TECHNICAL

BULLETIN
Silicone Gel for
HEPA Filters

What Generated this Piece A competitor has published a bulletin noting

Over the past six years, several that there may be possible industry-wide
incidents involving the use of silicone failures with regard to gel performance on
gel in HEPA filters, where oil aerosols HEPA filters.
such as Polyalphaolefin (PAO) are
routinely used to test filter integrity, Not one Camfil Farr product has been
have resulted in the formation of a identified as the culprit, when gel has been
liquid droplet on the downstream found dripping from an installed HEPA filter.
frame of the filter. The purpose of
this Technical Bulletin is to inform the
reader of the known facts surrounding
this abnormality.
Recently, a major HEPA filter
manufacturer (not Camfil Farr)
released a quality control alert
on the subject of gel or fluid seal Camfil Farr products undergo
issues relating to HEPA filters in continous rigorous testing, including
pharmaceutical facilities. gel components, to ensure product
That publication contains several performance, testing material
misleading statements that run compatability and suiability to purpose.
counter to the results of many scientific
investigations conducted by a number
of qualified researchers directly
associated with the manufacture and
use of HEPA filters.
These statements also run counter
Camfil Farr has a policy of rigorous Owing to the extremely stable,
to nearly a decade of experience and
testing of all filter component materials and relatively inert chemistry,
observations conducted on HEPA
prior to incorporating them in any characterizing the cured silicone
filters manufactured by Camfil Farr
product. gel used by Camfil Farr, and PAO,
and installed in Pharmaceutical and
no chemical reaction occurs when
related clean rooms around the world. Research the two materials come into contact.
The Facts Between 2004 and 2006, Camfil Farr When a vast excess of PAO is applied
conducted a series of tests with the over a surface of cured silicone gel,
Facilities using Camfil Farr filters have
purpose of fully understanding the some PAO may diffuse into the gel
not reported a single incident related
compatibility of our silicone gel with and cause minor swelling. Laboratory
to the use of silicone gel in connection
other materials and agents, including observations, and field experience
with filter integrity testing with (PAO).
PAO. At the same time, Camfil in many facilites, shows that this
Not one Camfil Farr product has been Farr collaborated with a principle physical effect is minor and in no way
identified as the culprit, when gel has investigator and polymer chemist of compromises the integrity of the gel
been found dripping from an installed a major domestic pharmaceutical system, or the effectiveness of the
HEPA filter. manufacturer, who was conducting filter seal. Degradation of Camfil Farr
similar tests and evaluations. silicone gel in contact with PAO does
The results of these trials and not occur.
the conclusions were in general
agreement.

www.camfilfarr.com
 TECHNICAL BULLETIN
Silicone Gel for HEPA Filters

Camfil Farr, and the aforementioned

chemist, independently studied other
commercially available gel systems in
an effort to understand the mechanism
of downstream droplet formation
related to field issues associated
with one particular HEPA filter
manufacturer. The conclusion was
that a single root cause did not exist
and that a number of factors needed
to be present for the issue to occur.
The issue has not affected filters
manufactured by Camfil Farr because
a number of contributing factors,
other than the interaction of PAO
and silicone gel, do not exist in
the design of the Camfil Farr filters
and component materials. These
experimental results and conclusions
were presented at a number of high
level industry conferences including
CETA, ISPE and NEBB in 2007.
Silicone Gel Chemistry
The silicone gel that Camfil Farr uses in
our HEPA filter manufacturing utilizes
unique and specifically formulated Camfil Farr is very concerned that If you have additional questions of
chemistry to offer superior cured the pharmaceutical community is concerns please contact us at info@
strength and physical characteristics. presented the facts related to this camfilfarr.com.
It is ideally suited to meet the issue and all subjects related to air
demands of HEPA filter applications, filtration so that end users can make
compared to other conventional and informed decisions.
commercially available silicone gel We engage in continous proactive References:
systems. The chemistry utilized, research in an effort to anticipate
results in a higher molecular weight of Bio-Pharma HEPA Specification (gel spec
customer needs and to avoid included)
unbound polymer, a higher cross link performaqnce problems as noted
density and superior structure of the herein. We also participate in industry NEBB Presentation, Steve Devine, Vice-
gel cross link network. As a result, conferences, and serve on committees President of Research & Development, Camfil
the Camfil Farr gel is tougher and to share our air filtration and industry Farr, 2007
resists degradation and exudation. knowledge for the benefit of the
Additionally, our state-of-the-art Brief discussion of Gel, Steve Devine, Vice-
community. President of Research & Development, Camfil
automated production equipment
ensures precise mixing of components Questions? Call us. Farr, 2007
during filter manufacturing.
If you have questions related to this Decon/PAO/Cleaning Agent Study, Steve
Collaborative Design subject, Camfil Farr has additional Devine, Vice-President of Research &
resources and information available. Development, Camfil Farr, 2007
Camfil Farr employs a system of best
practices as a form of quality control.
We engage in technical collaboration
with our colleagues, including our Comments or suggestions for revisions may be directed to
suppliers and end-users. Finally, we literature@camfilfarr.com or info@camfilfarr.com. Camfil Farr
implement and audit manufacturing reserves the right to continually update materials. Contact
your Camfil Farr Representative or Distributor for the latest
and quality control procedures to information.
ensure a high quality product suitable
for the intended use.

www.camfilfarr.com
© Camfil Farr, 2010