nd T
echn
olog
y fo
r va
riou
sC
lean
room
sta
ndar
ds.
8
Ad
dit
ion
al S
ou
rces
for
Ster
ile C
om
po
un
din
g In
form
atio
n:
Co
ntr
olle
d E
nvir
on
men
t C
on
sult
ing
. . .
. . .
. . .
. . .
jimw
agn
er@
fast
.net
CET
A A
pp
licat
ion
s G
uid
e .
. . .
. . .
. . .
. . .
. .w
ww
.cet
ain
tern
atio
nal
.org
NIO
SH A
lert
. . .
. . .
. . .
.ww
w.c
dc.
gov
/nio
sh/d
ocs
/200
4-H
azD
rug
Ale
rt
USF
DA
Gu
idan
ce fo
r In
du
stry
. . .
. . .
. . .
ww
w.fd
a.g
ov/c
der
/gu
idan
ce
USP
Ch
apte
r <79
7> .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. .w
ww
.usp
.org
Wh
ere
to fi
nd
it:
The
Bak
er C
om
pan
y .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
.cir
cle
read
er s
ervi
ce #
29
Co
nta
inm
ent T
ech
no
log
ies
Gro
up
. . .
. . .
. . .
.cir
cle
read
er s
ervi
ce #
60
Ger
mfr
ee L
abo
rato
ries
. . .
. . .
. . .
. . .
. . .
. . .
. . .
circ
le re
ader
ser
vice
#70
Inn
ovat
ive
Tech
no
log
y . .
. . .
. . .
. . .
. . .
. . .
. . .
.cir
cle
read
er s
ervi
ce #
80
Iso
Tech
Des
ign
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
.cir
cle
read
er s
ervi
ce #
90
Nu
Air
e .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
.cir
cle
read
er s
ervi
ce #
100
The
Che
moS
HIE
LD c
onne
cts
to th
e ex
haus
t sys
tem
for v
enti
ng to
the
outd
oors
.
Photo courtesy of The Baker Company
The
crit
ical
nat
ure
of s
teri
le c
omp
oun
din
g
req
uire
s a
com
mit
men
t to
qua
lity
that
mus
t
be
emb
race
d b
y th
e en
tire
com
pou
nd
ing
sta
ff.