Professional Documents
Culture Documents
305–312, 2003
© 2003 British Occupational Hygiene Society
Published by Oxford University Press
DOI: 10.1093/annhyg/meg043
Standard test methods ASTM F739 and EN 374 were compared by assessing the permeation of
70% isopropyl alcohol (2-propanol) through seven brands of surgical gloves. The two standards
differ in the flow rates of the collection medium and in the chemical permeation rate at which
the breakthrough time (BTT) is detected, the EN detection level being 10 times higher than the
permeation rate used by ASTM. In a departure from the EN standard method, a 4 h testing
time was used instead of 8 h. All of the tested gloves were from the same manufacturer and were
made from either natural rubber (NR) (six brands) or chloroprene rubber (CR) (one brand).
Two of the NR glove brands were double layered. For the thin NR gloves (0.22, 0.28 and
0.27 mm) the permeation rates were higher throughout the tests with a flow rate of 474 ml/min
(EN) of the collection medium (nitrogen) compared with the permeation rates obtained with a
flow rate of 52 ml/min (ASTM). These resulted in BTTs of 4.6, 6.5 and 7.6 min (EN) and 4.8, 6.5
and 9.1 min (ASTM), respectively. No statistical difference could be observed between the BTT
values obtained with the two standard methods for any of the thin gloves. Thus, although the
ASTM standard has a lower criterion for the detection of permeation, it does not necessarily
produce shorter BTTs. For the better barriers the methods yielded more equivalent permeation
rate curves and thus the EN BTTs were longer than the ASTM BTTs: the EN results were 21,
80, 122 and >240 min compared with the ASTM results of 12, 32, 38 and 103 min for glove thick-
nesses of 0.37 (NR), 0.22 + 0.22 (double layered NR), 0.31 + 0.29 (double layered NR) and
0.19 mm (CR), respectively.
305
306 E. A. Mäkelä, S. Vainiotalo and K. Peltonen
collection medium. The EN standard has a Pb that is the skin to the systemic circulation (Jensen, 1981;
10 times higher than the ASTM standard. The flow Fiserova-Bergerova et al., 1990). It is also known to
rate in the EN standard (5 test cell vol/min corre- be able to permeate through rubber gloves. The danger
sponding to 420–520 ml/min) can also be 10 times in its permeation through the gloves to the skin is that
higher than in the ASTM (50–150 ml/min). it may transfer other hazardous components in solu-
The measurement of the maximum permeation rate tion. For industrial gloves, the permeation of 100%
demands that additional factors that can restrict the IPA has been frequently studied, but only a few
mass transfer must be minimized. A slow desorption permeation tests have been reported for surgical or
rate of a chemical from the material surface decreases examination gloves. BTTs as low as 1 min have been
the permeation rate. The desorption rate can in some reported (Mellström et al., 1992; Forsberg and Keith,
cases be improved by increasing the flow rate of the 1999). Due to the high expected permeability, short
gaseous collection medium (Schwope et al., 1988b; BTTs and the common use of diluted IPA, we
Que Hee, 1996; Anna et al., 1998). On the other selected 70% IPA for use in these tests instead of
hand, this leads to dilution of the test chemical in the 100%.
diameters were measured in three directions for every first measuring point after which P has exceeded the
sample. Glove samples were weighed using an Pb.
analytical balance with a precision of 0.1 mg. The The ASTM standard requires the calculation of the
weight per unit area values were calculated. The average SSP, if the permeation rate reaches a
sample thicknesses were measured (Ames M034 E; constant level. The SSP is calculated from a few
Shirley Developments Ltd) using a pressure of 3.4 kPa points at the end of the three parallel tests.
and measuring diameter of 28.7 mm (Table 1). Three t-Tests (Microsoft® Excel 97 SR-2, T-test: Two-
values were measured for each sample. The samples Sample Assuming Equal Variances) with a signifi-
were not inspected for structural imperfections before cance level of 0.05 were applied for statistical
the chemical permeation testing took place. comparisons between the ASTM and the EN standard
As required by both standards, ASTM F739 and results or between results obtained with different
EN 374, a circular glove sample was mounted flow rates and the same permeation rate criteria.
between the two chambers of the standard test cell. Samples were injected (EC6W valve with valve
Collection medium was set to flow through the actuator E60; VICI Valco Instruments Co. Inc.,
Table 2. Isopropyl alcohol (70% v/v) breakthrough times measured for surgical gloves with two collection medium flow rates and
calculated at two permeation rate levels
Breakthrough time (min) (mean ± SD)
Standard used EN 374 ASTM F739
Flow rate (ml/min) 474 52 474 52
Permeation rate (µg/cm2/min1)a 1.0 0.1 0.1 1.0
Biogel® Super Sensitive 4.6 ± 0.6b 4.8 ± 0.9b 2.1 ± 0.1 9.6 ± 1.7
Regent® Surgical 6.5 ± 0.5b 6.5 ± 0.9b 3.4 ± 0.3 12 ± 1
Biogel® 7.6 ± 0.5b 9.1 ± 1.5b 3.5 ± 0.7 18 ± 3
Biogel® Orthopaedic 21 ± 2 12 ± 0c 9.8 ± 1.4c 25 ± 2
Biogel® Indicator 80 ± 13d 32 ± 2c 30 ± 5c 121 ± 26d
Biogel® Reveal 122 ± 6 38 ± 3c 37 ± 3c 153 ± 18
Skinsense™ N >240 103 ± 7c 97 ± 2c >240
Pb = 0.1 µg/cm2/min.
dThe result with the flow rate 52 ml/min does not differ statistically from the result with the flow rate 474 ml/min using
Pb = 1.0 µg/cm2/min.
luer-lock syringes (10 ml, Discardit™ II; Becton of the EN standard in the 4 h test with the Skin-
Dickinson, Madrid, Spain). Regression analyses sense™ N gloves, but reached the ASTM Pb of
(Microsoft® Excel 97 SR-2) were applied to the cali- 0.1 µg/cm2/min after 103 min. The BTTs and the
bration responses and they produced linear lines corresponding standard deviations are shown in
which were forced to 0 (r = 0.999 ± 0.001, P = 3.2 ± Table 2. Figure 1 illustrates the increase in the perme-
0.1 × 10–15). Calibration was performed daily before ation rates during the tests. The points where the
testing and was checked after each test. curves cross the Pb of 1.0 µg/cm2/min can be
observed as the corresponding BTTs. In all of the EN
testing, the BTTs for the parallel tests were within the
RESULTS
required range ± 20% of the mean.
The thicknesses of the gloves were 0.22, 0.28, 0.27 The BTT results were calculated for both of the Pb
and 0.37 mm for the single layered NR gloves values and for both of the flow rates. When viewed
Biogel® Super Sensitive, Regent® Surgical, Biogel® with the same flow rate (Table 2 and Fig. 2), the Pb
and Biogel® Orthopaedic, respectively. Weight per of 1.0 µg/cm2/min yielded about double or higher
unit area values were 197, 220, 244 and 302 g/m2. BTT values than the Pb of 0.1 µg/cm2/min. When
The Biogel® Indicator and Biogel® Reveal gloves comparing the ASTM results with the corresponding
were double gloves, whose inner and outer gloves EN results, it was found that the results of the thin NR
had about the same thickness and weight per unit gloves (Biogel® Super Sensitive, Regent® Surgical
area. Both Indicator gloves were equal in their thick- and Biogel®) did not differ statistically even though
ness and weight per unit area to the Super Sensitive there was a 10-fold difference in their Pb values. On
gloves and both Reveal gloves were approximately the other hand, for the different flow rates but the
the same as the standard Biogel® gloves. The CR same Pb, a statistical difference was found between
gloves, Skinsense™ N, were the thinnest of all at the BTTs at the Pb of 0.1 µg/cm2/min for the above
0.19 mm, but they had a relatively high weight per mentioned thin NR gloves and at the Pb of 1.0
unit area value of 255 g/m2. Further information on µg/cm2/min for all the gloves except the Biogel®
the gloves is shown in Table 1. Indicator gloves.
The BTTs using EN 374 to determine the perme- SSP rates according to the ASTM standard were
ation of 70% IPA were 4.6, 6.5, 7.6, 21, 80 and 122 attained in the single layered NR testing. The average
min for the NR gloves Biogel® Super Sensitive, SSPs of 70% IPA were 4.2, 4.2, 3.1 and 2.7 µg/cm2/min
Regent® Surgical, Biogel®, Biogel® Orthopaedic, for Biogel® Super Sensitive, Regent® Surgical,
Biogel® Indicator and Biogel® Reveal, respectively. Biogel® and Biogel® Orthopaedic, respectively. The
Following the same order of increasing weight per remaining gloves did not reach the SSP during the 4 h
unit area, the ASTM test results for the NR gloves test. SSP values were also calculated for the tests
were 4.8, 6.5, 9.1, 12, 32 and 38 min. The permeation using the EN flow rate of 474 ml/min: the SSPs of
rate of IPA did not reach the Pb of 1.0 µg/cm2/min IPA were 7.2, 5.3, 5.3, 3.2 and 1.7 µg/cm2/min for
2-Propanol permeation through surgical gloves 309
Fig. 1. Permeation of 70% isopropyl alcohol through surgical rubber gloves. The ASTM F739 test was made with a collecting
medium flow rate of 52 ml/min (crosses) and the EN 374 test with a rate of 474 ml/min (diamonds).
310 E. A. Mäkelä, S. Vainiotalo and K. Peltonen
Table 3. Average (n = 3) steady-state permeation rates (SSPs) tion against hazardous chemicals, it should have a
for isopropyl alcohol (70% v/v) BTT of at least 10 min and twice the working time
SSP (µg/cm2/min) (mean ± SD) with the chemical. The difference between the
Standard used EN 374 ASTM F739 recommended time of use for the gloves and the BTT
Flow rate (ml/min) 474 52 arises from the differences in conditions between
Biogel® Super Sensitive 7.2 ± 0.8 4.2 ± 0.2 everyday actual use and the standardized test method
Regent Surgical 5.3 ± 0.3 4.2 ± 0.6 (Leinster et al., 1990; Leinster, 1994). Thus the tested
Biogel® 5.3 ± 0.2 3.1 ± 0.5
single layered NR gloves cannot be recommended
against 70% IPA solutions, except for occasional
Biogel® Orthopaedic 3.2 ± 0.0 2.7 ± 0.2
very brief tasks. Even then there should not be
Biogel® Indicator 1.7 ± 0.1 Not detected
dermally toxic substances present which could
The SSP values are required by the ASTM F739 standard but permeate along with the IPA. For a short period of
not by EN 374. time, the double layered and the CR gloves should
provide protection.
This study shows that flow rate is a critical factor in
Biogel® Super Sensitive, Regent® Surgical, Biogel®, tests in which a gaseous collection medium is used.
Biogel® Orthopaedic and Biogel® Indicator gloves, Compared with the flow rate of 474 ml/min, the
respectively (Table 3). The SSPs differed statistically lower flow rate of 52 ml/min yielded lower perme-
significantly for the tests with different flow rates. ation rates throughout the tests and thus made the
BTTs longer in five of the seven test pairs when
DISCUSSION detected at the Pb of 1.0 µg/cm2/min and in three of
the seven test pairs when detected at the Pb of 0.1
Surgical or other thin rubber gloves may often µg/cm2/min (Table 2). The differences in the BTTs
provide insufficient protection against small organic with the different flow rates at a Pb of 1.0 µg/cm2/min
molecules. If the glove is to have any protective func- were so marked that they would influence how three
2-Propanol permeation through surgical gloves 311
of the gloves (Regent® Surgical, Biogel® and Biogel® ness was the same as the Biogel® gloves. Thus there
Indicator) would be classified for protection against was no evidence that the Biogel® polymer layer made
IPA according to the EN standard. the NR material less permeable to IPA.
The BTTs for the three thin NR materials (Biogel® Skinsense™ N proved to be the best barrier against
Super Sensitive, Regent® Surgical and Biogel®) were IPA of the tested gloves. It was the thinnest of the
about the same when tested using the two different materials and the least permeable. CR surgical gloves
standards, despite the 10-fold difference in the Pb have also proved to be effective against meth-
values (Table 2 and Fig. 2). It seems that in the tests acrylates and formaldehyde (Schwope et al., 1988a;
of these three materials with the collection medium Mäkelä et al., 1999, 2003). However, the CR gloves
flow rate of 52 ml/min the vaporization of IPA meant for healthcare are only sold as sterilized
suffered from the low mixing efficiency in the test surgical gloves, although they could also have poten-
cell, which has been discussed by Anna et al. (1998). tial in providing protection against hazardous chem-
Thus their BTTs became about twice as long as those icals, e.g. for laboratory workers. At present their
measured with the higher flow rate, if calculated at price may hinder their more extensive use outside the
of the EN test lessens the impact of the desorption editors. Protective gloves for occupational use. Boca Raton,
rate on the permeation results. The higher permeation FL: CRC Press, pp. 269–82.
Leinster P, Bonsall JL, Evans MJ, Lewis SJ. (1990) The appli-
rate produced by the higher collection medium flow cation of test data in the selection and use of gloves against
rate also results in a steeper slope of the permeation chemicals. Ann Occup Hyg; 34: 85–90.
rate versus time curve, which makes determination of Mäkelä EA, Väänänen V, Alanko K, Jolanki R, Estlander T,
the BTT more accurate. Thus the different conditions Kanerva L. (1999) Resistance of disposable gloves to perme-
of the two standards both have their advantages and ation by 2-hydroxyethyl methacrylate and triethyleneglycol
dimethacrylate. Occup Hyg; 5: 121–9.
without a large number of comparable test results, it Mäkelä EA, Vainiotalo S, Peltonen K. (2003) The permeability
is quite difficult to define which represents the better of surgical gloves to seven chemicals commonly used in
way of determining the BTT. hospitals. Ann Occup Hyg; 47: 313–23.
Mellström G. (1991a) Protective gloves of polymeric materials.
Experimental permeation testing and clinical study of side
Acknowledgements—The authors wish to express their grati- effects. Acta Derm Venereol Suppl (Stockh); 163: 1–54.
tude to Matti Jussila, the scientist, the technician and the Mellström GA. (1991b) Comparison of chemical permeation
computer programmer. The study was made possible by the data obtained with ASTM and ISO permeation test cells. I.