Suez Total Organic Carbon - March 2020 - 17

Pre-Acidified
TOC vial

Recovery of a customer mAb in various vial types
Certified
TOC vial

Pre-Acidified
TOC vial

DUCT
vial

mAb

100 ppb

74%

119%

59%

DNA

500 ppb

63%

95%

54%

Insulin

1000 ppb

68%

93%

65%

Terrific Broth

1500 ppb

78%

97%

79%

Urease

3000 ppb

85%

93%

85%

Hemoglobin

5000 ppb

90%

95%

91%

Figure 1. Vial selection results for a global
biopharmaceutical company
applications laboratory for testing and comparison in Sievers
Certified TOC vials (<10 ppb), Pre-Acidified TOC vials (<35 ppb), and
DUCT vials (<10 ppb and no ionic leaching). The results, as shown in
Figure 1, demonstrate that the Sievers Pre-Acidified vials were best
suited for this customer application.

vial suitability with common cleaning
validation compounds
The SUEZ applications services laboratory tested many common
compounds used in pharmaceutical and biopharmaceutical cleaning
validation applications to compare recoveries in different vial types.
The results from this testing are shown in Figure 2. Note that
the suitability of the DUCT and Pre-Acidified vials varied across
compounds. In some cases, the recoveries were equivalent and with
other compounds the recovery was better in one vial type.
In response to these results, SUEZ developed the Vial Selection
Guide1 to help customers set up similar studies to determine the
best vial for their applications.
The SUEZ applications services laboratory is also available as a
resource for customers with vial selection needs. The applications
laboratory can compare Sievers Pre-Acidified TOC vials, DUCT
vials, and conventional Certified TOC vials using customers'
specific compounds.

DUCT vial











Figure 2. Suitability of Sievers specialty TOC vials for
recovery of common cleaning validation compounds.

summary
Sievers Certified TOC, Pre-Acidified, and DUCT vials are:
*

Cleaned using validated and automated equipment in an ISO
7 Cleanroom environment; vials are scrupulously cleaned of
organic residues using low TOC reagent water

*

Tested for minimal TOC background, and certified to <10 ppb
(<35 ppb for Pre-Acidified vials) for use in critical applications
including USP, EP water testing, and cleaning validation

*

Available in the Sievers Certified Blue option, which
eliminates paper and cardboard products as potential
sources of microbial contamination in manufacturing and
lab spaces

SUEZ provides complete solutions for TOC analysis, including both
Pre-Acidified vials and DUCT vials in addition to traditional low TOC
vials. Whether you're testing for compliance, cleaning validation,
or difficult-to recover compounds, Sievers TOC vials ensure top
performance and minimize risks.

References
1.

Vial Selection Guide. SUEZ Water Technologies &
Solutions, 2018, https://my.suezwatertechnologies.
com/WTSCustomerPortal/s/contentdownload?DN=TBai_300_00332_EN.pdf

17
https://my.suezwatertechnologies.com/WTSCustomerPortal/s/content-download?DN=TBai_300_00332_EN.pdf
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