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| Sterility Testing Market |
Sterility
testing in pharmaceutical manufacturing is a vital
process during the sterilization and validation process along with
release testing. It is an essential part of every sterilization
validation process in several industries that makes it a vital
procedure in manufacturing industry. It is an extremely difficult
process that should be planned and executed with precision, which can
be helpful in eliminating false positive results. Laboratory
contamination or technician errors are the main causes of false
positive results. Planned testing should be carried out in a clean
room, where there is no or minimum chances of error are seen. This
would also ensure compliance with U.S. Pharmacopeia (USP)
requirements in terms of viable microbial air and surface counts. The
unique requirements to employ sterility testing procedures as an
official test and to determine the suitability are regulated under
the good manufacturing practices guidelines.
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An
understanding of sterility testing benefits in validation process,
designing is an important quality assurance issue is the need of
providing an appropriate and authentic sterility test data.
Furthermore, sterility testing is a tedious and artful process, which
requires to be carried out by trained professionals. Also,
investigation during the failure of sterility test, is a process that
needs close look in environmental data along with other factors such
as sample collection and sample procurement procedures. The rise in
demand for sterilized products and their exclusivity in various
industries is expected to fuel growth of the sterility testing market
in the near future. The growth media utilized during the sterility
testing must be properly prepared and tested to make the microbial
growth adequately efficient. Increasing advancements in terms of
sterility testing technologies is expected to support the sterility
testing market growth over the forecast period (2016-2024). Various
organizations are laying efforts in making the testing process more
time efficient. For instance, Milliflex Rapid System, launched in
2010, for making the sterility testing procedure more time efficient
without hindering the test result quality. The following decade is
expected to provide major growth traction to players involved in the
sterility testing market.
Novel
Technology in the pharmaceutical testing market is expected to favor
the growth in sterility testing market:
Conventionally
used microbiological testing methods for detection, enumeration,
sterilization and identification tend to use culture methods majorly
and were so often time consuming and labor-intensive. The drawback of
such procedures in practical considerations often limits the extent
to which microbiological tests applied regularly in both formulation
development stage and for microbiological quality assurance.
Furthermore, there are various well latest and upcoming methods such
as MF sterility test apparatus from Merk Millipore, which is
aseptically filter liquid samples for sterility testing apparatus
used in sterility testing and may find wide application in the
pharmaceutical sector. This is expected to be one of the important
factors supporting growth of the sterility testing market. Rapid
testing methods such as ATP bioluminescence, fluorescent labeling,
nucleic acid probes and electrical resistance are commonly used in
pharmaceutical testing. Obtaining perfect results by incorporating
single method for all requirements is challenging, as products vary
in their specifications, which is need to be adapted by the specific
demands of the pharmaceutical and medical device situation.
Presence
of major players in parenteral product manufacturing is projected to
favor growth of the sterility testing market
The
global sterility testing market is highly competitive and fragmented.
Major players in the market are developing novel products through
major spending on research and development to get a competitive edge
over their counterparts. For instance, due to the strong product
pipeline under market segment, Merck Millipore and bioMérieux are
considered to be the toughest competitor in the market. Key players
operating in the sterility testing market include
•
Merck Millipore
•
Thermo Fisher Scientific, Inc.
•
bioMérieux SA
•
SGS S.A.
•
Sartorius AG
•
WuXi AppTec
•
Charles River Laboratories International, Inc.
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Sterility
Testing Market Taxonomy:
By
Product Type:
•
Kits and Reagents
•
Instruments
•
Service
By
Test Type:
•
Membrane Filtration
•
Direct Inoculation
•
Container closure integrity testing
•
Antimicrobial effectiveness testing
•
Rapid micro test
-
ATP bioluminescence
-
Fluorescent labeling
-
Electrical resistance
By
Application:
•
Pharmaceutical and Biological Manufacturing
•
Medical Devices Manufacturing
•
Bioburden Test
•
Others Applications
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