Suez Total Organic Carbon - March 2020 - 16

application note

selecting the best TOC sample vial for
your application
Through its Sievers product line, SUEZ provides complete solutions
for TOC analysis, including low-level TOC standards and a range
of sample vials suitable for various applications. All scrupulously
cleaned for low-level, the vials range from regular TOC certified vials
to specialty coated or pre-acidified vials that can give superior TOC
recovery on challenging protein applications.

TOC vial applications
USP, EP, JP, KP, and IP Purified Water and Water for Injection Testing
Cleaning validation, including swab recoveries
Method validation and development

Sievers Pre-Acidified vials
*

Case of 72 vials

*

Automated, calibrated process for dispensing 20 ┬ÁL of
reagent grade phosphoric acid in each vial

*

Acidifies sample to approximately pH 2.5, which impedes
sample sticking to vial

*

Each lot certified to <35 ppb TOC; 6-month shelf life

*

Each 40 mL vial includes cap/septum with dust cap

*

No Hazmat shipment; available in cardboard packaging or
Certified Blue (cardboard free packaging)

Calibration and verification standards
Basic storage

Sievers DUCT vials

Other vial companies offer only basic low TOC vials for TOC sampling

*

Case of 30 vials

use. SUEZ understands the importance of traceable, certified low

*

Specialty coated glass vials developed for sensitive
pharmaceutical formulations

*

Specifically developed to avoid leaching and protein
adsorption from samples

*

Each lot certified to <10 ppb TOC and no ionic leaching

*

Each 30 mL vial includes a specialty cap/septum with
dust cap

*

Available in cardboard packaging or Certified Blue (cardboard
free packaging)

TOC vials, but also realizes that these vials may not be best for all
your specific application needs. For example, proteins and peptides
are known to adhere to many glass and plastic surfaces, including
typical borosilicate TOC sample vial containers that SUEZ and other
companies provide as standard low TOC vials. This adherence can
cause initial sample concentrations to be slightly lower and impact
the accuracy and relative standard deviation of TOC measurements.

Sievers specialty TOC vials
Sievers developed two specialty vial types that fit the application
needs of many customers: Pre-Acidified TOC vials and DUCT (Dual
Use Conductivity & TOC) vials. Both vial types are certified and lot
traceable, just like Sievers' heritage Certified TOC vials, but have been
found to perform better on specific product families.

16

TOC vial comparison for mAb applications
A global biopharmaceutical company producing a specific
monoclonal antibody (mAb) reached out to the SUEZ applications
services laboratory to evaluate the most compatible vial for its
cleaning validation studies. Samples of the mAb were sent to the



Suez Total Organic Carbon - March 2020

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