• Vials used to collect the CV samples;
• Standards bracketing the TOC samples
against any other reports covering the same
lot (providing full visibility into the quality
checks associated with empty vials);
• Reference materials; and
• TOC instrument health.
If these elements are validated through a FAR, then
the company can be confident that the measurement
does accurately reflect an increase in TOC, which can
help resolve the OOS investigation efficiently.
Why do accreditations matter?
ISO Guide 34 and ISO/IEC 17025 accreditations
ensure that manufactured reference materials used
for equipment calibrations are consistently produced, controlled, and audited to robust quality
standards. ISO Guide 34 provides the highest level
of quality assurance and certifies that a manufacturer’s processes comply with strict guidelines and
include all contributing factors to uncertainty. ISO/
IEC 17025 certifies the reliability of the testing
performed in conjunction with reference material
production and confirms the manufacturer’s ability
to produce precise, accurate test and
calibration data with the instruments
used to qualify each production lot.
Without these accreditations
(whether purchased from a supplier or
made in-house), pharmaceutical manufacturers cannot be confident in the
consistency and, thus, the traceability
Analytical Instruments: Full in-house
Pharmaceutical companies face mounting pressures for increased traceability
within their supply chains. This includes
the need to close out non-conformances
and OSSs quickly. Because of this, traceability of every material and instrument
used in processes becomes important.
Analytical Instruments addresses these
concerns by offering:
• The highest combined accredi-
tation standard in the industry
(ISO Guide 34 and ISO/IEC
17025 accredited for the produc-
tion and testing of TOC and con-
• Full traceability of both standards
and vials (due to cleaning its own
vials used in standards production).
• Full visibility and traceability of standards
and reference materials, and vials and instrument health, including the availability of
Failure Analysis Reports.
Complete traceability of reference materials, vials, and instruments helps pharmaceutical
companies efficiently “close the loop” on TOC
out-of-specifications … reducing risks, increasing
data quality, and ensuring a reliable and accurate
total TOC measurement solution.
Erin England is Consumables Product Manager with
GE Water & Process Technologies in Boulder, Colo. erin.
Cleaned vials in GE’s
Boulder, Colo., facility.
Image: GE Water &
Keep your cleanroom
more secure and clean
1668 Sag Harbor Tpke., Sag Harbor, N Y 11963 (800) 906-0137 (631) 725-8148 Fax www.dortronics.com
Maintain sterile operating conditions in pharmaceutical
laboratories or sensitive manufacturing cleanrooms with
customized 4000 series interlock solutions from Dortronics.
They help ensure that only authorized personnel who are
well versed in your cleanroom procedures are allowed access by
precisely controlling when and how the interlocked doors leading
to your cleanroom operate.
locks, washdown switches
and LED indicators keep
your cleanroom more
secure and clean!