Bioburden is defined
as the number in terms of percentage, colony or cell count of
bacteria that thrive on a given unsterilized surface. Bioburden
testing, also known as microbial limit testing provides
quantification of the bacterial cell cultures on a given unsterilized
surface. The major application of bioburden testing lies in implant
fixation procedures that require testing ofcertain tolerable
bioburden limit before implantation in the human body. The standard
for bioburden testing in the US is regulated by the US FDA, whereas
global standards are maintained by the ISO (International
Organization for Standardization). The quantification for the
standardization process is done in terms of colony forming unit
(CFU). Bioburden testing is essential in limiting the presence of
infection causing bacteria in an object that is to be integrated into
a human body as an implant. The testing is important to eliminate the
presence of bacterial residue and growth in any object present in
natural state. In addition it is almost impossible to remove
bacterial residue permanently in an object that is liable to be
exposed to open air. Hence sterilization process is performed on an
implant object or a device post understanding the bioburden limit.
This helps to select the appropriate sterilization technique in order
to remove the bacterial burden just prior to the medical (Or other
related) procedure. Bioburden testing has therefore saved numerous
lives.
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Based on technology,
bioburden testing is segmented into microbial filter method, advanced
colorimetric method, and plate count method. Among these, microbial
filter method is the most commonly used method for bioburden testing
procedures. The plate count method is among the oldest methods for
bioburden testing, however is not used regularly on a large scale
commercial basis due to its time consuming procedure. Advanced
colorimetric method is presently the most promising and widely used
bioburden testing technology. The congregation of colometer and
computational capabilities has enabled advanced colometric methods to
deliver quick results of quantifying bioburden.
Based on equipment,
bioburden testing market can be segmented into PCR (polymerase chain
reaction) instruments, cell counters, and automated microbial
identification systems that are software integrated. Application
segment for bioburden testing includes healthcare, aerospace
(satellite production & development), supercomputer (super-
microprocessor manufacturing) designing, and others (raw material,
equipment cleaning, food & beverage). The healthcare industry is
the largest application area of bioburden testing.
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Geographically, the
bioburden testing market is primarily concentrated in the North
America and Asia Pacific region. The demand for bioburden testing in
the Asia Pacific region is expected to grow, and very likely to
replace the North America market soon. Australia, Japan, and China
form the largest markets in the Asia Pacific region. South Asia and
South East Asia on the other hand show great potential in terms of
life sciences and raw material applications; although at present a
majority of the growing bioburden testing market consists of life
science applications. Besides this, a large number of contract
manufacturers reside in the Asia Pacific region. On the other hand,
European industries continue to remain a strong point in the global
bioburden testing market mainly due to the high quality of products
services offered, presence of numerous quality manufacturers and
their increased reliability. However certain significant restrictions
for bioburden testing remains valid in the European and North
American region, such as dearth of trained technicians, overwhelming
volume of service demand, and high cost of services, to name a few.
The bio-burden testing market in the Rest of the World (ROW) region
is expected to grow at a steady rate, albeit slower than the major
economies of the world.
Some of the well
known manufacturers/service providers of bioburden testing
equipment/service include: Charles River Laboratories International,
Inc., Sigma-Aldrich Corporation, SGS S.A., WuXi PharmaTech (Cayman),
and Inc., Merck & Co., Inc., Becton, Dickinson and Company, North
American Science Associates, Inc., Nelson Laboratories, Pacific
Biolabs, and ATS Labs, Inc.
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