N

Institution
Laboratory name
Location
Head/Responsible person
Standard Operating Procedure (SOP)
Fumigation of a biological safety cabinet
ode!
"ersion! no#
$ate! of release
Page ! 1 of 6
Content
1. Scope
2. Definitions and abbreviations
3. Personnel pre-qualifications
%#& 'edical fitness
%#( )ducation and training
. Procedure
*#& Principle
*#( Samples
*#% )+uipment and materials
*#* Reagents and solutions
*#, $etailed instructions
*#- Reporting
*#. /uality control
*#0 1aste management and safety precautions
!. "elated documents
6. "ationale for c#an$e of S%P version
ompiled by )2amined by 3ppro4ed by Replaced Ne5 4ersion
Name ode! ode!
$ate
Signature
Laboratory area! No of copies! Reason for c6ange!
N
Institution
Laboratory name
Location
Head/Responsible person
Standard Operating Procedure (SOP)
Fumigation of a biological safety cabinet
ode!
"ersion! no#
$ate! of release
Page ! 2 of 6
1. Scope
76is SOP describes t6e procedure for fumigating a biological safety cabinet (8S) in
78 laboratories# It is strongly recommended t6at t6is 6ig6ly speciali9ed procedure be
performed by a certified professional#
Fumigation of t6e 8S is re+uired before!
replacement of H)P3 filters:
release of t6e 8S for use after a ma;or bio6a9ardous spill:
repair 5or< re+uiring access to t6e sealed plenum:
ser4ice or replacement of t6e circulation fan or components:
maintenance 5or< in contaminated areas:
performance tests re+uiring entry into contaminated areas:
mo4ement of t6e 8S cabinet to anot6er laboratory:
c6anging 5or< programmes= e#g# to non>78 5or<:
release of t6e 8S cabinet for resale or sal4age#
2. Definitions and abbreviations
formalin
3 commercially a4ailable %-?*@A solution of formalde6yde 4apour in 5ater#
incident
3n e4ent t6at gi4es rise to an accident or 6as t6e potential to lead to an accident#
accident
3n undesired e4ent gi4ing rise to deat6= ill>6ealt6= in;ury= damage= loss or
distress#
8S! biological safety cabinet
FFP ! filtering facepiece particles
H)P3! 6ig6>efficiency particulate air
N3! not applicable
ppm! parts per million
3. Personnel pre-qualifications
3.1 Medical fitness
In accordance 5it6 national la5s and practices= arrangements s6ould be made for
appropriate 6ealt6 sur4eillance of 78 laboratory 5or<ers!
before enrolment in t6e 78 laboratory:
at regular inter4als t6ereafter:
after any bio6a9ard incident= annually or bi>annually:
at t6e onset of 78 symptoms#
Ideally= indi4idual medical records s6all be <ept for up to &@ years follo5ing t6e end of
occupational e2posure#
N
Institution
Laboratory name
Location
Head/Responsible person
Standard Operating Procedure (SOP)
Fumigation of a biological safety cabinet
ode!
"ersion! no#
$ate! of release
Page ! 3 of 6
Laboratory 5or<ers s6ould be educated about t6e symptoms of 78 and pro4ided 5it6
ready access to free medical care if symptoms arise#
onfidential HI" counselling and testing s6ould be offered to laboratory 5or<ers#
Options for reassignment of HI">positi4e or immuno>suppressed indi4iduals a5ay
from t6e 6ig6>ris< areas of t6e 78 laboratory s6ould be considered#
3ll cases of disease or deat6 identified in accordance 5it6 national la5s and/or
practice as resulting from occupational e2posure to biological agents s6all be notified
to t6e competent aut6ority#
8ecause of t6e 6ig6 ris< of infection associated 5it6 t6is procedure= it s6ould
preferably be carried out only by persons o4er &0 years of age= 56o are not pregnant
and 56o 6a4e no immunodeficiency of any cause (genetic disorder= infection=
immunosuppressi4e t6erapy)#
3.2 Education and training
76e certified professional 56o underta<es fumigation of t6e 8S s6ould 6a4e
appropriate education and aut6ori9ation t6roug6 6is or 6er o5n company# S6ould a
certified professional not be a4ailable= t6e tec6nician performing t6e procedure
s6ould recei4e education and training on t6e follo5ing topics!:
potential ris<s to 6ealt6 (symptoms of 78 disease and transmission):
6ygiene re+uirements:
5earing and use of protecti4e e+uipment and clot6ing:
6andling of potentially infectious materials:
5aste 6andling:
pre4ention of incidents and steps to be ta<en by 5or<ers in t6e case of
incidents (bio6a9ard incidents= c6emical= electrical and fire 6a9ards):
laboratory design= including airflo5 conditions:
6andling of 6a9ardous c6emicals:
countermeasures to be ta<en in case of une2pected e4ents#
76e training s6all be!
gi4en before t6e staff member ta<es up 6is/6er post
strictly super4ised:
adapted to ta<e account of ne5 or c6anged conditions:
repeated periodically= preferably e4ery year#
76e procedure must be performed under t6e close super4ision of a senior
professional before t6e trainee is allo5ed to practise alone#
. Procedure
4.1 Principle
Fumigation 5it6 formalde6yde 4apour is an e2tremely effecti4e bactericidal
procedure# 1ater 6as to be added to t6e formalin prior to 4apori9ation since 5ater
4apour generated in t6e process of dispersing formalde6yde pro4ides t6e optimum
le4el of relati4e 6umidity (minimal .@A) essential for t6e effecti4eness of t6e
fumigation met6od#
N
Institution
Laboratory name
Location
Head/Responsible person
Standard Operating Procedure (SOP)
Fumigation of a biological safety cabinet
ode!
"ersion! no#
$ate! of release
Page ! of 6
4.2 Samples
N3
4.3 Equipment and materials
8S ducted to t6e outside# If t6e 8S is 4ented to t6e outside t6roug6 a t6imble=
manufacturerBs safety measures s6ould be carefully follo5ed to seal t6e 8S and
pre4ent fumigant lea<age in t6e room#
Sealing tape
Plastic s6eeting
Filter bags= suitable for autocla4ing
Protecti4e clot6ing= including FFP(/NC, respirators
1arning sign > $O NO7 )N7)R (see an e2ample belo5)
4.4 Reagents and solutions
Formalin= *@A solution of formalde6yde 4apour in 5ater= commercially a4ailable#
76e +uantity of formalin re+uired is appro2imately ( ml per @#@(0 m
%
of t6e 8S
internal air space# In practical terms= t6is means %@ ml of formalin mi2ed 5it6 %@ ml of
5ater for a large (&0@ cm long) 8S or (, ml eac6 of formalin and 5ater for a smaller
(&(@ cm long) 8S#
Formalde6yde can be generated by boiling t6e mi2ture of formalin and 5ater in a
t6ermostatically controlled 6eating unit= suc6 as an electric frying pan or a 4apori9ing
unit#
4.5 Detailed instructions
S5itc6 off t6e cabinet fans#
Fill t6e 4apori9er or ot6er 6eating de4ice 5it6 t6e correct amount of formalin and
place it in t6e 8S#
76e 6eating de4ice s6ould be controlled t6roug6 a timer connected to t6e
internal plug in t6e 8S# onnections to an e2ternal plug 4ia an e2tension cord
may cause lea<age#
Set t6e timer for t6e duration of t6e 6eating process#
Set t6e timer so t6at t6e 4apori9er or 6eating de4ice s5itc6es on after a delay
sufficient to allo5 sealing of t6e 8S#
Seal t6e front screen and closure panel 5it6 plastic s6eeting and sealing tape to
ensure t6at t6ere are no lea<s#
$isplay a 5arning sign at t6e laboratory entrance to indicate t6at fumigation is in
process and t6at unaut6ori9ed persons are not permitted to enter#
3fter 6alf t6e formalin 6as e4aporated= s5itc6 t6e 8S fan on for &@?&, seconds
to e2pedite t6e passage of formalde6yde t6roug6 t6e filter#
3fter all t6e formalin 6as e4aporated= s5itc6 t6e 6eating de4ice off: s5itc6 t6e
8S fan on again for &@?&, seconds#
Lea4e t6e 8S in t6is condition for a minimum of - 6ours and preferably
o4ernig6t#
N
Institution
Laboratory name
Location
Head/Responsible person
Standard Operating Procedure (SOP)
Fumigation of a biological safety cabinet
ode!
"ersion! no#
$ate! of release
Page ! ! of 6
8efore 4enting t6e formalde6yde= c6ec< t6at no one is in t6e 4icinity of t6e
e26aust outlet#
S5itc6 on t6e 8S fan and unseal about (?% cm of t6e front screen for 6ig6>
4elocity influ2# 3fter &@ minutes= t6e sealing may be remo4ed completely#
Run t6e 8S for at least %@ minutes to remo4e t6e last traces of formalde6yde#
lean t6e inner surface of t6e 8S 5it6 a damp clot6#
Remo4e t6e 5arning sign#
Note: if t6e 8S 6as an automatic fumigation cycle= follo5 t6e detailed
instructions for fumigation pro4ided in t6e manufacturerBs manual#
Replacement of filters
)4en after fumigation= t6e H)P3 filters s6ould be considered as safe to 6andle
5it6 appropriate PP) rat6er t6an sterile# 3ppropriate personal protecti4e
e+uipment s6ould be used 56en 6andling 8S filters= including laboratory coat=
o4ers6oes= goggles= single>use disposable FFP(/NC, or FFP% respirator and
t6ic< rubber glo4es# 3fter remo4al= H)P3 filters are placed in an autocla4able
bag large enoug6 to be sealed and discarded (see belo5)#
3 ne5 H)P3 filter= 5it6 specifications ade+uate for t6e 8S model= s6ould be
installed according to t6e manufacturerBs instructions# Functional integrity of t6e
8S must be c6ec<ed and re>certified by a +ualified ser4ice professional (see
rele4ant SOP on maintenance and use of a 8S)
4.6 Reporting
76e date of t6e fumigation and t6e operatorBs name s6ould be recorded in t6e 8S
maintenance logboo<#
4. !ualit" control
N3
4.# $aste management and safet" precautions
&'treme care must be ta(en at all times )#en #andlin$ formalin. *t causes
burns and is very to'ic by in#alation+ *t is very destructive of mucous
membranes suc# as t#e upper respiratory tract+ eyes and s(in.
For 6umans= t6e ma2imum e2posure limit for formalde6yde is ( ppm or (#, mg/m
%
#
$uring fumigation= t6e concentration is many 6undreds of times 6ig6er t6an t6is: t6us
It is strongly recommended t6at t6is 6ig6ly speciali9ed procedure be performed by a
certified professional# If t6ere is any lingering smell of formalde6yde once t6e
fumigation procedure is finis6ed= t6ere s6ould be additional 4entilation of t6e
laboratory before normal use is resumed#
$arning. Formaldehyde can react with hydrochloric acid and chlorine-containing
disinfectants to form bis-chlormethyl-ether, a potent lung carcinogen. Hydrochloric
acid, hypochlorite (bleach) and other chlorine-containing disinfectants must be
remoed from !"# and its enironment before fumigation begins.
N
Institution
Laboratory name
Location
Head/Responsible person
Standard Operating Procedure (SOP)
Fumigation of a biological safety cabinet
ode!
"ersion! no#
$ate! of release
Page ! 6 of 6
Fumigated filters must be 5rapped in sealed bags and be autocla4ed and
incinerated#
Di4en t6e difficulties associated 5it6 fumigating a room= not least t6e difficulty of
completely sealing t6e room to pre4ent escape of formalde6yde into ot6er areas= any
plans for fumigation must be carefully considered= fully ;ustified and ris<>assessed#
!. "elated documents
'anufacturerEs manual= specific to eac6 8S
!iosafety in microbiological and biomedical laboratories= ,t6 ed# 1as6ington= $=
(@@.# Fnited States $epartment of Healt6 and Human Ser4ices/enters for $isease
ontrol and Pre4ention/National Institutes of Healt6= (@@.#
ollins = Gennedy $# $aboratory ac%uired infections: history, incidence, causes and
preention= *t6 ed# O2ford= 8utter5ort6>Heinemann= &CCC#
Healt6 anada# $aboratory biosafety manual= (nd ed# Otta5a= 'inister of Supply and
Ser4ices anada= &CC-#
Healt6 Ser4ices 3d4isory ommittee# "afe wor&ing and the preention of infection in
clinical laboratories# London= HS) 8oo<s= &CC&#
$aboratory biosafety manual= %rd ed# Dene4a= 1orld Healt6 Organi9ation= (@@*#
Standards 3ustralia/Standards Ne5 Healand# "afety in laboratories - microbiological
aspects and containment facilities# Sydney= Standards 3ustralia International= (@@(#
E%ample of a &arning sign
,-".*./
D% .%0 &.0&"
1%"2-LD&34D& /-S
D&C%.0-2*.-0*%.
2-5%" C3&2*C-L 3-6-"D