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.
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.
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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.
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.