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VENDOR VIEWPOINT
in the Sievers rapid bioburden analyzer, these raw materials can be
analyzed in less than 45 minutes without extensive incubation to
determine contamination levels. Instead of transporting samples to
the lab to complete microbial limit testing - which requires waiting
days for results - simple to complex, filterable raw materials can be
analyzed immediately after receiving. Rapid screening of incoming
materials decreases the time needed before releasing raw materials
into production with assurance of their microbial levels.
At-line Monitoring
Implementation of the Sievers rapid bioburden system in close
proximity to a sampling site provides at-line monitoring for faster
information related to contamination events, sanitization of
assets, etc. Some applications that would benefit from at-line rapid
monitoring include CCPs, or Critical Control Points, on water loops.
CCPs are often found on the return leg of a water loop and indicate
the quality of the water found within the interior of the water loop.
Monitoring CCPs provides an early warning of a contamination event
inside the water loop.
Another critical application is at-line monitoring of buffers or effluent
from purification columns. Over sanitizing purification columns
reduces their effective lifespan, causing underutilization of a high
value asset. Without rapid microbial detection, columns are assumed
to be contaminated and sanitized at the harshest level. Instead,
accurate and fast detection using RMMs enables proper sanitization
protocols suitable for contamination levels inside the column. This
can significantly increase the lifespan of the asset.
63
American Pharmaceutical Review | July/August 2023
Inside the QC Lab
The Sievers rapid bioburden analyzer is considered to be an alternative
method to the compendial plate count. Like any alternative method,
a validation will initially be required to prove suitability for purpose in
release testing. For quicker adoption, users can opt to explore a range
of applications such as kill-rate studies, preservative efficacy testing,
quantitative testing of reference microorganisms,and culture media
qualification in parallel to existing QC methods. Doing so will allow
the new instrument to evolve into a validated alternative method
based on the user's application priority.
Conclusion: Improving Speed and Decision
Making with RMMs
The Sievers rapid bioburden analyzer can be used for many
applications, in addition to water testing. Implementing rapid
bioburden testing in various locations inside a manufacturing site can
play a key role in decision making and manufacturing agility, resulting
in better contamination control strategies, cost savings, and speed.
Whether for faster release of raw materials, optimization of protocols
to prolong the lifespan of expensive assets, or near real-time
monitoring of products in the QC lab, rapid microbiological methods
can quickly provide critical information to maintain control of
production. Faster determination of whether a contamination event
has occurred allows for immediate action to preserve and protect
products, giving manufacturers confidence that their products meet
the highest quality standards for customers.
APR July/August 2023
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