Natural Rubber Latex NRL Allergen

DEVELOPMENTS IN
NATURAL RUBBER
LATEX MANAGEMENT
AND MANUFACTURING
Introduction
The natural rubber latex (NRL)
allergy issue caused the greatest
revolution in the history of
surgical and examination glove
manufacturing. From the time
that the FDA issued its NRL
allergy Medical Alert in 19911,
manufacturers of NRL medical
gloves have investigated and
implemented manufacturing
processes to reduce the NRL protein
allergen content of their products.
One of the initial difculties
faced by the glove producers was
the lack of test methodologies
for the measurement of the
water extractable NRL proteins
and allergens, that could easily
be conducted within their own
laboratories. As methodologies
became available manufacturers
were able to investigate which parts
of their processes had the biggest
impact on reducing the extractable
proteins (EP).
Manufacturers adopted three basic
approaches to reduce the NRL
protein allergen content of their
gloves.
Both these test methods are now

recognized standards, however the
results obtained from these tests
often do not correlate well with
allergenicity. Various substances,
such as residual accelerators,
can often interfere with the
measurements.
These were:
1. Developing leaching/washing
processes either on-line or in the
post processing of the gloves.
2. Utilization of chlorination
processes.
3. The development and utilization
of de-proteinized natural rubber
latex.
The other strategy to reduce the
risk of allergic reactions was the
development of suitable synthetic
gloves. However many synthetics do
not perform as well as NRL gloves.
A recent study by Korniewicz, et al2,
which used an in-use performance
model, demonstrated that NRL
gloves out performed most synthetic
gloves and that some synthetics had
unacceptable failure rates.
Latex allergen
measurements
The most common methods for
measuring NRL proteins are the
modied Lowry3 and the LEAP
assay4.
The method of choice for measuring

latex allergen content was to use
the FITkitTM 5. Developed by FIT
Biotech, in collaboration with the
leading scientists working in the
area of NRL allergy and with a major
glove manufacturer, FITkitTM shows
good correlation to the allergenicity
of gloves, measured by currently
available patient IgE based methods.
FITkitTM tests are reliable
immunological tests for direct
determination of clinically relevant
latex allergens in NRL products that
overcome the limitations of previous
methods. These highly sensitive tests
use specic monoclonal antibodies
developed against four clinically
relevant latex allergens (Hev b1, Hev
b3, Hev b5 & Hev b6.02) present
in NRL products, such as rubber
gloves.
Post processing
In the early days of the latex allergy
issue powdered gloves manufactured
by the standard methods, contained
some of the highest levels of NRL
allergens. Gloves that were produced
with post washing process using exmachine washing methods displayed
signicantly lower values of NRL
proteins.
The ex-machine washing, post

processing (Diagram 1), for
powdered gloves usually entailed
washing the gloves in hot water with
detergent and then nal rinsing with
hot water. The cycle times varied
from 1 hour to 1.5 hours. After the
washing process the gloves were
dried and powdered using a dry
powdering process.
Manufacture and post processing

of powdered gloves
This was also true for powder free

gloves (Diagram 2) except that
usually there was the additional step
of chlorination. Chlorination is a
process by which the rubber surface
is exposed to chlorine. The chlorine
reacts with the double bonds of the
polyisoprene and dramatically
changes the surface properties6.
The added benet of the chlorination
process is that the gloves need to be
neutralized and washed after their
exposure to chlorine. This washing
further assists in the reduction of the
allergen content.
NRL formulations had to be

specically developed to withstand
this type of aggressive processing.
Diagram 1
Manufacture and post processing

of powder free gloves
Diagram 2
Chart 1 shows how the allergen

content of gloves are reduced as
they progress through the after
processing stages. The allergen
content is measured using the
FITkitTM. The washing phase has
decreased the overall allergen
content by a factor of seven and by
the time the samples are completely
after processed and aged the allergen
content approaches zero.
Effect of post processing on allergen content
Sum
of4 allergens
(micro
g/g)
Glove processing stages
Chart 1
Deproteinised latex
Natural rubber latex is obtained
from the Hevea brasiliensis tree. The
fresh latex consists of 35% rubber
particles (natural polyisoprene)
and 6% of non-rubber particles, all
suspended in an ambient serum.
Proteins constitute approximately 1%
to 1.5% of the fresh latex.
Deproteinised and puried natural

rubber latex (DPNR) is usually
produced by the treatment of
eld latex with specic proteolytic
enzymes in the presence of specic
surfactant stabilizers followed by
concentration by centrifugation. The
Sumitomo Corporation were one of
the rst companies to commercialize
Production process of DPNR latex
Diagram 3
such a process7.
The DPNR produced by Sumitomo
is called SELATEX and claimed
to have allergen levels below
detection. A typical process for the
deproteinization of NRL is shown in
Diagram 3.
Treatment of NRL with surfactants,
such as Triton X-1008, have also
been shown to be effective in the
reduction of NRL allergen content.
In fact the four stage washing
process used reduced the serum
allergens by 93%.
High temperature
post washing versus
DPNR latex
High temperature washing of
the latex lm is very effective in
reducing the overall protein allergen
content of a latex lm. Diagram 4
schematically represents how High
Ammonia (HA) NR and DPNR
latices are coagulated to form lms
and then on-line leached.
The high temperature post washing

is, however, better, because it is able
to extract more of the EP as both
sides of the lm are exposed to the
cleaning process. The hot water also
hydrates the rubber lm and
as the lms interstitial spaces are

enlarged, the protein allergens are
easily extracted. As a result, the nal
lm formed by using standard HA
latex has a lower protein allergen
content than the lm formed using
the DPNR latex.
The high ammonia latex starts the

process with a much higher level of
extractable proteins (EP) than the
enzyme treated DPNR latex. The online leaching process has a similar
effect on both lms, but as can be
seen from the diagram the leaching
only occurs from one side of the
lm.
Diagram 4
In Table 1 there is a comparison of

the total allergen content of nished
gloves made from standard HA
latex and two types of commercially
available deproteinized latices.
that although the DPNR latices

produced lms with low allergen
content, the post processed gloves
had values of more than 20 times
lower.
The allergen content was measured

using the FITkitTM. The results show
The preferred protocol for the High

Temperature Post Washing was
to initially wash the gloves in an

industrial washer with hot water,
temperature greater than 80 C,
containing a non-ionic surfactant for
at least 20 minutes. The initial wash
was then followed by two clean hot
water, temperature greater than
80 C, rinse cycles.
Production process of DPNR latex

Latex Type
Glove Type
High Temp
Post
Washing
Hev b1
ng/ml
Hev b3
ng/ml
Hev b5
ng/ml
Hev
b6.02
ng/ml
Sum of 4
g/g
Total
Allergens
AU/ml
High Ammonia Latex
Powder-free
Yes
<10
<10
<5
<5
<0.15
0.2
High Ammonia Latex
Powder
Yes
<10
<10
<5
<5
<0.15
0.7
LOPROTEX (Getahindus)
Powder free
No
<10
<10
<5
<5
<0.15
19
DPNR 3821 (Sumitomo)
Powder free
No
<10
<10
<5
13.6
0.07
21
Table 1
Implications for
latex sensitive
people
Gloves made from NRL are still
considered to provide the wearer
with the best protective barrier
with the added benets of tactile
sensitivity and comfort. With
manufacturers now providing low
allergen gloves the incident rate of
latex sensitization has dramatically
reduced.
In a study conducted by Dr Henning
Allmers in German hospitals9, he
concluded that the preventative
measures to avoid occupational
NRL allergy, mainly the complete
replacement of powdered NRL
gloves by low protein, powder free
gloves and the use of NRL-free
materials by sensitized individuals,
provided for a successful secondary
prevention by keeping sensitized
healthcare workers in the workplace.
Conclusions
Natural rubber latex gloves still
remain the barrier of choice
amongst healthcare professionals.
Manufacturers have developed
technologies that allow them to
produce low allergen gloves as well
as synthetic gloves.
High Temperature Post Washing
remains the most effective way to
reduce the NRL allergen content of
NRL gloves.
Providing low allergen powder free
gloves and synthetic alternatives,
to healthcare workers signicantly
reduces the risk of sensitization.
These preventative measures also

brought about a signicant reduction
in the suspected cases of NRLcaused occupational asthma and/or
skin symptoms for approximately
half of all the German hospital staff
involved in the Dr Allmers study.
Ansell Healthcare Europe N.V.

Riverside Business Park, Spey House, Boulevard International 55, B-1070 Brussels, Belgium
Tel. +32 (0) 2 528 74 00 Fax +32 (0) 2 528 74 01
http://www.anselleurope.com, E-mail [email protected]
Paul Cacioli, Ph. D.

Ansell Limited
Level 3, 678 Victoria Street
Richmond, VIC 3121 Australia
Lai Hee Meng

Ansell Healthcare
Lot 16 Perisiaran Perusahaan
Selangor Darul Ehsan
Sha Alam, 40000 Malaysia
The Ansell name and logo are

trademarks owned by Ansell
Limited, or one of its afliates.
2005 All Rights Reserved.
References
1. FDA [1991]. FDA medical alert: allergic
reactions to latex-containing medical
devices. Rockville, MD: Food and Drug
Administration, MDA 91-1.
2. Korniewicz D, Garzon L, Seltzer J &
Feinleib M. Failure rates in non-latex
surgical gloves. Am J Infect Control.
(2004) 25 (8): 656-663.
3. ISO 12243:2003, Medical gloves made
from natural rubber latex Determination
of extractable protein using modied
Lowry method.
4. ASTM D6499-03, Standard test method
for the immunological measurement of
antigenic protein in natural rubber and its
products.
5. The Rubber International Magazine,
Volume 4, No.45, p. 37-42, September
2002.
6. T.C.Q. Noakes, T.C.Q., Surface Treatment
of Natural Rubber for Reduced Friction,
Proceedings International Rubber
Technology Conference, Penang, Malaysia,
p. 288-305, 1988.
7. Ichikawa, N., Miyamoto, Y., Hayashi, M.,
Low allergenic natural rubber and method
of preparing low allergenic natural rubber
latex, August 31, 2004, US Patent 6,784, 281.
8. Schloman, Jr., W.W. 2002. Surfactant
treatment reduces both allergen content
and cure efciency of Hevea latex.
P. 245-249. In: J.Janick and A. Whipkey
(eds.), Trends in new crops and new uses.
ASHA Press, Alexandria, VA.
9. Allmers, H., Schmengler, J., Skudlik, C.,
John, S. M., Current state of the art in
Natural Rubber Latex Allergy Prevention,
Infection Control, p 63 66, 2005.

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DEVELOPMENTS IN

Both these test methods are now

The method of choice for measuring

The ex-machine washing, post

Manufacture and post processing

This was also true for powder free

NRL formulations had to be

Manufacture and post processing

Chart 1 shows how the allergen

Effect of post processing on allergen content

Glove processing stages

Deproteinised and puried natural

Production process of DPNR latex

The high temperature post washing

as the lms interstitial spaces are

The high ammonia latex starts the

In Table 1 there is a comparison of

that although the DPNR latices

The allergen content was measured

The preferred protocol for the High

to initially wash the gloves in an

Production process of DPNR latex

High Ammonia Latex

High Ammonia Latex

DPNR 3821 (Sumitomo)

These preventative measures also

Ansell Healthcare Europe N.V.

Paul Cacioli, Ph. D.

Lai Hee Meng

The Ansell name and logo are

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