Safety Office

Reviewed: 17 July 2012

Reviewed: DD Month

Policy on the Fumigation of Microbiological Safety

Year

Cabinets using formaldehyde supported by evaluation

of comparative risks

1. Introduction
In certain circumstances it will be necessary to fumigate Microbiological Safety
Cabinets for purposes of decontamination. The fumigant commonly used is
formaldehyde, however this is an extremely toxic and unpleasant compound with
a Workplace Exposure Limit [WEL] of 2ppm. At the end of the process he
formaldehyde vapour must be vented to atmosphere to reduce the concentration
as low as practicable below the WEL. This can present difficulties, particularly
where recirculating MSCs are used.

The University has evaluated the risks associated with the use of formaldehyde as
a fumigant and compared these with the risks presented by the materials which
are habitually handled within microbiological safety cabinets. It is the
responsibility of the PI to carry out a risk assessment to determine whether the
nature of material handled in the cabinet warrants the MSC being fumigated prior
to routine service. The conclusions of the assessment must be documented.

The Safety Office advises that fumigation of cabinets is warranted in the following
circumstances:

 Before any maintenance work on the cabinet where the engineer needs to
access potentially contaminated parts. E.g.:
- When HEPA filters are to be changed
- Before carrying out filter penetration tests
- When access to the internal fans is required

 Before any maintenance or testing is carried out on MSCs used in

association with any Class 3 BA/GMO
 Before any maintenance or testing is carried out on MSCs used in
association with any Class 2 organisms where the risk of exposure cannot
be adequately managed by surface decontamination
 Cabinets in which there has been a major spillage of viable material where
inaccessible surfaces may have become contaminated. This should be
carried out at the time of the incident or as early as possible after the
incident has occurred.
 Where there are any significant changes to the nature of work carried out
[e.g. use of significantly different pathogen]

The following evaluation of risks supports the decision to move away from routine
fumigation of MSCs prior to service except in the circumstances outlined above.
2. Hazards associated with formaldehyde
2.1. Toxic properties
Formaldehyde is a very hazardous substance. Among its adverse effects
are the following:
Causes burns. Very toxic by inhalation, ingestion and through skin
absorption. Readily absorbed through skin. Mutagen. May cause damage
to kidneys. May cause allergic reaction. May cause sensitisation. May
cause heritable genetic damage. Lachrymator at levels from less than
20ppm upwards. Very destructive of mucous membranes and upper
respiratory tract, eyes and skin. Because of this high level of hazard, it is
presently assigned a Work Exposure Limit [WEL] in air of 2ppm
[2.5mg.m3], with the presumption that ambient levels must be maintained
as far below that limit as is reasonably practicable. Importantly,
formaldehyde was recently reclassified by the International Agency for
Research into Cancer [IARC] as a Class 1 carcinogen, and a cause of
nasopharyngeal cancer. This reclassification has been accepted by WHO
and the HSE has plans to review the WEL for this substance in the near
future with a strong probability that it will classify it as a class 1
carcinogen.

It should be noted that some individuals are not able to detect its
presence, even at levels around or above the WEL and therefore may not
be aware that they are being exposed, unless an appropriate monitoring
device is used.

2.2. Physical properties

Formaldehyde is explosive at 7.75% in dry air. Above explosive air-vapour
mixtures can be formed, unless the atmosphere is humid. Because it
penetrates poorly in very dry conditions, for both safety and efficacy the
conditions should be humid and warm [above 65% relative humidity and
above 20°C].
In order to achieve this, a proprietary fumigation kettle must be used to
produce the required vapour.

2.3. Chemical interaction

Under certain conditions formaldehyde can react with hypochlorite and
other chlorine containing chemicals such as Chloros to form bis-
(chloromethyl)-ether which is a known lung carcinogen. Chlorine
containing compounds must therefore be removed from rooms and
cabinets before fumigation.

2.4. Hazards associated with biological materials

The majority of MSCs are used in association with biological agents that
are classified as Group 2 biological agents or below. They are usually in
the form of primary and short term cell cultures derived from human
donors. These may be patients or healthy volunteers. The University Code
practice requires that:
  Wherever possible the blood or tissue must be obtained from screened
sources, e.g. National Blood Service
 Collaborating clinicians supplying blood or body tissue must be
informed in writing by the Head of School that they must take steps to
ensure they do not provide material from any of the following groups:

- Patients who have been identified as HIV, Hp B positive or from

high risk group such as intravenous drug users etc.
- Patients who are/may be suffering from any life threatening
transmissible human disease.

 Where samples are to be imported from overseas then consideration

must be given in the risk assessment to any endemic diseases or
parasitic infections that may be endemic in the country of origin. E.g.
HIV in certain African states, and to samples which may contain
parasites.

In the event that the research requires departure from the above
standards then the PI must give full justification and any MSCs used will
be subject to fumigation prior to service.

3. Evaluating the risk

3.1. Formaldehyde
The consequence of exposure of individuals to formaldehyde can be
serious in that it has both acute and chronic effects.

The potential numbers that could be exposed varies. It would include the
service engineer, the person setting up the fumigation process. Other staff
could be affected in the event of the problem arising with the seal integrity
of the process, which could result in the accidental release of gas.

There is documented evidence that formaldehyde vapour has built up to

levels well in excess of the WEL several hours after the cabinets have been
exhausted to atmosphere. Airborne concentration after the recommended
venting times have been reduced to 0.6ppm but have then increased to
7ppm after the cabinets have been switched off overnight.

On this basis the likelihood of exposure is considered to be ‘probable’ and

the risk therefore is MEDIUM.

3.2. Biological material

The consequence of exposure would be an individual contracting a human
disease.

The numbers of people that could be exposed would be 1.

Given the University policy [see 2.4 above] it is considered unlikely that
any infectious agent that causes serious human disease present would
 remain viable on the pre-filter provided the appropriate controls [detailed
below] are implemented.

However it is acknowledged that certain cabinets may pose an increased

risk due to the nature of the work undertaken in them, and these will
continue to be identified through risk assessment and will be fumigated
prior to service. See Appendix 1.

There are two potential routes of exposure:

Inhalation of infectious agents trapped on the pre-filter when it is

removed. The types of pathogens which could be present would be
unlikely to survive on the filter and remain viable. Removal of the pre-filter
with the cabinet running thus taking the air away from the engineer and
the provision of a suitable filter mask would remove this risk.

Skin penetration could occur due to a cut being sustained from a sharp
object within the cabinet or via a pre-existing cut on the hand or some
other defective barrier to the skin.

Scrupulous cleaning and surface decontamination with an effective

disinfectant, and covering cuts, wearing gloves and using forceps to
remove any solid debris will ensure that exposure via skin penetration is
unlikely.

Providing the aforementioned controls are in place the risk to human

health is considered to be low/effectively zero.

4. Alternative fumigants
Vapour pressure hydrogen peroxide is a safer alternative to formaldehyde. Where
it is necessary to fumigate Schools/Departments are strongly advised to use this
alternative and much safer technology.

I the event of formaldehyde continuing to be used as a fumigant this will require

a thorough risk and a standard safe operating procedure will be required. Only
experience trained staff should carry out this process, levels of formaldehyde
must be monitored and suitable respiratory protective equipment must be
available for use in the event of unexpected release of fumigant into the
laboratory.

Further details on the effectiveness of VPHP and on University’s policy can be

found in the ‘Policy on fumigation of microbiological safety cabinets’.

5. Conclusions
The above comparison of the relative risks clearly identifies that the risk of
fumigation with formaldehyde prior to service is far greater than the risks
presented by the materials used in the cabinet.
The attached protocol [Appendix1] clearly identifies the circumstances where
fumigation is n required and lays down clear instructions on how cabinets will be
surface decontaminated. Providing these are adhered to the risk to the service
engineer is considered to be low or effectively zero.
 Appendix 1

Decontamination of Microbiological Safety Cabinets prior to

service by engineer.

The following Safety Cabinets will be fumigated prior to service:

 Class 1 MSCs- these are usually used to protect the operator from
large aerosols of bacterial cultures and as such are more prone to
internal contamination with aerosol. Given they are usually ducted
fumigation is less problematic.
 Cabinets used to handle Group 3 biological agents
 Cabinets used to handle genetically modified micro-organisms and/or
human material or cell lines classified as group 2 biological agents,
where the risk of exposure cannot be adequately managed by surface
decontamination.
 Cabinets which are to undergo a HEPA filter or fan change.
 Cabinets in which there has been a major spillage of viable material
where inaccessible surfaces ma have become contaminated. This
should be carried out at the time of the incident or as early as possible
after the incident has occurred.

Other cabinets will be decontaminated according to the following procedure:

Procedure to be carried out by senior technical staff that have been

adequately trained.

 Wear lab coat and gloves

 Ensure cabinet is switched on
 Decontaminate the work tray with 1% Trigene or Virkon allowing a contact
time of 10 minutes [do not exceed maximum time as these can be
corrosive on prolonged contact]
 Remove the work tray. Douse the base, interior walls and visor liberally
with 1% Trigene/Virkon allowing a contact time of 10 minutes. Remove all
debris from the base of the cabinet. Look out for sharp objects and where
necessary use forceps to remove debris.
 Where the pre-filter is accessible spray it with 1% Trigene/Virkon solution
in situ
 Wipe down all exterior surfaces of the cabinet with 1% Trigene/Virkon
 Once the cabinet has been thoroughly decontaminated in accordance with
the above, complete a Safe Equipment Certificate and fix it to the cabinet.
You are also advised to keep a copy.

NOTE- DO NOT use alcohol sprays inside the MSC as this poses a fire/explosion
risk.

Procedure to be followed by Service Engineer

Do not start work in the area without reference to senior technical staff/person in
charge.
Check that a Sae Equipment Certificate is attached to the cabinet

Wear lab coat, gloves and a particulate face mask FFP2

Switch on the cabinet

Expose the pre-filter and spray with 10% Trigene or 2% Virkon solution and allow
a contact time of 10 minutes.

After 10 minutes remove the pre-filter and place in yellow waste sacks within the
confines of the cabinet with fans running where possible. Seal the bag and
arrange with departmental staff for its removal.

Carry out service as per BSEN 12469 : 2000