Suitabilityy of The Modified ASTM G-22 Test Method

“ Standard Practice For Determining Resistance Of

Plastics To Bacteria (Withdrawn 2002)” on Testing of
USP Grade Mineral Oil For NSF Standard 60 Certification

NSF Standard 60 Joint Committee Presentation

Calumet Specialty Products Partners L.P.
Erik Lorence
December 1, 2010
Calumet Specialty Products Partners L.P., is a petroleum hydrocarbon refiner
with 5 specialty manufacturing locations. Product lines include base oils,
process oils
oils, solvents
solvents, petrolatums
petrolatums, specialty products,
products and white oils.
oils

USP grade white mineral oils have been historically used as well pump lubricants
under the NSF standard 60 program.

USP grade white mineral oils are:

Approved
pp for direct and indirect food contact under the US FDA Title 21 CFR
sections 172.878 and 178.3620(a) respectively.

Used in pharmaceutical formulations.

Contain less than 35 parts per million of water.

Proven to not support microbial growth by 40 + years of historical data.

Many customers require that our oils be certified to the NSF
standard 60.
Products are carefully screened for NSF 60 standard
compliance. One screening process is a microbiological test
procedure to determine if the submitted product will sustain
microbiological
i bi l i l growth. h The
Th NSF currently l uses a modified
difi d
method based on the ASTM G-22 “ Standard Practice For
Determiningg Resistance of Plastics to Bacteria ((Withdrawn
2002)”.
 ASTM G-22 “Standard Practice for Determining
R i
Resistance off Plastics
Pl i to Bacteria
B i (Withdrawn
(Wi hd 2002)”
Scope: Covers 2 procedures A, and B for determining the effect of bacteria on
the properties of plastics in the form of molded and fabricated articles, tubes,
rods, sheets, and film materials. Procedure B provides a more extensive contact
between the test bacteria and the specimens than does procedure A.

According to ASTM, this procedure was withdrawn in 2002 as it was outdated,

and technically inaccurate. The ASTM suggested test replacement is JIS Z
2801 Test for Antimicrobial Activity of Plastics “Test
Test for Antimicrobial Activity
and Efficacy“ which is applicable to solid plastic surfaces.

According to ASTM, the scope of the G-22 test only covered molded and
fabricated plastic articles. As such, this test is not accurate, nor relevant, for
liquids such as mineral oils.
 Annex C: Modified ASTM G-22 Method Used by the
NSF to Qualify Products to the NSF 60 Standard

Background: Modification of ASTM G-22”Standard Practice for Determining

Resistance of Plastics to Bacteria (Withdrawn 2002)”

Products Covered (Scope): Applicable to all products used in well applications

such as well-drilling aids, muds, and grouts. Products shall be prepared
according to manufacturers instructions.

Evaluation: Samples determined to support microbial growth shall undergo the

Confirmatory testing protocol in C.6
Note: The current method in Annex C may give false positive results due to
interactions or interferences between certain product constituents and the test
medium, which may result in changes to the agar that can be interpreted to
represent microbial growth.Therefore, the test method in C.6 is required for
validating positive results.
 Here are our questions:

Why was the NSF modified G-22 test method scope

enlarged to include all well products as these were
not covered under the scope of ASTM G-22 G 22 ?

Why is confirmatory testing required ?

Why was this test method not discontinued when the

ASTM G-22 test method was discontinued in 2002 ?

Why is this test still being used on USP

grade mineral oils ?

What other tests have been evaluated or considered

for mineral oils ?
Calumet requests consideration of a more applicable test method.

Pharmaceutical Industry standard procedure for mineral oils is to use

the USP Method 61” Microbiological Examination of Nonsterile
products: Microbial Enumeration Tests”
Tests .