APR January/February 2022 - 79

VENDOR VIEWPOINT
triplicate and removes the variability of analysts having to generate a
curve. PPCs are also embedded in duplicate, so analysts do not have
to spike each product individually. The Eclipse is fully compliant with
USP <85>, EP 2.6.14 and JP 4.01, while simultaneously checking each
box for 21 CFR Part 11 compliance. Compared to traditional plate
assays for 21 samples, the pipetting steps are reduced from 242 to less
than 30. This reduces the risk for human error in pipetting mistakes,
reduces the risk for repetitive injury, and decreases the time spent
executing the test.
By removing so many aspects of human intervention, QC technologies
can drastically improve data integrity. Software is also a major factor.
The Eclipse software for endotoxin analysis offers a full 21 CFR Part
11 data integrity compliant package that includes ALCOA+ principles
to help adhere to those guidelines. When an assay is running, it
transmits data to the software every five seconds, so an analyst can
check assay progress frequently throughout the test to analyze data
in real time. The software also has a routine database backup and
restore function, ensuring data will not be lost. If a disaster occurred
or the system unexpectedly lost power, all data would be maintained
in the secured database.
All aspects of data integrity in quality control testing - including
bioburden, conductivity, TOC, and endotoxin - must be thoroughly
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American Pharmaceutical Review | January/February 2022
thought through with patient safety at the forefront. If testing
is compromised due to violations of data integrity, this puts the
patient at risk. Pharma 4.0 is a great example of how integrating
lab instrumentation with system software and connecting different
testing platforms improves the effectiveness of lab analysts and
makes their day-to-day lives easier. The concept of Pharma 4.0 ties
in directly with data integrity by monitoring QC testing in real time
and alerting the lab of errors or out-of-specification results. Obtaining
results in real time and being notified of failing tests allows the lab to
act more promptly to address the error or failure and get to the root
cause (taking the 'right the first time' approach) prior to completion
of testing. Overall, this will reduce lead times and allow labs to
get results faster and release product to market more efficiently.
Platforms that offer integrated instrumentation and software, such
as Sievers Instruments in the QC lab, provide an excellent starting
point for achieving a Pharma 4.0 environment by incorporating more
efficient and compliant testing solutions. These advancements in
instrumentation for endotoxin, bioburden, TOC, and conductivity
not only improve the quality of products and daily work lives of lab
analysts, but ultimately the patient.

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

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