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.
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.
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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
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. However, it is satisfactory to have the
developments in ATP bioluminescence offering with increased
sensitivity under adenylate kinase amplification potential
specificity, phage lysis and internal calibration against the effects
of excipients, laser scanning cytometry can be benefited through more
specificity in proposed development using fluorescently labeled
antibodies.
Major players in the sterility testing market are
engaged in research and development process. For instance, bioMérieux
SA – a biopharmaceutical company engaged in world class products
for in-vitro testing – launched The BacT/ALERT 3D Dual-T apparatus
for rapid and easy product control with non-destructive,
dual-temperature microbial detection system.
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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, and
Charles River Laboratories International, Inc.
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